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

About

Brief 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.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase II

Eligibility

Gender

All

Healthy Volunteers

Minimum Age

18 Years

Maximum Age

N/A

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.

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