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Sitravatinib Plus Pembrolizumab in Patients With Advanced Treatment-Naïve PD-L1+ Non-Squamous NSCLC

NCT04925986 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2025-04-17

Study results available
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Summary

This is a multicohort phase 2 study to evaluate the efficacy of pembrolizumab combined with the investigational drug sitravatinib in the frontline treatment of advanced, non-squamous PD-L1 positive NSCLC.

Conditions

  • Carcinoma, Non-Small-Cell Lung
  • Lung Diseases
  • Lung Neoplasms
  • Metastatic Lung Non-Small Cell Carcinoma
  • Stage IV Lung Non-Small Cell Cancer AJCC v7
  • PD-L1 Gene Mutation
  • Advanced Treatment-Naïve PD-L1
  • Sitravatinib
  • Pembrolizumab

Interventions

DRUG

Sitravatinib

Groups 1A and 2A receive Sitravatinib 100mg orally (PO) daily starting on cycle 1 day 1 (C1D1). Groups 1B and 2B) receive Sitravatinib 100mg orally (PO) daily starting on Cycle 2 Day 1 (C2D1).

DRUG

Pembrolizumab

All groups (1A, 1B, 2A, 2B) receive Pembrolizumab 200mg intravenous every three weeks (IV Q3w) on cycle 1 day 1 (C1D1).

Sponsors & Collaborators

  • Mirati Therapeutics Inc.

    collaborator INDUSTRY

  • Sarah Goldberg

    lead OTHER

Principal Investigators

  • Sarah Goldberg, MD MPH · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-10
Primary Completion
2023-06-22
Completion
2023-10-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04925986 on ClinicalTrials.gov