STRIVE: A Single-arm Phase 2 Study on Treatment of Lung Squamous Cell Carcinoma by Tiragolumab Plus Ivonescimab for Patients Who Progressed on Platinum Doublets and Anti-PD-1/PD-L1

Phase 2

Withdrawn

• Conditions: Lung Squamous Cell Carcinoma; Anti-PD1/PDL1 Antibody
• Interventions: Drug: Tiragolumab; Drug: Ivonescimab

• Registration Number: NCT07038915
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

To learn if the drug combination of tiragolumab and ivonescimab can help to control LSCC that got worse after standard treatment with platinum doublets and anti-PD-1/PD-L1 therapy.

Detailed Description

Primary Objectives To determine the objective response rate (ORR) of metastatic LSCC patients who progressed on platinum doublets and anti-PD1/PD-L1 treated with Tiragolumab/Ivonescimab.

Secondary Objectives To evaluate the investigator assessed progression-free survival (PFS) and overall survival (OS) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 of tiragolumab in combination with ivonescimab To evaluate the duration of response (DoR) of tiragolumab in combination with ivonescimab, as assessed by investigator, based on RECIST v1.1 To evaluate the safety and tolerability of tiragolumab in combination with ivonescimab

Study Timeline

• Study First Submitted: 2025-06-18
• Study First Submitted QC: 2025-06-18
• Study First Posted: 2025-06-26
• Status Verified: 2025-07
• Study Start: 2025-07-28
• Primary Completion: 2025-07-28
• Study Completion: 2025-07-28
• Last Update Submitted: 2025-07-31
• Last Update Posted: 2025-08-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	Tiragolumab	Treatment with Tiragolumab + Ivonescimab
Single Arm	Ivonescimab	Treatment with Tiragolumab + Ivonescimab

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