Actively Recruiting
Pembrolizumab and Olaparib Treatment of Extensive Small Cell Lung Cancer (ES-SCLC)
Led by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS · Updated on 2025-06-24
60
Participants Needed
12
Research Sites
222 weeks
Total Duration
On this page
Sponsors
I
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pembrolizumab and Olaparib Treatment of Extensive Small Cell Lung Cancer (ES-SCLC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent for the trial.
- Male or female aged 18 years or older at the time of consent.
- Confirmed diagnosis of extensive-stage small-cell lung cancer (Stage IV).
- Ability to provide a tissue sample from a recent biopsy within 6 weeks prior to study entry.
- No prior systemic treatment for extensive-stage small-cell lung cancer.
- Patients with prior chemo-radiotherapy for limited-stage SCLC must have a treatment-free interval of at least 6 months.
- Patients requiring thoracic radiotherapy can enroll if radiotherapy starts no earlier than 15 days after experimental treatment begins.
- Presence of target lesions measurable by RECIST 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Patients with paraneoplastic syndromes allowed if autoimmune origin is excluded.
- Life expectancy of at least 12 weeks.
- Ability to swallow medication.
- Ability to comply with study procedures.
- Adequate organ function confirmed by tests within 10 days prior to registration.
- Negative HIV test at screening.
- Negative total hepatitis B core antibody test or negative hepatitis B virus DNA test if positive.
- Negative hepatitis C virus antibody test or negative HCV RNA test if positive.
- Male patients must use condoms during treatment and for 3 months after last dose when having sex with pregnant women or women of childbearing potential, and female partners should use effective contraception.
- Female patients must not be pregnant or breastfeeding and either not be of childbearing potential or agree to contraception during treatment and for 120 days after last dose.
You will not qualify if you...
- Known active central nervous system metastases or carcinomatous meningitis, unless previously treated and stable for at least 4 weeks without steroids.
- Active or recent (within 2 years) autoimmune disease or immune deficiency requiring systemic treatment, with some exceptions for controlled hypothyroidism, type 1 diabetes, and certain mild skin conditions.
- History of lung diseases like idiopathic pulmonary fibrosis or pneumonitis, or active pneumonitis on screening.
- Radiotherapy within 2 weeks before starting study treatment.
- Live vaccines within 30 days before starting treatment.
- Uncontrolled cardiac conditions or significant cardiovascular disease within 3 months prior to treatment.
- Major surgery within 4 weeks before starting treatment or planned during the study.
- History of other malignancies within 3 years, except certain low-risk cancers.
- History or current pneumonitis requiring steroids.
- Active infections needing systemic therapy.
- Known active tuberculosis.
- Use of investigational therapy within 28 days before starting treatment.
- Prior treatment with agents targeting certain immune receptors or PARP inhibitors.
- Use of strong or moderate CYP3A inhibitors or inducers without appropriate washout periods.
- Severe allergies to pembrolizumab, olaparib, carboplatin, etoposide, or related substances.
- Psychiatric or substance abuse disorders interfering with study participation.
- Pregnant, breastfeeding, or planning to conceive or father children during the study and for 120 days after last dose.
- History of allogenic tissue or solid organ transplant.
- Positive pregnancy test within 72 hours prior to registration for women of childbearing potential.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
UO Oncologia Medica, IRST IRCCS
Meldola, Forlì Cesena, Italy, 47014
Actively Recruiting
2
Ospedale San Gerardo - ASST Monza
Monza, Monza E Brianza, Italy, 20900
Actively Recruiting
3
Azienda Ospedaliera Ospedali Riuniti Marche Nord
Pesaro, Pesaro Urbino, Italy, 61121
Actively Recruiting
4
IRCCS Istituto Tumori Giovanni Paolo II
Bari, Italy, 70124
Actively Recruiting
5
UO Oncologia, IRCCS Ospedale Sant'Orsola, AUSL Bologna
Bologna, Italy, 40138
Actively Recruiting
6
IRCCS Istituto Nazionale Tumori Fondazione "G. Pascale"
Naples, Italy, 80131
Actively Recruiting
7
Istituto Oncologico Veneto IRCCS
Padova, Italy, 35128
Actively Recruiting
8
Azienda USL della Romagna - Osp. Santa Maria delle Croci
Ravenna, Italy, 48121
Active, Not Recruiting
9
A.O. Arcispedale S. Maria Nuova IRCCS di Reggio Emilia
Reggio Emilia, Italy
Actively Recruiting
10
Azienda USL della Romagna - Osp. "Infermi" di Rimini
Rimini, Italy, 47923
Active, Not Recruiting
11
Istituti Fisioterapici Ospitalieri - IFO -Ospedale Regina Elena
Roma, Italy, 00128
Actively Recruiting
12
ASST dei Sette Laghi - Osp. di Circolo e Fondazione Macchi
Varese, Italy, 21100
Active, Not Recruiting
Research Team
O
Oriana Nanni
CONTACT
B
Bernadette Vertogen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here