Chemotherapy + Durvalumab for Lung Cancer

Recruiting in Palo Alto (17 mi)

+17 other locations

Overseen byEvanthia Galanis, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Alliance Foundation Trials, LLC.

Stay on Your Current Meds

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This is a single arm, phase II trial of combined neoadjuvant platinum doublet chemotherapy plus durvalumab followed by surgery, postoperative radiation and adjuvant durvalumab for 13 cycles for patients with potentially resectable stage IIIA and IIIB (T1-3, N2) NSCLC (per the 8th International Association for the Study of Lung Cancer classification). The primary objective of this study is to increase N2 nodal clearance (N2NC) to 50% or greater for combined platinum doublet chemotherapy with durvalumab induction therapy from historical rate of 30% for platinum doublet chemotherapy alone in patients with potentially resectable stage IIIA/B (N2) NSCLC.

Eligibility Criteria

Adults with stage IIIA/B Non-Small Cell Lung Cancer that can be removed by surgery. They must have good overall health, no prior lung cancer treatments or thoracic radiation, and not have certain autoimmune diseases or a history of other cancers within the last 2 years. Women who can bear children and men must agree to use contraception.

Inclusion Criteria

I am healthy enough for major lung surgery.

My organ and bone marrow functions are within normal ranges.

I agree to use birth control during and for 12 weeks after the study.

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Exclusion Criteria

I have or had an autoimmune or inflammatory disorder.

Your heart's electrical activity takes too long to reset itself, and this can be dangerous.

I have moderate to severe numbness, tingling, or pain in my hands or feet.

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Treatment Details

Interventions

Durvalumab (Checkpoint Inhibitor)
Platinum Doublet Chemotherapy (Chemotherapy)
Radiotherapy (Radiation)
Surgery (Procedure)

Trial OverviewThe trial tests if adding Durvalumab (an immune checkpoint inhibitor) to standard chemotherapy before and after surgery can improve outcomes for patients with operable lung cancer. It aims to clear cancer from lymph nodes better than chemotherapy alone.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment3 Interventions

Combined neoadjuvant platinum doublet chemotherapy plus durvalumab followed by surgery, postoperative radiation and adjuvant durvalumab for 13 cycles.

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

🇪🇺 Approved in European Union as Imfinzi for: