Study Details

PROTOCOL 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.

Participation Requirements

Age

18 Years +

Sex

ALL

Healthy Volunteers

Medical Condition

Lung Cancer, Advanced or Metastatic Non-Small-Cell Lung Cancer, Resectable Non-Small-Cell Lung Cancer

Gender

N/A

Date

March 2023 - January 2027

Study Type

INTERVENTIONAL

Study Phase

PHASE2

Product

Zimberelimab (ZIM), Domvanalimab (DOM), Sacituzumab govitecan-hziy (SG), Etrumadenant (ETRUMA), Carboplatin, Cisplatin, Pemetrexed, Paclitaxel, Nab-paclitaxel, Docetaxel, Nivolumab

Eligibility Information

Inclusion Criteria

All Substudies:
Histologically or cytologically documented non-small-cell lung cancer (NSCLC).
No known actionable genomic alterations for which targeted therapies are available.
Eastern cooperative oncology group (ECOG) performance status score of 0 or 1.
Measurable disease per response evaluation criteria in solid tumors.
Adequate hematologic and end-organ function.
Individuals of childbearing potential who engage in heterosexual intercourse must agree to use specified method(s) of contraception.
Substudy 01: All Experimental arms
Stage IV NSCLC.
For individuals with nonsquamous histology: Epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) alteration negative.
PD-L1 status by central confirmation.
No prior systemic treatment for metastatic NSCLC.
Substudy 02: All Experimental arms
Stage IV NSCLC.
In individuals with nonsquamous histology and actionable EGFR, ALK, or other known genomic alterations must have received treatment with at least 1 targeted therapy to the appropriate genomic alteration.
Substudy 03: All Experimental arms
Previously untreated individuals with resectable (Stage II, IIIA, IIIB (T[3-4]N2) NSCLC (per American Joint Committee on Cancer (AJCC) Edition 8).
Planned surgery must comprise of lobectomy, sleeve lobectomy, or bi-lobectomy.
PD-L1 status by central confirmation.
For individuals with nonsquamous histology: Epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) alteration negative.

Exclusion Criteria

All Substudies:
Mixed small-cell lung cancer and NSCLC histology.
Active second malignancy.
Active autoimmune disease.
History of or current non-infectious pneumonitis/interstitial lung disease.
Active serious infection within 4 weeks prior to study treatment.
Substudy 01 and 02
Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Received previous anticancer therapy within 4 weeks prior to enrollment.
Substudy 03: All Experimental arms
NSCLC previously treated with systemic therapy or radiotherapy.
Received prior treatment with any anti-PD-(L)-1 or other immune checkpoint inhibitors (CPIs).
Note: Other protocol defined inclusion/exclusion criteria may apply

Locations

Locations (87)

Arizona Oncology Associates,Substudy-01

Tucson, Arizona, United States, 85711

Arizona Oncology Associates,Substudy-02

Tucson, Arizona, United States, 85711

Rocky Mountain Cancer Center,Substudy-01

Denver, Colorado, United States, 80218

Rocky Mountain Cancer Center,Substudy-02

Denver, Colorado, United States, 80218

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

Fort Wayne, Indiana, United States, 46845

Baptist Health Lexington,Substudy-03

Lexington, Kentucky, United States, 40503

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

Saint Louis, Missouri, United States, 63110

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

Saint Louis, Missouri, United States, 63110

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

Saint Louis, Missouri, United States, 63110

Washington University School of Medicine - Siteman Cancer Center

Saint Louis, Missouri, United States, 63110

Oncology Hematology Care Clinical Trials, LLC,Substudy-01

Cincinnati, Ohio, United States, 45242

Oncology Hematology Care Clinical Trials, LLC,Substudy-02

Cincinnati, Ohio, United States, 45242

Oncology Associates of Oregon, PC,Substudy-01

Eugene, Oregon, United States, 97401

Oncology Associates of Oregon, PC,Substudy-02

Eugene, Oregon, United States, 97401

Texas Oncology - Central South,Substudy-01

Austin, Texas, United States, 78745

Texas Oncology - Central South,Substudy-02

Austin, Texas, United States, 78745

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

Fairfax, Virginia, United States, 22031

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

Fairfax, Virginia, United States, 22031

Fred Hutchinson Cancer Center,Substudy-01

Seattle, Washington, United States, 98109

Fred Hutchinson Cancer Center,Substudy-02

Seattle, Washington, United States, 98109

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

Porto Alegre, Brazil, 90110-270

Hospital Mae de Deus

Porto Alegre, Brazil, 90110-270

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

Porto Alegre, Brazil, 90610001

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

São Paulo, Brazil, 1509

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

São Paulo, Brazil, 1509

Queen Mary Hospital,Substudy-01

Hong Kong, Hong Kong, 999077

Queen Mary Hospital,Substudy-02

Hong Kong, Hong Kong, 999077

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, 3525408

Rambam Health Care Campus,Substudy-02

Haifa, Israel, 3525408

Rambam Health Care Campus,Substudy-03

Haifa, Israel, 3525408

Shaare Zedek Medical Center,Substudy-01

Jerusalem, Israel, 9103102

Shaare Zedek Medical Center,Substudy-02

Jerusalem, Israel, 9103102

Shaare Zedek Medical Center,Substudy-03

Jerusalem, Israel, 9103102

Hadassah University Medical Center,Substudy-03

Jerusalem, Israel, 91120

Rabin Medical Center,Substudy-03

Petah Tiqva, Israel, 49100

Tel Aviv Sourasky Medical Center,Substudy-01

Tel Aviv-Yafo, Israel, 64239

Tel Aviv Sourasky Medical Center,Substudy-02

Tel Aviv-Yafo, Israel, 64239

Tel-Aviv Sourasky Medical Center,Substudy-03

Tel Aviv-Yafo, Israel, 64239

Chungbuk National University Hospital,Substudy-01

Cheongju-si, Korea, Republic of, 28644

Chungbuk National University Hospital,Substudy-02

Cheongju-si, Korea, Republic of, 28644

National Cancer Center,Substudy-01

Goyang, Korea, Republic of, 410769

National Cancer Center,Substudy-02

Goyang, Korea, Republic of, 410769

National Cancer Center,Substudy-03

Goyang, Korea, Republic of, 410769

Chonnam National University Hwasun Hospital,Substudy-01

Gwangju, Korea, Republic of, 61469

Chonnam National University Hwasun Hospital,Substudy-03

Gwangju, Korea, Republic of, 61469

Seoul National University Bundang Hospital,Substudy-01

Gyeonggi-do, Korea, Republic of, 463-707

Seoul National University Bundang Hospital,Substudy-03

Gyeonggi-do, Korea, Republic of, 463-707

Kosin University Gospel Hospital,Substudy-01

Seo-gu, Korea, Republic of, 49267

Kosin University Gospel Hospital,Substudy-03

Seo-gu, Korea, Republic of, 49267

Severance Hospital, Yonsei University Health System,Substudy-03

Seoul, Korea, Republic of, 03722

Asan Medical Center,Substudy-02

Seoul, Korea, Republic of, 05505

Asan Medical Center,Substudy-03

Seoul, Korea, Republic of, 05505

Asan Medical Centre,Substudy-01

Seoul, Korea, Republic of, 05505

Samsung Medical Center,Substudy-01

Seoul, Korea, Republic of, 06351

Samsung Medical Center,Substudy-02

Seoul, Korea, Republic of, 06351

Samsung Medical Center,Substudy-03

Seoul, Korea, Republic of, 06351

Severance Hospital, Yonsei University Health System,Substudy-01

Seoul, Korea, Republic of, 120-752

Severance Hospital, Yonsei University Health System,Substudy-02

Seoul, Korea, Republic of, 120-752

Seoul National University,Substudy-01

Seoul, Korea, Republic of, 463-707

Seoul National University,Substudy-02

Seoul, Korea, Republic of, 463-707

Korea University Guro Hospital,Substudy-01

Seoul, Korea, Republic of, 8308

Korea University Guro Hospital,Substudy-03

Seoul, Korea, Republic of, 8308

Changhua Christian Hospital,Substudy-01

Changhua City, Taiwan, 500-06

Changhua Christian Hospital,Substudy-02

Changhua City, Taiwan, 500-06

Changhua Christian Hospital,Substudy-03

Changhua City, Taiwan, 500-06

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

Kaohsiung City, Taiwan, 80756

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

Kaohsiung City, Taiwan, 80756

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

Kaohsiung City, Taiwan, 80756

Kaohsiung Chang Gung Memorial Hospital,Substudy-01

Kaohsiung, Taiwan, 83301

Kaohsiung Chang Gung Memorial Hospital,Substudy-02

Kaohsiung, Taiwan, 83301

Kaohsiung Chang Gung Memorial Hospital,Substudy-03

Kaohsiung, Taiwan, 83301

National Taiwan University Hospital,Substudy-01

Taipei City, Taiwan, 100

National Taiwan University Hospital,Substudy-02

Taipei City, Taiwan, 100

Memorial Ankara Hospital,Substudy-03

Ankara, Turkey, 06520

Dicle University Medical Faculty,Substudy-03

Diyarbakir, Turkey, 21280

Necmettin Erbakan Universitesi,Substudy-03

Meram Konya, Turkey, 42080

Birmingham Heartlands Hospital,Substudy-03

Birmingham, United Kingdom, B9 5SS

University Hospitals Birmingham NHS Trust,Substudy-01

Birmingham, United Kingdom, B9 5SS

University Hospitals Birmingham NHS Trust,Substudy-02

Birmingham, United Kingdom, B9 5SS

St James University Hospital,,Substudy-01

Leeds, United Kingdom, LS9 7TF

St. Bartholomew's Hospital,Substudy-01

London, United Kingdom, E1 1BB

St. Bartholomew's Hospital,Substudy-02

London, United Kingdom, E1 1BB

St. Bartholomew's Hospital,Substudy-03

London, United Kingdom, E1 1BB

Study of Novel Treatment Combinations in Patients With Lung Cancer (VELOCITY-Lung)

OVERVIEW

PROTOCOL SUMMARY

Participation Requirements

Eligibility Information

Inclusion Criteria

Exclusion Criteria

Locations

Locations (87)

Arizona Oncology Associates,Substudy-01

Arizona Oncology Associates,Substudy-02

Rocky Mountain Cancer Center,Substudy-01

Rocky Mountain Cancer Center,Substudy-02

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

Baptist Health Lexington,Substudy-03

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

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

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

Washington University School of Medicine - Siteman Cancer Center

Oncology Hematology Care Clinical Trials, LLC,Substudy-01

Oncology Hematology Care Clinical Trials, LLC,Substudy-02

Oncology Associates of Oregon, PC,Substudy-01

Oncology Associates of Oregon, PC,Substudy-02

Texas Oncology - Central South,Substudy-01

Texas Oncology - Central South,Substudy-02

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

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

Fred Hutchinson Cancer Center,Substudy-01

Fred Hutchinson Cancer Center,Substudy-02

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

Hospital Mae de Deus

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

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

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

Queen Mary Hospital,Substudy-01

Queen Mary Hospital,Substudy-02

Queen Elizabeth Hospital,Substudy-01

Queen Elizabeth Hospital,Substudy-02

Prince of Wales Hospital,Substudy-01

Prince of Wales Hospital,Substudy-02

Rambam Health Care Campus,Substudy-01

Rambam Health Care Campus,Substudy-02

Rambam Health Care Campus,Substudy-03

Shaare Zedek Medical Center,Substudy-01

Shaare Zedek Medical Center,Substudy-02

Shaare Zedek Medical Center,Substudy-03

Hadassah University Medical Center,Substudy-03

Rabin Medical Center,Substudy-03

Tel Aviv Sourasky Medical Center,Substudy-01

Tel Aviv Sourasky Medical Center,Substudy-02

Tel-Aviv Sourasky Medical Center,Substudy-03

Chungbuk National University Hospital,Substudy-01

Chungbuk National University Hospital,Substudy-02

National Cancer Center,Substudy-01

National Cancer Center,Substudy-02

National Cancer Center,Substudy-03

Chonnam National University Hwasun Hospital,Substudy-01

Chonnam National University Hwasun Hospital,Substudy-03

Seoul National University Bundang Hospital,Substudy-01

Seoul National University Bundang Hospital,Substudy-03

Kosin University Gospel Hospital,Substudy-01

Kosin University Gospel Hospital,Substudy-03

Severance Hospital, Yonsei University Health System,Substudy-03

Asan Medical Center,Substudy-02

Asan Medical Center,Substudy-03

Asan Medical Centre,Substudy-01

Samsung Medical Center,Substudy-01

Samsung Medical Center,Substudy-02

Samsung Medical Center,Substudy-03

Severance Hospital, Yonsei University Health System,Substudy-01

Severance Hospital, Yonsei University Health System,Substudy-02

Seoul National University,Substudy-01

Seoul National University,Substudy-02

Korea University Guro Hospital,Substudy-01

Korea University Guro Hospital,Substudy-03

Changhua Christian Hospital,Substudy-01

Changhua Christian Hospital,Substudy-02

Changhua Christian Hospital,Substudy-03

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