A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements

Study Purpose

Phase 1 dose escalation will determine the first cycle dose-limiting toxicities (DLTs), the maximum tolerated dose (MTD), the biologically effective dose and recommended Phase 2 dose (RP2D) of repotrectinib given to adult subjects with advanced solid malignancies harboring an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. Midazolam DDI substudy will examine effect of of repotrectinib on CYP3A induction. Phase 2 will determine the confirmed Overall Response Rate (ORR) as assessed by Blinded Independent Central Review (BICR) of repotrectinib in each subject population expansion cohort of advanced solid tumors that harbor a ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. The secondary objective will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS) and clinical benefit rate (CBR) of repotrectinib in each expansion cohort of advanced solid tumors that harbor a ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 12 Years and Over
Gender All
More Inclusion & Exclusion Criteria

PHASE 1.Key

Inclusion Criteria:

1. Histologically or cytologically confirmed diagnosis of locally advanced, or metastatic solid tumor (including primary CNS tumors) (Stage IV, American Joint Committee on Cancer v.7) that harbors an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement by protocol specified tests. 2. ECOG PS 0-1. 3. Age ≥18 (or age ≥ 20 of age as required by local regulation). 4. Capability to swallow capsules intact (without chewing, crushing, or opening). 5. At least 1 measurable target lesion according to RECIST version 1.1. CNS-only measurable disease as defined by RECIST version 1.1 is allowed. 6. Prior cytotoxic chemotherapy is allowed. 7. Prior immunotherapy is allowed. 8. Resolution of all acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Grade less than or equal to 1. 9. Patients with asymptomatic CNS metastases (treated or untreated) and/or asymptomatic leptomeningeal carcinomatosis are eligible to enroll if they satisfy the protocol specified criteria. 10. Baseline laboratory values fulfilling the following requirements:Absolute neutrophils count (ANC) ≥1500/mm3 (1.5 × 109/L); Platelets (PLTs) ≥100,000/mm3 (100 × 109/L); Hemoglobin ≥ 9.0 g/dL transfusions are allowed; Serum creatinine or creatinine clearance Within normal limits or > 40 mL/min; Total serum bilirubin < 1.5 × ULN; Liver transaminases (ASTs/ALTs) < 2.5 × ULN; < 5 × ULN if liver metastases are present Alkaline phosphatase (ALP); < 2.5 × ULN; < 5 × ULN if liver and/or bone metastasis are present; Serum calcium, magnesium, and potassium Normal or CTCAE grade ≤ 1 with or without supplementation. 11. Life expectancy ≥ 3 months. PHASE 2 Key Inclusion Criteria. 1. Histologically or cytologically confirmed diagnosis of locally advanced, or metastatic solid tumor (including primary CNS tumors) that harbors a ROS1, or NTRK1-3 gene fusion. 2. Subject must have a documented ROS1 or NTRK1-3 gene fusion determined by tissue-based local testing using either: 1. a next-generation sequencing (NGS) or quantitative polymerase chain reaction (qPCR) test will be accepted to determine molecular eligibility. • Adequate tumor tissue needs to be sent to the Sponsor designated central diagnostic laboratory for retrospective confirmation by a central diagnostic laboratory test selected by the Sponsor. OR. 2. a fluorescence in situ hybridization (FISH) test AND prospective confirmation of fusion status by a central diagnostic laboratory test selected by the Sponsor PRIOR to enrollment will be accepted to determine molecular eligibility.
  • - Adequate tumor tissue must be sent to the Sponsor designated central diagnostic laboratory for prospective confirmation by a central diagnostic laboratory test selected by the Sponsor PRIOR to enrollment.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1. 4. Age ≥12 (or age ≥ 20 as required by local regulation). 5. Willing and able to provide written institutional review board (IRB)/institutional ethics committee-approved Informed Consent or an Assent signed by a parent or legal guardian for subjects age 12 to 17. 6. At least 1 measurable target lesion according to RECIST (v1.1) prospectively confirmed by Blinded Independent Central Radiology Review (BICR), selected by Sponsor, PRIOR to enrollment. Subjects with CNS-only measurable disease ≥10 mm as defined by RECIST (v1.1) are eligible. 7. Subjects with advanced solid tumors harboring ROS1, NTRK1, NTRK2, or NTRK3 rearrangement will be assigned into 6 distinct expansion (EXP) cohorts provided all inclusion and exclusion criteria are met. i. EXP-1: ROS1 TKI-naïve ROS1+ NSCLC ii. EXP-2: 1 Prior ROS1 TKI and 1 Platinum based chemo ROS1+ NSCLC iii. EXP-3: 2 Prior ROS1 TKIs ROS1+ NSCLC (No Chemo or IO) iv. EXP-4: 1 Prior ROS1 TKI ROS1+ NSCLC (No Chemo or IO) v. EXP-5: TRK TKI-naïve NTRK+ solid tumors vi. EXP-6: TRK TKI-pretreated NTRK+ solid tumors. 8. Subjects with asymptomatic CNS metastases (treated or untreated) and/or asymptomatic leptomeningeal carcinomatosis are eligible to enroll if they satisfy the protocol specified criteria. 9. Baseline laboratory values fulfilling the following requirements:Absolute neutrophils count (ANC) ≥1500/mm3 (1.5 × 109/L); Platelets (PLTs) ≥100,000/mm3 (100 × 109/L); Hemoglobin ≥ 9.0 g/dL transfusions are allowed; Serum creatinine or creatinine clearance > 40 mL/min; Total serum bilirubin < 1.5 × ULN; Liver transaminases (ASTs/ALTs) < 2.5 × ULN; < 5 × ULN if liver metastases are present Alkaline phosphatase (ALP); < 2.5 × ULN; < 5 × ULN if liver and/or bone metastasis are present; Serum calcium, magnesium, and potassium Normal or CTCAE grade ≤ 1 with or without supplementation. 10. Life expectancy ≥ 3 months. Key Exclusion Criteria PHASE 1 and PHASE 2. 1. Concurrent participation in another therapeutic clinical trial. 2. Symptomatic brain metastases or leptomeningeal involvement. 3. History of previous cancer, except for squamous cell or basal-cell carcinoma of the skin, or any in situ carcinoma that has been completely resected, requiring therapy within the previous 2 years. 4. Major surgery within 4 weeks of start of repotrectinib treatment. Radiation therapy (except palliative to relieve bone pain) within 2 weeks of study entry. Palliative radiation (≤10 fractions) must have been completed at least 48 hours prior to study entry. 5. Clinically significant cardiovascular disease (either active or within 6 months prior to enrollment): myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (New York Heart Association Classification Class ≥ II), cerebrovascular accident or transient ischemic attack, symptomatic bradycardia, requirement for anti-arrhythmic medication. Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥2. 6. Any of the following cardiac criteria: Mean resting corrected QT interval (ECG interval measured from the onset of the QRS complex to the end of the T wave) for heart rate (QTcF) > 470 msec obtained from 3 ECGs, using the screening clinic ECG machine-derived QTc value Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block, PR interval > 250 msec) Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or any concomitant medication known to prolong the QT interval. 7. Known active infections (bacterial, fungal, viral including HIV positivity). 8. Gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would impact drug absorption. 9. Peripheral neuropathy of CTCAE ≥grade 2. 10. History of extensive, disseminated, bilateral, or presence of CTCAE grade 3 or 4 interstitial fibrosis or interstitial lung disease including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis, and pulmonary fibrosis. Subjects with history of prior radiation pneumonitis are not excluded.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03093116
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Turning Point Therapeutics, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Bristol-Myers Squibb
Principal Investigator Affiliation Bristol-Myers Squibb
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia, Belgium, Canada, China, Denmark, France, Germany, Hong Kong, Hungary, Italy, Japan, Netherlands, Poland, Singapore, South Korea, Spain, Taiwan, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Locally Advanced Solid Tumors, Metastatic Solid Tumors
Study Website: View Trial Website
Additional Details

In Phase 2, study subjects will be enrolled into 6 distinct expansion (EXP) cohorts:

  • - EXP-1: ROS1 TKI-naïve ROS1+ NSCLC.
Up to one prior line of chemotherapy OR immunotherapy is allowed.
  • - EXP-2: 1 Prior ROS1 TKI AND 1 Platinum-based Chemotherapy ROS1+ NSCLC.
Disease progression, or intolerant to one prior line of a ROS1 TKI. Must have received one prior line of platinum based chemotherapy OR one prior line of platinum based chemotherapy in combination with immunotherapy before or after a ROS1 TKI.
  • - EXP-3: 2 Prior ROS1 TKIs AND NO Chemotherapy ROS1+ NSCLC.
Disease progression, or intolerant to 2 prior lines of a ROS1 TKI treatment. No prior lines of chemotherapy or immunotherapy are allowed.
  • - EXP-4: 1 Prior ROS1 TKI and NO Chemotherapy or Immunotherapy.
Disease progression or intolerant to one prior line of a ROS1 TKI. No prior lines of chemotherapy or immunotherapy are allowed.
  • - EXP-5: TRK TKI-naïve NTRK+ solid tumors.
Any number of prior lines of chemo or immunotherapy is allowed.
  • - EXP-6: TRK TKI-pretreated NTRK+ solid tumors.
Disease progression, or intolerant to 1 or 2 prior TRK TKIs. Any number of prior lines of chemo- or immunotherapy are allowed.

Arms & Interventions

Arms

Experimental: Repotrectinib (TPX-0005)

Phase 1 Oral repotrectinib (TPX-0005): Phase 1a dose escalation, Phase 1b food-effect sub-study, and Phase 1c dose escalation with food, and Midazolam drug-drug interaction sub-study. Phase 2 Oral repotrectinib (TPX-0005): 6 distinct expansion cohorts - EXP-1: ROS1 TKI-naïve ROS1+ NSCLC - EXP-2: 1 Prior ROS1 TKI and 1 Platinum based chemo ROS1+ NSCLC - EXP-3: 2 Prior ROS1 TKIs ROS1+ NSCLC (No Chemo or IO) - EXP-4: 1 Prior ROS1 TKI ROS1+ NSCLC (No Chemo or IO) - EXP-5: TRK TKI-naïve NTRK+ solid tumors - EXP-6: TRK TKI-pretreated NTRK+ solid tumors

Interventions

Drug: - Oral repotrectinib (TPX-0005)

Oral repotrectinib (TPX-0005) capsules.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Local Institution - 2129, Duarte 5344147, California 5332921

Status

Completed

Address

Local Institution - 2129

Duarte 5344147, California 5332921, 91010

Local Institution - 2120, Glendale 5352423, California 5332921

Status

Completed

Address

Local Institution - 2120

Glendale 5352423, California 5332921, 91206

Local Institution - 2136, La Jolla 5363943, California 5332921

Status

Withdrawn

Address

Local Institution - 2136

La Jolla 5363943, California 5332921, 92037

Local Institution - 2114, La Jolla 5363943, California 5332921

Status

Completed

Address

Local Institution - 2114

La Jolla 5363943, California 5332921, 92093

Local Institution - 2121, Long Beach 5367929, California 5332921

Status

Completed

Address

Local Institution - 2121

Long Beach 5367929, California 5332921, 90813

Local Institution - 2101, Orange 5379513, California 5332921

Status

Completed

Address

Local Institution - 2101

Orange 5379513, California 5332921, 92868

Orange 5379513, California 5332921

Status

Recruiting

Address

University of California Irvine Medical Center

Orange 5379513, California 5332921, 92868

Site Contact

Misako Nagasaka, Site 1001

[email protected]

714-456-5153

Local Institution - 2126, Santa Rosa 5393287, California 5332921

Status

Completed

Address

Local Institution - 2126

Santa Rosa 5393287, California 5332921, 95403

Local Institution - 1003, Aurora 5412347, Colorado 5417618

Status

Not yet recruiting

Address

Local Institution - 1003

Aurora 5412347, Colorado 5417618, 80045

Site Contact

Site 1003

[email protected]

855-907-3286

Local Institution - 2103, Aurora 5412347, Colorado 5417618

Status

Completed

Address

Local Institution - 2103

Aurora 5412347, Colorado 5417618, 80045

Local Institution - 2106, Washington D.C. 4140963, District of Columbia 4138106

Status

Completed

Address

Local Institution - 2106

Washington D.C. 4140963, District of Columbia 4138106, 20007

Local Institution - 2110, Washington D.C. 4140963, District of Columbia 4138106

Status

Completed

Address

Local Institution - 2110

Washington D.C. 4140963, District of Columbia 4138106, 20016

Local Institution - 2128, Hollywood 4158928, Florida 4155751

Status

Completed

Address

Local Institution - 2128

Hollywood 4158928, Florida 4155751, 33021

Local Institution - 2113, Tampa 4174757, Florida 4155751

Status

Completed

Address

Local Institution - 2113

Tampa 4174757, Florida 4155751, 33612

Local Institution - 2139, Athens 4180386, Georgia 4197000

Status

Completed

Address

Local Institution - 2139

Athens 4180386, Georgia 4197000, 30607

Local Institution - 2134, Columbus 4188985, Georgia 4197000

Status

Completed

Address

Local Institution - 2134

Columbus 4188985, Georgia 4197000, 31904

Local Institution - 2125, Chicago 4887398, Illinois 4896861

Status

Completed

Address

Local Institution - 2125

Chicago 4887398, Illinois 4896861, 60637

Local Institution - 2142, Peoria 4905687, Illinois 4896861

Status

Completed

Address

Local Institution - 2142

Peoria 4905687, Illinois 4896861, 61615

Local Institution - 2116, New Orleans 4335045, Louisiana 4331987

Status

Not yet recruiting

Address

Local Institution - 2116

New Orleans 4335045, Louisiana 4331987, 70121

Site Contact

Site 2116

[email protected]

855-907-3286

Local Institution - 2133, Baltimore 4347778, Maryland 4361885

Status

Completed

Address

Local Institution - 2133

Baltimore 4347778, Maryland 4361885, 21210

Local Institution - 2104, Boston 4930956, Massachusetts 6254926

Status

Completed

Address

Local Institution - 2104

Boston 4930956, Massachusetts 6254926, 02114

Local Institution - 1004, Boston 4930956, Massachusetts 6254926

Status

Not yet recruiting

Address

Local Institution - 1004

Boston 4930956, Massachusetts 6254926, 02214

Site Contact

Site 1004

[email protected]

855-907-3286

Local Institution - 2131, Boston 4930956, Massachusetts 6254926

Status

Completed

Address

Local Institution - 2131

Boston 4930956, Massachusetts 6254926, 02215

Local Institution - 2105, Ann Arbor 4984247, Michigan 5001836

Status

Completed

Address

Local Institution - 2105

Ann Arbor 4984247, Michigan 5001836, 48109

Local Institution - 2111, Detroit 4990729, Michigan 5001836

Status

Completed

Address

Local Institution - 2111

Detroit 4990729, Michigan 5001836, 48201

Local Institution - 2140, Detroit 4990729, Michigan 5001836

Status

Completed

Address

Local Institution - 2140

Detroit 4990729, Michigan 5001836, 48202-2608

Local Institution - 2132, Saint Paul 5045360, Minnesota 5037779

Status

Completed

Address

Local Institution - 2132

Saint Paul 5045360, Minnesota 5037779, 55101

Local Institution - 2147, Bolivar 4377835, Missouri 4398678

Status

Completed

Address

Local Institution - 2147

Bolivar 4377835, Missouri 4398678, 65613

Local Institution - 2115, St Louis 4407066, Missouri 4398678

Status

Completed

Address

Local Institution - 2115

St Louis 4407066, Missouri 4398678, 63110

Local Institution - 2122, New Brunswick 5101717, New Jersey 5101760

Status

Completed

Address

Local Institution - 2122

New Brunswick 5101717, New Jersey 5101760, 08901

Local Institution - 2117, New York 5128581, New York 5128638

Status

Completed

Address

Local Institution - 2117

New York 5128581, New York 5128638, 10016

Local Institution - 2102, New York 5128581, New York 5128638

Status

Completed

Address

Local Institution - 2102

New York 5128581, New York 5128638, 10065

Memorial Sloan Kettering Cancer Center, New York 5128581, New York 5128638

Status

Recruiting

Address

Memorial Sloan Kettering Cancer Center

New York 5128581, New York 5128638, 10065

Site Contact

Alexander Drilon, Site 1002

[email protected]

