RecruitingPhase 2NCT05633667

Study of Novel Treatment Combinations in Patients With Lung Cancer

A Phase 2 Platform Study Evaluating the Safety and Efficacy of Novel Treatment Combinations in Patients With Lung Cancer (VELOCITY-Lung)

Sponsor

Gilead Sciences

Enrollment

270 participants

Start Date

Mar 16, 2023

Study Type

INTERVENTIONAL

Conditions

Lung Cancer

Summary

The goal of this platform clinical trial is to test how well novel treatment combinations work in participants with lung cancer. Substudy-01 will compare the different novel combinations versus standard of care in participants with metastatic (cancer that has spread) non-small-cell lung cancer (NSCLC) who have not been treated before. Substudy-02 will compare the different novel combination versus standard of care in participants with cancer that has progressed after receiving previous treatment for metastatic NSCLC. Substudy-03 will compare the different novel combinations versus standard of care in participants with resectable stage II-III NSCLC. The primary objectives of this study are: Substudy-01 and Substudy-02: To evaluate the objective response rate (ORR) assessed per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Substudy-03: To evaluate the efficacy of treatment combinations based on complete pathological response (pCR) rate.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests new drug combinations for people with non-small cell lung cancer (NSCLC) that does not have a specific genetic mutation targetable by approved drugs. Different combinations of cancer treatments are being evaluated to find what works best. **You may be eligible if...** - You are 18 years or older - You have confirmed non-small cell lung cancer - Your tumor does not have known actionable genetic mutations (for which targeted drugs exist) - You are in good general health (ECOG score 0 or 1) - You have at least one measurable tumor **You may NOT be eligible if...** - Your tumor has a genetic mutation with an available targeted therapy - You are in poor general health - You do not have measurable disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGZimberelimab (ZIM)

Administered intravenously

DRUGDomvanalimab (DOM)

Administered intravenously

DRUGSacituzumab govitecan-hziy (SG)

Administered intravenously

DRUGEtrumadenant (ETRUMA)

Administered orally

DRUGCarboplatin

Administered intravenously

DRUGCisplatin

Administered intravenously

DRUGPemetrexed

Administered intravenously

DRUGPaclitaxel

Administered intravenously

DRUGNab-paclitaxel

Administered intravenously

DRUGDocetaxel

Administered intravenously

DRUGNivolumab

Administered intravenously

Locations(100)

Arizona Oncology Associates,Substudy-01

Tucson, Arizona, United States

Arizona Oncology Associates,Substudy-02

Tucson, Arizona, United States

Rocky Mountain Cancer Center,Substudy-01

Denver, Colorado, United States

Rocky Mountain Cancer Center,Substudy-02

Denver, Colorado, United States

Fort Wayne Medical Oncology and Hematology, Inc.,Substudy-03

Fort Wayne, Indiana, United States

Baptist Health Lexington,Substudy-03

Lexington, Kentucky, United States

Washington University School of Medicine - Siteman Cancer Center,Substudy-01

St Louis, Missouri, United States

Washington University School of Medicine - Siteman Cancer Center,Substudy-02

St Louis, Missouri, United States

Washington University School of Medicine - Siteman Cancer Center,Substudy-03

St Louis, Missouri, United States

Washington University School of Medicine - Siteman Cancer Center

St Louis, Missouri, United States

Oncology Hematology Care Clinical Trials, LLC,Substudy-01

Cincinnati, Ohio, United States

Oncology Hematology Care Clinical Trials, LLC,Substudy-02

Cincinnati, Ohio, United States

Oncology Associates of Oregon, PC,Substudy-01

Eugene, Oregon, United States

Oncology Associates of Oregon, PC,Substudy-02

Eugene, Oregon, United States

Texas Oncology - Central South,Substudy-01

Austin, Texas, United States

Texas Oncology - Central South,Substudy-02

Austin, Texas, United States

US Oncology Investigational Products Center (IPC),Substudy-01

Fairfax, Virginia, United States

US Oncology Investigational Products Center (IPC),Substudy-02

Fairfax, Virginia, United States

Fred Hutchinson Cancer Center,Substudy-01

Seattle, Washington, United States

Fred Hutchinson Cancer Center,Substudy-02

Seattle, Washington, United States

Fundação Pio XII - Hospital de Amor,Substudy-01

Barretos, Brazil

Centro Gaúcho Integrado de Oncologia Hematologia, Ensino e Pesquisa Ltda./Hospital Mãe de Deus,Substudy-03

Porto Alegre, Brazil

Hospital Mae de Deus,Substudy-01

Porto Alegre, Brazil

Hospital Mae de Deus

Porto Alegre, Brazil

Hospital Sao Lucas da PUC Rio Grande do Sul,Substudy-01

Porto Alegre, Brazil

Hospital Sao Lucas da PUC Rio Grande do Sul,Substudy-03

Porto Alegre, Brazil

BP-A Beneficencia Portuguesa De Sao Paulo,Substudy-01

São Paulo, Brazil

Fundação Antonio Prudente - Hospital do Câncer AC Camargo,Substudy-01

São Paulo, Brazil

Fundação Antonio Prudente/A.C. Camargo Cancer Center,Substudy-03

São Paulo, Brazil

Real e Benemérita Associação Portuguesa de Beneficência/Hospital Beneficência Portuguesa de São Paulo (Hospital BP),Substudy-03

