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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer; Advanced or Metastatic Non-Small-Cell Lung Cancer; Resectable Non-Small-Cell Lung Cancer
• Intervention / Treatment: Drug: Docetaxel; Drug: Paclitaxel; Drug: Carboplatin; Drug: Cisplatin; Drug: Pemetrexed; Drug: Nivolumab; Drug: Nab-paclitaxel; Drug: Etrumadenant (ETRUMA); Drug: Zimberelimab (ZIM); Drug: Domvanalimab (DOM); Drug: Sacituzumab govitecan-hziy (SG)

Detailed Description

This is a Phase 2, randomized platform study to evaluate novel treatment combinations in participants with lung cancer. New substudies and/or treatment arms may be added to the study through amendment of the master protocol and/or substudy protocols.

Each substudy will consist of a preliminary stage and an expansion stage. In the preliminary stage, experimental treatment arms will be compared to the historical standard of care (SOC) benchmark.

In the expansion stage, investigational treatment arms within substudies will be compared to the comparator arm of the substudy. Not all treatment arms from preliminary stage will proceed to the expansion stage.

• Study Type: Interventional
• Enrollment (Estimated): 270
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Gilead Clinical Study Information Center; Phone Number: 1-833-445-3230 (GILEAD-0); Email: GileadClinicalTrials@gilead.com

