Study Description

This study will evaluate DS-1062a 6.0 mg/kg vs docetaxel 75 mg/m^2 in participants with advanced or metastatic NSCLC with or without actionable genomic alterations (AGAs). Participants without actionable genomic alterations must have been previously treated with platinum-based chemotherapy and α (anti)-programmed cell death 1 (PD-1)/α-programmed cell death ligand 1 (PD-L1) monoclonal antibody, either in combination or sequentially. Participants with AGA must have progressed on or after 1 platinum-containing therapy and 1 to 2 prior lines of approved targeted therapy for the applicable genomic alteration. The study will be divided into 3 periods: Screening Period, Treatment Period, and Follow-up Period.

Condition or Disease	Intervention/Treatment
Non-small Cell Lung Cancer	Drug: DS-1062a Drug: Docetaxel

Study Design

Study Type	Interventional
Anticipated Enrollment	590 participants
Design Allocation	Randomized
Interventional Model	Parallel Assignment
Masking	None (Open Label)
Primary Purpose	Treatment
Official Title	Phase 3 Randomized Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer (TROPION-LUNG01)
Study Start Date	December 21, 2020
Actual Primary Completion Date	May 10, 2024
Anticipated Study Completion Date	June 21, 2025

Groups and Cohorts

Group/ Cohort	Intervention/ Treatment
DS-1062a 6.0 mg/kg Participants will be randomized to receive 6.0 mg/kg of DS-1062a.	Drug: DS-1062a DS-1062a will be administered as an intravenous (IV) infusion on Day 1 of each 3-week cycle
Docetaxel 75 mg/m^2 Participants will be randomized to receive 75 mg/m^2 docetaxel.	Drug: Docetaxel

Outcome Measures

Primary Outcome Measures

1. Progression-free Survival (PFS) As Assessed by Blinded Independent Central Review (BICR) Per RECIST v1.1 Following DS-1062a Versus Docetaxel [From randomization until disease progression or death (whichever occurs first), up to approximately 43 months]
   PFS is defined as the time from randomization to the earlier of the dates of the first documentation of radiographic progressive disease or death due to any cause.
2. Overall Survival (OS) Following DS-1062a Versus Docetaxel [From randomization until date of death due to any cause, up to approximately 43 months]
   OS is defined as the time from randomization to the date of death due to any cause.

