RecruitingPhase 2NCT05623319

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

Phase 2 Trial of Translational Approach to First Line cHemoimmunotherapy Followed by Maintenance With pembrOlizumab and Olaparib in Extensive-Stage Small-Cell Lung CanceR.


Sponsor

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

Enrollment

60 participants

Start Date

Mar 27, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — pembrolizumab (an immunotherapy) and olaparib (a targeted therapy) — as a first-line treatment for extensive-stage small cell lung cancer, meaning the cancer has spread beyond the chest. **You may be eligible if...** - You are 18 or older with confirmed extensive-stage small cell lung cancer - You have not previously received any systemic treatment for this cancer (or had prior chemoradiation for early-stage disease at least 6 months ago) - Your cancer has at least one measurable lesion on a scan - You are generally active and able to carry out daily activities - Your liver, kidneys, and blood counts are functioning adequately - HIV, hepatitis B, and hepatitis C tests are negative (or controlled) **You may NOT be eligible if...** - You have active, untreated brain metastases - You have an active autoimmune disease requiring systemic treatment (some exceptions apply, such as controlled thyroid disease or type 1 diabetes) - You have had a prior PARP inhibitor (like olaparib) or prior anti-PD1/PD-L1 immunotherapy - You have significant heart problems or a history of severe lung inflammation - You are pregnant or breastfeeding - You have had a major surgery within 4 weeks - You take strong medications that interact with olaparib Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPembrolizumab/Olaparib

Patients will receive pembrolizumab 200 mg 1q21 and chemotherapy -platinum compound (cisplatin 75 mg/m2 or carboplatin area under the curve of 5 mg per milliliter per minute) 1q21 plus etoposide 100 mg/m2 1-3q21- for 4 cycles (Induction Phase). In case of responsive or stable disease, patients will receive pembrolizumab 200 mg 1q21 plus olaparib 300 mg twice daily until progression (Maintenance Phase) or up to a maximum of 35 cycles.


Locations(12)

UO Oncologia Medica, IRST IRCCS

Meldola, Forlì Cesena, Italy

Ospedale San Gerardo - ASST Monza

Monza, Monza E Brianza, Italy

Azienda Ospedaliera Ospedali Riuniti Marche Nord

Pesaro, Pesaro Urbino, Italy

IRCCS Istituto Tumori Giovanni Paolo II

Bari, Italy

UO Oncologia, IRCCS Ospedale Sant'Orsola, AUSL Bologna

Bologna, Italy

IRCCS Istituto Nazionale Tumori Fondazione "G. Pascale"

Naples, Italy

Istituto Oncologico Veneto IRCCS

Padova, Italy

Azienda USL della Romagna - Osp. Santa Maria delle Croci

Ravenna, Italy

A.O. Arcispedale S. Maria Nuova IRCCS di Reggio Emilia

Reggio Emilia, Italy

Azienda USL della Romagna - Osp. "Infermi" di Rimini

Rimini, Italy

Istituti Fisioterapici Ospitalieri - IFO -Ospedale Regina Elena

Roma, Italy

ASST dei Sette Laghi - Osp. di Circolo e Fondazione Macchi

Varese, Italy

View Full Details on ClinicalTrials.gov

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NCT05623319


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