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, Korea, Republic of, Netherlands, Poland, Singapore, 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, California

Status

Completed

Address

Local Institution - 2129

Duarte, California, 91010

Local Institution - 2120, Glendale, California

Status

Completed

Address

Local Institution - 2120

Glendale, California, 91206

Local Institution - 2136, La Jolla, California

Status

Withdrawn

Address

Local Institution - 2136

La Jolla, California, 92037

Local Institution - 2114, La Jolla, California

Status

Completed

Address

Local Institution - 2114

La Jolla, California, 92093

Local Institution - 2121, Long Beach, California

Status

Completed

Address

Local Institution - 2121

Long Beach, California, 90813

Local Institution - 2101, Orange, California

Status

Completed

Address

Local Institution - 2101

Orange, California, 92868

Orange, California

Status

Recruiting

Address

University of California Irvine Medical Center

Orange, California, 92868

Site Contact

Misako Nagasaka, Site 1001

[email protected]

714-456-5153

Local Institution - 2126, Santa Rosa, California

Status

Completed

Address

Local Institution - 2126

Santa Rosa, California, 95403

Local Institution - 1003, Aurora, Colorado

Status

Not yet recruiting

Address

Local Institution - 1003

Aurora, Colorado, 80045

Site Contact

Site 1003

[email protected]

855-907-3286

Local Institution - 2103, Aurora, Colorado

Status

Completed

Address

Local Institution - 2103

Aurora, Colorado, 80045

Local Institution - 2106, Washington, District of Columbia

Status

Completed

Address

Local Institution - 2106

Washington, District of Columbia, 20007

Local Institution - 2110, Washington, District of Columbia

Status

Completed

Address

Local Institution - 2110

Washington, District of Columbia, 20016

Local Institution - 2128, Hollywood, Florida

Status

Completed

Address

Local Institution - 2128

Hollywood, Florida, 33021

Local Institution - 2113, Tampa, Florida

Status

Completed

Address

Local Institution - 2113

Tampa, Florida, 33612

Local Institution - 2139, Athens, Georgia

Status

Completed

Address

Local Institution - 2139

Athens, Georgia, 30607

Local Institution - 2134, Columbus, Georgia

Status

Completed

Address

Local Institution - 2134

Columbus, Georgia, 31904

Local Institution - 2125, Chicago, Illinois

Status

Completed

Address

Local Institution - 2125

Chicago, Illinois, 60637

Local Institution - 2142, Peoria, Illinois

Status

Completed

Address

Local Institution - 2142

Peoria, Illinois, 61615

Local Institution - 2116, New Orleans, Louisiana

Status

Not yet recruiting

Address

Local Institution - 2116

New Orleans, Louisiana, 70121

Site Contact

Site 2116

[email protected]

855-907-3286

Local Institution - 2133, Baltimore, Maryland

Status

Completed

Address

Local Institution - 2133

Baltimore, Maryland, 21210

Local Institution - 2104, Boston, Massachusetts

Status

Completed

Address

Local Institution - 2104

Boston, Massachusetts, 02114

Local Institution - 1004, Boston, Massachusetts

Status

Not yet recruiting

Address

Local Institution - 1004

Boston, Massachusetts, 02214

Site Contact

Site 1004

[email protected]

855-907-3286

Local Institution - 2131, Boston, Massachusetts

Status

Completed

Address

Local Institution - 2131

Boston, Massachusetts, 02215

Local Institution - 2105, Ann Arbor, Michigan

Status

Completed

Address

Local Institution - 2105

Ann Arbor, Michigan, 48109

Local Institution - 2111, Detroit, Michigan

Status

Completed

Address

Local Institution - 2111

Detroit, Michigan, 48201

Local Institution - 2140, Detroit, Michigan

Status

Completed

Address

Local Institution - 2140

Detroit, Michigan, 48202-2608

Local Institution - 2132, Saint Paul, Minnesota

Status

Completed

Address

Local Institution - 2132

Saint Paul, Minnesota, 55101

Local Institution - 2147, Bolivar, Missouri

Status

Completed

Address

Local Institution - 2147

Bolivar, Missouri, 65613

Local Institution - 2115, Saint Louis, Missouri

Status

Completed

Address

Local Institution - 2115

Saint Louis, Missouri, 63110

Local Institution - 2122, New Brunswick, New Jersey

Status

Completed

Address

Local Institution - 2122

New Brunswick, New Jersey, 08901

Local Institution - 2117, New York, New York

Status

Completed

Address

Local Institution - 2117

New York, New York, 10016

Local Institution - 2102, New York, New York

Status

Completed

Address

Local Institution - 2102

New York, New York, 10065

Memorial Sloan Kettering Cancer Center, New York, New York

Status

Recruiting

Address

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Site Contact

Alexander Drilon, Site 1002

[email protected]

646-888-4206

Local Institution - 2144, Goldsboro, North Carolina

Status

Completed

Address

Local Institution - 2144

Goldsboro, North Carolina, 27534

Local Institution - 2112, Canton, Ohio

Status

Completed

Address

Local Institution - 2112

Canton, Ohio, 44718

Local Institution - 2143, Cincinnati, Ohio

Status

Completed

Address

Local Institution - 2143

Cincinnati, Ohio, 45220

Local Institution - 2109, Cleveland, Ohio

Status

Completed

Address

Local Institution - 2109

Cleveland, Ohio, 44195

Local Institution - 2123, Columbus, Ohio

Status

Completed

Address

Local Institution - 2123

Columbus, Ohio, 43210

Local Institution - 2119, Toledo, Ohio

Status

Completed

Address

Local Institution - 2119

Toledo, Ohio, 43614

Local Institution - 2108, Philadelphia, Pennsylvania

Status

Completed

Address

Local Institution - 2108

Philadelphia, Pennsylvania, 19111-2497

Local Institution - 2148, Memphis, Tennessee

Status

Completed

Address

Local Institution - 2148

Memphis, Tennessee, 38120

Local Institution - 2130, Dallas, Texas

Status

Completed

Address

Local Institution - 2130

Dallas, Texas, 75390

Local Institution - 2127, Houston, Texas

Status

Completed

Address

Local Institution - 2127

Houston, Texas, 77030

Local Institution - 2138, Houston, Texas

Status

Completed

Address

Local Institution - 2138

Houston, Texas, 77030

Local Institution - 2146, Kingwood, Texas

Status

Completed

Address

Local Institution - 2146

Kingwood, Texas, 77339

Local Institution - 2137, Fairfax, Virginia

Status

Completed

Address

Local Institution - 2137

Fairfax, Virginia, 22031

Local Institution - 2107, Seattle, Washington

Status

Completed

Address

Local Institution - 2107

Seattle, Washington, 98109

Local Institution - 2141, Tacoma, Washington

Status

Withdrawn

Address

Local Institution - 2141

Tacoma, Washington, 98405

Local Institution - 2145, Appleton, Wisconsin

Status

Completed

Address

Local Institution - 2145

Appleton, Wisconsin, 54911

International Sites

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

Status

Completed

Address

Local Institution - 6102

Camperdown, New South Wales, 2050

Local Institution - 6103, Adelaide, South Australia, Australia

Status

Completed

Address

Local Institution - 6103

Adelaide, South Australia, 5042

Local Institution - 6101, Melbourne, Victoria, Australia

Status

Completed

Address

Local Institution - 6101

Melbourne, Victoria, 3000

Local Institution - 3301, East Melbourne, Australia

Status

Completed

Address

Local Institution - 3301

East Melbourne, , 3002

Local Institution - 4802, Antwerp, Belgium

Status

Completed

Address

Local Institution - 4802

Antwerp, , 2650

Local Institution - 4801, Leuven, Belgium

Status

Completed

Address

Local Institution - 4801

Leuven, , 3000

Local Institution - 2202, Edmonton, Alberta, Canada

Status

Completed

Address

Local Institution - 2202

Edmonton, Alberta, T6G 1Z2

Local Institution - 2205, Vancouver, British Columbia, Canada

Status

Withdrawn

Address

Local Institution - 2205

Vancouver, British Columbia, V5Z 4E7

Local Institution - 2201, Toronto, Ontario, Canada

Status

Completed

Address

Local Institution - 2201

Toronto, Ontario, M5G 2M9

Local Institution - 6503, Toronto, Ontario, Canada

Status

Active, not recruiting

Address

Local Institution - 6503

Toronto, Ontario, M5G 2M9

Local Institution - 2203, Ontario, Canada

Status

Completed

Address

Local Institution - 2203

Ontario, , L6R 37R

Local Institution - 2204, Ottawa, Canada

Status

Completed

Address

Local Institution - 2204

Ottawa, , K1H 8L6

Local Institution - 6702, Beijing, Beijing, China

Status

Completed

Address

Local Institution - 6702

Beijing, Beijing, 100021

Beijing Cancer hospital, Beijing, Beijing, China

Status

Recruiting

Address

Beijing Cancer hospital

Beijing, Beijing, 100142

Site Contact

Jian Fang, Site 6703

[email protected]

