Durvalumab (MEDI4736) With or Without SBRT in Clinical Stage I, II and IIIA Non-small Cell Lung Cancer

Phase 2

Completed

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: Durvalumab; Other: Durvalumab plus SBRT

• Registration Number: NCT02904954
• Lead Sponsor: Weill Medical College of Cornell University

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 Timeline

• Study First Submitted: 2016-05-18
• Study First Submitted QC: 2016-09-13
• Study First Posted: 2016-09-19
• Study Start: 2016-12-02
• Primary Completion: 2020-09-16
• Results First Submitted: 2021-07-12
• Results First Submitted QC: 2021-07-12
• Results First Posted: 2021-08-03
• Study Completion: 2022-10-04
• Status Verified: 2023-01
• Last Update Submitted: 2023-10-06
• Last Update Posted: 2023-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2 (Durvalumab plus SBRT)	Durvalumab	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.
Arm 2 (Durvalumab plus SBRT)	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.
Arm 1 (Durvalumab monotherapy)	Durvalumab	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.

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Major Pathological Response (MPR)	Durvalumab start date to surgical resection, up to 10 weeks	MPR is defined as ≤10% residual viable tumor in the resected specimen.

Secondary Outcome Measures

Name	Time	Method
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.	Disease recurrence or death from any cause assessed using history, physical examination and CT scanning, histologically or cytologically confirmed whenever possible.
Objective Clinical Response Rate	Treatment day 1 up to weeks 6-7	Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by PET/CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of diameters of target lesions; Progressive Disease (PD), \>=20% increase in the sum of diameters of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.

Trial Locations

Locations (1)

Weill Cornell Medicine; 🇺🇸 New York, New York, United States