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

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT02904954
Phase
PHASE2
Status
Completed

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

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

Interventions

Study Details

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.

Key Dates

Start date
Dec 2, 2016
Status verified
Jan 2023
Primary completion
Sep 16, 2020
Completion
Oct 4, 2022

Study Design

Enrollment
60 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Experimental: 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.

Primary Outcome Measure

Number of Subjects With Major Pathological Response (MPR) [ Time Frame: Durvalumab start date to surgical resection, up to 10 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Weill Cornell MedicineNew YorkNew York10065-

Find similar trials in New York, NY

By research site
Weill Cornell Medicine· New York, NY

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