Study of Sacituzumab Govitecan-hziy Combinations in First-line Treatment of Participants With Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) Without Actionable Genomic Alterations

• Status: Not yet recruiting
• Trial end date: 2026-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objectives of the study are to assess the objective response rate (ORR) and to determine the recommended Phase 2 dose (RP2D) of SG in combination with pembrolizumab or pembrolizumab and a platinum agent (carboplatin or cisplatin) in participants with advanced or metastatic non-small-cell lung cancer (NSCLC) without actionable genomic alterations.

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

Details

• Lead Sponsor: Gilead Sciences
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Carboplatin; Pembrolizumab

Criteria

Key Inclusion Criteria:

• Individuals with pathologically documented evidence of Stage IV non-small cell lung Cancer (NSCLC) disease at the time of enrollment

• Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as per RECIST Version 1.1 criteria by investigator

• No prior systemic treatment for metastatic NSCLC

• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

• Adequate hematologic counts

• Adequate hepatic function

Key Exclusion Criteria:

• Mixed SCLC and NSCLC histology

• Active second malignancy

• NSCLC that is eligible for definitive local therapy alone

• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy

• Has an active autoimmune disease that has required systemic treatment in past 2 years

• Has had an allogenic tissue/solid organ transplant.

• Has severe (≥ Grade 3) hypersensitivity to SG, pembrolizumab, carboplatin, or cisplatin, their metabolites, or formulation excipient

• Has received radiation therapy to the lung

• Individuals may not have received systemic anticancer treatment within the previous 6 months

• Is currently participating in or has participated in a study of an investigational agent

• Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses

• Known active central nervous system (CNS) metastases

• History of cardiac disease

• Active chronic inflammatory bowel disease

• Active serious infection requiring antibiotics

• Active or chronic hepatitis B infection

• Positive hepatitis C antibody

• Positive serum pregnancy test or women who are lactating

Note: Other protocol defined Inclusion/Exclusion criteria may apply.