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Enzyme Inhibitor

Berzosertib + Standard Chemotherapy for Lung Cancer

Phase 1 & 2
Waitlist Available
Led By Liza C Villaruz
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have histologically confirmed NSCLC of predominantly squamous cell histology, stage IV (American Joint Committee on Cancer [AJCC] 8th edition)
Age >= 18 years. Because no dosing or adverse event data are currently available on the use of these drug combinations in patients < 18 years of age, children are excluded from this study, but will be eligible for future pediatric trials
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months post treatment
Awards & highlights

Study Summary

This trial is testing a combination of drugs to treat squamous cell non-small cell lung cancer. The drugs are given to see if they work better than just the chemotherapy drugs carboplatin and gemcitabine.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects include reactions related to immune system activation, such as inflammation in various organs, infusion-related reactions, fatigue, digestive issues like nausea or diarrhea, blood disorders including low counts of different types of cells which could increase infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
My lung cancer is mainly squamous cell type and is stage IV.
I am 18 years old or older.
I am fully active or can carry out light work.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months post treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free survival (PFS) (Phase 2)
Recommended phase 2 dose (RP2D) (Phase 1B)
Secondary outcome measures
Overall response (OR)
Overall survival (OS)
PFS in the subset of patients with ATM-deficient squamous cell non-small cell lung cancer
+1 more
Other outcome measures
ATM assay
Determination if features of whole exome and ribonucleic acid (RNA) sequencing are predictive OR, OS, or PFS

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
Back pain
Shortness of Breath
Abdominal pain
Kidney Injury and/or Infection
Weight Loss
Malnutrition, Hypercalcemia and Weakness
Intractable pain, back pain, hip pain
Activated partial thromboplastin time prolonged
Pleural effusion
Atrial fibrillation with rapid ventricular response
Respiratory failure
Skin rash
Study treatment Arm
Single Arm

Trial Design

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.
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
Completed Phase 2
Magnetic Resonance Imaging
Completed Phase 3
Computed Tomography
Completed Phase 2
Completed Phase 3
Completed Phase 2
Gemcitabine Hydrochloride
Completed Phase 3
Completed Phase 2

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,657 Previous Clinical Trials
40,933,561 Total Patients Enrolled
Liza C VillaruzPrincipal InvestigatorUniversity of Pittsburgh Cancer Institute LAO
1 Previous Clinical Trials
66 Total Patients Enrolled

Media Library

Berzosertib (Enzyme Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04216316 — Phase 1 & 2
Lung Cancer Research Study Groups: Arm A (pembrolizumab, gemcitabine, carboplatin, M6620), Arm B (pembrolizumab, gemcitabine, carboplatin)
Lung Cancer Clinical Trial 2023: Berzosertib Highlights & Side Effects. Trial Name: NCT04216316 — Phase 1 & 2
Berzosertib (Enzyme Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04216316 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this study being conducted in several hospitals around town?

"There are 16 recruiting patients for this clinical trial such as University of Pittsburgh Cancer Institute (UPCI) in Pittsburgh, Siteman Cancer Center at West County Hospital in Creve Coeur, and Dartmouth Hitchcock Medical Center in Lebanon."

Answered by AI

Why did researchers design this trial in this way?

"The primary outcome of this trial, which will be measured over a From the date of randomization to time of progression or death, whichever occurs first, assessed up to 12 months post treatment time frame is to Recommended phase 2 dose (RP2D) (Phase 1B). Secondary outcomes include Worst grade of adverse events which is defined as Adverse events will be tabulated according to Common Terminology Criteria for Adverse Events version 5.0 type, grade and relation to treatment. The worst grade of adverse event will be determined for each participant, and the distributions of worst grades will be compared between arms using a cumulative logit model."

Answered by AI

Is this the first time Pembrolizumab has been trialed?

"Pembrolizumab is being trialed in 409 Phase 3 clinical studies with a total of 1964 active trials. 84434 locations are running these tests, with the majority located in Shanghai, China."

Answered by AI

Are patients being accepted into this research project at this time?

"This clinical trial is still recruiting patients, according to the latest information on clinicaltrials.gov. The trial was originally posted on June 1st, 2020 and was last updated on November 15th, 2022."

Answered by AI

What are some conditions that Pembrolizumab has been found to be an effective treatment for?

"Pembrolizumab is an effective treatment for various types of cancer, including lymphoma, non-Hodgkin's melanoma, and recurrent cervical cancer."

Answered by AI
~8 spots leftby Aug 2024