## Protocol Section
### Identification Module
**NCT ID:** NCT04515979

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

**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

#### Organization Study ID Info
**ID:** MP-VAC-205
#### Organization
**Class:** INDUSTRY
**Full Name:** MedPacto, Inc.
#### Secondary ID Infos
**Domain:** Merck
**ID:** MK3475 B37
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2025-12-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-09-24

**Type:** ACTUAL

**Last Update Submit Date:** 2021-09-22

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2022-08-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2020-12-17

**Type:** ACTUAL

**Status Verified Date:** 2021-09

#### Study First Post Date
**Date:** 2020-08-17
**Type:** ACTUAL
**Study First Submit Date:** 2020-08-11
**Study First Submit QC Date:** 2020-08-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** MedPacto, Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Carcinoma, Non-Small-Cell Lung

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 55

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Drug: Vactosertib 300 mg BID and pembrolizumab 200 mg IV

**Label:** vactosertib+Pembrolizumab

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- vactosertib+Pembrolizumab

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

**Name:** Vactosertib 300 mg BID and pembrolizumab 200 mg IV

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

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

**Measure:** ORR per RECIST 1.1

**Time Frame:** 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

### Eligibility Module

**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 Age:** 19 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** kyounghee.kim@medpacto.com

**Name:** kyounghee kim

**Phone:** 82-2-6938-0235

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Seoul

**Contacts:**

***Contact 1:***

- **Name:** Sㄷ-hoon Lee, Phd

- **Role:** CONTACT

**Country:** Korea, Republic of

**Facility:** Samsung Medical Center

**Status:** RECRUITING

**Zip:** 06351

#### Overall Officials

**Official 1:**

**Affiliation:** MedPacto, Inc.

**Name:** Bitna Oh, MD

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000002283

- Term: Carcinoma, Bronchogenic

- ID: D000001984

- Term: Bronchial Neoplasms

- ID: D000008175

- Term: Lung Neoplasms

- ID: D000012142

- Term: Respiratory Tract Neoplasms

- ID: D000013899

- Term: Thoracic Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

### Condition Browse Module - Browse Leaves

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M11172

- Name: Lung Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M5546

- Name: Carcinoma, Non-Small-Cell Lung

- Relevance: HIGH

- As Found: Carcinoma, Non-Small-Cell Lung

- ID: M5540

- Name: Carcinoma, Bronchogenic

- Relevance: LOW

- As Found: Unknown

- ID: M5260

- Name: Bronchial Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M14979

- Name: Respiratory Tract Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M16658

- Name: Thoracic Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002289

- Term: Carcinoma, Non-Small-Cell Lung

### Intervention Browse Module - Ancestors

- ID: D000074322

- Term: Antineoplastic Agents, Immunological

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000082082

- Term: Immune Checkpoint Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000047428

- Term: Protein Kinase Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M349416

- Name: Pembrolizumab

- Relevance: HIGH

- As Found: Blind

- ID: M96450

- Name: Vactosertib

- Relevance: HIGH

- As Found: Evidence for

- ID: M1346

- Name: Antineoplastic Agents, Immunological

- Relevance: LOW

- As Found: Unknown

- ID: M2342

- Name: Immune Checkpoint Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M25820

- Name: Protein Kinase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000582435

- Term: Pembrolizumab

- ID: C000590371

- Term: Vactosertib

### Misc Info Module

- Version Holder: 2024-05-24
