Durvalumab + Radiotherapy for Stage III Non-Small Cell Lung Cancer

Recruiting in Palo Alto (17 mi)

David Gerber, M.D.: Internal Medicine ...

Overseen byYuanyuan Zhang, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Texas Southwestern Medical Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?Single arm, Phase II trial of concurrent Durvalumab (MEDI 4736) and radiotherapy followed by consolidative Durvalumb (MEDI 4736) for Stage III Non-Small Cell Lung Cancer (NSCLC)

Eligibility Criteria

Adults over 18 with stage IIIA or IIIB non-small cell lung cancer (NSCLC) that can't be operated on. They must have a life expectancy of at least 12 weeks, good organ function, and no severe illnesses or allergies to trial drugs. Women must not be pregnant and participants agree to use contraception.

Inclusion Criteria

My N2 disease was confirmed by a biopsy or a PET/CT scan.

My cancer is at a stage where surgery isn't an option due to large lymph nodes in my chest.

I had lung infection due to blockage but don't need IV antibiotics anymore.

+13 more

Exclusion Criteria

You have a serious health problem, a history of certain medical conditions, a recent surgery, or are not using contraception during the study.

Receiving any other investigational agents for the treatment of the cancer under study

I've had radiation in the same area as my current cancer.

+4 more

Participant Groups

This Phase II trial tests Durvalumab with thoracic radiotherapy followed by additional Durvalumab for NSCLC. It's a single-arm study where all eligible patients receive the same treatment without comparison groups.

1Treatment groups

Experimental Treatment

Group I: Single Arm: Therapeutic InterventionExperimental Treatment2 Interventions

All subjects receive the same therapeutic intervention of 1500mg intravenous durvalumab once every 4 weeks while receiving a 60 Gy/30 Fraction course of thoracic radiotherapy. After radiotherapy is complete, subjects continue to receive 1500mg intravenous durvalumab once every 4 weeks for up to one year following the start of treatment.