This study is NOT currently recruiting participants.
Number
000288-C
Sponsoring Institute
National Cancer Institute (NCI)
Recruitment Detail
Type: Completed Study; data analyses ongoing Gender: Male & Female Min Age: 18 Years Max Age: N/A
Referral Letter Required
No
Population Exclusion(s)
Children;Fetuses;Neonates;Pregnant Women
Keywords
Chemotherapeutic Agents; Solid Tumors; DNA damage response; ATR inhibition
Recruitment Keyword(s)
None
Condition(s)
Small Cell Lung Cancer; Platinum-resistance
Investigational Drug(s)
Berzosertib (M6620) Topotecan
Investigational Device(s)
Intervention(s)
Drug: Topotecan Drug: Berzosertib
Supporting Site
National Cancer Institute
Small cell lung cancer (SCLC) is an aggressive cancer. It often relapses, which means it worsens or returns after a period of improvement with treatment. Researchers want to see if a combination of drugs can help.
Objective:
To find out whether the combination of 2 drugs, berzosertib and topotecan, is a safe and effective treatment for people with relapsed SCLC.
Eligibility:
Adults aged 18 and older with SCLC who initially received a platinum-based chemotherapy treatment for their disease but have experienced a relapse.
Design:
Participants will be screened with a medical history, physical exam, and electrocardiogram (to check heart function). They will give blood samples. Their ability to perform their normal activities will be reviewed. They will complete surveys. They will have imaging scans and/or bone scans to assess their cancer. During scans, they may be injected with a dye to make the image clearer. They may have a tumor biopsy.
Some screening tests will be repeated at study visits.
Participants will receive treatment in 21-day cycles. They will get berzosertib on Day 2 and Day 5 of each cycle. They will get topotecan on Days 1-5 of each cycle. Both drugs will be given by intravenous infusion. They may get other drugs to help them make white blood cells and help them not feel sick. They may continue treatment until their cancer gets worse or they have unacceptable side effects.
Participants will have follow-up visits within 7 days and at 30 days after treatment ends. Then they will have phone calls or in-person visits every 12 weeks for the rest of their life.
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INCLUSION CRITERIA: ->= 18 years of age at the time of signing the informed consent -Histologically confirmed SCLC -Radiologically confirmed progression after first-line or chemoradiation platinum-based treatment (carboplatin or cisplatin), with or without immunotherapy, for treatment of limited or extensive stage SCLC, with a PFI < 90 days
->= 18 years of age at the time of signing the informed consent
-Histologically confirmed SCLC
-Radiologically confirmed progression after first-line or chemoradiation platinum-based treatment (carboplatin or cisplatin), with or without immunotherapy, for treatment of limited or extensive stage SCLC, with a PFI < 90 days
Principal Investigator
Referral Contact
For more information: