Durvalumab(MEDI4736) and AZD6738 Combination Therapy in Relapsed Small Cell Lung Cancer Subjects

Sponsor
Se-Hoon Lee
Study ID
NCT04361825
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    Durvalumab 1500mg via IV administered for every 4weeks(fixed dosing for subjects \> 30 kg body weight) in Day 1 of each cycle and AZD 6738 240mg bid per os administered in each cycle days 1 and 7. One cycle is consisted of 28 days.

Study Details

This study is a single arm, multi-center phase II study of durvalumab and AZD6738 combination therapy in subjects with relapsed small cell lung cancer (SCLC) as a second or third line chemotherapy.

Key Dates

Start date
Jun 17, 2020
Status verified
Dec 2023
Primary completion
Oct 25, 2023
Completion
Oct 25, 2023

Study Design

Enrollment
42 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Durvalumab(MEDI4736) and AZD6738 combination

Primary Outcome Measure

Efficacy of durvalumab and AZD6738 combination therapy in subjects with relapsed SCLC subjects as 2nd or 3rd line therapy: Objective response rate(ORR) [ Time Frame: Up to 30 months ]

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