OncoMatch/Clinical Trials/NCT06769126
Using Biomarker Tests to Select and Test New, Personalized Treatments for Extensive Stage Small Cell Lung Cancer, PRISM Study
Is NCT06769126 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for extensive stage lung small cell carcinoma.
Treatment: Ceralasertib · Durvalumab · Etoposide · Monalizumab · Platinum Compound · Saruparib — This phase II trial tests how well biomarker tests on patients tumor tissue works in selecting personalized treatments for patients with extensive stage small cell lung cancer (ES-SCLC). Biomarker tests look for certain features in cancer cells that may give doctors more information about what is driving cancer and how to treat it. Based on the biomarker test results, study doctors can determine the subtype of ES-SCLC that study treatments can target. This study also tests different types of maintenance treatment for ES-SCLC with drugs durvalumab, saruparib, ceralasertib or monalizumab. Maintenance treatment is given after initial treatment and is given to help keep the cancer under control and prevent it from getting worse. Immunotherapy with monoclonal antibodies, such as durvalumab and monalizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Saruparib is a PARP inhibitor. PARP is a protein that helps repair damaged deoxyribonucleic acid (DNA). Blocking PARP may prevent cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Ceralasertib may stop the growth of tumor cells and may kill them by blocking some of the enzymes needed for tumor cell growth. Giving biomarker selected personalized maintenance treatment with durvalumab, saruparib, ceralasertib or monalizumab may work better in treating patients with ES-SCLC.
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Required: SLFN11 subtype A, N, I, or P
SLFN11 testing results and have been determined to have subtype A, N, I, or P: confirmed by BostonGene and assigned to a cohort
Disease stage
Required: Stage IV
Excluded: Stage III
Extensive Stage Small Cell Lung Cancer; history of limited stage small cell lung cancer [excluded]
Performance status
ZUBROD 0–2
Prior therapy
Must have received: platinum-based chemotherapy — frontline induction
frontline induction treatment with platinum plus etoposide in combination with durvalumab
Must have received: anti-PD-L1 therapy (durvalumab) — frontline induction
frontline induction treatment with platinum plus etoposide in combination with durvalumab
Cannot have received: anti-PD-1 therapy (atezolizumab, pembrolizumab, nivolumab)
Exception: durvalumab allowed
must not have received immunotherapy other than durvalumab (e.g., atezolizumab) prior to enrollment; must not have received atezolizumab, pembrolizumab, or nivolumab as part of frontline induction treatment
Cannot have received: anti-PD-L1 therapy (atezolizumab, pembrolizumab, nivolumab)
Exception: durvalumab allowed
must not have received atezolizumab, pembrolizumab, or nivolumab as part of frontline induction treatment
Cannot have received: investigational agent
must not have received any investigational agent for the treatment of ES-SCLC
Cannot have received: prophylactic cranial irradiation
must not have received prophylactic cranial irradiation (PCI)
Lab requirements
Blood counts
Hemoglobin > 9.0 g/dL; ANC ≥ 1.5 x 10^3/uL; Platelets ≥ 100 x 10^3/uL
Kidney function
creatinine ≤ 1.5x IULN OR measured/calculated creatinine clearance ≥ 45 mL/min
Liver function
Total bilirubin ≤ institutional ULN unless history of Gilbert's disease (then ≤ 5x ULN); AST/ALT ≤ 5 × institutional ULN
Hemoglobin > 9.0 g/dL; ANC ≥ 1.5 x 10^3/uL; Platelets ≥ 100 x 10^3/uL; Total bilirubin ≤ institutional ULN unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN; AST/ALT ≤ 5 × institutional ULN; creatinine ≤ 1.5x IULN OR measured OR calculated creatinine clearance ≥ 45 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Loma Linda University Medical Center · Loma Linda, California
- Eisenhower Medical Center · Rancho Mirage, California
- University of California Davis Comprehensive Cancer Center · Sacramento, California
- UCHealth University of Colorado Hospital · Aurora, Colorado
- UCHealth Memorial Hospital Central · Colorado Springs, Colorado
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