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STATUS Recruiting

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

LAST UPDATED

July 14 2025

Clinicaltrials.gov ID

NCT05633667

OVERVIEW

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

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.

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Participation Requirements

Calendar

Age

18 Years +

Condition

Sex

ALL

Healthy Icon

Healthy Volunteers

No

Study Details

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

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.
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Exclusion

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
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Locations

Locations (88)
Withdrawn

Arizona Oncology Associates,Substudy-01

Tucson, Arizona, United States, 85711

Study Complete

Arizona Oncology Associates,Substudy-02

Tucson, Arizona, United States, 85711

Withdrawn

Rocky Mountain Cancer Center,Substudy-01

Denver, Colorado, United States, 80218

Withdrawn

Rocky Mountain Cancer Center,Substudy-02

Denver, Colorado, United States, 80218

Recruiting

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

Fort Wayne, Indiana, United States, 46845

Recruiting

Baptist Health Lexington,Substudy-03

Lexington, Kentucky, United States, 40503

Recruiting

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

St Louis, Missouri, United States, 63110

Recruitment Complete

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

St Louis, Missouri, United States, 63110

Recruiting

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

St Louis, Missouri, United States, 63110

Recruiting

Washington University School of Medicine - Siteman Cancer Center

St Louis, Missouri, United States, 63110

Recruitment Complete

Oncology Hematology Care Clinical Trials, LLC,Substudy-01

Cincinnati, Ohio, United States, 45242

Recruitment Complete

Oncology Hematology Care Clinical Trials, LLC,Substudy-02

Cincinnati, Ohio, United States, 45242

Recruitment Complete

Oncology Associates of Oregon, PC,Substudy-01

Eugene, Oregon, United States, 97401

Recruitment Complete

Oncology Associates of Oregon, PC,Substudy-02

Eugene, Oregon, United States, 97401

Withdrawn

Texas Oncology - Central South,Substudy-01

Austin, Texas, United States, 78745

Withdrawn

Texas Oncology - Central South,Substudy-02

Austin, Texas, United States, 78745

Withdrawn

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

Fairfax, Virginia, United States, 22031

Recruitment Complete

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

Fairfax, Virginia, United States, 22031

Recruiting

Fred Hutchinson Cancer Center,Substudy-01

Seattle, Washington, United States, 98109

Recruitment Complete

Fred Hutchinson Cancer Center,Substudy-02

Seattle, Washington, United States, 98109

Recruiting

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

Porto Alegre, Brazil, 90110-270

Recruiting

Hospital Mae de Deus

Porto Alegre, Brazil, 90110-270

Recruiting

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

Porto Alegre, Brazil, 90610001

Recruiting

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

São Paulo, Brazil, 1509

Recruiting

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

São Paulo, Brazil, 1509

Recruiting

Queen Mary Hospital,Substudy-01

Hong Kong, Hong Kong, 999077

Recruitment Complete

Queen Mary Hospital,Substudy-02

Hong Kong, Hong Kong, 999077

Recruiting

Queen Elizabeth Hospital,Substudy-01

Hong Kong, Hong Kong

Recruitment Complete

Queen Elizabeth Hospital,Substudy-02

Hong Kong, Hong Kong

Recruiting

Prince of Wales Hospital,Substudy-01

New Territories, Hong Kong

Recruitment Complete

Prince of Wales Hospital,Substudy-02

New Territories, Hong Kong

Recruiting

Rambam Health Care Campus,Substudy-01

Haifa, Israel, 3525408

Recruitment Complete

Rambam Health Care Campus,Substudy-02

Haifa, Israel, 3525408

Recruiting

Rambam Health Care Campus,Substudy-03

Haifa, Israel, 3525408

Recruiting

Shaare Zedek Medical Center,Substudy-01

Jerusalem, Israel, 9103102

Recruitment Complete

Shaare Zedek Medical Center,Substudy-02

Jerusalem, Israel, 9103102

Recruiting

Shaare Zedek Medical Center,Substudy-03

Jerusalem, Israel, 9103102

Recruiting

Hadassah University Medical Center,Substudy-03

Jerusalem, Israel, 91120

Recruiting

Rabin Medical Center,Substudy-03

Petah Tikva, Israel, 49100

Recruiting

Tel Aviv Sourasky Medical Center,Substudy-01

Tel Aviv, Israel, 64239

Recruitment Complete

Tel Aviv Sourasky Medical Center,Substudy-02

Tel Aviv, Israel, 64239

Recruiting

Tel-Aviv Sourasky Medical Center,Substudy-03

Tel Aviv, Israel, 64239

Recruiting

Chungbuk National University Hospital,Substudy-01

Cheongju-si, South Korea, 28644

Recruitment Complete

Chungbuk National University Hospital,Substudy-02

Cheongju-si, South Korea, 28644

Recruiting

National Cancer Center,Substudy-01

Goyang, South Korea, 410769

Recruitment Complete

National Cancer Center,Substudy-02

Goyang, South Korea, 410769

Recruiting

National Cancer Center,Substudy-03

Goyang, South Korea, 410769

Recruiting

Chonnam National University Hwasun Hospital,Substudy-01

Gwangju, South Korea, 61469

Recruiting

Chonnam National University Hwasun Hospital,Substudy-03

Gwangju, South Korea, 61469

Recruiting

Seoul National University Bundang Hospital,Substudy-01

Gyeonggi-do, South Korea, 463-707

Recruiting

Seoul National University Bundang Hospital,Substudy-03

Gyeonggi-do, South Korea, 463-707

Recruiting

Kosin University Gospel Hospital,Substudy-01

Seogu, South Korea, 49267

Recruiting

Kosin University Gospel Hospital,Substudy-03

Seogu, South Korea, 49267

Recruiting

Severance Hospital, Yonsei University Health System,Substudy-03

Seoul, South Korea, 03722

Recruitment Complete

Asan Medical Center,Substudy-02

Seoul, South Korea, 05505

Recruiting

Asan Medical Center,Substudy-03

Seoul, South Korea, 05505

Recruiting

Asan Medical Centre,Substudy-01

Seoul, South Korea, 05505

Recruiting

Samsung Medical Center,Substudy-01

Seoul, South Korea, 06351

Recruitment Complete

Samsung Medical Center,Substudy-02

Seoul, South Korea, 06351

Recruiting

Samsung Medical Center,Substudy-03

Seoul, South Korea, 06351

Recruiting

Severance Hospital, Yonsei University Health System,Substudy-01

Seoul, South Korea, 120-752

Recruitment Complete

Severance Hospital, Yonsei University Health System,Substudy-02

Seoul, South Korea, 120-752

Withdrawn

Seoul National University,Substudy-01

Seoul, South Korea, 463-707

Recruitment Complete

Seoul National University,Substudy-02

Seoul, South Korea, 463-707

Recruiting

Korea University Guro Hospital,Substudy-01

Seoul, South Korea, 8308

Recruiting

Korea University Guro Hospital,Substudy-03

Seoul, South Korea, 8308

Recruiting

Changhua Christian Hospital,Substudy-01

Changhua, Taiwan, 500-06

Recruitment Complete

Changhua Christian Hospital,Substudy-02

Changhua, Taiwan, 500-06

Recruiting

Changhua Christian Hospital,Substudy-03

Changhua, Taiwan, 500-06

Recruiting

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

Kaohsiung City, Taiwan, 80756

Recruitment Complete

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

Kaohsiung City, Taiwan, 80756

Recruiting

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

Kaohsiung City, Taiwan, 80756

Recruiting

Kaohsiung Chang Gung Memorial Hospital,Substudy-01

Kaohsiung City, Taiwan, 83301

Recruitment Complete

Kaohsiung Chang Gung Memorial Hospital,Substudy-02

Kaohsiung City, Taiwan, 83301

Recruiting

Kaohsiung Chang Gung Memorial Hospital,Substudy-03

Kaohsiung City, Taiwan, 83301

Recruiting

National Taiwan University Hospital,Substudy-01

Taipei, Taiwan, 100

Recruitment Complete

National Taiwan University Hospital,Substudy-02

Taipei, Taiwan, 100

Recruiting

Memorial Ankara Hospital,Substudy-03

Ankara, Turkey (Türkiye), 06520

Recruiting

Dicle University Medical Faculty,Substudy-03

Diyarbakır, Turkey (Türkiye), 21280

Recruiting

Necmettin Erbakan Universitesi,Substudy-03

Meram Konya, Turkey (Türkiye), 42080

Recruiting

Gazi University Medical Faculty,Substudy-03

Yenimahalle, Turkey (Türkiye)

Recruiting

Birmingham Heartlands Hospital,Substudy-03

Birmingham, United Kingdom, B9 5SS

Recruiting

University Hospitals Birmingham NHS Trust,Substudy-01

Birmingham, United Kingdom, B9 5SS

Recruitment Complete

University Hospitals Birmingham NHS Trust,Substudy-02

Birmingham, United Kingdom, B9 5SS

Recruiting

St James University Hospital,,Substudy-01

Leeds, United Kingdom, LS9 7TF

Recruiting

St. Bartholomew's Hospital,Substudy-01

London, United Kingdom, E1 1BB

Recruitment Complete

St. Bartholomew's Hospital,Substudy-02

London, United Kingdom, E1 1BB

Recruiting

St. Bartholomew's Hospital,Substudy-03

London, United Kingdom, E1 1BB