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

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04515979
• Other study ID #: MP-VAC-205
• Secondary ID: MK3475 B37
• Status: Recruiting
• Phase: Phase 2
• Start date: December 17, 2020
• Est. completion date: December 30, 2025

Study information

• Verified date: September 2021
• Source: MedPacto, Inc.
• Contact: kyounghee kim
• Phone: 82-2-6938-0235
• Email: kyounghee.kim[@]medpacto.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: December 30, 2025
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• 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).

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
MedPacto, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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