868613701224460

Daping, Chongqing, China

Status

Recruiting

Address

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

Daping, Chongqing, 00000

Site Contact

Yong He, Site 6736

[email protected]

13908338998

Local Institution - 6719, Fuzhou, Fujian, China

Status

Completed

Address

Local Institution - 6719

Fuzhou, Fujian, 000000

Xiamen, Fujian, China

Status

Recruiting

Address

The First Affiliated hospital of Xiamen University-oncology

Xiamen, Fujian, 361003

Site Contact

Jingxun Wu, Site 6708

[email protected]

15160085395

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

Status

Recruiting

Address

Guangdong Provincial People'S Hospital

Guangzhou, Guangdong, 510120

Site Contact

Jinji Yang, Site 6747

[email protected]

855-907-3286

Local Institution - 6733, Guangzhou, Guangdong, China

Status

Completed

Address

Local Institution - 6733

Guangzhou, Guangdong, 510120

Local Institution - 6505, Shenzhen, Guangdong, China

Status

Active, not recruiting

Address

Local Institution - 6505

Shenzhen, Guangdong, 518053

Harbin, Heilongjiang, China

Status

Recruiting

Address

The Affiliated Tumor Hospital of Harbin Medical University

Harbin, Heilongjiang, 150081

Site Contact

Yan Yu, Site 6722

[email protected]

13904505825

Local Institution - 6504, Shatin, Hong Kong, China

Status

Active, not recruiting

Address

Local Institution - 6504

Shatin, Hong Kong, 999077

Wuhan, Hubei, China

Status

Recruiting

Address

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

Wuhan, Hubei, 430022

Site Contact

Xiaorong Dong, Site 6710

[email protected]

13986252286

Local Institution - 6705, Changsha, Hunan, China

Status

Completed

Address

Local Institution - 6705

Changsha, Hunan, 410011

Changsha, Hunan, China

Status

Recruiting

Address

Hunan Cancer Hospital-thoracic oncology II

Changsha, Hunan, 410013

Site Contact

Nong Yang, Site 6718

[email protected]

13055193557

Local Institution - 6748, Nanjing, Jiangsu, China

Status

Completed

Address

Local Institution - 6748

Nanjing, Jiangsu, 210008

Xuzhou City, Jiangsu, China

Status

Recruiting

Address

XuZhou Central Hospital/Oncology Department

Xuzhou City, Jiangsu, 00000

Site Contact

Xiang Wang, Site 6732

[email protected]

855-907-3286

Changchun, Jilin, China

Status

Recruiting

Address

Jilin Cancer Hospital/Medical Oncology Department

Changchun, Jilin, 130012

Site Contact

Meili Sun, Site 6720

[email protected]

18953116532

Changchun, Jilin, China

Status

Recruiting

Address

Jilin Cancer Hospital/Medical Oncology Department

Changchun, Jilin, 130012

Site Contact

Ying Cheng, Site 6717

[email protected]

8613943012851

Changchun, Jilin, China

Status

Recruiting

Address

The first hospital of Jilin university-Oncology Department

Changchun, Jilin, 130021

Site Contact

Jiuwei Cui, Site 6714

[email protected]

8615843073215

Liaoning Cancer Hospital, Shenyang, Liaoning, China

Status

Recruiting

Address

Liaoning Cancer Hospital

Shenyang, Liaoning, 110801

Site Contact

Rui Ma, Site 6742

[email protected]

855-907-3286

Tangdu Hospital, Xi'an, Shan3xi, China

Status

Recruiting

Address

Tangdu Hospital

Xi'an, Shan3xi, 710038

Site Contact

Haichuan Su, Site 6754

[email protected]

855-907-3286

Shanxi Bethune Hospital, Taiyuan, Shanxi, China

Status

Recruiting

Address

Shanxi Bethune Hospital

Taiyuan, Shanxi, 030032

Site Contact

Junping Zhang, Site 6749

[email protected]

13994204099

Chengdu City, Sichuan, China

Status

Recruiting

Address

Sichuan Cancer Hospital/Medical Oncology Department

Chengdu City, Sichuan, 00000

Site Contact

Wenxiu Yao, Site 6728

[email protected]

18908178836

Chongqing, Sichuan, China

Status

Recruiting

Address

The First Hospital Affiliated To AMU - Southwest Hospital

Chongqing, Sichuan, 400030

Site Contact

Liang Gong, Site 6716

[email protected]

