Study of Novel Treatment Combinations in Patients With Lung Cancer

Launched by GILEAD SCIENCES · Nov 21, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring new combinations of treatments for patients with lung cancer, specifically a type called non-small-cell lung cancer (NSCLC). The trial has three different groups, or substudies. The first group is looking at patients with advanced lung cancer who have never received treatment before. The second group is for patients whose cancer has worsened after previous treatment. The third group is for patients with earlier-stage lung cancer that can still be surgically removed. The goal is to see how effective these new treatment combinations are compared to the standard care currently offered.

To be eligible for this trial, participants must have been diagnosed with NSCLC and meet certain health criteria, like having measurable disease and good overall health status. They should not have received previous treatments for their lung cancer (for some groups) and must not have specific genetic changes that would allow for targeted therapies. If someone joins this trial, they can expect to receive either the new treatment combinations or the standard care and will be closely monitored for their response to the treatment. It’s also important for potential participants to know that there are certain health conditions that might exclude them from joining the study.

Gender

ALL

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