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

Overseen By Christian Chukwuma

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Texas Southwestern Medical Center

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Metastatic disease, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

10 Participants Needed

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)

Research Team

Yuanyuan Zhang, MD

Principal Investigator

UT Southwestern Medical Center

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.

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.

Treatment Details

Interventions

• Durvalumab
• Thoracic RT

Trial Overview 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.

Participant Groups

Group I: Single Arm: Therapeutic Intervention Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

AstraZeneca

Industry Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology