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)

Sponsor
University of Cologne
Study ID
NCT06419179
Phase
PHASE2
Status
Enrolling By Invitation

Conditions

  • Small Cell Lung Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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)

Key Dates

Start date
Oct 9, 2024
Status verified
May 2025
Primary completion
Sep 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
29 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Combination of olaparib and durvalumab after four cycles of standard 1st line treatment
    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 Measure

Progression-free survival (PFS) [ Time Frame: Approximately two years (from First patient in (FSI) to Last patient last visit (LSLV)) ]

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