A Randomized Phase 2 Trial of Durvalumab (MEDI4736) With or Without SBRT in Clinical Stage I, II, and IIIA Non-small Cell Lung Cancer (NSCLC)
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Number of Subjects With Major Pathological Response (MPR)
Study Overview
Brief Summary
The purpose of this study is to find out the effectiveness of the drug durvalumab (MEDI4736) with or without stereotactic body radiation therapy (SBRT) as treatment for stage I (tumors > 2cm), II, and IIIA non-small cell lung cancer (NSCLC) prior to surgery and one year following surgery.
Detailed Description
This is a randomized open label phase II trial of preoperative anti-PD-L1 antibody durvalumab with or without concurrent non-ablative radiation followed by surgical resection and postoperative monthly maintenance durvalumab for twelve months, following standard of care postoperative therapy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Arm 1 (Durvalumab monotherapy)
Durvalumab (MEDI4736) 1.12 g administered pre-operatively every 3 weeks for 2 cycles followed by surgical resection. Durvalumab monotherapy 1.5 g will be given for 12 months post-operatively.
Intervention: Durvalumab (Drug)
Arm 2 (Durvalumab plus SBRT)
Durvalumab (MEDI4736) 1.12 g administered pre-operatively every 3 weeks for 2 cycles plus radiotherapy delivered in 3 daily fractions starting concurrently with the first cycle of durvalumab (MEDI4736) followed by surgical resection. Durvalumab monotherapy 1.5 g will be given for 12 months post-operatively.
Intervention: Durvalumab (Drug)
Arm 2 (Durvalumab plus SBRT)
Durvalumab (MEDI4736) 1.12 g administered pre-operatively every 3 weeks for 2 cycles plus radiotherapy delivered in 3 daily fractions starting concurrently with the first cycle of durvalumab (MEDI4736) followed by surgical resection. Durvalumab monotherapy 1.5 g will be given for 12 months post-operatively.
Intervention: Durvalumab plus SBRT (Other)
Outcomes
Primary Outcomes
Number of Subjects With Major Pathological Response (MPR)
Time Frame: Durvalumab start date to surgical resection, up to 10 weeks
MPR is defined as ≤10% residual viable tumor in the resected specimen.
Secondary Outcomes
- Kaplan-Meier Disease-Free Survival Proportion at 2 Years(From date of Durvalumab start date until the date of first documented progression or date of death from any cause, whichever came first, assessed every 6 months for 2 years.)
- Objective Clinical Response Rate(Treatment day 1 up to weeks 6-7)