Tests durvalumab and olaparib after first-line treatment in extensive small-cell lung cancer
Tests durvalumab and olaparib as maintenance treatment in adults with extensive small-cell lung cancer.
Plain-language title generated from the registry record
Registry title: 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 facts
- Where
- Berlin, Cologne, Heidelberg, Hemer, and Oldenburg, GermanySee the 5 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with newly diagnosed advanced or metastatic small-cell lung cancer whose tumor tests positive for homologous recombination deficiency (HRD) and who finished 4 cycles of first-line carboplatin or cisplatin, etoposide and durvalumab without progression.
- Age
- 18 Years to 120 Years
- Sex
- All sexes can join.
- Disease stage
- Newly diagnosed small-cell lung cancer, UICC stage III that cannot be treated with radiochemotherapy aimed at removing all of the disease, or stage IV. At least one measurable site of disease (RECIST v1.1).
- Earlier treatment
- Must have completed 4 cycles (21-day cycles) of carboplatin or cisplatin, etoposide and durvalumab, ending 1 to 14 days before study treatment starts, with durvalumab given at least three times. No disease progression during or after this treatment.
- Biomarker or test result
- The tumor must test positive for homologous recombination deficiency (HRD) at central testing.
Main reasons for not taking part
- First-line treatment other than carboplatin/cisplatin, etoposide and durvalumab
- Disease progression on scans or by symptoms
- Symptomatic uncontrolled brain or spinal cord metastases
- History of leptomeningeal carcinomatosis
- Unresolved side effects of grade 2 or higher from earlier cancer treatment, with a few exceptions
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 120 years old?
Source: NCT06419179, who can take part
Where in Germany
- Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbHBerlin, GermanyTaking people
- University Hospital Cologne AöRCologne, GermanyTaking people
- Thoraxklinik Heidelberg gGmbHHeidelberg, GermanyTaking people
- Lungenklinik Hemer Deutscher Gemeinschafts-Diakonieverband GmbHHemer, GermanyTaking people
- Pius Hospital OldenburgOldenburg, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- University of Cologne
- Trial code
- NCT06419179EU 2024-512373-27-00
- Record updated
- 20 May 2025
- Original description
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)Read full original descriptionShow less
A Multicenter Phase II Trial of Maintenance Durvalumab (MEDI4736) and Olaparib (AZD2281) After Standard 1st Line Treatment (Carboplatin/Cisplatin, Etoposide, Durvalumab) in Homologous Recombination Deficiency (HRD) Positive Extensive Disease (ED) Small-cell Lung Cancer (SCLC)
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)
Inclusion: Newly diagnosed, histologically documented advanced or metastatic small-cell lung cancer (UICC stage III which is not amenable to curative radiochemotherapy or stage IV). [...]; Either de novo biopsies collected as part of routine clinical practice or archival tumor samples (taken ≤6 months prior to screening) are acceptable; Planned or ongoing treatment with carboplatin/cisplatin, etoposide, durvalumab as 1st-line SoC. Pre-screening must begin no later than the start of the 3rd cycle to allow sufficient time for molecular analyses. [...]; Available radiographic chest and abdominal CT or MRI scans performed up to 42 days before initial first line treatment with carboplatin/cisplatin, etoposide and durvalumab; At least one measurable site of disease as defined by RECIST v1.1 criteria; [...]; Completed pre-screening with fulfillment of all inclusion and exclusion criteria of pre-screening. Pre-screening must have tested positive for homologous recombination deficiency as defined in this protocol at central testing. [...]; Patients must not have radiographic or clinic disease progression while on induction therapy and/or prior to start of study treatment; Patients must have received 4 cycles (21-day cycles) of induction with carboplatin or cisplatin, etoposide and durvalumab completed within 1 to 14 days prior to initiation of study treatment on C5D1. Patients must have received durvalumab at minimum three times during the four induction cycles; Adequate organ and marrow function.
Exclusion: Induction therapy other than carboplatin/cisplatin, etoposide and durvalumab. (The administration of one induction cycle without durvalumab is permitted.); Negative HRD result in a previous pre-screening in this trial; Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days; Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy. Exceptions are:; Alopecia (any Grade); Vitiligo (any Grade); Hypothyroidism stable on hormone replacement (Grade ≤2); Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician; Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab or olaparib may be included only after consultation with the Sponsor; Radiographic or clinical evidence of progressive disease; History of leptomeningeal carcinomatosis; [...]; Patients with symptomatic uncontrolled central nervous system (CNS) metastases.