M6620 + Topotecan for Small Cell Lung Cancer

Palo Alto (17 mi)

Overseen byAnish Thomas

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

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.

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

My hepatitis B virus is under control with treatment.

My small cell lung cancer has returned and can be measured.

I had hepatitis C but am cured, or I'm being treated with no detectable virus.

I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

I do not have Li-Fraumeni syndrome.

I am not pregnant or breastfeeding.

I am not taking any strong medication that affects liver enzymes.

I have recovered from side effects of cancer treatment, except for hair loss or nerve issues.

I have previously been treated with topotecan.

I have allergies to medications similar to M6620 or topotecan.

My cancer is high grade neuroendocrine without small cell features.

Treatment Details

The trial is testing if adding berzosertib (M6620) to topotecan chemotherapy is more effective for patients whose small cell lung cancer has returned compared to topotecan alone. Berzosertib may block enzymes that help cancer cells repair damaged DNA.

3Treatment groups

Experimental Treatment

Active Control

Group I: Cohort II (exploratory cohort: topotecan, berzosertib (M6620))Experimental Treatment5 Interventions

Cohort II: Participants receive topotecan hydrochloride IV over 30 minutes on days 1-5 and 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. Participants undergo a CT scan during screening and on study as well as a tumor biopsy during screening. Participants may also undergo blood sample collection during screening and on study.

Group II: Cohort I Arm II (topotecan hydrochloride, berzosertib (M6620))Experimental Treatment5 Interventions

Participants receive topotecan hydrochloride IV over 30 minutes on days 1-5 and 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. Participants undergo a CT scan during screening and on study as well as a tumor biopsy during screening. Participants may also undergo blood sample collection during screening and on study.

Group III: Cohort I Arm I (topotecan hydrochloride)Active Control4 Interventions

Participants receive topotecan hydrochloride IV over 30 minutes on days 1-5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants may crossover to Arm II at disease progression. Participants undergo a CT scan during screening and on study as well as a tumor biopsy during screening. Participants may also undergo blood sample collection during screening and on study.