12 Participants Needed

Berzosertib + Standard Chemotherapy for Lung Cancer

Recruiting at 37 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: National Cancer Institute (NCI)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

Dept of Medicine | University of Pittsburgh

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

I can provide tumor tissue samples or am willing to have a biopsy for study purposes.
I had platinum-based chemotherapy for early-stage lung cancer over a year ago and haven't had chemo or immunotherapy for metastatic disease.
My lung cancer is mainly squamous cell type and is stage IV.
See 17 more

Exclusion Criteria

I have no allergies to berzosertib, pembrolizumab, gemcitabine, carboplatin, or similar drugs.
I do not have any ongoing infections or recent vaccinations.
I should be cautious with Berzosertib due to my genetic condition affecting DNA repair.
See 11 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Lead-in Phase 1B

Determine the recommended phase 2 dose (RP2D) of carboplatin in combination with berzosertib and gemcitabine/pembrolizumab

Up to completion of cycle 1

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

Up to 21 months
Cycles every 21 days, then every 6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months
Every 3 months

Treatment Details

Interventions

  • Berzosertib
  • Carboplatin
  • Gemcitabine Hydrochloride
  • Pembrolizumab
Trial Overview The study is testing whether adding Berzosertib to the usual lung cancer treatments (Carboplatin and Gemcitabine) along with Pembrolizumab improves outcomes. It's in phases Ib/II to determine the best dose of Carboplatin and how well patients respond to this combination therapy.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A (pembrolizumab, gemcitabine, carboplatin, M6620)Experimental Treatment7 Interventions
Patients receive pembrolizumab IV over 30 minutes on day 1, gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, carboplatin IV over 30 minutes on day 1, and berzosertib IV over 60 minutes on days 2 and 9. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive pembrolizumab IV over 30 minutes on day 1 and berzosertib IV over 60 minutes on days 2 and 9. Cycles repeat every 21 days for up to 9 months in the absence of disease progression or unacceptable toxicity. Patients then receive pembrolizumab alone IV over 30 minutes on day 1. Cycles repeat every 6 weeks for up to 1 more year in the absence of disease progression or unacceptable toxicity. Patients undergo MRI scans and/or CT scans, and undergo blood specimen collection on study.
Group II: Arm B (pembrolizumab, gemcitabine, carboplatin)Active Control6 Interventions
Patients receive pembrolizumab, gemcitabine, and carboplatin as in Arm A. Patients undergo MRI scans and/or CT scans, and undergo blood specimen collection on study.

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Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14,080
Recruited
41,180,000+