Clinical trial · Interventional
Vactosertib in Combination with Pembrolizumab for PD-L1 Positive Non-small Cell Lung Cancer (NSCLC) Subjects
A Phase 2, Open-label, Multicenter Study to Assess the Efficacy and Safety of Vactosertib in Combination with Pembrolizumab As a First-line Treatment for Subjects with PD-L1 Positive Advanced Non-Small Cell Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): This is because Medpacto decided to modify its development strategy as the business and development environment changed.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vactosertib 300 mg BID and pembrolizumab 200 mg IV | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- vactosertib+Pembrolizumab
- description
- Vactosertib (5days on and 2days off) Pembrolizumab 200mg Q3Weeks
- interventionNames
- Drug: Vactosertib 300 mg BID and pembrolizumab 200 mg IV
Primary outcomes (1)
- measure
- ORR per RECIST 1.1
- timeFrame
- From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
- description
- ORR in PD-L1≥1% and PD-L1≥50% population per RECIST 1.1 by investigators
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available