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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Sarah Goldberg
Study ID
NCT04925986
Phase
PHASE2
Status
Terminated

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Feb 10, 2022
Status verified
Apr 2025
Primary completion
Jun 22, 2023
Completion
Oct 30, 2023

Study Design

Enrollment
9 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1A: PD-L1 1-49%, Main Study Population
    Participants with PD-L1 Tumor Proportion Score (TPS) 1-49% receive Pembrolizumab 200mg intravenous (IV) every 3 weeks (Q3w) and Sitravatinib 100mg PO (by mouth) daily, beginning on cycle 1 day 1 (C1D1).
  • Experimental: Group 1B: PD-L1 1-49%, Pembrolizumab run-in population
    Participants with PD-L1 Tumor Proportion Score (TPS) 1-49% receive Pembrolizumab 200mg intravenous (IV) for one dose alone, beginning on cycle 1 day 1 (C1D1). On Cycle 2 Day 1 (C2D1), participants receive Pembrolizumab 200mg intravenous (IV) once every 3 weeks (Q3w) and Sitravatinib 100mg PO (by mouth) daily.
  • Experimental: Group 2A: PD-L1 ≥ 50%, Main Study Population
    Participants with PD-L1 Tumor Proportion Score (TPS) ≥ 50% receive Pembrolizumab 200mg intravenous (IV) every 3 weeks (Q3w) and Sitravatinib 100mg PO (by mouth) daily, beginning on cycle 1 day 1 (C1D1).
  • Experimental: Group 2B: PD-L1 ≥ 50%, Pembrolizumab run-in population
    Participants with PD-L1 Tumor Proportion Score (TPS) ≥ 50% receive Pembrolizumab 200mg intravenous (IV) for one dose alone, beginning on cycle 1 day 1 (C1D1). On Cycle 2 Day 1 (C2D1), participants receive Pembrolizumab 200mg intravenous (IV) once every 3 weeks (Q3w) and Sitravatinib 100mg PO (by mouth) daily.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: up to 267 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Yale UniversityNew HavenConnecticut06520-

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