+8613983965893

Local Institution - 6725, Hangzhou, Zhejiang, China

Status

Completed

Address

Local Institution - 6725

Hangzhou, Zhejiang, 310016

Zhejiang Cancer Hospital-Oncology, Hangzhou, Zhejiang, China

Status

Recruiting

Address

Zhejiang Cancer Hospital-Oncology

Hangzhou, Zhejiang, 310022

Site Contact

Yiping Zhang, Site 6721

[email protected]

855-907-3286

Changsha, China

Status

Recruiting

Address

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

Changsha, , 00000

Site Contact

Jie Meng, Site 6734

[email protected]

855-907-3286

Chengdu, China

Status

Recruiting

Address

West China Hospital Sichuan University/Lung cancer center

Chengdu, , 00000

Site Contact

Feng Luo, Site 6724

[email protected]

+8618980601766

Hangzhou, China

Status

Recruiting

Address

The First Affiliated Hospital - Zhejiang University School of Medicine

Hangzhou, , 310003

Site Contact

Jianying Zhou, Site 6712

[email protected]

8613505719970

Anhui Provincial Hospital, Hefei, China

Status

Recruiting

Address

Anhui Provincial Hospital

Hefei, , 230001

Site Contact

Yueyin Pan, Site 6704

[email protected]

8613805695536

Shanghai Chest Hospital, Shanghai, China

Status

Recruiting

Address

Shanghai Chest Hospital

Shanghai, , 200030

Site Contact

Liyan Jiang, Site 6709

[email protected]

855-907-3286

Shanghai Chest Hospital, Shanghai, China

Status

Recruiting

Address

Shanghai Chest Hospital

Shanghai, , 200030

Site Contact

Shun Lu, Site 6701

[email protected]

8613601813062

Weifang City, China

Status

Recruiting

Address

Weifang People's Hospital/Medical Oncology Department

Weifang City, , 00000

Site Contact

Guohua Yu, Site 6727

[email protected]

855-907-3286

Zhengzhou, China

Status

Recruiting

Address

Henan Cancer Hospital/The 1st pneumology department

Zhengzhou, , 00000

Site Contact

Xiufeng Hu, Site 6715

[email protected]

+8618339920984

Local Institution - 4901, Copenhagen, Denmark

Status

Completed

Address

Local Institution - 4901

Copenhagen, , 2100

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

Status

Completed

Address

Local Institution - 4201

Marseille, Bouches-du-Rhône, 13005

Local Institution - 4207, Brest, France

Status

Completed

Address

Local Institution - 4207

Brest, , 29200

Local Institution - 4204, Dijon Cedex, France

Status

Completed

Address

Local Institution - 4204

Dijon Cedex, , 21079

Local Institution - 4206, Grenoble Cedex 9, France

Status

Completed

Address

Local Institution - 4206

Grenoble Cedex 9, , 38043

Centre Antoine-Lacassagne, Nice, France

Status

Recruiting

Address

Centre Antoine-Lacassagne

Nice, , 06189

Site Contact

Esma Saada-Bouzid, Site 4205

[email protected]

33492031514

Chu Poitiers, Poitiers, France

Status

Recruiting

Address

Chu Poitiers

Poitiers, , 86000

Site Contact

Nicolas Isambert, Site 4208

[email protected]

+3333380737753

Local Institution - 4203, St Mande, France

Status

Completed

Address

Local Institution - 4203

St Mande, , 94163

Institute Gustave Roussy, Villejuif, France

Status

Recruiting

Address

Institute Gustave Roussy

Villejuif, , 98405

Site Contact

Benjamin Besse, Site 4202

[email protected]

