GUIDANCE – A multicenter phase II trial of maintenance durvalumab and olaparib after standard 1st line treatment (carboplatin/ cisplatin, etoposide, durvalumab) in HRD positive extensive disease (ED) small-cell lung cancer (SCLC)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-512373-27-00

Acronym

Uni-Koeln-5159

Enrollment

Registered

2024-09-23

Start date

2024-09-30

Completion date

Unknown

Last updated

2026-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced/inoperable or metastatic small-cell lung cancer

Brief summary

Progression-free survival (PFS) according to investigator-assessed RECIST 1.1 from start of maintenance therapy

Detailed description

Incidence, severity and grading of AEs and SAEs, frequency of dose interruptions and reductions, Objective response rate (best response) of maintenance (ORR), duration of response (DOR) and disease control rate (DCR) according to investigatorassessed RECIST 1.1, immune objective response rate (iORR), immune duration of response (iDOR), immune disease control rate (iDCR), immune progression-free survival (iPFS) according to iRECIST and OS, PFS, ORR, DOR and DCR according to investigator-assessed RECIST 1.1, iORR, iDOR, iDCR, iPFS according to iRECIST and OS in pre-specified patient subgroups

Interventions

DRUGIMFINZI 50 mg/mL concentrate for solution for infusion.

DRUGLynparza 150 mg film-coated tablets

DRUGLynparza 100 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression-free survival (PFS) according to investigator-assessed RECIST 1.1 from start of maintenance therapy	—

Secondary

Measure	Time frame
Incidence, severity and grading of AEs and SAEs, frequency of dose interruptions and reductions, Objective response rate (best response) of maintenance (ORR), duration of response (DOR) and disease control rate (DCR) according to investigatorassessed RECIST 1.1, immune objective response rate (iORR), immune duration of response (iDOR), immune disease control rate (iDCR), immune progression-free survival (iPFS) according to iRECIST and OS, PFS, ORR, DOR and DCR according to investigator-assessed RECIST 1.1, iORR, iDOR, iDCR, iPFS according to iRECIST and OS in pre-specified patient subgroups	—

Measure

Time frame

—

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026