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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
Timeline
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 belowSelect...
My lung cancer is mainly squamous cell type and is stage IV.
Select...
I am 18 years old or older.
Select...
I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months post treatment
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 moreOther outcome measures
ATM assay
Determination if features of whole exome and ribonucleic acid (RNA) sequencing are predictive OR, OS, or PFS
Inflammation
Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1730
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Computed Tomography
2017
Completed Phase 2
~2720
Carboplatin
2014
Completed Phase 3
~6670
Berzosertib
2021
Completed Phase 2
~80
Gemcitabine Hydrochloride
2005
Completed Phase 3
~5420
Pembrolizumab
2017
Completed Phase 2
~2010
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
Eligibility Criteria:
This trial includes the following eligibility 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.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.I completed immunotherapy for early-stage cancer over a year ago.I do not have severe bone marrow issues or major bleeding.I haven't taken strong immune-weakening medicines in the last 28 days, except for low-dose steroids or inhalers.My brain metastases are stable, and I'm on a steady dose of medication for it.I haven't had radiation therapy within a week before taking gemcitabine.I am not taking strong medication that affects how my body processes certain drugs.I can understand and am willing to sign the consent form, or I have someone who can do it for me.My heart function is classified as class 2B or better, despite my history of heart issues or treatments.Your platelet count is higher than the lower limit of normal.I have another cancer type, but it won't affect this trial's treatment.Patients must have a specific amount of disease that can be measured using a standard method.I am 18 years old or older.Your AST and ALT levels in your blood are not more than three times the normal limit at the hospital where you are being treated.I have not had a solid organ transplant or needed immunosuppressants for autoimmune disease in the last 2 years.I am fully active or can carry out light work.I have not had chemotherapy for cancer that has spread.Your bilirubin levels are within the normal range set by the hospital.I have chronic hepatitis B but it's under control with treatment.Your white blood cell count is too low.I am not pregnant or breastfeeding.Your white blood cell count is at least 3,000 per microliter.My kidney function is within the safe range for the trial.I have not had a stem cell transplant from another person.I have HIV, am on effective treatment, and my viral load is undetectable.I had hepatitis C but am cured, or I'm being treated with no detectable virus.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (pembrolizumab, gemcitabine, carboplatin, M6620)
- Group 2: Arm B (pembrolizumab, gemcitabine, carboplatin)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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