Study of Novel Treatment Combinations in Patients With Lung Cancer

Last updated: January 22, 2025
Sponsor: Gilead Sciences
Overall Status: Active - Recruiting

Phase

2

Condition

Non-small Cell Lung Cancer

Lung Disease

Lung Cancer

Treatment

Nivolumab

Cisplatin

Nab-paclitaxel

Clinical Study ID

NCT05633667
GS-US-624-6376
MOH_2022-12-13_012231
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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 mustagree 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 knowngenomic alterations must have received treatment with at least 1 targeted therapy tothe 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

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 carcinomatousmeningitis.

  • 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 checkpointinhibitors (CPIs).

Note: Other protocol defined inclusion/exclusion criteria may apply

Study Design

Total Participants: 593
Treatment Group(s): 11
Primary Treatment: Nivolumab
Phase: 2
Study Start date:
March 16, 2023
Estimated Completion Date:
January 31, 2027

Connect with a study center

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

    Porto Alegre, 90110-270
    Brazil

    Active - Recruiting

  • Hospital Mae de Deus

    Porto Alegre, 90110-270
    Brazil

    Active - Recruiting

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

    Porto Alegre, 90610001
    Brazil

    Active - Recruiting

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

    São Paulo, 1509
    Brazil

    Active - Recruiting

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

    São Paulo, 1509
    Brazil

    Active - Recruiting

  • Queen Elizabeth Hospital,Substudy-01

    Hong Kong,
    Hong Kong

    Active - Recruiting

  • Queen Elizabeth Hospital,Substudy-02

    Hong Kong,
    Hong Kong

    Site Not Available

  • Queen Mary Hospital,Substudy-01

    Hong Kong, 999077
    Hong Kong

    Active - Recruiting

  • Queen Mary Hospital,Substudy-02

    Hong Kong, 999077
    Hong Kong

    Active - Recruiting

  • Prince of Wales Hospital,Substudy-01

    New Territories,
    Hong Kong

    Active - Recruiting

  • Prince of Wales Hospital,Substudy-02

    New Territories,
    Hong Kong

    Active - Recruiting

  • Rambam Health Care Campus,Substudy-01

    Haifa, 3525408
    Israel

    Active - Recruiting

  • Rambam Health Care Campus,Substudy-02

    Haifa, 3525408
    Israel

    Site Not Available

  • Rambam Health Care Campus,Substudy-03

    Haifa, 3525408
    Israel

    Active - Recruiting

  • Hadassah University Medical Center,Substudy-03

    Jerusalem, 91120
    Israel

    Active - Recruiting

  • Shaare Zedek Medical Center,Substudy-01

    Jerusalem, 9103102
    Israel

    Active - Recruiting

  • Shaare Zedek Medical Center,Substudy-02

    Jerusalem, 9103102
    Israel

    Site Not Available

  • Shaare Zedek Medical Center,Substudy-03

    Jerusalem, 9103102
    Israel

    Active - Recruiting

  • Rabin Medical Center,Substudy-03

    Petah Tiqva, 49100
    Israel

    Active - Recruiting

  • Tel Aviv Sourasky Medical Center,Substudy-01

    Tel Aviv-Yafo, 64239
    Israel

    Active - Recruiting

  • Tel Aviv Sourasky Medical Center,Substudy-02

    Tel Aviv-Yafo, 64239
    Israel

    Site Not Available

  • Tel-Aviv Sourasky Medical Center,Substudy-03

    Tel Aviv-Yafo, 64239
    Israel

    Active - Recruiting

  • Chungbuk National University Hospital,Substudy-01

    Cheongju-si, 28644
    Korea, Republic of

    Active - Recruiting

  • Chungbuk National University Hospital,Substudy-02

    Cheongju-si, 28644
    Korea, Republic of

    Active - Recruiting

  • Chungbuk National University Hospital,Substudy-01

    Cheongjusi, 28644
    Korea, Republic of

    Site Not Available

  • Chungbuk National University Hospital,Substudy-02

    Cheongjusi, 28644
    Korea, Republic of

    Active - Recruiting

  • National Cancer Center,Substudy-01

    Goyang, 410769
    Korea, Republic of

    Active - Recruiting

  • National Cancer Center,Substudy-02

    Goyang, 410769
    Korea, Republic of

    Site Not Available

  • National Cancer Center,Substudy-03

    Goyang, 410769
    Korea, Republic of

    Active - Recruiting

  • Chonnam National University Hwasun Hospital,Substudy-01

    Gwangju, 61469
    Korea, Republic of

    Active - Recruiting

  • Chonnam National University Hwasun Hospital,Substudy-03

    Gwangju, 61469
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Bundang Hospital,Substudy-01

    Gyeonggi-do, 463-707
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Bundang Hospital,Substudy-03

    Gyeonggi-do, 463-707
    Korea, Republic of

    Active - Recruiting

  • Kosin University Gospel Hospital,Substudy-01

    Seo-gu, 49267
    Korea, Republic of

    Active - Recruiting

  • Kosin University Gospel Hospital,Substudy-03

    Seo-gu, 49267
    Korea, Republic of

    Active - Recruiting

  • Asan Medical Center,Substudy-02

    Seoul, 05505
    Korea, Republic of

    Site Not Available

  • Asan Medical Center,Substudy-03

    Seoul, 05505
    Korea, Republic of

    Active - Recruiting

  • Asan Medical Centre,Substudy-01

    Seoul, 05505
    Korea, Republic of

    Active - Recruiting

  • Korea University Guro Hospital,Substudy-01

    Seoul, 8308
    Korea, Republic of

    Active - Recruiting

  • Korea University Guro Hospital,Substudy-03

    Seoul, 8308
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center,Substudy-01

