Vactosertib in Combination With Pembrolizumab for PD-L1 Positive Non-small Cell Lung Cancer (NSCLC) Subjects

• Status: Recruiting
• Trial end date: 2025-12-30
• Target enrollment: 0
• Participant gender: All

Summary

This is Phase 2, open label, multi-center study to assess safety and efficacy of vactosertib in combination with pembrolizumab as 1st line treatment for subjects with advanced or metastatic, PD-L1 positive, non-small cell lung cancer (NSCLC) who have not previously received systemic therapy for advanced disease and in whom EGFR, ALK, BRAF, ROS1-directed therapy is not indicated.

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

Details

• Lead Sponsor: MedPacto, Inc.
• Treatments: Pembrolizumab

Criteria

Inclusion Criteria:

• Have a histologically- or cytologically-documented NSCLC advanced or stage IV lung cancer

• Have confirmation that EGFR, ALK, BRAF, ROS1-directed therapy is not indicated

• Have measurable disease based on RECIST 1.1

• PD-L1 expression is ≥1% as determined by the PD-L1 IHC 22C3 pharmDx assay

• Have a life expectancy of at least 3 months.

• ECOG 0 or 1

• Subjects must be able to swallow tablets and absorb vactosertib.

• Have adequate organ function as indicated by the following laboratory values in

Exclusion Criteria:

• Is currently participating in a study of an investigational agent

• Has received prior systemic cytotoxic chemotherapy for metastatic disease/ antineoplastic biological therapy /Had major surgery / radiation therapy to the lung

• Has received a live vaccine within 30 days prior to the first dose of study drug.

• Is taking prohibited medications

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

• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.

• Had a severe hypersensitivity reaction to treatment with another mAb previously.

• Has severe hypersensitivity to vactosertib and/or any of its excipients