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

JRCT ID: jRCTs071210050

Registered date:05/08/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: extensive-stage small cell lung cancer
• Date of first enrollment: 30/08/2021
• Target sample size: 40
• Study type: Interventional

Intervention(s)

Continue administration of the protocol treatments until meeting the withdrawal criteria of this study.
[protocol treatments]
1.Induction therapy
[CBDCA + ETP + Durvalumab] every 3 weeks x 4 cycles
2.Maintenance therapy
Durvalumab every 4weeks x until PD

Outcome(s)

• Primary Outcome: Safety
• Secondary Outcome: 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)

Key inclusion & exclusion criteria

• Age minimum: >= 75age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Koichi Azuma
• Source(s) of Monetary Support: AstraZeneca K.K.