Carcinoma, Non-Small-Cell Lung
Conditions
Brief 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.
Detailed description
Approximately 55 NSCLC subjects with PD-L1 tumor proportion score (TPS) ≥ 1% are expected to be enrolled in this study. Subjects' TPS will be determined by PD-L1 IHC 22C3 pharmDx assay performed according to local laboratory regulations prior to study enrollment. Subjects who received adjuvant or neoadjuvant therapy are permitted onto the study if the therapy was completed at least 12 months prior to the development of metastatic disease. Eligible subjects will receive: • Vactosertib 300 mg orally (PO) BID for 5 days with 2 days off period (5 days on/2days off) and pembrolizumab 200 mg IV on Day 1 of every 3-week cycle (Q3W).
Interventions
DRUGVactosertib 300 mg BID and pembrolizumab 200 mg IV
Vactosertib 300 mg orally (PO) BID(5 days on/2days off) and pembrolizumab 200 mg IV (Q3W).
Sponsors
MedPacto, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR per RECIST 1.1 | 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 | ORR in PD-L1≥1% and PD-L1≥50% population per RECIST 1.1 by investigators |
Countries
South Korea
Outcome results
None listed