MedPath

Pembrolizumab/Vibostolimab (MK-7684A) or Atezolizumab in Combination With Chemotherapy in First Line Treatment of Extensive-Stage Small Cell Lung Cancer (MK-7684A-008, KEYVIBE-008)

Phase 3
Active, not recruiting
Conditions
Small Cell Lung Carcinoma
Interventions
Drug: Saline placebo
Biological: Pembrolizumab/Vibostolimab Co-Formulation
Registration Number
NCT05224141
Lead Sponsor
Merck Sharp & Dohme LLC
Brief Summary

This study will evaluate the combination of a fixed dose pembrolizumab/vibostolimab co-formulation (MK-7684A) with etoposide/platinum chemotherapy followed by MK-7684A compared to the combination of atezolizumab with etoposide/platinum chemotherapy followed by atezolizumab in the first-line treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC). The primary hypothesis is, with respect to overall survival, MK-7684A in combination with the background therapy of etoposide/platinum followed by MK-7684A, is superior to atezolizumab in combination with the background therapy of etoposide/platinum followed by atezolizumab.

Detailed Description

With Amendment 4, the experimental Pembrolizumab/Vibostolimab arm (MK-7684A) was discontinued and all ongoing participants were offered an option to move to the comparator Atezolizumab monotherapy arm for the remainder of the study. There will be no further analyses of efficacy, and no European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) and Lung Cancer 13 module (EORTC QLQ-LC13) outcome measures will be reported.

Effective as of Amendment 5, participants with access to approved standard of care (SOC) should be considered for discontinuation from the study. Those benefiting from atezolizumab, but unable to access it as SOC outside the study, may continue on study and receive treatment with atezolizumab until discontinuation criteria are met.

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
460
Inclusion Criteria
  • Has histologically or cytologically confirmed diagnosis of ES-SCLC in need of first-line therapy
  • Has ES-SCLC defined as Stage IV (T any, N any, M1a/b/c) by the American Joint Committee on Cancer, Eighth Edition or T3-T4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan
  • Males agree to use contraception, refrain from donating sperm, and abstain from heterosexual intercourse
  • Females are not pregnant or breastfeeding, is not a woman of childbearing potential (WOCBP) or is a WOCBP who uses a highly effective contraceptive method, or is abstinent from heterosexual intercourse
  • Has measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
  • Has a predicted life expectancy of >3 months
Exclusion Criteria
  • Is considered a poor medical risk due to a serious, uncontrolled medical disorder or non-malignant systemic disease
  • Has received prior treatment for Small Cell Lung Cancer (SCLC)
  • Is expected to require any other form of antineoplastic therapy for SCLC while on study
  • Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
  • Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
  • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Has a history of severe hypersensitivity reaction (≥Grade 3) to any study intervention and/or any of its excipients
  • Has an active autoimmune disease that has required systemic treatment in past 2 years
  • Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
  • Has a known history of, or active, neurologic paraneoplastic syndrome
  • Has an active infection requiring systemic therapy
  • Has a known history of human immunodeficiency virus (HIV) infection
  • Has a known history of Hepatitis B or known active Hepatitis C virus infection
  • Has had an allogenic tissue/solid organ transplant
  • Has had major surgery within prior 3 weeks or has not recovered adequately from toxicity and/or complications from an intervention prior to receiving the first dose of study intervention
  • Has symptomatic ascites or pleural effusion

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
AtezolizumabSaline placeboParticipants will receive 4 cycles (each cycle is 3 weeks) of 1200 mg atezolizumab Q3W, in combination with 100 mg/m\^2 etoposide and platinum (AUC 5 mg/mL/min carboplatin or 75 mg/m\^2 cisplatin) chemotherapy Q3W for a total of approximately 12 weeks. This will be followed by additional cycles of atezolizumab Q3W until any of the conditions for discontinuation are met. To maintain the blinding, saline placebo will be administered on cycle 1 day 1 and then Q3W as needed beyond cycle 1.
Pembrolizumab/VibostolimabPembrolizumab/Vibostolimab Co-FormulationParticipants will receive 4 cycles (each cycle is 3 weeks) of a fixed-dose coformulation of 200 mg pembrolizumab and 200 mg vibostolimab (MK-7684A) every 3 weeks (Q3W), in combination with 100 mg/m\^2 etoposide, and platinum (Area Under the Curve (AUC) 5 mg/mL/min carboplatin or 75 mg/m\^2 cisplatin) chemotherapy Q3W for a total of approximately 12 weeks. This will be followed by additional cycles of MK-7684A Q3W until any of the conditions for discontinuation are met. To maintain the blinding, saline placebo will be administered on cycle 1 day 1 and then Q3W as needed beyond cycle 1.
Pembrolizumab/VibostolimabSaline placeboParticipants will receive 4 cycles (each cycle is 3 weeks) of a fixed-dose coformulation of 200 mg pembrolizumab and 200 mg vibostolimab (MK-7684A) every 3 weeks (Q3W), in combination with 100 mg/m\^2 etoposide, and platinum (Area Under the Curve (AUC) 5 mg/mL/min carboplatin or 75 mg/m\^2 cisplatin) chemotherapy Q3W for a total of approximately 12 weeks. This will be followed by additional cycles of MK-7684A Q3W until any of the conditions for discontinuation are met. To maintain the blinding, saline placebo will be administered on cycle 1 day 1 and then Q3W as needed beyond cycle 1.
Pembrolizumab/VibostolimabEtoposideParticipants will receive 4 cycles (each cycle is 3 weeks) of a fixed-dose coformulation of 200 mg pembrolizumab and 200 mg vibostolimab (MK-7684A) every 3 weeks (Q3W), in combination with 100 mg/m\^2 etoposide, and platinum (Area Under the Curve (AUC) 5 mg/mL/min carboplatin or 75 mg/m\^2 cisplatin) chemotherapy Q3W for a total of approximately 12 weeks. This will be followed by additional cycles of MK-7684A Q3W until any of the conditions for discontinuation are met. To maintain the blinding, saline placebo will be administered on cycle 1 day 1 and then Q3W as needed beyond cycle 1.
Pembrolizumab/VibostolimabCisplatinParticipants will receive 4 cycles (each cycle is 3 weeks) of a fixed-dose coformulation of 200 mg pembrolizumab and 200 mg vibostolimab (MK-7684A) every 3 weeks (Q3W), in combination with 100 mg/m\^2 etoposide, and platinum (Area Under the Curve (AUC) 5 mg/mL/min carboplatin or 75 mg/m\^2 cisplatin) chemotherapy Q3W for a total of approximately 12 weeks. This will be followed by additional cycles of MK-7684A Q3W until any of the conditions for discontinuation are met. To maintain the blinding, saline placebo will be administered on cycle 1 day 1 and then Q3W as needed beyond cycle 1.
Pembrolizumab/VibostolimabCarboplatinParticipants will receive 4 cycles (each cycle is 3 weeks) of a fixed-dose coformulation of 200 mg pembrolizumab and 200 mg vibostolimab (MK-7684A) every 3 weeks (Q3W), in combination with 100 mg/m\^2 etoposide, and platinum (Area Under the Curve (AUC) 5 mg/mL/min carboplatin or 75 mg/m\^2 cisplatin) chemotherapy Q3W for a total of approximately 12 weeks. This will be followed by additional cycles of MK-7684A Q3W until any of the conditions for discontinuation are met. To maintain the blinding, saline placebo will be administered on cycle 1 day 1 and then Q3W as needed beyond cycle 1.
AtezolizumabEtoposideParticipants will receive 4 cycles (each cycle is 3 weeks) of 1200 mg atezolizumab Q3W, in combination with 100 mg/m\^2 etoposide and platinum (AUC 5 mg/mL/min carboplatin or 75 mg/m\^2 cisplatin) chemotherapy Q3W for a total of approximately 12 weeks. This will be followed by additional cycles of atezolizumab Q3W until any of the conditions for discontinuation are met. To maintain the blinding, saline placebo will be administered on cycle 1 day 1 and then Q3W as needed beyond cycle 1.
AtezolizumabCarboplatinParticipants will receive 4 cycles (each cycle is 3 weeks) of 1200 mg atezolizumab Q3W, in combination with 100 mg/m\^2 etoposide and platinum (AUC 5 mg/mL/min carboplatin or 75 mg/m\^2 cisplatin) chemotherapy Q3W for a total of approximately 12 weeks. This will be followed by additional cycles of atezolizumab Q3W until any of the conditions for discontinuation are met. To maintain the blinding, saline placebo will be administered on cycle 1 day 1 and then Q3W as needed beyond cycle 1.
AtezolizumabCisplatinParticipants will receive 4 cycles (each cycle is 3 weeks) of 1200 mg atezolizumab Q3W, in combination with 100 mg/m\^2 etoposide and platinum (AUC 5 mg/mL/min carboplatin or 75 mg/m\^2 cisplatin) chemotherapy Q3W for a total of approximately 12 weeks. This will be followed by additional cycles of atezolizumab Q3W until any of the conditions for discontinuation are met. To maintain the blinding, saline placebo will be administered on cycle 1 day 1 and then Q3W as needed beyond cycle 1.
AtezolizumabAtezolizumabParticipants will receive 4 cycles (each cycle is 3 weeks) of 1200 mg atezolizumab Q3W, in combination with 100 mg/m\^2 etoposide and platinum (AUC 5 mg/mL/min carboplatin or 75 mg/m\^2 cisplatin) chemotherapy Q3W for a total of approximately 12 weeks. This will be followed by additional cycles of atezolizumab Q3W until any of the conditions for discontinuation are met. To maintain the blinding, saline placebo will be administered on cycle 1 day 1 and then Q3W as needed beyond cycle 1.
Primary Outcome Measures
NameTimeMethod
Overall Survival (OS)Up to approximately 25.6 months

