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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Carcinoma, Non-Small-Cell Lung
• Intervention / Treatment: Drug: Vactosertib 300 mg BID and pembrolizumab 200 mg IV

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).

• Study Type: Interventional
• Enrollment (Anticipated): 55
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: kyounghee kim; Phone Number: 82-2-6938-0235; Email: kyounghee.kim@medpacto.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06351
    • Recruiting
    • Samsung Medical Center
    • Contact: Sㄷ-hoon Lee, Phd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: vactosertib+Pembrolizumab; Vactosertib (5days on and 2days off) Pembrolizumab 200mg Q3Weeks	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: MedPacto, Inc.
• Investigators: Study Director: Bitna Oh, MD, MedPacto, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2020
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): December 30, 2025

Study Registration Dates

• First Submitted: August 11, 2020
• First Submitted That Met QC Criteria: August 13, 2020
• First Posted (Actual): August 17, 2020

Study Record Updates

• Last Update Posted (Actual): September 24, 2021
• Last Update Submitted That Met QC Criteria: September 22, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Antineoplastic Agents; Antineoplastic Agents, Immunological; Pembrolizumab
• Other Study ID Numbers: MP-VAC-205; MK3475 B37 (Other Identifier: Merck)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No