Testing the Addition of an Anti-cancer Drug, Berzosertib (M6620, VX-970), to the Usual Treatments… (NCT04216316) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Berzosertib (M6620, VX-970), to the Usual Treatments (Carboplatin and Gemcitabine) and to Pembrolizumab for Patients With Advanced Squamous Cell Non-small Cell Lung Cancer
United States12 participantsStarted 2021-04-14
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must have histologically confirmed NSCLC of predominantly squamous cell histology, stage IV (American Joint Committee on Cancer \[AJCC\] 8th edition)
* Patients must have measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1
* Patients must have tumor tissue available at time of enrollment, or be willing to undergo a biopsy for integrated biomarker studies
* Patients with a history of prior platinum-based systemic chemotherapy given as neoadjuvant, adjuvant, or consolidation therapy for early stage or loco-regionally advanced NSCLC are eligible, if therapy is completed one year prior to initiation of treatment. Patients must not have had prior systemic chemotherapy or immunotherapy for metastatic disease
* Patients with prior immunotherapy given as neoadjuvant, adjuvant, or consolidation therapy for early stage or loco-regionally advanced disease are eligible, if treatment is completed one year prior to initiation of treatment
* Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (Karnofsky \> 60%)
* 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
* Leukocytes \>= 3,000/mcL
* Absolute neutrophil count \> lower limit of normal (LLN)
* Platelets \> LLN
* Total bilirubin =\< i…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Patients Who Experienced a DLT
Timeframe: Up to completion of cycle 1
2
Recommended Phase 2 Dose (RP2D)
Timeframe: Up to completion of cycle 1
3
12-month Progression-free Survival (PFS) - Total Population
Timeframe: At 12 months
4
24-month Progression-free Survival (PFS) - Total Population
Timeframe: At 24 months
5
Progression-free Survival (PFS) - Total Population
Timeframe: Up to 30 months
6
12-month Progression-free Survival (PFS) - By Dose Level