646-888-4206

Local Institution - 2144, Goldsboro 4468261, North Carolina 4482348

Status

Completed

Address

Local Institution - 2144

Goldsboro 4468261, North Carolina 4482348, 27534

Local Institution - 2112, Canton 5149222, Ohio 5165418

Status

Completed

Address

Local Institution - 2112

Canton 5149222, Ohio 5165418, 44718

Local Institution - 2143, Cincinnati 4508722, Ohio 5165418

Status

Completed

Address

Local Institution - 2143

Cincinnati 4508722, Ohio 5165418, 45220

Local Institution - 2109, Cleveland 5150529, Ohio 5165418

Status

Completed

Address

Local Institution - 2109

Cleveland 5150529, Ohio 5165418, 44195

Local Institution - 2123, Columbus 4509177, Ohio 5165418

Status

Completed

Address

Local Institution - 2123

Columbus 4509177, Ohio 5165418, 43210

Local Institution - 2119, Toledo 5174035, Ohio 5165418

Status

Completed

Address

Local Institution - 2119

Toledo 5174035, Ohio 5165418, 43614

Local Institution - 2108, Philadelphia 4560349, Pennsylvania 6254927

Status

Completed

Address

Local Institution - 2108

Philadelphia 4560349, Pennsylvania 6254927, 19111-2497

Local Institution - 2148, Memphis 4641239, Tennessee 4662168

Status

Completed

Address

Local Institution - 2148

Memphis 4641239, Tennessee 4662168, 38120

Local Institution - 2130, Dallas 4684888, Texas 4736286

Status

Completed

Address

Local Institution - 2130

Dallas 4684888, Texas 4736286, 75390

Local Institution - 2127, Houston 4699066, Texas 4736286

Status

Completed

Address

Local Institution - 2127

Houston 4699066, Texas 4736286, 77030

Local Institution - 2138, Houston 4699066, Texas 4736286

Status

Completed

Address

Local Institution - 2138

Houston 4699066, Texas 4736286, 77030

Local Institution - 2146, Kingwood 7534469, Texas 4736286

Status

Completed

Address

Local Institution - 2146

Kingwood 7534469, Texas 4736286, 77339

Local Institution - 2137, Fairfax 4758023, Virginia 6254928

Status

Completed

Address

Local Institution - 2137

Fairfax 4758023, Virginia 6254928, 22031

Local Institution - 2107, Seattle 5809844, Washington 5815135

Status

Completed

Address

Local Institution - 2107

Seattle 5809844, Washington 5815135, 98109

Local Institution - 2141, Tacoma 5812944, Washington 5815135

Status

Withdrawn

Address

Local Institution - 2141

Tacoma 5812944, Washington 5815135, 98405

Local Institution - 2145, Appleton 5244080, Wisconsin 5279468

Status

Completed

Address

Local Institution - 2145

Appleton 5244080, Wisconsin 5279468, 54911

International Sites

Local Institution - 6102, Camperdown 2172563, New South Wales 2155400, Australia

Status

Completed

Address

Local Institution - 6102

Camperdown 2172563, New South Wales 2155400, 2050

Local Institution - 6103, Adelaide 2078025, South Australia 2061327, Australia

Status

Completed

Address

Local Institution - 6103

Adelaide 2078025, South Australia 2061327, 5042

Local Institution - 6101, Melbourne 2158177, Victoria 2145234, Australia

Status

Completed

Address

Local Institution - 6101

Melbourne 2158177, Victoria 2145234, 3000

Local Institution - 3301, East Melbourne 6952201, Australia

Status

Completed

Address

Local Institution - 3301

East Melbourne 6952201, , 3002

Local Institution - 4802, Antwerp 2803138, Belgium

Status

Completed

Address

Local Institution - 4802

Antwerp 2803138, , 2650

Local Institution - 4801, Leuven 2792482, Belgium

Status

Completed

Address

Local Institution - 4801

Leuven 2792482, , 3000

Local Institution - 2202, Edmonton 5946768, Alberta 5883102, Canada

Status

Completed

Address

Local Institution - 2202

Edmonton 5946768, Alberta 5883102, T6G 1Z2

Local Institution - 2205, Vancouver 6173331, British Columbia 5909050, Canada

Status

Withdrawn

Address

Local Institution - 2205

Vancouver 6173331, British Columbia 5909050, V5Z 4E7

Local Institution - 2201, Toronto 6167865, Ontario 6093943, Canada

Status

Completed

Address

Local Institution - 2201

Toronto 6167865, Ontario 6093943, M5G 2M9

Local Institution - 6503, Toronto 6167865, Ontario 6093943, Canada

Status

Active, not recruiting

Address

Local Institution - 6503

Toronto 6167865, Ontario 6093943, M5G 2M9

Local Institution - 2203, Ontario, Canada

Status

Completed

Address

Local Institution - 2203

Ontario, , L6R 37R

Local Institution - 2204, Ottawa 6094817, Canada

Status

Completed

Address

Local Institution - 2204

Ottawa 6094817, , K1H 8L6

Local Institution - 6702, Beijing 1816670, Beijing Municipality 2038349, China

Status

Completed

Address

Local Institution - 6702

Beijing 1816670, Beijing Municipality 2038349, 100021

Beijing Cancer hospital, Beijing 1816670, Beijing Municipality 2038349, China

Status

Recruiting

Address

Beijing Cancer hospital

Beijing 1816670, Beijing Municipality 2038349, 100142

Site Contact

Jian Fang, Site 6703

[email protected]

