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ATR Kinase Inhibitor
Lurbinectedin + Berzosertib for Small Cell Lung Cancer
Phase 1 & 2
Recruiting
Led By Anish Thomas, M.D.
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
Both Phase I and Phase II: Adequate organ functions including Hemoglobin greater than or equal to 9.0 g/dL, Absolute neutrophil count greater than or equal to 1.5x10(9)/L, Platelets greater than or equal to 100x10(9)/L, Total Bilirubin less than or equal to 2.0 mg/dL, Transaminases less than or equal to 2 x ULN or if liver metastases were present, less than or equal to 3 x ULN, Creatinine less than or equal to 1.5 mg/dL or creatinine clearance by Cockcroft-Gault formula greater than or equal to 60 mL/min
Phase I: Histologically confirmed advanced solid cancers will be eligible. At least one prior chemotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up phase ii
Awards & highlights
Study Summary
This trial is testing a combination of drugs to see if they may be effective in shrinking tumors for people with small cell lung cancer or high-grade neuroendocrine cancers.
Who is the study for?
Adults 18+ with solid tumors, SCLC, or HGNEC who understand the study and consent to participate. They must use contraception if of child-bearing potential, have an ECOG performance status ≤2 (indicating a level of functioning), measurable disease per RECIST 1.1 criteria, and adequate organ function. Excluded are those with symptomatic brain metastases not stabilized by treatment, HIV-positive individuals on antiretroviral therapy, anyone eligible for curative therapy elsewhere, participants in other trials or allergic to similar compounds.Check my eligibility
What is being tested?
The trial is testing the effectiveness of combining lurbinectedin and berzosertib to shrink tumors in patients with SCLC and HGNEC. Participants receive lurbinectedin via IV on day one and berzosertib on days one and two every three weeks (21-day cycle). The best dose will be determined based on response which is monitored through physical exams, blood tests including heart function checks via electrocardiograms, CT scans for tumor assessment.See study design
What are the potential side effects?
Potential side effects may include reactions at the infusion site from IV administration; changes in blood counts leading to increased infection risk or bleeding; fatigue; possible liver enzyme alterations indicating liver stress; kidney function changes measured by creatinine levels; hair loss due to drug toxicity.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood tests show normal organ function.
Select...
I have advanced cancer and have had at least one chemotherapy treatment.
Select...
I can take care of myself but might not be able to do heavy physical work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ phase i
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~phase i
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical response rate
MTD
Secondary outcome measures
Duration of response
Overall survival (OS)
Pharmacodynamic markers of response
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: 2/ Phase IIExperimental Treatment2 Interventions
Berzosertib + lurbinectedin at MTD
Group II: 1/ Phase IExperimental Treatment2 Interventions
Dose escalation of Berzosertib + lurbinectedin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Berzosertib
2021
Completed Phase 2
~80
Lurbinectedin
2022
Completed Phase 2
~90
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,665 Previous Clinical Trials
40,925,779 Total Patients Enrolled
Anish Thomas, M.D.Principal InvestigatorNational Cancer Institute (NCI)
9 Previous Clinical Trials
737 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My blood tests show normal organ function.I have advanced cancer and have had at least one chemotherapy treatment.I am not taking any strong medication that affects liver enzymes during the study.I agree to use birth control during the study.I am 18 years old or older.I am not HIV-positive.My tumor can potentially be cured with treatment.My cancer is confirmed as SCLC or HGNEC.I haven't had chemotherapy, major surgery in the last 2 weeks, or radiotherapy in the last 24 hours.My brain metastases are treated and stable without steroids for 1 week.I can take care of myself but might not be able to do heavy physical work.You have a disease that can be measured according to specific guidelines. If you are in Phase I, having a disease that can be evaluated but not measured is also okay.I do not have any severe illness that could interfere with the study.
Research Study Groups:
This trial has the following groups:- Group 1: 2/ Phase II
- Group 2: 1/ Phase I
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.
What is the total participants for this research project?
"That is correct, the online information indicates that this study requires 75 participants and is being conducted at a single site."
Answered by AI
Are there any vacancies in this research project for new participants?
"Yes, according to the latest information on clinicaltrials.gov, this study is open for recruitment. The trial was first announced on June 1st, 2021 and was most recently updated on October 14th, 2022. Currently, the study is looking for 75 individuals at a single site."
Answered by AI
Does Lurbinectedin have a long and successful history in clinical trials?
"To date, there have been 24 clinical trials researching Lurbinectedin. Of those active studies, 2 are in Phase 3. The many trials for Lurbinectedin primarily take place in Sacramento, California; however, 564 locations across the globe are running trials for this treatment."
Answered by AI
What are the main goals that we hope to achieve with this research?
"The primary goal for this phase II clinical trial is to establish the maximum tolerated dose (MTD). Additionally, researchers will measure overall survival (OS), duration of response, and the pharmacokinetic profile of berzosertib and lurbinectedin."
Answered by AI
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