São Paulo, Brazil

Queen Mary Hospital,Substudy-01

Hong Kong, Hong Kong

Queen Mary Hospital,Substudy-02

Hong Kong, Hong Kong

Queen Elizabeth Hospital,Substudy-01

Hong Kong, Hong Kong

Queen Elizabeth Hospital,Substudy-02

Hong Kong, Hong Kong

Prince of Wales Hospital,Substudy-01

New Territories, Hong Kong

Prince of Wales Hospital,Substudy-02

New Territories, Hong Kong

Rambam Health Care Campus,Substudy-01

Haifa, Israel

Rambam Health Care Campus,Substudy-02

Haifa, Israel

Rambam Health Care Campus,Substudy-03

Haifa, Israel

Shaare Zedek Medical Center,Substudy-01

Jerusalem, Israel

Shaare Zedek Medical Center,Substudy-02

Jerusalem, Israel

Shaare Zedek Medical Center,Substudy-03

Jerusalem, Israel

Hadassah Medical Center,Substudy-01

Jerusalem, Israel

Hadassah University Medical Center,Substudy-03

Jerusalem, Israel

Rabin Medical Center,Substudy-03

Petah Tikva, Israel

Tel Aviv Sourasky Medical Center,Substudy-01

Tel Aviv, Israel

Tel Aviv Sourasky Medical Center,Substudy-02

Tel Aviv, Israel

Tel-Aviv Sourasky Medical Center,Substudy-03

Tel Aviv, Israel

Chungbuk National University Hospital,Substudy-01

Cheongju-si, South Korea

Chungbuk National University Hospital,Substudy-02

Cheongju-si, South Korea

National Cancer Center,Substudy-01

Goyang, South Korea

National Cancer Center,Substudy-02

Goyang, South Korea

National Cancer Center,Substudy-03

Goyang, South Korea

Chonnam National University Hwasun Hospital,Substudy-01

Gwangju, South Korea

Chonnam National University Hwasun Hospital,Substudy-03

Gwangju, South Korea

Seoul National University Bundang Hospital,Substudy-01

Gyeonggi-do, South Korea

Seoul National University Bundang Hospital,Substudy-03

Gyeonggi-do, South Korea

Kosin University Gospel Hospital,Substudy-01

Seogu, South Korea

Kosin University Gospel Hospital,Substudy-03

Seogu, South Korea

Severance Hospital, Yonsei University Health System,Substudy-03

Seoul, South Korea

Asan Medical Center,Substudy-02

Seoul, South Korea

Asan Medical Center,Substudy-03

Seoul, South Korea

Asan Medical Centre,Substudy-01

Seoul, South Korea

Samsung Medical Center,Substudy-01

Seoul, South Korea

Samsung Medical Center,Substudy-02

Seoul, South Korea

Samsung Medical Center,Substudy-03

Seoul, South Korea

Severance Hospital, Yonsei University Health System,Substudy-01

Seoul, South Korea

Severance Hospital, Yonsei University Health System,Substudy-02

Seoul, South Korea

Seoul National University,Substudy-01

Seoul, South Korea

Seoul National University,Substudy-02

Seoul, South Korea

Korea University Guro Hospital,Substudy-01

Seoul, South Korea

Korea University Guro Hospital,Substudy-03

Seoul, South Korea

Changhua Christian Hospital,Substudy-01

Changhua, Taiwan

Changhua Christian Hospital,Substudy-02

Changhua, Taiwan

Changhua Christian Hospital,Substudy-03

Changhua, Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital,Substudy-01

Kaohsiung City, Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital,Substudy-02

Kaohsiung City, Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital,Substudy-03

Kaohsiung City, Taiwan

Kaohsiung Chang Gung Memorial Hospital,Substudy-01

Kaohsiung City, Taiwan

Kaohsiung Chang Gung Memorial Hospital,Substudy-02

Kaohsiung City, Taiwan

Kaohsiung Chang Gung Memorial Hospital,Substudy-03

Kaohsiung City, Taiwan

National Taiwan University Hospital,Substudy-01

Taipei, Taiwan

National Taiwan University Hospital,Substudy-02

Taipei, Taiwan

Adana City Training and Research Hospital,Substudy-01

Adana, Turkey (Türkiye)

Memorial Ankara Hastanesi,Substudy-01

Ankara, Turkey (Türkiye)

Memorial Ankara Hospital,Substudy-03

Ankara, Turkey (Türkiye)

Medical Park Samsun,Substudy-01

Atakum, Turkey (Türkiye)

Dicle University,Substudy-01

Diyarbakır, Turkey (Türkiye)

Dicle University Medical Faculty,Substudy-03

Diyarbakır, Turkey (Türkiye)

Necmettin Erbakan University Meram Faculty of Medicine,Substudy-01

Konya, Turkey (Türkiye)

Necmettin Erbakan Universitesi,Substudy-03

Meram Konya, Turkey (Türkiye)

Gazi University Medical Faculty,Substudy-01

Yenimahalle, Turkey (Türkiye)

Gazi University Medical Faculty,Substudy-03

Yenimahalle, Turkey (Türkiye)

Birmingham Heartlands Hospital,Substudy-03

Birmingham, United Kingdom

University Hospitals Birmingham NHS Trust,Substudy-01

Birmingham, United Kingdom

University Hospitals Birmingham NHS Trust,Substudy-02

Birmingham, United Kingdom

St James University Hospital,,Substudy-01

Leeds, United Kingdom

St. Bartholomew's Hospital,Substudy-01

London, United Kingdom

St. Bartholomew's Hospital,Substudy-02

London, United Kingdom

St. Bartholomew's Hospital,Substudy-03

London, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT05633667

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