868613701224460

Daping 8397695, Chongqing Municipality 1814905, China

Status

Recruiting

Address

Daping Hospital, the Third Affiliated Hospital of Third Military Medical University /Cancer Center

Daping 8397695, Chongqing Municipality 1814905, 00000

Site Contact

Yong He, Site 6736

[email protected]

13908338998

Local Institution - 6719, Fuzhou 1810821, Fujian 1811017, China

Status

Completed

Address

Local Institution - 6719

Fuzhou 1810821, Fujian 1811017, 000000

Xiamen 1790645, Fujian 1811017, China

Status

Recruiting

Address

The First Affiliated hospital of Xiamen University-oncology

Xiamen 1790645, Fujian 1811017, 361003

Site Contact

Jingxun Wu, Site 6708

[email protected]

15160085395

Guangdong Provincial People'S Hospital, Guangzhou 1809858, Guangdong 1809935, China

Status

Recruiting

Address

Guangdong Provincial People'S Hospital

Guangzhou 1809858, Guangdong 1809935, 510120

Site Contact

Jinji Yang, Site 6747

[email protected]

855-907-3286

Local Institution - 6733, Guangzhou 1809858, Guangdong 1809935, China

Status

Completed

Address

Local Institution - 6733

Guangzhou 1809858, Guangdong 1809935, 510120

Local Institution - 6505, Shenzhen 1795565, Guangdong 1809935, China

Status

Active, not recruiting

Address

Local Institution - 6505

Shenzhen 1795565, Guangdong 1809935, 518053

Harbin 2037013, Heilongjiang 2036965, China

Status

Recruiting

Address

The Affiliated Tumor Hospital of Harbin Medical University

Harbin 2037013, Heilongjiang 2036965, 150081

Site Contact

Yan Yu, Site 6722

[email protected]

13904505825

Local Institution - 6504, Shatin 1818920, HONG KONG, China

Status

Active, not recruiting

Address

Local Institution - 6504

Shatin 1818920, HONG KONG, 999077

Wuhan 1791247, Hubei 1806949, China

Status

Recruiting

Address

Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology/Cancer Center Department

Wuhan 1791247, Hubei 1806949, 430022

Site Contact

Xiaorong Dong, Site 6710

[email protected]

13986252286

Local Institution - 6705, Changsha 1815577, Hunan 1806691, China

Status

Completed

Address

Local Institution - 6705

Changsha 1815577, Hunan 1806691, 410011

Changsha 1815577, Hunan 1806691, China

Status

Recruiting

Address

Hunan Cancer Hospital-thoracic oncology II

Changsha 1815577, Hunan 1806691, 410013

Site Contact

Nong Yang, Site 6718

[email protected]

13055193557

Local Institution - 6748, Nanjing 1799962, Jiangsu 1806260, China

Status

Completed

Address

Local Institution - 6748

Nanjing 1799962, Jiangsu 1806260, 210008

Xuzhou 10630003, Jiangsu 1806260, China

Status

Recruiting

Address

XuZhou Central Hospital/Oncology Department

Xuzhou 10630003, Jiangsu 1806260, 00000

Site Contact

Xiang Wang, Site 6732

[email protected]

855-907-3286

Changchun 2038180, Jilin 2036500, China

Status

Recruiting

Address

Jilin Cancer Hospital/Medical Oncology Department

Changchun 2038180, Jilin 2036500, 130012

Site Contact

Meili Sun, Site 6720

[email protected]

18953116532

Changchun 2038180, Jilin 2036500, China

Status

Recruiting

Address

Jilin Cancer Hospital/Medical Oncology Department

Changchun 2038180, Jilin 2036500, 130012

Site Contact

Ying Cheng, Site 6717

[email protected]

8613943012851

Changchun 2038180, Jilin 2036500, China

Status

Recruiting

Address

The first hospital of Jilin university-Oncology Department

Changchun 2038180, Jilin 2036500, 130021

Site Contact

Jiuwei Cui, Site 6714

[email protected]

8615843073215

Liaoning Cancer Hospital, Shenyang 2034937, Liaoning 2036115, China

Status

Recruiting

Address

Liaoning Cancer Hospital

Shenyang 2034937, Liaoning 2036115, 110801

Site Contact

Rui Ma, Site 6742

[email protected]

855-907-3286

Tangdu Hospital, Xi'an 1790630, Shan3xi, China

Status

Recruiting

Address

Tangdu Hospital

Xi'an 1790630, Shan3xi, 710038

Site Contact

Haichuan Su, Site 6754

[email protected]

855-907-3286

Shanxi Bethune Hospital, Taiyuan 1793511, Shanxi 1795912, China

Status

Recruiting

Address

Shanxi Bethune Hospital

Taiyuan 1793511, Shanxi 1795912, 030032

Site Contact

Junping Zhang, Site 6749

[email protected]

13994204099

Chengdu 1815286, Sichuan 1794299, China

Status

Recruiting

Address

Sichuan Cancer Hospital/Medical Oncology Department

Chengdu 1815286, Sichuan 1794299, 00000

Site Contact

Wenxiu Yao, Site 6728

[email protected]

18908178836

Chongqing, Sichuan 1794299, China

Status

Recruiting

Address

The First Hospital Affiliated To AMU - Southwest Hospital

Chongqing, Sichuan 1794299, 400030

Site Contact

Liang Gong, Site 6716

[email protected]

+8613983965893

Local Institution - 6725, Hangzhou 1808926, Zhejiang 1784764, China

Status

Completed

Address

Local Institution - 6725

Hangzhou 1808926, Zhejiang 1784764, 310016

Zhejiang Cancer Hospital-Oncology, Hangzhou 1808926, Zhejiang 1784764, China

Status

Recruiting

Address

Zhejiang Cancer Hospital-Oncology

Hangzhou 1808926, Zhejiang 1784764, 310022

Site Contact

Yiping Zhang, Site 6721

[email protected]

855-907-3286

Changsha 1815577, China

Status

Recruiting

Address

The Third Xiangya Hospital of Central South University/Department of Respiratory and Critical Care Medicine

Changsha 1815577, , 00000

Site Contact

Jie Meng, Site 6734

[email protected]

855-907-3286

Chengdu 1815286, China

Status

Recruiting

Address

West China Hospital Sichuan University/Lung cancer center

Chengdu 1815286, , 00000

Site Contact

Feng Luo, Site 6724

[email protected]

+8618980601766

Hangzhou 1808926, China

Status

Recruiting

Address

The First Affiliated Hospital - Zhejiang University School of Medicine

Hangzhou 1808926, , 310003

Site Contact

Jianying Zhou, Site 6712

[email protected]

8613505719970

Anhui Provincial Hospital, Hefei 1808722, China

Status

Recruiting

Address

Anhui Provincial Hospital

Hefei 1808722, , 230001

Site Contact

Yueyin Pan, Site 6704

[email protected]

8613805695536

Shanghai Chest Hospital, Shanghai 1796236, China

Status

Recruiting

Address

Shanghai Chest Hospital

Shanghai 1796236, , 200030

Site Contact

Liyan Jiang, Site 6709

[email protected]

855-907-3286

Shanghai Chest Hospital, Shanghai 1796236, China

Status

Recruiting

Address

Shanghai Chest Hospital

Shanghai 1796236, , 200030

Site Contact

Shun Lu, Site 6701

[email protected]

8613601813062

Weifang 1791681, China

Status

Recruiting

Address

Weifang People's Hospital/Medical Oncology Department

Weifang 1791681, , 00000

Site Contact

Guohua Yu, Site 6727

[email protected]

855-907-3286

Zhengzhou 1784658, China

Status

Recruiting

Address

Henan Cancer Hospital/The 1st pneumology department

Zhengzhou 1784658, , 00000

Site Contact

Xiufeng Hu, Site 6715

[email protected]

+8618339920984

Local Institution - 4901, Copenhagen 2618425, Denmark

Status

Completed

Address

Local Institution - 4901

Copenhagen 2618425, , 2100

Local Institution - 4201, Marseille 2995469, Bouches-du-Rhône, France

Status

Completed

Address

Local Institution - 4201

Marseille 2995469, Bouches-du-Rhône, 13005

Local Institution - 4207, Brest 3030300, France

Status

Completed

Address

Local Institution - 4207

Brest 3030300, , 29200

Local Institution - 4204, Dijon 3021372, France

Status

Completed

Address

Local Institution - 4204

Dijon 3021372, , 21079

Local Institution - 4206, Grenoble 3014728, France

Status

Completed

Address

Local Institution - 4206

Grenoble 3014728, , 38043

Centre Antoine-Lacassagne, Nice 2990440, France

Status

Recruiting

Address

Centre Antoine-Lacassagne

Nice 2990440, , 06189

Site Contact

Esma Saada-Bouzid, Site 4205

[email protected]

33492031514

Chu Poitiers, Poitiers 2986495, France

Status

Recruiting

Address

Chu Poitiers

Poitiers 2986495, , 86000

Site Contact

Nicolas Isambert, Site 4208

[email protected]

+3333380737753

Local Institution - 4203, Saint-Mandé 2978621, France

Status

Completed

Address

Local Institution - 4203

Saint-Mandé 2978621, , 94163

Institute Gustave Roussy, Villejuif 2968705, France

Status

Recruiting

Address

Institute Gustave Roussy

Villejuif 2968705, , 98405

Site Contact

Benjamin Besse, Site 4202

[email protected]

