Study on Pembrolizumab with or without Maintenance Olaparib for First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT03976362

Provider View

This clinical trial is comparing two treatment options for patients with metastatic squamous non-small cell lung cancer (NSCLC). It aims to find out if adding the drug olaparib to pembrolizumab improves patient outcomes compared to using pembrolizumab alone.

Patient Parameters

Program Overview

The study is testing whether combining pembrolizumab with olaparib is more effective than pembrolizumab with a placebo in treating metastatic squamous non-small cell lung cancer (NSCLC). The main goals are to see if this combination can help patients live longer without the cancer getting worse and to improve overall survival rates.

Description

This study has two parts: an Induction Phase and a Maintenance Phase.

In the Induction Phase, participants receive pembrolizumab along with chemotherapy drugs carboplatin and a taxane (either paclitaxel or nab-paclitaxel) for four cycles.

In the Maintenance Phase, participants whose cancer has responded to the initial treatment or remained stable will be randomly assigned to receive either pembrolizumab with olaparib or pembrolizumab with a placebo. This phase can last for up to 31 cycles, or until the cancer progresses, side effects become too severe, or the doctor decides to stop treatment.

Participants who were taking a placebo will stop taking it but will continue in the study.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with squamous non-small cell lung cancer (NSCLC).
  • Cancer is at Stage IV.
  • Have measurable cancer based on specific medical criteria.
  • Have not received previous treatment for advanced or metastatic NSCLC.
  • Provide a tumor tissue sample for analysis.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Expected to live at least 3 more months.
  • Have adequate organ function.
  • Agree to use contraception during treatment and for 180 days after.
  • Men must not donate sperm during treatment and for 180 days after.

Exclusion Criteria

  • Have non-squamous NSCLC.
  • Have another cancer that is progressing or required treatment in the last 3 years.
  • Have active cancer spread to the brain or spinal cord.
  • Have allergies to any study drugs or their components.
  • Have severe allergies to pembrolizumab.
  • Have an active autoimmune disease needing treatment in the last 2 years.
  • Have an immune deficiency or are on long-term steroid therapy.
  • Have HIV, hepatitis B, or active hepatitis C.
  • Have lung diseases like interstitial lung disease or pneumonitis needing steroids.
  • Have previously taken olaparib or similar drugs.
  • Have taken drugs targeting PD-L1, PD-L2, or similar immune receptors.
  • Have myelodysplastic syndrome or acute myeloid leukemia.

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