Secondary Outcome Measures

1. Progression-free Survival (PFS) As Assessed by Investigator Per RECIST v1.1 Following DS-1062a Versus Docetaxel [From randomization until disease progression or death (whichever occurs first), up to approximately 43 months]
   PFS is defined as the time from randomization to the earlier of the dates of the first documentation of radiographic progressive disease or death due to any cause.
2. Objective Response Rate (ORR) As Assessed by Blinded Independent Central Review (BICR) and Investigator As Per RECIST v1.1 Following DS-1062a Versus Docetaxel [From randomization until disease progression or death (whichever occurs first), up to approximately 43 months]
   ORR is defined as the proportion of participants with a best overall response of complete response (CR) or partial response (PR).
3. Duration of Response (DOR) As Assessed by Blinded Independent Central Review (BICR) and Investigator As Per RECIST v1.1 Following DS-1062a Versus Docetaxel [From date of first objective response (CR or PR) to date of first radiographic disease progression or death due to any cause (whichever occurs first), up to approximately 43 months]
   DOR is defined as the time from the date of the first documentation of objective response (confirmed CR or confirmed PR) to the date of the first documentation of radiographic PD or death due to any cause, whichever occurs first.
4. Disease Control Rate (DCR) As Assessed by Blinded Independent Central Review (BICR) and Investigator As Per RECIST v1.1 Following DS-1062a Versus Docetaxel [From randomization until disease progression or death (whichever occurs first), up to approximately 43 months]
   DCR is defined as the proportion of participants who achieved a best overall response (BOR) of CR, PR, or stable disease (SD).
5. Time to Response (TTR) As Assessed by Blinded Independent Central Review (BICR) and Investigator As Per RECIST v1.1 Following DS-1062a Versus Docetaxel [From randomization to date of first objective response (CR or PR), up to approximately 43 months]
   TTR is defined as the time from randomization to the date of the first documentation of objective response (CR or PR) in responding participants.
6. Time to Deterioration (TTD) Following DS-1062a Versus Docetaxel [Baseline and assessed on Day 15 of each cycle until disease progression or end of treatment (each cycle is 21 days) and then once more at +90 days end of treatment]
   TTD is defined as the time from randomization to the first onset of a ≥10-point increase in cough, chest pain, or dyspnea, confirmed by a second ≥10-point increase from randomization in the same symptom at the next scheduled assessment, or confirmed by death within 21 days of the first ≥10-point increase from randomization.
7. Percentage of Participants Who Reported Treatment-emergent Adverse Events Following DS-1062a Versus Docetaxel [Baseline up to 35 days after last study dose, up to approximately 43 months]
   Reported treatment-emergent adverse events, serious adverse events, adverse events of special interest, and those considered related to the study drug or study procedures, or that are associated with study treatment reduction, interruption, or discontinuation.
8. Pharmacokinetic Parameter Maximum Plasma Concentration (Cmax) of DS-1062a, Total Anti-Trophoblast cell surface protein 2 (Anti-TROP2) Antibody, and Active Metabolite MAAA-1181a [Cycle 1, Day 1: predose and 30 minutes, 3 hours, 5 hours, and 7 hours postdose and Days 2, 4, 8, and 15; Cycles 2, 3, 4, 6, and 8, Day 1: predose and 1 hour postdose (each cycle is 21 days)]
9. Pharmacokinetic Parameter Time to Maximum Plasma Concentration (Tmax) of DS-1062a, Total Anti-TROP2 Antibody, and Active Metabolite MAAA-1181a [Cycle 1, Day 1: predose and 30 minutes, 3 hours, 5 hours, and 7 hours postdose and Days 2, 4, 8, and 15; Cycles 2, 3, 4, 6, and 8, Day 1: predose and 1 hour postdose (each cycle is 21 days)]
10. Pharmacokinetic Parameter Area Under the Plasma Concentration-Time Curve (AUC) of DS-1062a, Total Anti-TROP2 Antibody, and Active Metabolite MAAA-1181a [Cycle 1, Day 1: predose and 30 minutes, 3 hours, 5 hours, and 7 hours postdose and Days 2, 4, 8, and 15; Cycles 2, 3, 4, 6, and 8, Day 1: predose and 1 hour postdose (each cycle is 21 days)]
    Area under the plasma concentration-time curve up to last quantifiable time (AUClast) and area under the plasma concentration-time curve during dosing interval (AUCtau) will be assessed.
11. Proportion of Participants Who Are Anti-Drug Antibody (ADA)-Positive (Baseline and Post-Baseline) and Proportion of Participants Who Have Treatment-emergent ADA [Cycle 1, Day 1 predose; Cycle 1, Day 8; Cycles 2, 4, and subsequent cycles, Day 1 predose; end of treatment; 28-day safety follow up; and long-term survival follow up every 3 months, up to approximately 43 months (each cycle is 21 days)]