33142114211

Local Institution - 4704, Berlin 2950159, Germany

Status

Completed

Address

Local Institution - 4704

Berlin 2950159, , 13125

Local Institution - 4701, Cologne 2886242, Germany

Status

Completed

Address

Local Institution - 4701

Cologne 2886242, , 50937

Local Institution - 4703, Dresden 2935022, Germany

Status

Completed

Address

Local Institution - 4703

Dresden 2935022, , 01307

Local Institution - 4702, Heidelberg 2907911, Germany

Status

Completed

Address

Local Institution - 4702

Heidelberg 2907911, , 69120

Local Institution - 6502, Hong Kong 1819729, Hong Kong

Status

Active, not recruiting

Address

Local Institution - 6502

Hong Kong 1819729, , 0

Local Institution - 6501, Hong Kong 1819729, Hong Kong

Status

Active, not recruiting

Address

Local Institution - 6501

Hong Kong 1819729, ,

Local Institution - 5101, Budapest 3054643, Hungary

Status

Completed

Address

Local Institution - 5101

Budapest 3054643, , 1083

Local Institution - 5103, Budapest 3054643, Hungary

Status

Completed

Address

Local Institution - 5103

Budapest 3054643, , 1121

Local Institution - 4301, Milan 6951411, MI, Italy

Status

Completed

Address

Local Institution - 4301

Milan 6951411, MI, 20133

Local Institution - 4306, Milan 6951411, Italy

Status

Completed

Address

Local Institution - 4306

Milan 6951411, , 20122

Local Institution - 4307, Palermo 2523920, Italy

Status

Withdrawn

Address

Local Institution - 4307

Palermo 2523920, , 90146

Local Institution - 4303, Pordenone 3170147, Italy

Status

Completed

Address

Local Institution - 4303

Pordenone 3170147, , 33081

Local Institution - 4304, Ravenna 3169561, Italy

Status

Not yet recruiting

Address

Local Institution - 4304

Ravenna 3169561, , 48121

Site Contact

Site 4304

[email protected]

855-907-3286

Local Institution - 4305, Reggio Emilia 3169522, Italy

Status

Completed

Address

Local Institution - 4305

Reggio Emilia 3169522, , 42123

Local Institution - 4308, Roma 8957247, Italy

Status

Completed

Address

Local Institution - 4308

Roma 8957247, , 144

Local Institution - 4302, Terni 3165771, Italy

Status

Completed

Address

Local Institution - 4302

Terni 3165771, , 05100

Ehime University Hospital, Tōon 11611474, Ehime 1864226, Japan

Status

Recruiting

Address

Ehime University Hospital

Tōon 11611474, Ehime 1864226, 791-0295

Site Contact

Naoyuki Nogami, Site 6609

[email protected]

855-907-3286

Hokkaido University Hospital, Sapporo 2128295, Hokkaido 2130037, Japan

Status

Recruiting

Address

Hokkaido University Hospital

Sapporo 2128295, Hokkaido 2130037, 0608648

Site Contact

Jun Sakakibara, Site 6607

[email protected]

+81-11-716-1161

Kanagawa cancer center, Yokohama 1848354, Kanagawa 1860291, Japan

Status

Recruiting

Address

Kanagawa cancer center

Yokohama 1848354, Kanagawa 1860291, 2418515

Site Contact

Kato Terufumi, Site 6603

[email protected]

+8145520222200000000

Osaka City General Hospital, Osaka 1853909, Osaka 1853904, Japan

Status

Recruiting

Address

Osaka City General Hospital

Osaka 1853909, Osaka 1853904, 5340021

Site Contact

Haruko Daga, Site 6605

[email protected]

81669293269

National Cancer Center Hospital., Chuo-ku, Tokyo 1850144, Japan

Status

Recruiting

Address

National Cancer Center Hospital.

Chuo-ku, Tokyo 1850144, 1040045

Site Contact

Yasushi Goto, Site 6604

[email protected]

+819043996497

Tottori University Hospital, Yonago 1848277, Tottori 1849890, Japan

Status

Recruiting

Address

Tottori University Hospital

Yonago 1848277, Tottori 1849890, 683-8504

Site Contact

Kodani Masahiro, Site 6606

[email protected]

855-907-3286

National Cancer Center Hospital East, Kashiwa 1859924, Japan

Status

Recruiting

Address

National Cancer Center Hospital East

Kashiwa 1859924, , 277-8577

Site Contact

Koichi Goto, Site 6601

[email protected]

81471331111

Nagoya University Hospital, Nagoya 1856057, Japan

Status

Recruiting

Address

Nagoya University Hospital

Nagoya 1856057, , 466-8560

Site Contact

Yuichi Ando, Site 6608

[email protected]

81527412111

Osaka International Cancer institute, Osaka 1853909, Japan

Status

Recruiting

Address

Osaka International Cancer institute

Osaka 1853909, , 5418567

Site Contact

Motohiro 基裕 Tamiya 田宮, Site 6602

[email protected]

81669451181

Local Institution - 4502, Amsterdam 2759794, Netherlands

Status

Completed

Address

Local Institution - 4502

Amsterdam 2759794, , 1066 CX

Local Institution - 4501, Groningen 2755251, Netherlands

Status

Completed

Address

Local Institution - 4501

Groningen 2755251, , 9713 GZ

Gdansk 3099434, Poland

Status

Recruiting

Address

Ośrodek Badań Klinicznych Wczesnych Faz, Uniwersyteckie Centrum Kliniczne

Gdansk 3099434, , 80-214

Site Contact

Rafal Dziadziuszko, Site 4601

[email protected]

