Biomarker Directed Trial of Temozolomide and Stenoparib in Relapsed SCLC

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 toxicity period will be 1 cycle of 21 days. This study will explore if the biomarkers the investigators test predict sensitivity to the combination of Stenoparib plus TMZ and therefore leads to a better t

Trial Details

NCT ID
NCT06681220
Phase
PHASE1 / PHASE2
Sponsor
VA Office of Research and Development
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • Stenoparib/Temozolomide
  • Lurbinectedin
Locations (sample)
  • Palo Alto, California, United States|37.44188,-122.14302
  • Chicago, Illinois, United States|41.85003,-87.65005
  • Indianapolis, Indiana, United States|39.76838,-86.15804
  • Louisville, Kentucky, United States|38.25424,-85.75941
  • Ann Arbor, Michigan, United States|42.27756,-83.74088

Key Eligibility 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.

For full eligibility, visit ClinicalTrials.gov.

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