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

NCT04515979 | Terminated Phase 2

• 2 other identifiers: MP-VAC-205MK3475 B37
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

• ORR per RECIST 1.1

  ORR in PD-L1≥1% and PD-L1≥50% population per RECIST 1.1 by investigators

  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

Study Arms (1)

vactosertib+Pembrolizumab

EXPERIMENTAL

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

Drug: Vactosertib 300 mg BID and pembrolizumab 200 mg IV

Interventions

Vactosertib 300 mg BID and pembrolizumab 200 mg IV DRUG

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

Also known as: Vactosertib 300 mg BID and keytruda 200 mg IV

vactosertib+Pembrolizumab

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MedPacto, Inc.: lead

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

vactosertib; BID protein, human; pembrolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Minkyu Heo

  MedPacto, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: August 17, 2020
• Study Start: December 17, 2020
• Primary Completion: August 5, 2024
• Study Completion: August 5, 2024
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)