Maintenance Durvalumab (MEDI4736) and Olaparib (AZD2281) After Standard 1st Line Treatment (Carboplatin/Cisplatin, Etoposide, Durvalumab) in HRD Positive Extensive Disease (ED) Small-cell Lung Cancer (SCLC)
- Registration Number
- NCT06419179
- Lead Sponsor
- University of Cologne
- Brief Summary
Maintenance durvalumab (MEDI4736) and olaparib (AZD2281) after standard 1st line treatment (carboplatin/ cisplatin, etoposide, durvalumab) in HRD positive extensive disease (ED) small-cell lung cancer (SCLC)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 29
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Combination of olaparib and durvalumab after four cycles of standard 1st line treatment Durvalumab Study treatment (olaparib and durvalumab) starts with the initiation of maintenance therapy and is administered at a 28-day cycle until progression, unacceptable toxicity, or discontinuation for other reasons. Induction therapy (four cycles of carboplatin/cisplatin, etoposide, durvalumab (the administration of one induction cycle without durvalumab is permitted)) is administered as part of standard of care. Combination of olaparib and durvalumab after four cycles of standard 1st line treatment Olaparib Study treatment (olaparib and durvalumab) starts with the initiation of maintenance therapy and is administered at a 28-day cycle until progression, unacceptable toxicity, or discontinuation for other reasons. Induction therapy (four cycles of carboplatin/cisplatin, etoposide, durvalumab (the administration of one induction cycle without durvalumab is permitted)) is administered as part of standard of care.
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS) Approximately two years (from First patient in (FSI) to Last patient last visit (LSLV)) PFS according to investigator-assessed RECIST 1.1 from start of maintenance therapy
- Secondary Outcome Measures
Name Time Method ORR of maintenance. Approximately two years (from FSI to LSLV) Grading is based on RECIST 1.1
Incidence, severity and grading of adverse events (AE) and seriouse adverse events (SAE). Approximately two years (from FSI to LSLV) Grading is based on CTCAE Version 5
Trial Locations
- Locations (1)
University Hospital Cologne
🇩🇪Cologne, North Rhine-Westphalia, Germany