Eligibility Criteria

Ages Eligible for Study	18 Years and Older (Adult, Older Adult)
Sexes Eligible for Study	All
Accepts Healthy Volunteers	No
Inclusion Criteria	Participants eligible for inclusion in the study must meet all inclusion criteria within 28 days of randomization into the study. Sign and date the inform consent form (ICF) prior to the start of any study specific qualification procedures. Adults ≥18 years (if the legal age of consent is >18 years old, then follow local regulatory requirements) Life expectancy ≥3 months Has pathologically documented Stage IIIB, IIIC, or stage IV NSCLC disease with or without actionable genomic alterations (AGA) at the time of randomization (based on the American Joint Committee on Cancer, Eighth Edition) and meets following criteria for NSCLC: Participants without AGA: Must have documented negative test results for epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK). Must have no known genomic alterations in ROS proto-oncogene 1 (ROS1), neurotrophic tyrosine receptor kinase (NTRK), proto oncogene B-raf (BRAF), mesenchymal-epithelial transition (MET) exon 14 skipping, or rearranged during transfection (RET). Participants with AGA must have one or more documented actionable genomic alteration(s): EGFR, ALK, ROS1, NTRK, BRAF, MET exon 14 skipping, or RET. Has documentation of radiographic disease progression while on or after receiving the most recent treatment regimen for advanced or metastatic NSCLC. Participant without AGA must meet 1 of the following prior therapy requirements for advanced or metastatic NSCLC: Received platinum-based chemotherapy in combination with α-PD-1/α-PD-L1 monoclonal antibody as the only prior line of therapy. Includes participants who received prior platinum-based/chemotherapy with or without radiotherapy with maintenance α-PD-1/α-PD-L1 monoclonal antibody for Stage III disease and relapsed/progressed within 6 months from the last dose of platinum-based chemotherapy. Includes participants who received prior platinum-based/chemotherapy with or without radiotherapy (with or without maintenance α-PD-1/α-PD-L1 monoclonal antibody) for Stage III disease and subsequently received α-PD-1/α-PD-L1 monoclonal antibody therapy (with or without platinum-based chemotherapy) for recurrent disease. Received platinum-based chemotherapy and α-PD-1/α-PD-L1 monoclonal antibody (in either order) sequentially as the only 2 prior lines of therapy. Participants with AGA must meet the following for advanced or metastatic NSCLC: Participants who have been treated with 1 or 2 prior lines of applicable targeted therapy that is locally approved for the participant's genomic alteration at the time of screening; Participants who have tumors with EGFR L858R or exon 19 deletion mutations must have received prior Osimertinib. Those who received a targeted agent as adjuvant therapy for early-stage disease must have relapsed or progressed while on the treatment or within 6 months of the last dose OR received at least one additional course of targeted therapy for the same genomic alteration (which may or may not be same agent used in the adjuvant setting) for relapsed/progressive disease. Participants who have been treated with a prior TKI must receive additional approved targeted therapy, if locally available and clinically appropriate, for the applicable genomic alteration, or the participant will not be allowed in the study. Participants who have received platinum-based chemotherapy as the only prior line of cytotoxic therapy: One platinum-containing regimen for advanced disease Those who received a platinum-containing regimen as adjuvant therapy for early-stage disease must have relapsed or progressed while on the treatment or within 6 months of the last dose OR received at least one additional course of platinum-containing therapy (which may or may not be same as in the adjuvant setting) for relapsed/progressive disease. May have received up to one α-PD-1/α-PD-L1 monoclonal antibody alone or in combination with a cytotoxic agent. Must undergo a pre-treatment tumor biopsy procedure or if available, tumor tissue previously retrieved from a biopsy procedure performed within 2 years prior to the participant signing informed consent and that has a minimum of 10 × 4 micron sections or a tissue block equivalent of 10 × 4 micron sections may be substituted for the pre-treatment biopsy procedure during Screening. If a documented law or regulation prohibits (or does not approve) sample collection, then such samples will not be collected/submitted Measurable disease based on local imaging assessment using RECIST v1.1 Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at Screening Within 7 days before randomization, has adequate bone marrow, hepatic, and renal function Left ventricular ejection fraction (LVEF) ≥50% by either echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 28 days before randomization Adequate blood clotting function defined as international normalized ratio/prothrombin time and either partial thromboplastin or activated partial thromboplastin time ≤1.5 × upper limit of normal (ULN) Adequate treatment washout period before randomization Females of childbearing potential must have a negative serum pregnancy test at screening and must be willing to use highly effective birth control from the time of enrollment up to 7 months after the last dose of DS-1062a or for at least 6 months after the last dose of docetaxel Males must be surgically sterile or must use a condom in addition to highly effective birth control if his partners are of reproductive potential from the time of enrollment and for at least 4 months after last dose of DS-1062a or for at least 6 months after the last dose of docetaxel Male participants must not freeze or donate sperm from the time of Screening and throughout the study period and for at least 4 months after the last dose of DS-1062a or for at least 6 months after the last dose of docetaxel Female participants must not donate, or retrieve for their own use, ova from the time of Screening and throughout the study period and for at least 7 months after the last dose of DS-1062a and for at least 6 months after the last dose of docetaxel
Exclusion Criteria	Mixed small-cell lung cancer (SCLC) and NSCLC histology Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Participants with clinically inactive brain metastases may be included in the study. Participants with treated brain metastases who are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. Has leptomeningeal carcinomatosis or metastasis Had prior treatment with: Any agent including antibody drug conjugate (ADC) containing a chemotherapeutic agent targeting topoisomerase I TROP2-targeted therapy Docetaxel Had prior treatment with platinum-based chemotherapy and prior immunotherapy for Stage II NSCLC disease (eg, in the neo-adjuvant or adjuvant setting) without subsequently meeting the prior therapy requirements for Stage III or metastatic NSCLC disease Has NSCLC disease that is eligible for definitive local therapy alone Has uncontrolled or significant cardiac disease, including: Mean QT interval corrected for heart rate using Fridericia's formula >470 msec (based on the average of Screening triplicate 12-lead electrocardiogram [ECG] determinations). Myocardial infarction or uncontrolled/unstable angina within 6 months before randomization Congestive heart failure (CHF) (New York Heart Association Class II to IV) at Screening. Participants with a history of Class II to IV CHF prior to Screening, must have returned to Class I CHF and have LVEF ≥50% (by either an ECHO or MUGA scan within 28 days before randomization) in order to be eligible. Uncontrolled or significant cardiac arrhythmia LVEF <50% by ECHO or MUGA scan within 28 days before randomization Uncontrolled hypertension (resting systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg) within 28 days before randomization Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months before randomization, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc.), or any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement (ie, rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc.), or prior pneumonectomy. Significant third-space fluid retention (for example ascites or pleural effusion) and is not amenable for required repeated drainage Clinically significant corneal disease Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals; suspected infections (eg, prodromal symptoms); or inability to rule out infections Has known human immunodeficiency virus (HIV) infection that is not well controlled Has an active or uncontrolled hepatitis B and/or hepatitis C infection, is positive for hepatitis B or C virus based on the evaluation of results of tests for hepatitis B (hepatitis B surface antigen [HBsAg], anti-hepatitis B surface antibody [anti-HBs], anti-hepatitis B core antibody [anti-HBc], or hepatitis B virus [HBV] DNA), and/or hepatitis C infection (as per hepatitis C virus [HCV] RNA) within 28 days of randomization. Has a history of malignancy, other than NSCLC, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated, with no evidence of disease for ≥3 years Toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet improved to NCI-CTCAE version 5.0 Grade ≤1 or baseline Has a history of severe hypersensitivity reactions to either the drug substances, inactive ingredients (including but not limited to polysorbate 80) of DS-1062a or docetaxel, or monoclonal antibodies Pregnant or breastfeeding Has substance abuse or any other medical conditions such as clinically significant cardiac or psychological conditions

Contacts and Locations

Sponsors and Collaborators	Daiichi Sankyo, AstraZeneca
	AstraZeneca
Locations	Ironwood Cancer and Research Center | Chandler, Arizona, United States, 85224 St. Joseph Heritage Healthcare | Anaheim, California, United States, 92835 The Oncology Institute of Hope and Innovation | Glendale, California, United States, 91204 University of California San Diego | La Jolla, California, United States, 92093 UCLA | Los Angeles, California, United States, 90095 PIH Health | Whittier, California, United States, 90602 Memorial Healthcare System- Memorial Cancer Institute | Hollywood, Florida, United States, 33021 Orlando Health | Orlando, Florida, United States, 32806 Florida Cancer Specialists | Tallahassee, Florida, United States, 32308 Northwestern University | Chicago, Illinois, United States, 60611 University of Chicago | Chicago, Illinois, United States, 60637 Ft. Wayne Medical Oncology and Hematology | Fort Wayne, Indiana, United States, 46804 Baptist Health Louisville | Louisville, Kentucky, United States, 40207 Baton Rouge General | Baton Rouge, Louisiana, United States, 70809 American Oncology Partners of Maryland | Bethesda, Maryland, United States, 20817 Dana-Farber Cancer Institute | Boston, Massachusetts, United States, 02115 Karmanos Cancer Institute | Detroit, Michigan, United States, 48201 OptumCare Cancer Care | Las Vegas, Nevada, United States, 89106 Meridian Hematology and Oncology | Manahawkin, New Jersey, United States, 08050 Astera Cancer Care | Somerset, New Jersey, United States, 08873 Montefiore Medical Center | Bronx, New York, United States, 10461 Messino Cancer Centers | Asheville, North Carolina, United States, 28806 University Hospitals Cleveland Medical Center | Cleveland, Ohio, United States, 44106 Roger Williams Medical Center | Providence, Rhode Island, United States, 02908 Avera Cancer Institute | Sioux Falls, South Dakota, United States, 57105 Sarah Cannon Research Institute | Nashville, Tennessee, United States, 37203 The Center for Cancer and Blood Disorders | Fort Worth, Texas, United States, 76104 Utah Cancer Specialists | Salt Lake City, Utah, United States, 84106 University of Virginia Health System | Charlottesville, Virginia, United States, 22903 Virginia Cancer Specialist | Fairfax, Virginia, United States, 22031 Kadlec Clinic Hematology and Oncology | Kennewick, Washington, United States, 99336 Northwest Medical Specialties | Tacoma, Washington, United States, 98405 CER San Juan | Buenos Aires, Argentina, 01878 Centro de Investigacion Pergamino S.A. | Pergamino, Argentina, B2700CPM Instituto de OncologÃÂ-a de Rosario | Rosario, Argentina, S2000KZE Gaston Martinengo | Rosario, Argentina, S2000 Flinders Medical Centre | Bedford Park, Australia, 05042 Blacktown Hosital | Blacktown, Australia, 02148 Austin Hospital | Heidelberg, Australia, 03084 Macquarie Hospital | North Ryde, Australia, 02109 Crown Princess Mary Cancer Centre Westmead Hospital | Sydney, Australia, 2145 Southern Medical Day Care Centre | Wollongong, Australia, 02500 Centre Hospitalier Jolimont-Lobbes | Haine-Saint-Paul, Belgium, 07100 CHA Centre Hospitalier de l Ardenne | Libramont, Belgium, B-6800 CHR site de la Citadelle | Liège, Belgium, 04000 CHU UCL Namur | Yvoir, Belgium, 05530 Instituto do Cancer do Ceara - ICC | Fortaleza, Brazil, 60430-230 Hospital Sao Lucas da Pucrs | Porto Alegre, Brazil, 90610-000 Hospital Nossa Senhora da Conceição | Porto Alegre, Brazil, 91350-200 Instituto