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

MedPacto

Status and phase

Terminated

Phase 2

Conditions

Carcinoma, Non-Small-Cell Lung

Treatments

Drug: Vactosertib 300 mg BID and pembrolizumab 200 mg IV

Study type

Interventional

Funder types

Industry

Identifiers

NCT04515979

MP-VAC-205

MK3475 B37 (Other Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment

11 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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