33142114211

Local Institution - 4704, Berlin, Germany

Status

Completed

Address

Local Institution - 4704

Berlin, , 13125

Local Institution - 4703, Dresden, Germany

Status

Completed

Address

Local Institution - 4703

Dresden, , 01307

Local Institution - 4702, Heidelberg, Germany

Status

Completed

Address

Local Institution - 4702

Heidelberg, , 69120

Local Institution - 4701, Koln, Germany

Status

Completed

Address

Local Institution - 4701

Koln, , 50937

Local Institution - 6502, Hong Kong, Hong Kong

Status

Active, not recruiting

Address

Local Institution - 6502

Hong Kong, , 0

Local Institution - 6501, Hong Kong, Hong Kong

Status

Active, not recruiting

Address

Local Institution - 6501

Hong Kong, ,

Local Institution - 5101, Budapest, Hungary

Status

Completed

Address

Local Institution - 5101

Budapest, , 1083

Local Institution - 5103, Budapest, Hungary

Status

Completed

Address

Local Institution - 5103

Budapest, , 1121

Local Institution - 4301, Milano, MI, Italy

Status

Completed

Address

Local Institution - 4301

Milano, MI, 20133

Local Institution - 4306, Milano, Italy

Status

Completed

Address

Local Institution - 4306

Milano, , 20122

Local Institution - 4307, Palermo, Italy

Status

Withdrawn

Address

Local Institution - 4307

Palermo, , 90146

Local Institution - 4303, Pordenone, Italy

Status

Completed

Address

Local Institution - 4303

Pordenone, , 33081

Local Institution - 4304, Ravenna, Italy

Status

Not yet recruiting

Address

Local Institution - 4304

Ravenna, , 48121

Site Contact

Site 4304

[email protected]

855-907-3286

Local Institution - 4305, Reggio Emilia, Italy

Status

Completed

Address

Local Institution - 4305

Reggio Emilia, , 42123

Local Institution - 4308, Roma, Italy

Status

Completed

Address

Local Institution - 4308

Roma, , 144

Local Institution - 4302, Terni, Italy

Status

Completed

Address

Local Institution - 4302

Terni, , 05100

Ehime University Hospital, Toon, Ehime, Japan

Status

Recruiting

Address

Ehime University Hospital

Toon, Ehime, 791-0295

Site Contact

Naoyuki Nogami, Site 6609

[email protected]

855-907-3286

Hokkaido University Hospital, Sapporo-shi, Hokkaido, Japan

Status

Recruiting

Address

Hokkaido University Hospital

Sapporo-shi, Hokkaido, 0608648

Site Contact

Jun Sakakibara, Site 6607

[email protected]

+81-11-716-1161

Kanagawa cancer center, Yokohama, Kanagawa, Japan

Status

Recruiting

Address

Kanagawa cancer center

Yokohama, Kanagawa, 2418515

Site Contact

Kato Terufumi, Site 6603

[email protected]

+8145520222200000000

Osaka City General Hospital, Osaka-shi, Osaka, Japan

Status

Recruiting

Address

Osaka City General Hospital

Osaka-shi, Osaka, 5340021

Site Contact

Haruko Daga, Site 6605

[email protected]

81669293269

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

Status

Recruiting

Address

National Cancer Center Hospital.

Chuo-ku, Tokyo, 1040045

Site Contact

Yasushi Goto, Site 6604

[email protected]

+819043996497

Tottori University Hospital, Yonago, Tottori, Japan

Status

Recruiting

Address

Tottori University Hospital

Yonago, Tottori, 683-8504

Site Contact

Kodani Masahiro, Site 6606

[email protected]

855-907-3286

National Cancer Center Hospital East, Kashiwa, Japan

Status

Recruiting

Address

National Cancer Center Hospital East

Kashiwa, , 277-8577

Site Contact

Koichi Goto, Site 6601

[email protected]

81471331111

Nagoya University Hospital, Nagoya-shi, Japan

Status

Recruiting

Address

Nagoya University Hospital

Nagoya-shi, , 466-8560

Site Contact

Yuichi Ando, Site 6608

[email protected]

81527412111

Osaka International Cancer institute, Osaka, Japan

Status

Recruiting

Address

Osaka International Cancer institute

Osaka, , 5418567

Site Contact

Motohiro 基裕 Tamiya 田宮, Site 6602

[email protected]

81669451181

Local Institution - 3003, Seoul, Gangnam-gu, Korea, Republic of

Status

Completed

Address

Local Institution - 3003

Seoul, Gangnam-gu, 06351

Local Institution - 6308, Hwasun-eup, Hwasun-gun, Jeonnam, Korea, Republic of

Status

Completed

Address

Local Institution - 6308

Hwasun-eup, Hwasun-gun, Jeonnam, 519-763

Yonsei University Health System, Seoul, Seodaemun-gu, Korea, Republic of

Status

Recruiting

Address

Yonsei University Health System

Seoul, Seodaemun-gu, 03722

Site Contact

Byoung Chul Cho, Site 3002

[email protected]

