Study on Ramucirumab and Pembrolizumab vs Usual Care for Advanced or Returning Non-Small Cell Lung Cancer

Sponsor: SWOG Cancer Research Network

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05633602

Provider View

This clinical trial is comparing a new treatment combination of ramucirumab and pembrolizumab with standard chemotherapy for patients with advanced or returning non-small cell lung cancer. The study aims to find out if the new combination is more effective than the usual treatment.

Patient Parameters

Program Overview

This phase III study is testing whether a combination of two drugs, ramucirumab and pembrolizumab, is better than standard chemotherapy for treating non-small cell lung cancer (NSCLC) that is either stage IV or has come back after treatment. Ramucirumab is a type of drug that may stop tumors from growing by preventing new blood vessels from forming. Pembrolizumab is an immunotherapy drug that helps the immune system attack cancer cells. Chemotherapy works by killing cancer cells or stopping them from growing and spreading. The study will help doctors understand if the new drug combination is more effective than the usual chemotherapy treatment.

Description

PRIMARY OBJECTIVE:

  • To compare the overall survival of patients with advanced or returning non-small cell lung cancer who have already been treated with platinum-based chemotherapy and immunotherapy. Patients will be randomly assigned to receive either the new combination of pembrolizumab and ramucirumab or the standard chemotherapy treatment.

SECONDARY OBJECTIVE:

  • To report any serious and unexpected side effects related to the treatments in each group.

STUDY DESIGN:

  • Participants will be randomly assigned to one of two groups:
    • Group A: Will receive standard chemotherapy treatment.
    • Group B: Will receive ramucirumab and pembrolizumab through an IV.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of stage IV or returning non-small cell lung cancer.
  • Must have received at least one treatment with anti-PD-1 or anti-PD-L1 therapy for any stage of NSCLC.
  • Must have experienced disease progression more than 84 days after starting their most recent anti-PD-1 or PD-L1 therapy.
  • Must have had a stable, partial, or complete response to anti-PD-1 or anti-PD-L1 therapy for stage IV or recurrent disease.
  • If anti-PD-1 or PD-L1 therapy was given as the only treatment, disease progression must have occurred within 365 days of starting the therapy.
  • Must have received platinum-based chemotherapy and experienced disease progression during or after this treatment.
  • If there is a known mutation with an FDA-approved targeted therapy, must have received at least one of these therapies.
  • Must be 18 years or older.
  • Must be able to safely receive the study drug combination and standard care treatments.
  • Must have a Zubrod performance status of 0-2, indicating good overall health.

Exclusion Criteria

  • Must not have received more than one line of anti-PD-1 or anti-PD-L1 therapy for stage IV or recurrent disease.
  • Must not be receiving or planning to receive another investigational therapy during the study.

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