About the study

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.

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria

1. Have a histologically
2. or cytologically-documented NSCLC advanced or stage IV lung cancer
3. Have confirmation that EGFR, ALK, BRAF, ROS1-directed therapy is not indicated
4. Have measurable disease based on RECIST 1.1
5. PD-L1 expression is ≥1% as determined by the PD-L1 IHC 22C3 pharmDx assay
6. Have a life expectancy of at least 3 months.
7. ECOG 0 or 1
8. Subjects must be able to swallow tablets and absorb vactosertib.
9. Have adequate organ function as indicated by the following laboratory values in

Exclusion criteria

1. Is currently participating in a study of an investigational agent
2. Has received prior systemic cytotoxic chemotherapy for metastatic disease/ antineoplastic biological therapy /Had major surgery / radiation therapy to the lung
3. Has received a live vaccine within 30 days prior to the first dose of study drug.
4. Is taking prohibited medications
5. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
6. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
7. Had a severe hypersensitivity reaction to treatment with another mAb previously.
8. Has severe hypersensitivity to vactosertib and/or any of its excipients

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.