Small Cell Lung Carcinoma
Conditions
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)
Interventions
DRUGDurvalumab
1500 mg i.v. Q4W
DRUGOlaparib
300 mg BID orally
Sponsors
AstraZeneca
University of Cologne
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
Pre-Screening: * 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. * \[...\] Inclusion Criteria Screening: * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| ORR of maintenance. | Approximately two years (from FSI to LSLV) | Grading is based on RECIST 1.1 |
Countries
Germany
Outcome results
None listed