82222288126

Local Institution - 3002, Seoul, Seoul Teugbyeolsi, Korea, Republic of

Status

Withdrawn

Address

Local Institution - 3002

Seoul, Seoul Teugbyeolsi, 03080

Local Institution - 6301, Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of

Status

Completed

Address

Local Institution - 6301

Seoul, Seoul-teukbyeolsi [Seoul], 03080

Local Institution - 6303, Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of

Status

Completed

Address

Local Institution - 6303

Seoul, Seoul-teukbyeolsi [Seoul], 06351

Local Institution - 6306, Cheongju-si, Korea, Republic of

Status

Completed

Address

Local Institution - 6306

Cheongju-si, , 28644

Seoul National University Hospital, Seoul, Korea, Republic of

Status

Recruiting

Address

Seoul National University Hospital

Seoul, , 03080

Site Contact

Dong-Wan Kim, Site 3001

[email protected]

+821027324635

Local Institution - 6302, Seoul, Korea, Republic of

Status

Completed

Address

Local Institution - 6302

Seoul, , 03722

Local Institution - 6307, Seoul, Korea, Republic of

Status

Completed

Address

Local Institution - 6307

Seoul, , 05030

Local Institution - 6305, Seoul, Korea, Republic of

Status

Completed

Address

Local Institution - 6305

Seoul, , 05505

Local Institution - 6304, Seoul, Korea, Republic of

Status

Completed

Address

Local Institution - 6304

Seoul, , 06591

Local Institution - 4502, Amsterdam, Netherlands

Status

Completed

Address

Local Institution - 4502

Amsterdam, , 1066 CX

Local Institution - 4501, Groningen, Netherlands

Status

Completed

Address

Local Institution - 4501

Groningen, , 9713 GZ

Gdańsk, Poland

Status

Recruiting

Address

Ośrodek Badań Klinicznych Wczesnych Faz, Uniwersyteckie Centrum Kliniczne

Gdańsk, , 80-214

Site Contact

Rafal Dziadziuszko, Site 4601

[email protected]

48585844571

Local Institution - 4604, Lublin, Poland

Status

Completed

Address

Local Institution - 4604

Lublin, , 20-609

Local Institution - 4605, Poznań, Poland

Status

Completed

Address

Local Institution - 4605

Poznań, , 60-693

Local Institution - 4603, Szczecin, Poland

Status

Completed

Address

Local Institution - 4603

Szczecin, , 70-784

Local Institution - 4602, Warszawa, Poland

Status

Completed

Address

Local Institution - 4602

Warszawa, , 02-781

Local Institution - 6401, Singapore, Singapore

Status

Completed

Address

Local Institution - 6401

Singapore, , 119074

Local Institution - 6402, Singapore, Singapore

Status

Completed

Address

Local Institution - 6402

Singapore, , 169610

Local Institution - 4102, Barcelona, Spain

Status

Completed

Address

Local Institution - 4102

Barcelona, , 08028

Local Institution - 4101, Barcelona, Spain

Status

Completed

Address

Local Institution - 4101

Barcelona, , 8035

Local Institution - 4106, Madrid, Spain

Status

Completed

Address

Local Institution - 4106

Madrid, , 28033

Local Institution - 4104, Madrid, Spain

Status

Completed

Address

Local Institution - 4104

Madrid, , 28040

Local Institution - 4103, Madrid, Spain

Status

Completed

Address

Local Institution - 4103

Madrid, , 28041

Local Institution - 4105, Madrid, Spain

Status

Completed

Address

Local Institution - 4105

Madrid, , 28050

Clinica Universidad de Navarra, Pamplona, Spain

Status

Recruiting

Address

Clinica Universidad de Navarra

Pamplona, , 31008

Site Contact

Ignacio Gil Bazo, Site 4108

[email protected]

+34948255400

Valencia, Spain

Status

Recruiting

Address

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

Valencia, , 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, Taiwan

Status

Active, not recruiting

Address

Local Institution - 6203

Tainan, , 704

Local Institution - 6202, Taipei, Taiwan

Status

Completed

Address

Local Institution - 6202

Taipei, , 10449

Local Institution - 4401, London, United Kingdom

Status

Completed

Address

Local Institution - 4401

London, , SW3 6JJ

Local Institution - 4402, London, United Kingdom

Status

Completed

Address

Local Institution - 4402

London, , W12 OHS

Local Institution - 4404, London, United Kingdom

Status

Completed

Address

Local Institution - 4404

London, , W1G 6AD

Local Institution - 4403, Manchester, United Kingdom

Status

Completed

Address

Local Institution - 4403

Manchester, , M20 4BX

Local Institution - 4405, Sutton, United Kingdom

Status

Completed

Address

Local Institution - 4405

Sutton, , SM2 5PT

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