48585844571

Local Institution - 4604, Lublin 765876, Poland

Status

Completed

Address

Local Institution - 4604

Lublin 765876, , 20-609

Local Institution - 4605, Poznan 3088171, Poland

Status

Completed

Address

Local Institution - 4605

Poznan 3088171, , 60-693

Local Institution - 4603, Szczecin 3083829, Poland

Status

Completed

Address

Local Institution - 4603

Szczecin 3083829, , 70-784

Local Institution - 4602, Warsaw 756135, Poland

Status

Completed

Address

Local Institution - 4602

Warsaw 756135, , 02-781

Local Institution - 6401, Singapore 1880252, Singapore

Status

Completed

Address

Local Institution - 6401

Singapore 1880252, , 119074

Local Institution - 6402, Singapore 1880252, Singapore

Status

Completed

Address

Local Institution - 6402

Singapore 1880252, , 169610

Local Institution - 3003, Seoul 1835848, Gangnam-gu, South Korea

Status

Completed

Address

Local Institution - 3003

Seoul 1835848, Gangnam-gu, 06351

Local Institution - 6308, Hwasun-eup, Hwasun-gun, Jeollanam-do 1845788, South Korea

Status

Completed

Address

Local Institution - 6308

Hwasun-eup, Hwasun-gun, Jeollanam-do 1845788, 519-763

Yonsei University Health System, Seoul 1835848, Seodaemun-gu, South Korea

Status

Recruiting

Address

Yonsei University Health System

Seoul 1835848, Seodaemun-gu, 03722

Site Contact

Byoung Chul Cho, Site 3002

[email protected]

82222288126

Local Institution - 3002, Seoul 1835848, Seoul Teugbyeolsi, South Korea

Status

Withdrawn

Address

Local Institution - 3002

Seoul 1835848, Seoul Teugbyeolsi, 03080

Local Institution - 6301, Seoul 1835848, Seoul-teukbyeolsi [Seoul], South Korea

Status

Completed

Address

Local Institution - 6301

Seoul 1835848, Seoul-teukbyeolsi [Seoul], 03080

Local Institution - 6303, Seoul 1835848, Seoul-teukbyeolsi [Seoul], South Korea

Status

Completed

Address

Local Institution - 6303

Seoul 1835848, Seoul-teukbyeolsi [Seoul], 06351

Local Institution - 6306, Cheongju-si 1845604, South Korea

Status

Completed

Address

Local Institution - 6306

Cheongju-si 1845604, , 28644

Seoul National University Hospital, Seoul 1835848, South Korea

Status

Recruiting

Address

Seoul National University Hospital

Seoul 1835848, , 03080

Site Contact

Dong-Wan Kim, Site 3001

[email protected]

+821027324635

Local Institution - 6302, Seoul 1835848, South Korea

Status

Completed

Address

Local Institution - 6302

Seoul 1835848, , 03722

Local Institution - 6307, Seoul 1835848, South Korea

Status

Completed

Address

Local Institution - 6307

Seoul 1835848, , 05030

Local Institution - 6305, Seoul 1835848, South Korea

Status

Completed

Address

Local Institution - 6305

Seoul 1835848, , 05505

Local Institution - 6304, Seoul 1835848, South Korea

Status

Completed

Address

Local Institution - 6304

Seoul 1835848, , 06591

Local Institution - 4102, Barcelona 3128760, Spain

Status

Completed

Address

Local Institution - 4102

Barcelona 3128760, , 08028

Local Institution - 4101, Barcelona 3128760, Spain

Status

Completed

Address

Local Institution - 4101

Barcelona 3128760, , 8035

Local Institution - 4106, Madrid 3117735, Spain

Status

Completed

Address

Local Institution - 4106

Madrid 3117735, , 28033

Local Institution - 4104, Madrid 3117735, Spain

Status

Completed

Address

Local Institution - 4104

Madrid 3117735, , 28040

Local Institution - 4103, Madrid 3117735, Spain

Status

Completed

Address

Local Institution - 4103

Madrid 3117735, , 28041

Local Institution - 4105, Madrid 3117735, Spain

Status

Completed

Address

Local Institution - 4105

Madrid 3117735, , 28050

Clinica Universidad de Navarra, Pamplona 3114472, Spain

Status

Recruiting

Address

Clinica Universidad de Navarra

Pamplona 3114472, , 31008

Site Contact

Ignacio Gil Bazo, Site 4108

[email protected]

+34948255400

Valencia 2509954, Spain

Status

Recruiting

Address

Instituto Valenciano de Oncología (IVO) - Unidad de Investigación Clínica FINCIVO

Valencia 2509954, , 46009

Site Contact

Angel Guerrero, Site 4107

[email protected]

855-907-3286

Local Institution - 6201, Taiepi, Taiwan

Status

Active, not recruiting

Address

Local Institution - 6201

Taiepi, , 100

Local Institution - 6203, Tainan City 1668355, Taiwan

Status

Active, not recruiting

Address

Local Institution - 6203

Tainan City 1668355, , 704

Local Institution - 6202, Taipei 1668341, Taiwan

Status

Completed

Address

Local Institution - 6202

Taipei 1668341, , 10449

Local Institution - 4401, London 2643743, United Kingdom

Status

Completed

Address

Local Institution - 4401

London 2643743, , SW3 6JJ

Local Institution - 4402, London 2643743, United Kingdom

Status

Completed

Address

Local Institution - 4402

London 2643743, , W12 OHS

Local Institution - 4404, London 2643743, United Kingdom

Status

Completed

Address

Local Institution - 4404

London 2643743, , W1G 6AD

Local Institution - 4403, Manchester 2643123, United Kingdom

Status

Completed

Address

Local Institution - 4403

Manchester 2643123, , M20 4BX

Local Institution - 4405, Sutton 2636503, United Kingdom

Status

Completed

Address

Local Institution - 4405

Sutton 2636503, , SM2 5PT

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