Nacional de Cancer-INCA | Rio De Janeiro, Brazil, 20231-050 Hospital de Base de Sao Jose do Rio Preto | São José Do Rio Preto, Brazil, 15090-000 Cross Cancer Institute | Edmonton, Alberta, Canada, T6G 1Z2 University Health Network - Princess Margaret Hospital | Toronto, Ontario, Canada, M5G0A3 Sunnbrook Health Sciences Centre | Toronto, Ontario, Canada, ON M4N 3M5 MUHC-Glen Site and MUHC Research Institute | Montréal, Quebec, Canada, H4A 3J1 Beijing Cancer Hospital | Beijing, China, 100142 Hunan Cancer Hospital | Changsha, China, Xiangya Hospital central south university | Changsha, China, Linyi Cancer Hospital | Hangzhou, China, 310003 The First Affiliated Hospital of Zhejiang University | Hangzou, China, 310022 Harbin Medical University Cancer Hospital | Heilongjiang, China, 150081 Jiamusi Cancer Tuberculosis Hospital | Heilongjiang, China, 154007 Fudan University Shanghai Cancer Center | Henan, China, 450008 Hubei Cancer Hospital | Hubei, China, 430079 Jiangsu Province Hospital | Nanjing, China, The First Affiliated Hospital of Xi'an Jiaotong University | Shandong, China, 276000 Henan Cancer Hospital | Shanghai Sheng, China, 200032 Shanghai Chest Hospital | Shanghai, China, Zhejiang Cancer Hospital | Shanxi, China, 710061 West China Hospital, Sichuan University | Sichuan Province, China, Tianjin Medical University Cancer Institute and Hospital | Tianjin, China, 300060 Affiliated Cancer Hospital of Xinjiang Medical University | Urumqi, China, Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology | Wuhan, China, 43002 Sir Run Run Shaw Hospital Zhejiang University School of Medicine | Zhejiang, China, 310016 Vseobecna Fakultni Nemocnice VFN | Praha, Czechia, 12800 Hopital Jean Minjoz | Besançon, France, 25030 Centre Hospitalier Universitaire de Grenoble | Grenoble, France, 38043 Centre Leon Berard | Lyon, France, 69008 CHU Louis Pradel | Lyon, France, APHM - Hopital Nord | Marseille, France, 13915 University Hospital of Nantes - Thoracic Oncology | Nantes, France, 44000 Institut Curie | Paris, France, 75248 CHU de Poitier Pole regional de Cancerologie | Poitiers, France, 86000 Hopital Pontchaillou | Rennes, France, 35000 Hopitaux Universitaire de Strasbourg | Strasbourg, France, 67098 Hopital Foch | Sureesnes, France, 92150 CHU Toulouse Hopital Larrey | Toulouse, France, 31059 Gustav Roussy Cancer Campus Grand Paris | Villejuif, France, 94805 Charite - Universitaetsmedizin Berlin | Berlin, Germany, 10117 Evangelische Lungenklinik Berlin | Berlin, Germany, 13125 IKF Krankenhaus Nordwest | Frankfurt am main, Germany, 60488 Universitaetsklinikum Freiburg | Freiburg, Germany, 79106 Asklepios Fachklinik Muenchen-Gauting | Gauting, Germany, 82131 Thoraxklinik Heidelberg gGmbH | Heidelberg, Germany, 69126 Lungenklinik Hemer | Hemer, Germany, 58675 Klinikverbund Allgäu | Kempten, Germany, 87439 Universitaet zu Koeln - Uniklinik Koeln | Koeln, Germany, 50937 Medizinische Klinik V | Standort Gießen, Germany, Klinikum Traunstein | Traunstein, Germany, Queen Mary Hospital | Hong Kong, Hong Kong, 999077 Prince of Wales Hospital / The Chinese University of Hong Kong | Hong Kong, Hong Kong, 99999 Orszagos Koranyi TBC es Pulmonologiai Intezet | Budapest, Hungary, 01121 Uzsoki Utcai Korhaz | Budapest, Hungary, 1145 Szent Borbala Korhaz | Tatabánya, Hungary, 02800 Tolna Megyei Balassa Janos Korhaz | Tolna, Hungary, Tudogyogyintezet Torokbalint | Torokbalint, Hungary, H-2045 Azienda Ospedaliero- Universitaria Policlinico