A Study of Novel Treatment Combinations in Patients With Lung Cancer

• Status: Not yet recruiting
• Trial end date: 2028-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this platform clinical trial is to test novel treatment combinations in participants with lung cancer. The platform study will consist of 2 initial substudies. New substudies and/or treatment arms may be added to the study through amendment of the master protocol and/or substudy protocols.

Two initial substudies will enroll in parallel:

The goal of Substudy-01 is to see if different combinations of experimental drugs named zimberelimab, domvanalimab, sacituzumab govitecan and etrumadenant are safe and effective for persons with no prior systemic treatment as compared to standard of care.

The goal of Substudy-02 is to see if different combinations of experimental drugs named zimberelimab, sacituzumab govitecan, etrumadenant are safe and effective for persons whose cancer has progressed after receiving previous treatment for metastatic NSCLC (form of cancer that can spread from one part of body to another). The safety and effectiveness will be compared to standard of care.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Cisplatin; Docetaxel; Paclitaxel; Pemetrexed

Criteria

Key Inclusion Criteria:

All Substudies:

• Histologically or cytologically documented non-small-cell lung cancer (NSCLC) with evidence of stage IV disease.

• No known actionable genomic alterations for which approved therapies are available.

• No prior systemic treatment for metastatic NSCLC.

• Eastern cooperative oncology group (ECOG) performance status score of 0 or 1.

• Measurable disease as per response evaluation criteria in solid tumors (RECIST) 1.1 criteria.

• 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

• For individuals with nonsquamous histology: Epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) alteration negative.

Substudy 02: All Experimental arms

• In individuals with nonsquamous histology, individuals with EGFR, ALK, or any other known actionable genomic alterations must have received treatment with at least 1 approved tyrosine kinase inhibitor (TKI) appropriate to the genomic alteration.

• Progression or disease recurrence after platinum-based chemotherapy with anti-PD-1 or anti-PD-L1 antibody OR sequential treatment (in any order).

Key Exclusion Criteria:

All Substudies:

• Mixed small-cell lung cancer and NSCLC histology.

• Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.

• Received previous anticancer therapy within 4 weeks prior to enrollment.

• 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.

Note: Other protocol defined inclusion/exclusion criteria may apply