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An Open Label, Multicenter Phase 2 Study of Durvalumab (MEDI4736) + Olaparib as Maintenance Therapy in Chinese

NCT05245994 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-02-18

No results posted yet for this study

Summary

The purpose of this study was to evaluate the efficacy and safety of combining durvalumab with EP followed by durvalumab + olaparib maintenance therapy as first-line treatment in patients with extensive-disease small-cell lung cancer (SCLC).

Conditions

Interventions

DRUG

Durvalumab, etoposide, and cisplatin/carboplatin followed by durvalumab and olaparib

Durvalumab 1500 mg intravenous infusion, started to be used simultaneously with chemotherapy at week 0 and continued after chemotherapy. Starting from week 0, the dose of etoposide + carboplatin or cisplatin in the study will not exceed the dose for specific indications in the product instructions (etoposide \[80 to 100mg/m2\] via intravenous infusion and carboplatin \[ The area under the curve (AUC) is 5-6\] by intravenous infusion or cisplatin \[75-80 mg/m2\] by intravenous infusion), using up to 4 cycles. The choice of platinum drugs is at the discretion of the investigator. The initial dose of olaparib is 300mg twice daily. Olaparib tablets should be taken at the same time each day, approximately 12 hours apart with one glass of water. The tablets should be swallowed whole and not chewed, crushed, dissolved or divided. Olaparib tablets can be taken with or without food.

Sponsors & Collaborators

  • Li Zhang, MD

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-21
Primary Completion
2023-05-31
Completion
2023-11-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05245994 on ClinicalTrials.gov