Study Locations

• Brazil
  • Barretos, Brazil, 14784-400
    • Recruiting
    • Fundação Pio XII - Hospital de Amor,Substudy-01
  • Porto Alegre, Brazil, 90110-270
    • Recruiting
    • Hospital Mae de Deus
  • Porto Alegre, Brazil, 90110-270
    • Recruiting
    • Centro Gaúcho Integrado de Oncologia Hematologia, Ensino e Pesquisa Ltda./Hospital Mãe de Deus,Substudy-03
  • Porto Alegre, Brazil, 90610001
    • Recruiting
    • Hospital Sao Lucas da PUC Rio Grande do Sul,Substudy-03
  • Porto Alegre, Brazil, 90110-270
    • Recruiting
    • Hospital Mae de Deus,Substudy-01
  • Porto Alegre, Brazil, 90610001
    • Recruiting
    • Hospital Sao Lucas da PUC Rio Grande do Sul,Substudy-01
  • São Paulo, Brazil, 1509
    • 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
    • BP-A Beneficencia Portuguesa De Sao Paulo,Substudy-01
  • São Paulo, Brazil, 1509
    • Recruiting
    • Fundação Antonio Prudente - Hospital do Câncer AC Camargo,Substudy-01
• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Queen Elizabeth Hospital,Substudy-01
  • Hong Kong, Hong Kong
    • Active, not recruiting
    • Queen Elizabeth Hospital,Substudy-02
  • Hong Kong, Hong Kong, 999077
    • Recruiting
    • Queen Mary Hospital,Substudy-01
  • Hong Kong, Hong Kong, 999077
    • Active, not recruiting
    • Queen Mary Hospital,Substudy-02
  • New Territories, Hong Kong
    • Recruiting
    • Prince of Wales Hospital,Substudy-01
  • New Territories, Hong Kong
    • Active, not recruiting
    • Prince of Wales Hospital,Substudy-02
• Israel
  • Haifa, Israel, 3525408
    • Recruiting
    • Rambam Health Care Campus,Substudy-01
  • Haifa, Israel, 3525408
    • Active, not recruiting
    • Rambam Health Care Campus,Substudy-02
  • Haifa, Israel, 3525408
    • Recruiting
    • Rambam Health Care Campus,Substudy-03
  • Jerusalem, Israel, 9103102
    • Recruiting
    • Shaare Zedek Medical Center,Substudy-01
  • Jerusalem, Israel, 9103102
    • Active, not recruiting
    • Shaare Zedek Medical Center,Substudy-02
  • Jerusalem, Israel, 9103102
    • Recruiting
    • Shaare Zedek Medical Center,Substudy-03
  • Jerusalem, Israel, 91120
    • Recruiting
    • Hadassah University Medical Center,Substudy-03
  • Jerusalem, Israel, 91120
    • Recruiting
    • Hadassah Medical Center,Substudy-01
  • Petah Tikva, Israel, 49100
    • Withdrawn
    • Rabin Medical Center,Substudy-03
  • Tel Aviv, Israel, 64239
    • Recruiting
    • Tel Aviv Sourasky Medical Center,Substudy-01
  • Tel Aviv, Israel, 64239
    • Active, not recruiting
    • Tel Aviv Sourasky Medical Center,Substudy-02
  • Tel Aviv, Israel, 64239
    • Recruiting
    • Tel-Aviv Sourasky Medical Center,Substudy-03
• South Korea
  • Cheongju-si, South Korea, 28644
    • Active, not recruiting
    • Chungbuk National University Hospital,Substudy-02
  • Cheongju-si, South Korea, 28644
    • Active, not recruiting
    • Chungbuk National University Hospital,Substudy-01
  • Goyang, South Korea, 410769
    • Recruiting
    • National Cancer Center,Substudy-01
  • Goyang, South Korea, 410769
    • Active, not recruiting
    • National Cancer Center,Substudy-02
  • Goyang, South Korea, 410769
    • Recruiting
    • National Cancer Center,Substudy-03
  • Gwangju, South Korea, 61469
    • Recruiting
    • Chonnam National University Hwasun Hospital,Substudy-01
  • Gwangju, South Korea, 61469
    • Recruiting
    • Chonnam National University Hwasun Hospital,Substudy-03
  • Gyeonggi-do, South Korea, 463-707
    • Recruiting
    • Seoul National University Bundang Hospital,Substudy-01
  • Gyeonggi-do, South Korea, 463-707
    • Recruiting
    • Seoul National University Bundang Hospital,Substudy-03
  • Seogu, South Korea, 49267
    • Active, not recruiting
    • Kosin University Gospel Hospital,Substudy-01
  • Seogu, South Korea, 49267
    • Active, not recruiting
    • Kosin University Gospel Hospital,Substudy-03
  • Seoul, South Korea, 03722
    • Recruiting
    • Severance Hospital, Yonsei University Health System,Substudy-03
  • Seoul, South Korea, 05505
    • Active, not recruiting
    • Asan Medical Center,Substudy-02
  • Seoul, South Korea, 05505
    • Recruiting
    • Asan Medical Center,Substudy-03
  • Seoul, South Korea, 06351
    • Active, not recruiting
    • Samsung Medical Center,Substudy-02
  • Seoul, South Korea, 06351
    • Recruiting
    • Samsung Medical Center,Substudy-03
  • Seoul, South Korea, 120-752
    • Recruiting
    • Severance Hospital, Yonsei University Health System,Substudy-01
  • Seoul, South Korea, 120-752
    • Active, not recruiting
    • Severance Hospital, Yonsei University Health System,Substudy-02
  • Seoul, South Korea, 463-707
    • Withdrawn
    • Seoul National University,Substudy-01
  • Seoul, South Korea, 463-707
    • Active, not recruiting
    • Seoul National University,Substudy-02
  • Seoul, South Korea, 8308
    • Recruiting
    • Korea University Guro Hospital,Substudy-03
  • Seoul, South Korea, 05505
    • Active, not recruiting
    • Asan Medical Centre,Substudy-01
  • Seoul, South Korea, 06351
    • Active, not recruiting
    • Samsung Medical Center,Substudy-01
  • Seoul, South Korea, 8308
    • Active, not recruiting
    • Korea University Guro Hospital,Substudy-01
• Taiwan
  • Changhua, Taiwan, 500-06
    • Recruiting
    • Changhua Christian Hospital,Substudy-01
  • Changhua, Taiwan, 500-06
