Study of Novel Treatment Combinations in Patients With Lung Cancer
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.
Checked against the public recordLast updated Jun 1, 2026 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Gilead Sciences
- Interventions being studied
- Drug: Zimberelimab (ZIM); Drug: Domvanalimab (DOM); Drug: Sacituzumab govitecan-hziy (SG); Drug: Etrumadenant (ETRUMA); Drug: Carboplatin; Drug: Cisplatin; Drug: Pemetrexed; Drug: Paclitaxel; Drug: Nab-paclitaxel; Drug: Docetaxel; Drug: Nivolumab
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Arizona Oncology Associates,Substudy-02Tucson, Arizona
- Fort Wayne Medical Oncology and Hematology, Inc.,Substudy-03Fort Wayne, Indiana
- Baptist Health Lexington,Substudy-03Lexington, Kentucky
- Washington University School of Medicine - Siteman Cancer Center,Substudy-01St Louis, Missouri
- Washington University School of Medicine - Siteman Cancer Center,Substudy-02St Louis, Missouri
- Washington University School of Medicine - Siteman Cancer Center,Substudy-03St Louis, Missouri
- Washington University School of Medicine - Siteman Cancer CenterSt Louis, Missouri
- Oncology Hematology Care Clinical Trials, LLC,Substudy-01Cincinnati, Ohio
- Oncology Hematology Care Clinical Trials, LLC,Substudy-02Cincinnati, Ohio
- Oncology Associates of Oregon, PC,Substudy-01Eugene, Oregon
- Oncology Associates of Oregon, PC,Substudy-02Eugene, Oregon
- Fundação Pio XII - Hospital de Amor,Substudy-01Barretos
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 1, 2026. Always confirm current availability with the study team.