Biomarker Directed Trial of Temozolomide and PARP Inhibition in Relapsed SCLC

Randomized phase 2, multicenter, clinical trial to assess the efficacy of PARP inhibitorplus Temozolomide (TMZ) in biomarker selected relapsed SCLC patients. The investigatorswill test for sensitivity of two biomarkers in the blood SLFN11 and MGMT.Biomarker‐positive (sensitive) patients are randomized 2:1 to either experimental Arm 2(PARP inhibitor 200mg + 40mg TMZ oral daily for 21 days or 3.2mg/m2 Lurbinectedin IVinfusion over one‐hour every 21 days.). This requires 101 sensitive patients (67 oncombination drug and 34 on Lurbinectedin). Biomarker‐negative (resistant) patients willbe enrolled on the control Arm 1 standard of care 3.2mg/m2 Lurbinectedin IV infusion overone‐hour every 21 days. This requires 51 resistant patients on the control arm. Theinvestigators will determine if biomarker (positive) sensitive patients will benefit fromthe oral combination PARP inhibitor + TMZ.