A Phase 2 Platform Study of Immunomodulatory Compounds in ICI-refractory Non-small Cell Lung Cancer

Not Applicable

Not yet recruiting

• Conditions: Non-Small Cell Lung Cancer; ICI-refractory
• Interventions: Drug: SAR445877

• Registration Number: NCT07133425
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

To learn if SAR445877 can help to control locally advanced or metastatic NSCLC in patients who have previously received ICI therapy.

Detailed Description

Primary Objectives

* To identify early efficacy signals for SAR445877 in ICI-exposed NSCLC participants

* Identify biomarkers related to the mechanism of action in SAR445877 and predictive of response/resistance in ICI-exposed NSCLC participants

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-19
• Study First Submitted QC: 2025-08-19
• Last Update Submitted: 2025-08-19
• Study First Posted: 2025-08-21
• Last Update Posted: 2025-08-21
• Study Start: 2026-02-05
• Primary Completion: 2028-02-01
• Study Completion: 2030-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Phase II biomarker study of SAR445877	SAR445877	Will receive SAR445877 by vein over about 60 minutes every 2 weeks, on Day 1 of each 14-day cycle.

Primary Outcome Measures

Name	Time	Method
Safety and adverse events (AEs)	Through study completion; an average of 1 year	Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Trial Locations

Locations (1)

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States