Biomarker Directed Trial of Temozolomide and Stenoparib in Relapsed SCLC

Recruiting Phase 1 Phase 2 Interventional Study
Relapsed Small Cell Lung Cancer Recurrent Small Cell Lung Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
166 (estimated)
Sponsor
VA Office of Research and Development · Federal
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About This Trial
Randomized phase 2, multicenter, biomarker directed clinical trial with a safety lead-in to assess the efficacy of Stenoparib plus Temozolomide (TMZ) in relapsed Small Cell Lung Cancer patients. Participants will receive either a combination of oral Stenoparib at the highest tolerated dose with oral Temozolomide 40mg daily or standard of care Lurbinectedin for 21-day cycles. The Dose limiting toxi…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Age 18 years or older at the time of consent. * Histological or cytological diagnosis of extensive-stage small cell lung cancer. * Patients must have received one prior line of systemic therapy. * Patients must have received first-line therapy with Carboplatin and Etoposide…
Contacts

Shadia Jalal, MD

(317) 274-5500

Shadia.Jalal@va.gov

CONTACT