Overall Survival (OS) is the time from randomization to the date of death due to any cause.

Secondary Outcome Measures
NameTimeMethod
Progression-Free Survival (PFS)Up to approximately 25.6 months

Progression-Free Survival (PFS) is the time from randomization to the first documented disease progression (PD) or death due to any cause, whichever occurs first.

Objective Response Rate (ORR)Up to approximately 25.6 months

Objective Response Rate (ORR) is the percentage of participants who have a Complete Response (CR) (disappearance of all target lesions) or a Partial Response (PR) (at least a 30% decrease in the sum of diameters of target lesions).

Duration of Response (DOR)Up to approximately 25.6 months

Duration of Response (DOR) is the time from first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions), until progressive disease (PD) or death.

Percentage of Participants Who Experienced an Adverse Event (AE)Up to approximately 60 months

An AE is any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.

Percentage of Participants Who Discontinued Study Treatment Due to an AEUp to approximately 60 months

An AE is any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.

Change from Baseline in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)Baseline and up to approximately 37 months

The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall QoL during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome.

Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30Baseline and up to approximately 37 months

The EORTC QLQ-C30 is a cancer specific health-related QoL questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function.

Change from Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30Baseline and up to approximately 37 months

The EORTC QLQ-C30 is a cancer specific health-related QoL questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea.

Change from Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13)Baseline and up to approximately 37 months

The EORTC QLQ-LC13 is a lung cancer specific health-related QoL questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing.

Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13Baseline and up to approximately 37 months

EORTC QLQ-LC13 is a lung cancer specific health-related QoL questionnaire. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain.

Time to True Deterioration (TTD) in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the EORTC QLQ-C30Baseline and up to approximately 37 months

The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the QoL of individuals with cancer. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall QoL during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.

TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30Baseline and up to approximately 37 months

The EORTC QLQ-C30 is a cancer specific health-related QoL questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.

TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30Baseline and up to approximately 37 months

The EORTC QLQ-C30 is a cancer specific health-related QoL questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.

TTD in Cough Score (Item 31) on the EORTC QLQ-LC13Baseline and up to approximately 37 months

The EORTC QLQ-LC13 is a lung cancer specific health-related QoL questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.

TTD in Chest Pain Score (Item 40) on the EORTC QLQ-LC13Baseline and up to approximately 37 months

The EORTC QLQ-LC13 is a lung cancer specific health-related QoL questionnaire. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.

Trial Locations

Locations (140)

National Cancer Center Hospital East ( Site 3002)

🇯🇵

Kashiwa, Chiba, Japan

Lakeridge Health ( Site 0102)

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Oshawa, Ontario, Canada

LungenClinic Grosshansdorf-Onkologie ( Site 0903)

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Grosshansdorf, Schleswig-Holstein, Germany

Turku University Hospital-The Department of Pulmonary Medicine ( Site 0701)

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Turku, Varsinais-Suomi, Finland

St. James's Hospital ( Site 1200)

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Dublin, Ireland

Sheba Medical Center-ONCOLOGY ( Site 1302)

🇮🇱

Ramat Gan, Israel

Rambam Health Care Campus-Oncology ( Site 1301)

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Haifa, Israel

Shizuoka Cancer Center ( Site 3007)

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Nagaizumi, Shizuoka, Japan

Boca Raton Regional Hospital-Lynn Cancer Institute ( Site 0014)

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Boca Raton, Florida, United States

Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Medical Oncology ( Site 0200)

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Buenos Aires, Caba, Argentina

Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0005)

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Lancaster, Pennsylvania, United States

Los Angeles Hematology Oncology Medical Group ( Site 0006)

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Los Angeles, California, United States

VA West Los Angeles Medical Center ( Site 0004)

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Los Angeles, California, United States

Instituto de Investigaciones Clínicas Mar del Plata ( Site 0201)

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Mar del Plata, Buenos Aires, Argentina

Dana-Farber Cancer Institute ( Site 0018)

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Boston, Massachusetts, United States

Anhui Cancer Hospital ( Site 2915)

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Hefei, Anhui, China

Fujian Provincial Cancer Hospital-oncology department ( Site 2904)

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Fuzhou, Fujian, China

Jilin Cancer Hospital-GCP office ( Site 2909)

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Changchun, Jilin, China

The First Hospital of Jilin University ( Site 2914)

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Changchun, Jilin, China

Assistance Publique Hôpitaux de Marseille - Hôpital Nord ( Site 0805)

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Marseille, Bouches-du-Rhone, France

Shanghai Chest Hospital-Oncology department ( Site 2900)

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Shanghai, Shanghai, China

SRH Wald-Klinikum Gera-Lungenkrebszentrum ( Site 0900)

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Gera, Thuringen, Germany

Calvary Mater Newcastle ( Site 2703)

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Waratah, New South Wales, Australia

Sir Run Run Shaw Hospital-Medical Oncology ( Site 2906)

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Hangzhou, Zhejiang, China

Hunan Cancer Hospital ( Site 2907)

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Changsha, Hunan, China

West China Hospital Sichuan University ( Site 2903)

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Chengdu, Sichuan, China

Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1403)

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Rozzano, Milano, Italy

Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2901)

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Beijing, Beijing, China

Henan Cancer Hospital ( Site 2916)

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Zhengzhou, Henan, China

The First Affiliated Hospital of Soochow University ( Site 2913)

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Suzhou, Jiangsu, China

Wuhan Union Hospital Cancer Center-Cancer Center ( Site 2912)

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Wuhan, Hubei, China

Thoraxklinik-Heidelberg gGmbH-Studienzentrum Thoraxonkologie ( Site 0905)

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Heidelberg, Baden-Wurttemberg, Germany

Hubei Cancer Hospital ( Site 2922)

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Wuhan, Hubei, China

The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 2910)

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Xi'an, Shaanxi, China

Vaasan Keskussairaala-Department of Clinical Oncology ( Site 0700)

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Vaasa, Pohjanmaa, Finland

Zhejiang Cancer Hospital-Oncology ( Site 2919)

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Hangzhou, Zhejiang, China

Centre Hospitalier Universitaire de Limoges - Hôpital Dupuyt-Unité d'oncologie thoracique et cutané

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Limoges, Haute-Vienne, France

Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1401)

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Milan, Lombardia, Italy

Torokbalint Tudogyogyintezet-Onkopulmonologiai Jarobeteg Centrum ( Site 1101)

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Törökbálint, Pest, Hungary

Azienda Ospedaliera Dei Colli-U.O.C Pneumologia Oncologica DH PNL ONC ( Site 1402)

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Naples, Campania, Italy

Kanagawa cancer center-Department of Thoracic Oncology ( Site 3004)

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Yokohama, Kanagawa, Japan

Niigata Cancer Center Hospital ( Site 3005)

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Niigata-shi, Niigata, Japan

Chonnam National University Hwasun Hospital-Pulmonology ( Site 2800)

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Hwasun, Jeonranamdo, Korea, Republic of

TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2401)

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Istanbul, Turkey

Ege University Medicine of Faculty-Chest Diseases Department ( Site 2402)

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Bornova, Izmir, Turkey

Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 2100)

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Barcelona, Spain

I.E.U. Medical Point Hastanesi-Oncology ( Site 2408)

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Izmir, Karsiyaka, Izmir, Turkey

Hacettepe Universitesi-oncology hospital ( Site 2409)

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Ankara, Turkey

Ankara Bilkent City Hospital ( Site 2403)

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Ankara, Turkey

The Christie-Clinical Research Facility ( Site 2607)

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Manchester, England, United Kingdom

Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 2103)

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Sevilla, Spain

Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 2407)

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Adana, Turkey

Memorial Ankara Hastanesi-Medical Oncology ( Site 2406)

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Ankara, Turkey

Mount Vernon Hospital ( Site 2602)

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Northwood, Hillingdon, United Kingdom

Heartlands Hospital-Oncology Research ( Site 2604)

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Birmingham, United Kingdom

Infirmary Cancer Care ( Site 0022)

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Mobile, Alabama, United States

Kyungpook National University Chilgok Hospital-Pulmonology ( Site 2801)

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Deagu, Taegu-Kwangyokshi, Korea, Republic of

Chungnam national university hospital-Department of Internal Medicine ( Site 2802)

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Daejeon, Taejon-Kwangyokshi, Korea, Republic of

Fort Wayne Medical Oncology and Hematology ( Site 0013)

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Fort Wayne, Indiana, United States

Cancer and Hematology Centers of Western Michigan ( Site 0001)

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Grand Rapids, Michigan, United States

Blue Ridge Cancer Care ( Site 0015)

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Blacksburg, Virginia, United States

University of Virginia Cancer Center ( Site 0019)

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Charlottesville, Virginia, United States

Harbin Medical University Cancer Hospital-oncology of department ( Site 2920)

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Harbin, Heilongjiang, China

Sichuan Cancer hospital ( Site 2923)

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Chengdu, Sichuan, China

Klinik Penzing-2. Lungenabteilung ( Site 0502)

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Vienna, Wien, Austria

Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 0106)

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Kingston, Ontario, Canada

Lungenfachklinik Immenhausen-Thoracic Oncology ( Site 0907)

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Immenhausen, Hessen, Germany

Medizinische Hochschule Hannover-Department of Pneumology ( Site 0901)

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Hannover, Niedersachsen, Germany

Fudan University Shanghai Cancer Center ( Site 2908)

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Shanghai, Shanghai, China

Beaumont Hospital, Dublin-Cancer Clinical Trials & Research Unit ( Site 1201)

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Dublin, Ireland

Petz Aladar Egyetemi Oktato Korhaz-Pulmonológia (Dr. Szalai Zsuzsanna) ( Site 1102)

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Gyor, Gyor-Moson-Sopron, Hungary

Istituto Nazionale Tumori Regina Elena-Oncologia Medica 2 ( Site 1400)

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Rome, Roma, Italy

Shaare Zedek Medical Center-Oncology ( Site 1300)

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Jerusalem, Israel

Korea University Guro Hospital-Internal Medicine ( Site 2803)

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Seoul, Korea, Republic of

Maastricht UMC+-Pulmonary disease ( Site 1602)

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Maastricht, Limburg, Netherlands

Jeroen Bosch Hospital-Pulmonology ( Site 1605)

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Den Bosch, Noord-Brabant, Netherlands

Przychodnia Lekarska KOMED ( Site 1701)

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Konin, Wielkopolskie, Poland

Hospital Universitario 12 de Octubre-Medical Oncology ( Site 2102)

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Madrid, Madrid, Comunidad De, Spain

H.R.U Málaga - Hospital General-Oncology ( Site 2104)

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Málaga, Malaga, Spain

Medipol University Medical Faculty-oncology ( Site 2400)

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Istanbul, Turkey

Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 2701)

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St Albans, Victoria, Australia

Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 0505)

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Linz, Oberosterreich, Austria

Sanatorio Parque ( Site 0202)

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Rosario, Santa Fe, Argentina

Isala, locatie Zwolle-Poli Longziekten ( Site 1612)

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Zwolle, Overijssel, Netherlands

Medizinische Universität Graz ( Site 0504)

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Graz, Steiermark, Austria

CHU de Toulouse - Hopital Larrey-service de pneumologie ( Site 0800)

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Toulouse, Haute-Garonne, France

University General Hospital of Heraklion ( Site 1004)

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Heraklion, Irakleio, Greece

European Interbalkan Medical Center ( Site 1000)

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Thessaloniki, Greece

Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1105)

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Kecskemét, Bacs-Kiskun, Hungary

Aichi Cancer Center Hospital ( Site 3016)

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Nagoya, Aichi, Japan

National Hospital Organization Hokkaido Cancer Center ( Site 3015)

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Sapporo, Hokkaido, Japan

Kanazawa University Hospital ( Site 3006)

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Kanazawa, Ishikawa, Japan

Kansai Medical University Hospital ( Site 3009)

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Hirakata, Osaka, Japan

Japanese Foundation for Cancer Research ( Site 3003)

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Koto, Tokyo, Japan

National Hospital Organization Kyushu Medical Center ( Site 3013)

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Fukuoka, Japan

Okayama University Hospital ( Site 3011)

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Okayama, Japan

Hattiesburg Clinic Hematology/Oncology ( Site 0003)

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Hattiesburg, Mississippi, United States

Frankston Hospital-Oncology and Haematology ( Site 2702)

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Frankston, Victoria, Australia

Ziekenhuis Rijnstate ( Site 1606)

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Arnhem, Gelderland, Netherlands

Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0203)

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ABB, Caba, Argentina

Kepler Universitätsklinikum ( Site 0507)

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Linz, Oberosterreich, Austria

Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 0501)

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Wien, Austria

Oulun yliopistollinen sairaala-Oncology and Hematology ( Site 0702)

🇫🇮

Oulu, Pohjois-Pohjanmaa, Finland

Errikos Dunant Hospital Center-Second Department of Oncology and Clinical Trials Unit ( Site 1002)

🇬🇷

Athens, Attiki, Greece

Sotiria Thoracic Diseases Hospital of Athens ( Site 1003)

🇬🇷

Athens, Attiki, Greece

Metropolitan Hospital ( Site 1001)

🇬🇷

Athens, Attiki, Greece

Somogy Megyei Kaposi Mór Oktató Kórház-Pulmonologiai Osztaly ( Site 1104)

🇭🇺

Kaposvár, Somogy, Hungary

National Hospital Organization Shikoku Cancer Center ( Site 3012)

🇯🇵

Matsuyama, Ehime, Japan

Kurume University Hospital ( Site 3014)

🇯🇵

Kurume, Fukuoka, Japan

Klaipeda University Hospital-Oncology chemotherapy ( Site 1502)

🇱🇹

Klaipeda, Klaipedos Miestas, Lithuania

National Cancer Institute-Department of Thoracic Surgery and Oncology ( Site 1501)

🇱🇹

Vilnius, Vilniaus Miestas, Lithuania

Centro de Investigacion Clinica de Oaxaca ( Site 0410)

🇲🇽

Oaxaca, Mexico

Medische Centrum Leeuwarden ( Site 1619)

🇳🇱

Leeuwarden, Fryslan, Netherlands

Sendai Kousei Hospital ( Site 3001)

🇯🇵

Sendai, Miyagi, Japan

Arké SMO S.A. de C.V. ( Site 0401)

🇲🇽

Mexico, Distrito Federal, Mexico

Erasmus Medisch Centrum ( Site 1621)

🇳🇱

Rotterdam, Zuid-Holland, Netherlands

Martini Ziekenhuis ( Site 1618)

🇳🇱

Groningen, Netherlands

Hospital of Lithuanian University of Health Sciences Kauno klinikos-Pulmonology ( Site 1500)

🇱🇹

Kaunas, Lithuania

iCan Oncology Center Centro Medico AVE ( Site 0406)

🇲🇽

Monterrey, Nuevo Leon, Mexico

Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1709)

🇵🇱

Siedlce, Mazowieckie, Poland

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier

🇵🇱

Warszawa, Mazowieckie, Poland

Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1703)

🇵🇱

Przemysl, Podkarpackie, Poland

Szpital Specjalistyczny w Prabutach Spolka z o.o. ( Site 1706)

🇵🇱

Prabuty, Pomorskie, Poland

Centrum Pulmonologii i Torakochirurgii w Bystrej ( Site 1707)

🇵🇱

Bystra, Slaskie, Poland

Hospital Civil Fray Antonio Alcalde-Oncology ( Site 0407)

🇲🇽

Guadalajara, Jalisco, Mexico

Actualidad Basada en la Investigación del Cáncer-Lung Cancer ( Site 0403)

🇲🇽

Guadalajara, Jalisco, Mexico

Med-Polonia Sp. z o. o. ( Site 1710)

🇵🇱

Poznan, Wielkopolskie, Poland

Champalimaud Foundation ( Site 1812)

🇵🇹

Lisbon, Lisboa, Portugal

Hospital CUF Descobertas ( Site 1815)

🇵🇹

Lisbon, Lisboa, Portugal

Centro Hospitalar do Porto - Hospital de Santo António ( Site 1813)

🇵🇹

Porto, Portugal

Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 1810)

🇵🇹

Porto, Portugal

MedEuropa Bucuresti - Centru de Radioterapie-Oncology ( Site 1905)

🇷🇴

București, Bucuresti, Romania

Centrul medical Focus ( Site 1903)

🇷🇴

București, Bucuresti, Romania

Cardiomed SRL Cluj-Napoca ( Site 1900)

🇷🇴

Cluj-Napoca, Cluj, Romania

Centrul de Oncologie Oncolab-Medical Oncology ( Site 1904)

🇷🇴

Craiova, Dolj, Romania

Centrul de Oncologie "Sfântul Nectarie"-Medical Oncology ( Site 1901)

🇷🇴

Craiova, Dolj, Romania

Cabinet Medical Oncomed ( Site 1902)

🇷🇴

Timișoara, Timis, Romania

Hospital Provincial del Centenario ( Site 0205)

🇦🇷

Rosario, Santa Fe, Argentina

Nepean Hospital ( Site 2700)

🇦🇺

Penrith, New South Wales, Australia

Beijing Peking Union Medical College Hospital ( Site 2921)

🇨🇳

Beijing, Beijing, China

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