    • Active, not recruiting
    • Changhua Christian Hospital,Substudy-02
  • Changhua, Taiwan, 500-06
    • Recruiting
    • Changhua Christian Hospital,Substudy-03
  • Kaohsiung City, Taiwan, 80756
    • Recruiting
    • Kaohsiung Medical University Chung-Ho Memorial Hospital,Substudy-03
  • Kaohsiung City, Taiwan, 80756
    • Active, not recruiting
    • Kaohsiung Medical University Chung-Ho Memorial Hospital,Substudy-02
  • Kaohsiung City, Taiwan, 83301
    • Recruiting
    • Kaohsiung Chang Gung Memorial Hospital,Substudy-01
  • Kaohsiung City, Taiwan, 83301
    • Active, not recruiting
    • Kaohsiung Chang Gung Memorial Hospital,Substudy-02
  • Kaohsiung City, Taiwan, 83301
    • Recruiting
    • Kaohsiung Chang Gung Memorial Hospital,Substudy-03
  • Kaohsiung City, Taiwan, 80756
    • Active, not recruiting
    • Kaohsiung Medical University Chung-Ho Memorial Hospital,Substudy-01
  • Taipei, Taiwan, 100
    • Recruiting
    • National Taiwan University Hospital,Substudy-01
  • Taipei, Taiwan, 100
    • Active, not recruiting
    • National Taiwan University Hospital,Substudy-02
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 01120
    • Recruiting
    • Adana City Training and Research Hospital,Substudy-01
  • Ankara, Turkey (Türkiye), 06520
    • Recruiting
    • Memorial Ankara Hospital,Substudy-03
  • Ankara, Turkey (Türkiye), 06520
    • Recruiting
    • Memorial Ankara Hastanesi,Substudy-01
  • Atakum, Turkey (Türkiye), 55200
    • Recruiting
    • Medical Park Samsun,Substudy-01
  • Diyarbakır, Turkey (Türkiye), 21280
    • Recruiting
    • Dicle University Medical Faculty,Substudy-03
  • Diyarbakır, Turkey (Türkiye), 21100
    • Recruiting
    • Dicle University,Substudy-01
  • Konya, Turkey (Türkiye), 42080
    • Recruiting
    • Necmettin Erbakan University Meram Faculty of Medicine,Substudy-01
  • Meram Konya, Turkey (Türkiye), 42080
    • Recruiting
    • Necmettin Erbakan Universitesi,Substudy-03
  • Yenimahalle, Turkey (Türkiye)
    • Recruiting
    • Gazi University Medical Faculty,Substudy-03
  • Yenimahalle, Turkey (Türkiye)
    • Recruiting
    • Gazi University Medical Faculty,Substudy-01
• United Kingdom
  • Birmingham, United Kingdom, B9 5SS
    • Active, not recruiting
    • University Hospitals Birmingham NHS Trust,Substudy-02
  • Birmingham, United Kingdom, B9 5SS
    • Active, not recruiting
    • Birmingham Heartlands Hospital,Substudy-03
  • Birmingham, United Kingdom, B9 5SS
    • Active, not recruiting
    • University Hospitals Birmingham NHS Trust,Substudy-01
  • Leeds, United Kingdom, LS9 7TF
    • Recruiting
    • St James University Hospital,,Substudy-01
  • London, United Kingdom, E1 1BB
    • Recruiting
    • St. Bartholomew's Hospital,Substudy-01
  • London, United Kingdom, E1 1BB
    • Recruiting
    • St. Bartholomew's Hospital,Substudy-03
  • London, United Kingdom, E1 1BB
    • Active, not recruiting
    • St. Bartholomew's Hospital,Substudy-02
• United States
  • Arizona
    • Tucson, Arizona, United States, 85711
      • Withdrawn
      • Arizona Oncology Associates,Substudy-01
    • Tucson, Arizona, United States, 85711
      • Completed
      • Arizona Oncology Associates,Substudy-02
  • Colorado
    • Denver, Colorado, United States, 80218
      • Withdrawn
      • Rocky Mountain Cancer Center,Substudy-01
    • Denver, Colorado, United States, 80218
      • Withdrawn
      • Rocky Mountain Cancer Center,Substudy-02
  • Indiana
    • Fort Wayne, Indiana, United States, 46845
      • Recruiting
      • Fort Wayne Medical Oncology and Hematology, Inc.,Substudy-03
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Recruiting
      • Baptist Health Lexington,Substudy-03
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University School of Medicine - Siteman Cancer Center
    • St Louis, Missouri, United States, 63110
      • Active, not recruiting
      • 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
      • Active, not recruiting
      • Washington University School of Medicine - Siteman Cancer Center,Substudy-01
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Active, not recruiting
      • Oncology Hematology Care Clinical Trials, LLC,Substudy-01
    • Cincinnati, Ohio, United States, 45242
      • Active, not recruiting
      • Oncology Hematology Care Clinical Trials, LLC,Substudy-02
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Active, not recruiting
      • Oncology Associates of Oregon, PC,Substudy-02
    • Eugene, Oregon, United States, 97401
      • Completed
      • Oncology Associates of Oregon, PC,Substudy-01
  • Texas
    • Austin, Texas, United States, 78745
      • Withdrawn
      • Texas Oncology - Central South,Substudy-01
    • Austin, Texas, United States, 78745
      • Withdrawn
      • Texas Oncology - Central South,Substudy-02
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Withdrawn
      • US Oncology Investigational Products Center (IPC),Substudy-01
    • Fairfax, Virginia, United States, 22031
      • Withdrawn
      • US Oncology Investigational Products Center (IPC),Substudy-02
  • Washington
    • Seattle, Washington, United States, 98109
      • Withdrawn
      • Fred Hutchinson Cancer Center,Substudy-01
    • Seattle, Washington, United States, 98109
      • Withdrawn
      • Fred Hutchinson Cancer Center,Substudy-02

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key 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.

Key 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

10

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Substudy 01: ZIM + Platinum Based Chemotherapy; Expansion Stage Only: Participants will receive ZIM plus any one of the chemotherapy (choice of chemotherapy is dependent on histology). Platinum Based Chemotherapy will be cisplatin or carboplatin and pemetrexed (non-squamous histology) or carboplatin, paclitaxel and nabpaclitaxel (squamous histology).	Drug: Paclitaxel; Administered intravenously; Drug: Carboplatin; Administered intravenously; Drug: Cisplatin; Administered intravenously; Drug: Pemetrexed; Administered intravenously; Drug: Nab-paclitaxel; Administered intravenously; Drug: Zimberelimab (ZIM); Administered intravenously; Other Names: AB122; GS-0122
Experimental: Substudy 03 - ZIM + DOM + Platinum-based Chemotherapy; Participants will receive ZIM plus DOM and any one of the chemotherapy (choice of chemotherapy is dependent on histology). Platinum Based Chemotherapy will be carboplatin and pemetrexed (non-squamous histology) or carboplatin and paclitaxel (squamous histology).	Drug: Paclitaxel; Administered intravenously; Drug: Carboplatin; Administered intravenously; Drug: Pemetrexed; Administered intravenously; Drug: Zimberelimab (ZIM); Administered intravenously; Other Names: AB122; GS-0122; Drug: Domvanalimab (DOM); Administered intravenously; Other Names: AB154; GS-0154
Experimental: Substudy 03 - ZIM + Platinum-based Chemotherapy; Participants will receive ZIM plus any one of the chemotherapy (choice of chemotherapy is dependent on histology). Platinum Based Chemotherapy will be carboplatin and pemetrexed (non-squamous histology) or carboplatin and paclitaxel (squamous histology).	Drug: Paclitaxel; Administered intravenously; Drug: Carboplatin; Administered intravenously; Drug: Pemetrexed; Administered intravenously; Drug: Zimberelimab (ZIM); Administered intravenously; Other Names: AB122; GS-0122
Active Comparator: Substudy 03: Nivolumab + Platinum-based Chemotherapy; Participants will receive nivolumab plus any one of the chemotherapy (choice of chemotherapy is dependent on histology). Platinum Based Chemotherapy will be carboplatin and pemetrexed (non-squamous histology) or carboplatin and paclitaxel (squamous histology).	Drug: Paclitaxel; Administered intravenously; Drug: Carboplatin; Administered intravenously; Drug: Pemetrexed; Administered intravenously; Drug: Nivolumab; Administered intravenously
Experimental: Substudy 01: Zimberelimab (ZIM) + Sacituzumab govitecan-hziy (SG) + Domvanalimab (DOM); Participants will receive ZIM, SG and DOM until disease progression (PD), unacceptable toxicity, or protocol specified discontinuation criteria are met.	Drug: Zimberelimab (ZIM); Administered intravenously; Other Names: AB122; GS-0122; Drug: Domvanalimab (DOM); Administered intravenously; Other Names: AB154; GS-0154; Drug: Sacituzumab govitecan-hziy (SG); Administered intravenously; Other Names: IMMU-132; GS-0132
Experimental: Substudy 01: ZIM + DOM + Etrumadenant (ETRUMA); Participants will receive ZIM, DOM and ETRUMA until PD, unacceptable toxicity, or protocol specified discontinuation criteria are met.	Drug: Etrumadenant (ETRUMA); Administered orally; Other Names: AB928; GS-0928; Drug: Zimberelimab (ZIM); Administered intravenously; Other Names: AB122; GS-0122; Drug: Domvanalimab (DOM); Administered intravenously; Other Names: AB154; GS-0154
Experimental: Substudy 01: ZIM + ETRUMA; Participants will receive ZIM and ETRUMA until PD, unacceptable toxicity, or protocol specified discontinuation criteria are met.	Drug: Etrumadenant (ETRUMA); Administered orally; Other Names: AB928; GS-0928; Drug: Zimberelimab (ZIM); Administered intravenously; Other Names: AB122; GS-0122
Experimental: Substudy 02: SG + ZIM + ETRUMA; Participants will receive SG, ZIM and ETRUMA until PD, unacceptable toxicity, or protocol specified discontinuation criteria are met.	Drug: Etrumadenant (ETRUMA); Administered orally; Other Names: AB928; GS-0928; Drug: Zimberelimab (ZIM); Administered intravenously; Other Names: AB122; GS-0122; Drug: Sacituzumab govitecan-hziy (SG); Administered intravenously; Other Names: IMMU-132; GS-0132
Active Comparator: Substudy 02: Either Docetaxel or SG (Monotherapy Only); Participants will receive either Docetaxel or SG until PD, unacceptable toxicity, or protocol specified discontinuation criteria are met.	Drug: Docetaxel; Administered intravenously; Drug: Sacituzumab govitecan-hziy (SG); Administered intravenously; Other Names: IMMU-132; GS-0132
Experimental: Substudy 01: Zimberelimab (ZIM) + Sacituzumab govitecan-hziy (SG); Participants will receive ZIM and SG until disease progression (PD), unacceptable toxicity, or protocol specified discontinuation criteria are met.	Drug: Zimberelimab (ZIM); Administered intravenously; Other Names: AB122; GS-0122; Drug: Sacituzumab govitecan-hziy (SG); Administered intravenously; Other Names: IMMU-132; GS-0132

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Substudies 01 and 02: Objective Response Rate (ORR) as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1	ORR is defined as the proportion of participants achieving a complete response (CR) or partial response (PR) as confirmed at least 4 weeks after the first detection of response.	Up to 5 years
Substudy 03: Complete Pathological Response (pCR) Rate	pCR is defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes as assessed by local pathology review.	Up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All Substudies: Overall survival (OS)	OS is defined as the time from the date of randomization until death from any cause.	Up to 5 years
All Substudies: Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Related TEAEs		First dose date up to 24 months plus 100 days
All Substudies: Percentage of Participants Experiencing Clinical Laboratory Abnormalities		First dose date up to 24 months plus 100 days
Substudies 01 and 02: Progression-free Survival (PFS) According to RECIST Version 1.1	PFS is defined as the time from the date of randomization until disease progression (PD) or death, whichever comes first.	Up to 5 years
Substudies 01 and 02: Duration of response (DOR) According to RECIST Version 1.1	DOR is defined as the time from the first response (CR or PR) until the first documented PD, or death, whichever comes first.	Up to 5 years
Substudy 03: Event-Free Survival (EFS)	Event-Free Survival (EFS) is defined as the time from randomization until any of the following events: any progression precluding surgery or preventing completion of surgery, progression or recurrence of disease after surgery (local or distant), as assessed by investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), or death due to any cause, whichever occurs first. Participants who do not undergo surgery for reasons other than progression will be considered to have had an event at progression or at death.	Up to 5 years
Substudy 03: Major Pathological Response (MPR) Rate	MPR rate is defined as the percentage of participants with ≤ 10% residual tumor in lung and lymph nodes at surgery as evaluated by local pathology review.	Up to 5 years

Collaborators and Investigators

• Sponsor: Gilead Sciences
• Collaborators: Arcus Biosciences, Inc.
• Investigators: Study Director: Gilead Study Director, Gilead Sciences

Publications and helpful links

Helpful Links

• Gilead Clinical Trials Website

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2023
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029

Study Registration Dates

• First Submitted: November 21, 2022
• First Submitted That Met QC Criteria: November 21, 2022
• First Posted (Actual): December 1, 2022

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Amino Acids, Peptides, and Proteins; Proteins; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Coordination Complexes; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Taxoids; Cyclodecanes; Diterpenes; Platinum Compounds; Docetaxel; Nivolumab; Pemetrexed; Carboplatin; Paclitaxel; Cisplatin; 130-nm albumin-bound paclitaxel; zimberelimab; sacituzumab govitecan
• Other Study ID Numbers: GS-US-624-6376; MOH_2022-12-13_012231 (Registry Identifier: Israel Clinical Research Site)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No