M6620 + Topotecan for Small Cell Lung Cancer
Trial Summary
What is the purpose of this trial?
This trial is testing if combining two drugs, berzosertib and topotecan, works better than using topotecan alone for patients with relapsed small cell lung cancer or small cell cancer from other areas. Topotecan damages cancer cell DNA, and berzosertib stops the cells from fixing this damage, making the treatment more effective.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications, but you should avoid medications that strongly affect the enzyme CYP3A4, like certain antibiotics and herbal supplements. It's important to discuss your current medications with the trial team to ensure there are no interactions.
What data supports the effectiveness of the drug combination M6620 (Berzosertib) and Topotecan for treating small cell lung cancer?
Research shows that some small cell lung cancers, which become resistant to standard treatments, may benefit from a combination of topotecan and berzosertib. This combination targets cancer cells that have become resistant to platinum-based chemotherapy, offering a potential new option for patients.12345
What is known about the safety of the combination of M6620 (Berzosertib) and Topotecan in humans?
The combination of M6620 (Berzosertib) and Topotecan has been tested in humans and is generally well tolerated, with the most common serious side effects being low blood cell counts, such as anemia (low red blood cells), leukopenia (low white blood cells), and neutropenia (low neutrophils, a type of white blood cell). One patient experienced severe thrombocytopenia (low platelets) requiring a transfusion, which was a dose-limiting side effect.13678
What makes the drug combination of M6620 (Berzosertib) and Topotecan unique for treating small cell lung cancer?
Research Team
Anish Thomas
Principal Investigator
National Cancer Institute LAO
Eligibility Criteria
Adults with relapsed small cell lung cancer or small cell cancers from other body parts, who have measurable disease and are in good physical condition. They must not be pregnant, agree to contraception, and can't have untreated brain metastases or severe illnesses that could interfere with the trial.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive topotecan hydrochloride IV over 30 minutes on days 1-5, with or without berzosertib (M6620) IV over 60 minutes on days 2 and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion, with follow-up at 4 weeks and then every 12 weeks thereafter.
Treatment Details
Interventions
- Berzosertib
- Topotecan Hydrochloride
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor