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Recruiting Phase 2 NCT05623319

Pembrolizumab and Olaparib Treatment of Extensive Small Cell Lung Cancer (ES-SCLC)

Trial Parameters

Condition SCLC,Extensive Stage
Sponsor Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 60
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-03-27
Completion 2027-07
Interventions
Pembrolizumab/Olaparib

Brief Summary

This is an open-label, single arm, phase 2 trial enrolling patients with untreated Extensive-Stage Small-Cell Lung Cancer (ES SCLC), with a strong translational attitude.

Eligibility Criteria

The Inclusion Criteria: 1. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial. 2. Male/female participants who are at least 18 years of age on the day of signing informed consent. 3. Cytologically/histologically confirmed diagnosis of SCLC per the Veterans Administration Lung Study Group (VALG) staging system will be enrolled in this study. Patients must have extensive stage (ES) SCLC defined as Stage IV (T any, N any, M 1a/b/c) by the American Joint Committee on Cancer, Eighth Edition. 4. Possibility of obtaining tissue sample, via a biopsy of the primary tumour or metastatic tumour tissue, within the 6 weeks prior to study entry. An archival biopsy is acceptable as long as there has been no intervening anticancer treatment since the time the biopsy was obtained to enrolment in this clinical study and as long as it was within 6 weeks of study entry. Tissue sample would consist of formalin-fixed, paraffin-embedded tumour

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