    Seoul, 06351
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center,Substudy-02

    Seoul, 06351
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center,Substudy-03

    Seoul, 06351
    Korea, Republic of

    Active - Recruiting

  • Seoul National University,Substudy-01

    Seoul, 463-707
    Korea, Republic of

    Site Not Available

  • Seoul National University,Substudy-02

    Seoul, 463-707
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital, Yonsei University Health System,Substudy-01

    Seoul, 120-752
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital, Yonsei University Health System,Substudy-02

    Seoul, 120-752
    Korea, Republic of

    Site Not Available

  • Severance Hospital, Yonsei University Health System,Substudy-03

    Seoul, 03722
    Korea, Republic of

    Active - Recruiting

  • Changhua Christian Hospital,Substudy-01

    Changhua City, 500-06
    Taiwan

    Active - Recruiting

  • Changhua Christian Hospital,Substudy-02

    Changhua City, 500-06
    Taiwan

    Site Not Available

  • Changhua Christian Hospital,Substudy-03

    Changhua City, 500-06
    Taiwan

    Active - Recruiting

  • Kaohsiung Chang Gung Memorial Hospital,Substudy-01

    Kaohsiung, 83301
    Taiwan

    Active - Recruiting

  • Kaohsiung Chang Gung Memorial Hospital,Substudy-02

    Kaohsiung, 83301
    Taiwan

    Site Not Available

  • Kaohsiung Chang Gung Memorial Hospital,Substudy-03

    Kaohsiung, 83301
    Taiwan

    Active - Recruiting

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

    Kaohsiung City, 80756
    Taiwan

    Active - Recruiting

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

    Kaohsiung City, 80756
    Taiwan

    Active - Recruiting

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

    Kaohsiung City, 80756
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital,Substudy-01

    Taipei City, 100
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital,Substudy-02

    Taipei City, 100
    Taiwan

    Site Not Available

  • Memorial Ankara Hospital,Substudy-03

    Ankara, 06520
    Turkey

    Active - Recruiting

  • Dicle University Medical Faculty,Substudy-03

    Diyarbakir, 21280
    Turkey

    Active - Recruiting

  • Necmettin Erbakan Universitesi,Substudy-03

    Meram Konya, 42080
    Turkey

    Active - Recruiting

  • Birmingham Heartlands Hospital,Substudy-03

    Birmingham, B9 5SS
    United Kingdom

    Active - Recruiting

  • University Hospitals Birmingham NHS Trust,Substudy-01

    Birmingham, B9 5SS
    United Kingdom

    Active - Recruiting

  • University Hospitals Birmingham NHS Trust,Substudy-02

    Birmingham, B9 5SS
    United Kingdom

    Active - Recruiting

  • St James University Hospital,,Substudy-01

    Leeds, LS9 7TF
    United Kingdom

    Active - Recruiting

  • St. Bartholomew's Hospital,Substudy-01

    London, E1 1BB
    United Kingdom

    Active - Recruiting

  • St. Bartholomew's Hospital,Substudy-02

    London, E1 1BB
    United Kingdom

    Active - Recruiting

  • St. Bartholomew's Hospital,Substudy-03

    London, E1 1BB
    United Kingdom

    Active - Recruiting

  • Arizona Oncology Associates,Substudy-01

    Tucson, Arizona 85711
    United States

    Site Not Available

  • Arizona Oncology Associates,Substudy-02

    Tucson, Arizona 85711
    United States

    Active - Recruiting

  • Rocky Mountain Cancer Center,Substudy-01

    Denver, Colorado 80218
    United States

    Site Not Available

  • Rocky Mountain Cancer Center,Substudy-02

    Denver, Colorado 80218
    United States

    Active - Recruiting

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

    Fort Wayne, Indiana 46845
    United States

    Active - Recruiting

  • Baptist Health Lexington,Substudy-03

    Lexington, Kentucky 40503
    United States

    Active - Recruiting

  • Washington University School of Medicine - Siteman Cancer Center

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

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

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

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

    Saint Louis, Missouri 63110
    United States

    Site Not Available

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

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Oncology Hematology Care Clinical Trials, LLC,Substudy-01

    Cincinnati, Ohio 45242
    United States

    Active - Recruiting

  • Oncology Hematology Care Clinical Trials, LLC,Substudy-02

    Cincinnati, Ohio 45242
    United States

    Active - Recruiting

  • Oncology Associates of Oregon, PC,Substudy-01

    Eugene, Oregon 97401
    United States

    Active - Recruiting

  • Oncology Associates of Oregon, PC,Substudy-02

    Eugene, Oregon 97401
    United States

    Active - Recruiting

  • Texas Oncology - Central South,Substudy-01

    Austin, Texas 78745
    United States

    Site Not Available

  • Texas Oncology - Central South,Substudy-02

    Austin, Texas 78745
    United States

    Active - Recruiting

  • Texas Oncology,Substudy-01

    Austin, Texas 78745
    United States

    Active - Recruiting

  • Texas Oncology,Substudy-02

    Austin, Texas 78745
    United States

    Active - Recruiting

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

    Fairfax, Virginia 22031
    United States

    Site Not Available

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

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

  • Fred Hutchinson Cancer Center,Substudy-01

    Seattle, Washington 98109
    United States

    Active - Recruiting

  • Fred Hutchinson Cancer Center,Substudy-02

    Seattle, Washington 98109
    United States

    Active - Recruiting

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