Durvalumab + Radiation Therapy for Lung Cancer

Recruiting in Palo Alto (17 mi)

+11 other locations

Overseen byNarek Shaverdian, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The purpose of this study is to see if Durvalumab and radiation therapy can delay the worsening of disease in patients with non-small cell lung cancer normally treated with sequential chemotherapy followed by radiation therapy.

Eligibility Criteria

This trial is for adults with newly diagnosed or recurrent stage II-III non-small cell lung cancer (NSCLC) who can't have surgery and aren't fit for chemotherapy. They should expect to live at least 12 weeks, be able to consent, and meet certain health criteria like proper organ function. Pregnant women, those on recent immunosuppressants, or with other active cancers can't join.

Inclusion Criteria

I can take care of myself and perform daily activities.

Female participants must either be past menopause or have a negative pregnancy test if they are still having periods.

My lung cancer type has been confirmed by a standard biopsy.

See 9 more

Exclusion Criteria

I have a lung or esophagus condition that needs treatment.

I cannot undergo radiotherapy due to health reasons.

I have another cancer that is getting worse or needs treatment.

See 16 more

Treatment Details

Interventions

Durvalumab (PD-L1 Inhibitor)
Radiation Therapy (Radiation)

Trial OverviewThe study tests if combining Durvalumab (an immune therapy drug) with radiation therapy delays NSCLC progression compared to the usual treatment sequence of chemo followed by radiation. Participants will receive both Durvalumab and targeted radiation treatments.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Non-Small Cell Lung CancerExperimental Treatment2 Interventions

All participants have locally-advanced non-small cell lung cancer, Stage II-III. Treatment will consist of durvalumab administered concurrently with thoracic radiation consisting of 60 Gy in 30 fractions. Patients will be monitored weekly during on-treatment visits. Durvalumab will then be continued up to 1 year as maintenance or until disease progression or unacceptable toxicity. Optional Research MRIs (Does not apply to the Alliance Sites. Research MRIs will only be done at MSKCC)

Durvalumab is already approved in European Union, United States, Japan for the following indications:

🇪🇺 Approved in European Union as Imfinzi for: