Berzosertib + Standard Chemotherapy for Lung Cancer
Trial Summary
What is the purpose of this trial?
This phase Ib/II trial studies the best dose of carboplatin when given together with berzosertib, gemcitabine and pembrolizumab and to see how well it works in treating patients with stage IV squamous cell non-small cell lung cancer that has spared to other placed in the body (advanced). Berzosertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as carboplatin and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving berzosertib together with carboplatin, gemcitabine, and pembrolizumab may work better in treating patients with squamous cell non-small cell lung cancer compared to carboplatin, gemcitabine, and pembrolizumab alone.
Research Team
Liza C. Villaruz
Principal Investigator
University of Pittsburgh Cancer Institute LAO
Eligibility Criteria
Adults over 18 with advanced stage IV squamous cell non-small cell lung cancer that hasn't spread widely can join this trial. They should have finished any early-stage chemotherapy a year before, have stable brain metastases if present, and normal organ function tests. Participants must not have had prior treatments for metastatic disease or be on certain drugs that interact with the trial medications.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Lead-in Phase 1B
Determine the recommended phase 2 dose (RP2D) of carboplatin in combination with berzosertib and gemcitabine/pembrolizumab
Phase II Treatment
Patients receive pembrolizumab, gemcitabine, carboplatin, and berzosertib in cycles every 21 days for up to 4 cycles, followed by pembrolizumab and berzosertib for up to 9 months, and then pembrolizumab alone for up to 1 more year
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Berzosertib
- Carboplatin
- Gemcitabine Hydrochloride
- Pembrolizumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor