← Back to Search

Checkpoint Inhibitor

Combination Therapy for Non-Small Cell Lung Cancer

Phase 2

Recruiting

Led By Christopher G Azzoli, MD

Research Sponsored by Brown University

Eligibility Criteria Checklist

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

Must have

Evidence of postmenopausal status or negative urinary or serum pregnancy test for female premenopausal patients

Pathologically confirmed NSCLC

Must not have

No prior history of thoracic radiation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from beginning of study treatment to approximately day 49-63 on study.

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a combination of therapies for stage IB-III non-small cell lung cancer. If successful, it could become a new standard of care for this disease.

Who is the study for?

This trial is for adults over 18 with operable stage IB-IIIB non-small cell lung cancer (NSCLC) who can undergo surgery. They must have good organ function, be able to tolerate lung resection, and not be pregnant or nursing. Participants need an ECOG Performance Status of 0-1, indicating they are fully active or restricted in physically strenuous activity but ambulatory.

What is being tested?

The study tests a combination of pre-operative treatments: ipilimumab + nivolumab immunotherapies with low-dose stereotactic body radiation therapy (SBRT). It aims to see how well the cancer responds before surgery. The main goal is to measure the pathologic response after treatment.

What are the potential side effects?

Possible side effects include immune-related reactions such as inflammation in various organs, skin rash, endocrine disorders like thyroid dysfunction, fatigue, gastrointestinal issues like diarrhea or colitis, and potential complications from radiation therapy.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am postmenopausal or not pregnant if premenopausal.

Select...

My lung cancer diagnosis was confirmed through a lab test.

Select...

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

Select...

I am fully active or can carry out light work.

Select...

My lungs are strong enough for surgery.

Select...

I am older than 18 years.

Select...

I understand the details of the clinical trial and can consent to participate.

Exclusion Criteria

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

Select...

I have never had radiation therapy to the chest area.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from beginning of study treatment to approximately day 49-63 on study.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from beginning of study treatment to approximately day 49-63 on study.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from beginning of study treatment to approximately day 49-63 on study. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of Patients with a Pathologic Response

Secondary study objectives

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

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: Protocol TherapyExperimental Treatment3 Interventions

Ipilimumab: 1mg/kg IV day 1. Nivolumab: 3mg/kg IV days 1, 15, 29. SBRT delivered as 1-2 fractions to the gross primary tumor and nodal disease following day 1 infusion and completed by day 3 (7Gy x 1; 4Gy x 2).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2015

Completed Phase 3

~4010

SBRT

2014

Completed Phase 2

~1060