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)

NCT06419179 | Enrolling By Invitation Phase 2 DMC

• 2 other identifiers: Uni-Koeln-51592024-512373-27-00
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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)

Conditions

Small Cell Lung Carcinoma

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  PFS according to investigator-assessed RECIST 1.1 from start of maintenance therapy

  Approximately two years (from First patient in (FSI) to Last patient last visit (LSLV))

Secondary Outcomes (2)

• Incidence, severity and grading of adverse events (AE) and seriouse adverse events (SAE).

  Approximately two years (from FSI to LSLV)

• ORR of maintenance.

  Approximately two years (from FSI to LSLV)

Study Arms (1)

Combination of olaparib and durvalumab after four cycles of standard 1st line treatment

EXPERIMENTAL

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.

Drug: Durvalumab; Drug: Olaparib

Interventions

Durvalumab DRUG

1500 mg i.v. Q4W

Also known as: MEDI4736, IMFINZI

Combination of olaparib and durvalumab after four cycles of standard 1st line treatment

Olaparib DRUG

300 mg BID orally

Also known as: AZD2281, LYNPARZA

Combination of olaparib and durvalumab after four cycles of standard 1st line treatment

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• \[...\]

You may not qualify if:

• 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
• Induction therapy other than carboplatin/cisplatin, etoposide and durvalumab. (The administration of one induction cycle without durvalumab is permitted.)
• Radiographic or clinical evidence of progressive disease.
• Negative HRD result in a previous pre-screening in this trial.
• \[...\]
• Patients with symptomatic uncontrolled central nervous system (CNS) metastases.
• Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days.
• History of leptomeningeal carcinomatosis.
• 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

Sponsors & Collaborators

• University of Cologne: lead
• AstraZeneca: collaborator

Study Sites (1)

University Hospital Cologne

Cologne, North Rhine-Westphalia, 50937, Germany

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

durvalumab; olaparib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jürgen Wolf, MD

  University Hospital Cologne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Prof. Dr. Jürgen Wolf

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 17, 2024
• Study Start: October 9, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)