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Checkpoint Inhibitor

Chemotherapy + Durvalumab for Lung Cancer

Phase 2

Waitlist Available

Led By Monica Bertagnolli, MD

Research Sponsored by Alliance Foundation Trials, LLC.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

N2 nodes must be discrete (ie, not invading surrounding structures) and less than 3 cm in maximum diameter

Women of childbearing potential (WOCBP) must be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 3 months after the last dose of study medication

Must not have

Active or prior documented autoimmune or inflammatory disorders

Patients with ≥Grade 2 peripheral neuropathy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new combination of drugs to treat NSCLC. The goal is to increase the N2 nodal clearance (N2NC) to 50% or greater.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Durvalumab may cause immune-related side effects like inflammation in various organs, infusion reactions, fatigue, possible worsening of pre-existing autoimmune conditions, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My N2 lymph nodes are separate from surrounding tissues and smaller than 3 cm.

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I am using two birth control methods or am not having sex to join this study.

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I am fully active or can carry out light work.

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I have had a biopsy of the lymph nodes in my chest before surgery.

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I have never had radiation therapy to my chest.

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My lung cancer is at a stage where surgery could remove it completely.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have or had an autoimmune or inflammatory disorder.

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

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I have had a solid organ transplant.

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I have received treatment for non-small cell lung cancer before.

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I do not have any serious ongoing illnesses that could affect my participation in the study.

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My cancer is not a mix of small cell and non-small cell lung cancer.

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My cancer has spread to one or more lymph nodes.

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I have received an organ transplant from another person.

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I have had radiation therapy to the chest area before.

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I haven't taken high-dose steroids or other immune-weakening drugs in the last 2 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

N2 nodal clearance (N2NC)

Secondary study objectives

Evaluate event free survival (EFS)

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Overall survival rate

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Durvalumab

2017

Completed Phase 2

~3750

Surgery

2000

Completed Phase 3

~2490