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

NCT ID: NCT04515979

Last Updated: 2024-12-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-17
• Study Completion Date: 2024-08-05

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).

Conditions

Carcinoma, Non-Small-Cell Lung

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

vactosertib+Pembrolizumab

Vactosertib (5days on and 2days off) Pembrolizumab 200mg Q3Weeks

Group Type: EXPERIMENTAL

Vactosertib 300 mg BID and pembrolizumab 200 mg IV

Intervention Type: DRUG

Vactosertib 300 mg orally (PO) BID(5 days on/2days off) and pembrolizumab 200 mg IV (Q3W).

Interventions

Vactosertib 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).

Intervention Type: DRUG

Other Intervention Names

Vactosertib 300 mg BID and keytruda 200 mg IV

Eligibility 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MedPacto, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Minkyu Heo

Role: STUDY_DIRECTOR

MedPacto, Inc.

Locations

Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

MK3475 B37

Identifier Type: OTHER

Identifier Source: secondary_id

MP-VAC-205

Identifier Type: -

Identifier Source: org_study_id