A Phase II study of Durvalumab (MEDI4736) plus carboplatin and etoposide in elderly patients with extensive-stage small-cell lung cancer

Phase 2

• Conditions: extensive-stage small cell lung cancer

• Registration Number: JPRN-jRCTs071210050
• Lead Sponsor: Koichi Azuma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-05
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1) Histologically or cytologically confirmed small-cell lung cancer
2) Extensive-stage (ES)-SCLC
3) No prior systemic chemotherapy for ES-SCLC
4) 75 years of age or older
5) ECOG performance status of 0 to 1
6) With measurable lesions according to the RECIST criteria version 1.1
7) Written informed consent
8) Expected to survive for 12 weeks or longer
9) Body weight > 30kg

Exclusion Criteria

1) Synchronous or metachronous (within a year) malignancies
2) Active infection requiring systemic therapy and/or surgical procedures such as drainage
3) Active hepatitis B and C, and active tuberculosis
4) Interstitial lung disease on CT
5) Active autoimmune or inflammatory disease, or the history of autoimmune disease
6) Administration of immunosuppressants within 14 days prior to the protocol treatment
7) Grade2 or worse complications
8) Uncontrolled complications
9) Surgical treatment with general anesthesia within 14 days prior to the registration

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety

Secondary Outcome Measures

Name	Time	Method
Objective response rate, median progression-free survival, 12-month overall survival rates, Completion rate of the induction therapy (4cycles), QOL (FACT-L), Comprehensive Geriatric Assessment (IADL)