Study on GT103 and Pembrolizumab for Treating Advanced or Metastatic STK11 Mutant Non-Small Cell Lung Cancer

Sponsor: Roswell Park Cancer Institute

Sponsor score: 40

ClinicalTrials ID:NCT07017829

Provider View

This clinical trial is testing a new treatment combining GT103 and pembrolizumab to see if it can help patients with advanced or metastatic non-small cell lung cancer that has a specific STK11 mutation. The study aims to find out if this combination can effectively stop the cancer from growing and spreading.

Patient Parameters

Program Overview

This study is exploring a new treatment for patients with advanced or metastatic non-small cell lung cancer (NSCLC) that has a specific mutation called STK11. The treatment combines two drugs: GT103, a monoclonal antibody that targets a protein on cancer cells, and pembrolizumab, an immunotherapy that helps the immune system attack cancer. The goal is to see if this combination can stop the cancer from growing and improve patient outcomes.

Description

The main goal of this study is to see if the combination of GT103 and pembrolizumab can keep the cancer from getting worse for at least six months in patients with advanced or metastatic STK11 mutant non-small cell lung cancer (NSCLC). Researchers will also look at other outcomes, like how many patients respond to the treatment, how long they live, and how long the treatment works.

Patients will receive GT103 and pembrolizumab through an IV on the first day of each treatment cycle, which repeats every 21 days for up to two years, as long as the cancer does not progress and side effects are manageable. Throughout the study, patients will have various tests, including heart scans, MRIs, CT scans, and blood tests, to monitor their health and the treatment's effects. Some patients may also have biopsies to study the cancer more closely.

After finishing the treatment, patients will have follow-up visits every 30 days for four months to check on their health and any long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have a confirmed diagnosis of STK11 mutant non-small cell lung cancer (NSCLC) based on specific lab tests.
  • Must have previously been treated with pembrolizumab and be eligible to continue it after progression.
  • Have adequate blood cell counts and organ function, including:
    • Neutrophil count of at least 1.5 x 10^9/L.
    • Platelet count of at least 100 x 10^9/L.
    • Hemoglobin level of at least 9 g/dL.
    • Kidney function with a GFR greater than 45 mL/min.
    • Liver enzymes and bilirubin levels within specified limits.
    • Normal heart function and blood pressure.
  • Have measurable cancer as defined by standard criteria.
  • Agree to use effective contraception during the study if of childbearing potential.
  • Understand the study and agree to sign informed consent.
  • Agree to provide blood samples and tumor tissue for research purposes.

Exclusion Criteria

  • Have received chemotherapy within four weeks before starting the study.
  • Have had recent radiation therapy or surgery that has not fully healed.
  • Have active or untreated brain metastases.
  • Have certain genetic mutations in the cancer that are not part of the study.
  • Have a history of autoimmune disorders, except for certain conditions that are well-controlled.
  • Are currently taking immunosuppressive medications or have not recovered from their effects.
  • Have serious infections or other uncontrolled medical conditions.
  • Have known allergies to the study drugs.
  • Have had recent heart problems or uncontrolled high blood pressure.
  • Have been diagnosed with another invasive cancer within the past two years, with some exceptions.
  • Are pregnant or breastfeeding.
  • Are unable or unwilling to follow the study requirements.

Locations

FACILITYZIPCITYSTATE
Roswell Park Cancer Institute14263BuffaloNew York

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.