Lung Cancer Clinical Trial

Study of Novel Treatment Combinations in Patients With 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 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. New substudies and/or treatment arms may be added to the study through amendment of the master protocol and/or substudy protocols.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

397

Study ID:

NCT05633667

Recruitment Status:

Recruiting

Sponsor:

Gilead Sciences

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There are 25 Locations for this study

See Locations Near You

Arizona Oncology Associates,Substudy-01
Tucson Arizona, 85711, United States
Arizona Oncology Associates,Substudy-02
Tucson Arizona, 85711, United States
Rocky Mountain Cancer Center,Substudy-01
Denver Colorado, 80218, United States
Rocky Mountain Cancer Center,Substudy-02
Denver Colorado, 80218, United States
Fort Wayne Medical Oncology and Hematology, Inc.,Substudy-03
Fort Wayne Indiana, 46845, United States
Washington University School of Medicine - Siteman Cancer Center,Substudy-01
Saint Louis Missouri, 63110, United States
Washington University School of Medicine - Siteman Cancer Center,Substudy-02
Saint Louis Missouri, 63110, United States
Washington University School of Medicine - Siteman Cancer Center
Saint Louis Missouri, 63110, United States
Oncology Hematology Care Clinical Trials, LLC,Substudy-01
Cincinnati Ohio, 45242, United States
Oncology Hematology Care Clinical Trials, LLC,Substudy-02
Cincinnati Ohio, 45242, United States
Oncology Associates of Oregon, PC,Substudy-01
Eugene Oregon, 97401, United States
Oncology Associates of Oregon, PC,Substudy-02
Eugene Oregon, 97401, United States
Texas Oncology,Substudy-01
Austin Texas, 78745, United States
Texas Oncology,Substudy-02
Austin Texas, 78745, United States
US Oncology Investigational Products Center (IPC),Substudy-01
Fairfax Virginia, 22031, United States
US Oncology Investigational Products Center (IPC),Substudy-02
Fairfax Virginia, 22031, United States
Fred Hutchinson Cancer Center,Substudy-01
Seattle Washington, 98109, United States
Fred Hutchinson Cancer Center,Substudy-02
Seattle Washington, 98109, United States
Queen Elizabeth Hospital,Substudy-01
Hong Kong , , Hong Kong
Queen Elizabeth Hospital,Substudy-02
Hong Kong , , Hong Kong
Queen Mary Hospital,Substudy-01
Hong Kong , , Hong Kong
Queen Mary Hospital,Substudy-02
Hong Kong , , Hong Kong
Prince of Wales Hospital,Substudy-02
New Territories , , Hong Kong
Rambam Health Care Campus,Substudy-01
Haifa , 35254, Israel
Rambam Health Care Campus,Substudy-02
Haifa , 35254, Israel
Rambam Health Care Campus,Substudy-03
Haifa , 35254, Israel
Shaare Zedek Medical Center,Substudy-01
Jerusalem , 91031, Israel
Shaare Zedek Medical Center,Substudy-02
Jerusalem , 91031, Israel
Shaare Zedek Medical Center,Substudy-03
Jerusalem , 91031, Israel
Hadassah University Medical Center,Substudy-03
Jerusalem , 91120, Israel
Tel Aviv Sourasky Medical Center,Substudy-01
Tel Aviv-Yafo , 64239, Israel
Tel Aviv Sourasky Medical Center,Substudy-02
Tel Aviv-Yafo , 64239, Israel
Tel-Aviv Sourasky Medical Center,Substudy-03
Tel Aviv-Yafo , 64239, Israel
Chungbuk National University Hospital,Substudy-01
Cheongju-si , 28644, Korea, Republic of
Chungbuk National University Hospital,Substudy-02
Cheongju-si , 28644, Korea, Republic of
National Cancer Center,Substudy-01
Goyang , 41076, Korea, Republic of
National Cancer Center,Substudy-02
Goyang , 41076, Korea, Republic of
Asan Medical Center,Substudy-02
Seoul , 05505, Korea, Republic of
Asan Medical Centre,Substudy-01
Seoul , 05505, Korea, Republic of
Samsung Medical Center,Substudy-01
Seoul , 06351, Korea, Republic of
Samsung Medical Center,Substudy-02
Seoul , 06351, Korea, Republic of
Severance Hospital, Yonsei University Health System,Substudy-01
Seoul , 120-7, Korea, Republic of
Severance Hospital, Yonsei University Health System,Substudy-02
Seoul , 120-7, Korea, Republic of
Seoul National University,Substudy-01
Seoul , 463-7, Korea, Republic of
Seoul National University,Substudy-02
Seoul , 463-7, Korea, Republic of
Changhua Christian Hospital,Substudy-01
Changhua City , 500-0, Taiwan
Changhua Christian Hospital,Substudy-02
Changhua City , 500-0, Taiwan
Changhua Christian Hospital,Substudy-03
Changhua City , 500-0, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital,Substudy-01
Kaohsiung City , 80756, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital,Substudy-02
Kaohsiung City , 80756, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital,Substudy-03
Kaohsiung City , 80756, Taiwan
Kaohsiung Chang Gung Memorial Hospital,Substudy-01
Kaohsiung , 83301, Taiwan
Kaohsiung Chang Gung Memorial Hospital,Substudy-02
Kaohsiung , 83301, Taiwan
Kaohsiung Chang Gung Memorial Hospital,Substudy-03
Kaohsiung , 83301, Taiwan
National Taiwan University Hospital,Substudy-01
Taipei City , 100, Taiwan
National Taiwan University Hospital,Substudy-02
Taipei City , 100, Taiwan
University Hospitals Birmingham NHS Trust,Substudy-01
Birmingham , B9 5S, United Kingdom
University Hospitals Birmingham NHS Trust,Substudy-02
Birmingham , B9 5S, United Kingdom
St. Bartholomew's Hospital,Substudy-01
London , E1 1B, United Kingdom
St. Bartholomew's Hospital,Substudy-02
London , E1 1B, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

397

Study ID:

NCT05633667

Recruitment Status:

Recruiting

Sponsor:


Gilead Sciences

How clear is this clinincal trial information?

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