S. Orsola-Malpighi | Bologna, Italy, 40138 Azienda Ospedaliera Universitaria Policlinico G Rodolico San Marco | Catania, Italy, 95030 ASL 3 Genovese Oncologia Medica Villa Scassi | Genova, Italy, 16149 Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico | Milano, Italy, 20122 IRCCS Istituto Europeo di Oncologia | Milano, Italy, 20141 Fondazione IRCCS Istituto Nazionale Tumori | Milan, Italy, 20133 Azienda Ospedaliero-Universitaria San Luigi Gonzaga | Orbassano, Italy, 10043 Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Roma, Italy, 00168 Instituicao de Fisioterapeutas Ocupacionais | Roma, Italy, RM00144 Hyogo Cancer Center | Akashi, Japan, 673-8558 Niigata Cancer Center Hospital | Chuo Ku, Japan, 951-8566 Kyushu University Hospital | Fukuoka, Japan, 812-8582 Saitama Medical University International Medical Center | Hidaka, Japan, 350-1298 Kansai Medical University Hospital | Hirakata, Japan, 573-1191 Kanazawa University Hospital | Kanazawa, Japan, 920-8641 National Cancer Center Hospital East | Kashiwa, Japan, 277-8577 The Cancer Institute Hospital of JFCR | Koto-Ku, Japan, 135-8550 Kyoto University Hospital | Kyoto, Japan, 606-8507 NHO Shikoku Cancer Center | Matsuyama, Japan, 791-0280 Shizuoka Cancer Center | Nagaizumi-chō, Japan, 411-8777 Okayama University Hospital | Okayama, Japan, 36927 Osaka City General Hospital | Osaka-shi, Japan, 534-0021 Osaka International Cancer Institute | Osaka, Japan, 541-8567 Saitama Cancer Center | Saitama, Japan, 362-0806 Sendai Kousei Hospital | Sendai-shi, Japan, 980-0873 NHO Hokkaido Cancer Center | Shiroishi, Japan, 003-0804 Tokushima University Hospital | Tokushima, Japan, 770-8503 National Cancer Center Hospital | Tokyo, Japan, 104-0045 Fujita Health University Hospital | Toyoake, Japan, 470-1192 Kindai University Hospital | Ōsaka-sayama, Japan, 589-8511 Chungbuk National University Hospital | Cheongju-si, Korea, Republic of, 28644 Kyungpook National University Chilgok Hospital | Daegu, Korea, Republic of, 41404 St. Vincents Hospital The Catholic University of Korea | Gyeonggi-do, Korea, Republic of, 16247 Seoul National University Bundang Hospital | Seongnam-si, Korea, Republic of, 13620 Kangbuk Samsung Hospital | Seoul, Korea, Republic of, 03181 Yonsei University Health System - Severance Hospital | Seoul, Korea, Republic of, 03722 Asan Medical Center | Seoul, Korea, Republic of, 05505 Samsung Medical Center | Seoul, Korea, Republic of, 06351 The Catholic University of Korea, Seoul St. Marys Hospital | Seoul, Korea, Republic of, 06591 Seoul National University Boramae Medical Center | Seoul, Korea, Republic of, 07061 San Peregrino Cancer Center | Aguascalientes, Mexico, 20230 Hospital Medica Sur Tlalpan | Ciudad de mexico, Mexico, 14050 Hospital Civil de Guadalajara Fray Antonio Alcalde | Guadalajara, Mexico, 44280 Hospital Universitario Jose Eleuterio Gonzalez | Monterrey, Mexico, 64460 Erasmus MC | Amsterdam, Netherlands, 3000 CA Amphia Ziekenhuis | Breda, Netherlands, 4818 CK Isala Klinieken | Harderwijk, Netherlands, 3844 DG St. Jansdal Ziekenhuis | Rotterdam, Netherlands, 3015 CD II Klinika Chorob Pluc i Gruzlicy | Białystok, Poland, 15-276 Szpitale Pomorskie Sp.zo.o | Gdynia, Poland, 81-519 Ms Pneumed | Lublin, Poland, 20-090 SP Zespol Gruzlicy i Chorob Pluc | Olsztyn, Poland, 10-357 Med Polonia Sp. z o.o. | Poznań, Poland, 60-693 Szpital Specjalistyczny w Prabutach Sp. z o.o. | Prabuty, Poland, 82-550 Oddział Onkologii Wojewódzki Szpital Specjalistyczny Słupsk | Słupsk, Poland, 76-200 Magodent Sp. z.o.o Szpital Elblaska | Warsaw, Poland, 01-748 Maria Sklodowska-Curie National Research Institute of Oncology | Warsaw, Poland, 02-781 FDI Clinical Research | San Juan, Puerto Rico, 00927 SC Oncopremium Team SRL | Baia Mare, Romania, 430291 Centrul Medical Sanador | Bucharest, Romania, 20125 Institutul Oncologic Profesor Doctor Alexandru Trestioreanu | Bucuresti, Romania, 022328 Clinical Emergency Hospital | Constanţa, Romania, 900591 Onco Clinic Consult SA | Craiova, Romania, 200103 Sf Nectarie Oncology Center | Craiova, Romania, 200347 Oncolab SRL | Craiova, Romania, 200385 SC Oncomed SRL | Timişoara, Romania, 300425 Kursk Regional Clinical Oncology Dispensary | Kursk, Russian Federation, 305524 Federal State Budgetary Institution - N.N. Blokhin National Medical Research Center of Oncology | Moscow, Russian Federation, 115478 University Headache Clinic LLC | Moscow, Russian Federation, 121467 VitaMed LLC | Moscow, Russian Federation, 129515 Institute of Oncology Hadassah Moscow | Moscow, Russian Federation, LLC MSCH "Klinitsist" | Novosibirsk, Russian Federation, 630099 N.N. Petrov Research Institute of Oncology | Saint Petersburg, Russian Federation, 197758 National Cancer Centre Singapore | Singapore, Singapore, 169610 ICON Cancer Centre Farrer Park Hospital | Singapore, Singapore, 217562 OncoCare Cancer Centre - Gleneagles Medical Centre Location | Singapore, Singapore, 258499 Hospital de la Santa Creu i Sant Pau | Barcelona, Spain, 08025 Hospital Clinic i Provincial de Barcelona | Barcelona, Spain, 08036 Hospital Universitario Vall d'Hebron | Barcelona, Spain, 80350 Hospital Universitario Fundacion Jimenez Diaz | Madrid, Spain, 28040 Hospital Universitario 12 de Octubre | Madrid, Spain, 28041 Hospital Puerte de Hierro de Majadahonda | Madrid, Spain, 28222 Hospital Regional Universitario Málaga | Málaga, Spain, 29010 CHUO | Ourense, Spain, 32005 Hospital Virgen Macarena | Sevilla, Spain, 41007 Hospital Universitario de Valme | Sevilla, Spain, 41014 Hospital General Universitario de Valencia | Valencia, Spain, 46014 Hospital Universitari i Politecnic La Fe | Valencia, Spain, 46026 Hospital Clinico Universitario Lozano Bleza | Zaragoza, Spain, 50009 Inselspital Universitätsspital Bern | Bern, Switzerland, 3010 Kantonsspital St. Gallen | Saint Gallen, Switzerland, 9007 Stadtspital Waid ; Triemli, Site Triemli - clinic for Medical oncology & hematology | Zürich, Switzerland, 8063 E-Da Hospital | Kaohsiung City, Taiwan, 00824 Chang Gung Memorial Hospital CGMH - Kaohsiung Branch | Niaosong, Taiwan, 00833 Chung Shan Medical University Hospital | Taichung, Taiwan, 00420 Taichung Veterans General Hospital | Taichung, Taiwan, 40705 National Cheng Kung University Hospital NCKUH | Tainan, Taiwan, 00704 Chi Mei Medical Center CMMC - Liouying Branch | Tainan, Taiwan, 00736 National Taiwan University Hospital NTUH | Taipei, Taiwan, 00100 LinKou Chang Gung Memorial Hospital | Taoyuan, Taiwan, 333 University College Hospital | London, United Kingdom, NW1 2BU The Christie Hospital | Manchester, United Kingdom, M20 4BX The James Cook University Hospital | Middlesbrough, United Kingdom, TS4 3BW
Investigators

More Information

Additional Relevant MeSH Terms

• Lung Neoplasms
• Carcinoma, Non-Small-Cell Lung
• Respiratory Tract Neoplasms
• Thoracic Neoplasms
• Neoplasms by Site
• Neoplasms
• Lung Diseases
• Respiratory Tract Diseases
• Carcinoma, Bronchogenic
• Bronchial Neoplasms