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Checkpoint Inhibitor

Radioimmunotherapy vs Chemoimmunotherapy for Non-Small Cell Lung Cancer

Phase 2

Waitlist Available

Led By Nasser K Altorki, MD

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

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

Must have

Adequate organ and bone marrow function as defined below: ANC ≥1.5 x10(3)/uL, Platelets ≥75 x10(3)/uL, Hemoglobin ≥9 g/dL, Serum creatinine ≤1.5 X upper limit of normal (ULN) OR calculated CrCl ≥50 ml/min (using the Cockcroft-Gault formula), Serum total bilirubin ≤1.5 X ULN, except in patients with clinically documented Gilbert's Syndrome where ≤3x the ULN is permitted, Aspartate aminotransferase (AST)/ Alanine aminotransferase (ALT) ≤3 X ULN

No known EGFR mutations or ALK fusions.

Must not have

Uncontrolled, intercurrent illness including ongoing or active infection requiring antibiotics, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements

Interstitial lung disease or active, noninfectious pneumonitis that requires immune-suppressive doses of glucocorticoids to assist with management

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the time of surgical resection (weeks 9-13) until hospital discharge, approximately 2-5 days after surgical resection.

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to see if using Cemiplimab with chemotherapy or Cemiplimab with stereotactic body radiation therapy (SBRT) can effectively treat stages IB, II, and

Who is the study for?

This trial is for individuals with stages IB, II, and III (N2) Non-Small Cell Lung Cancer who are planning to have surgery. Participants must be fit for both chemotherapy and immunotherapy. They cannot join if they've had previous treatments for NSCLC or have certain medical conditions that the study outlines.

What is being tested?

The trial tests two pre-surgery treatments: Cemiplimab combined with platinum-based chemotherapy (Arm A), or Cemiplimab with stereotactic body radiation therapy (SBRT) (Arm B). After surgery, participants in both groups will continue to receive Cemiplimab for one year.

What are the potential side effects?

Possible side effects include reactions related to the immune system such as skin issues, hormone gland problems, inflammation of organs like lungs or intestines; fatigue from radiation; and typical chemo side effects like nausea, hair loss, and increased infection risk.

Eligibility Criteria

Inclusion Criteria

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

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My cancer does not have EGFR mutations or ALK fusions.

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My cancer has been tested for PD-L1 expression.

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I am older than 18 years.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I have not received any treatment for lung cancer.

Exclusion Criteria

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

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I do not have any uncontrolled illnesses or infections that require antibiotics.

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I have a lung condition treated with high-dose steroids.

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I do not have HIV, hepatitis B, or hepatitis C.

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I have had a stem cell or organ transplant in the past.

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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the time of surgical resection (weeks 9-13) until hospital discharge, approximately 2-5 days after surgical resection.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the time of surgical resection (weeks 9-13) until hospital discharge, approximately 2-5 days after surgical resection.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the time of surgical resection (weeks 9-13) until hospital discharge, approximately 2-5 days after surgical resection. 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 participants with pathological complete response (pCR)

Secondary study objectives

Change from baseline in health-related quality of life, as measured by the European Organization for Research and Treatment of Cancer-Core Quality of Life Questionnaire (EORTC QLQ-C30)

Change from baseline in health-related quality of life, as measured by the European Organization for Research and Treatment of Cancer-Core Quality of Life Questionnaire (EORTC QLQ-LC13)

Change in number of participants with distant recurrence

+8 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cemiplimab with chemotherapy (Arm A)Experimental Treatment2 Interventions

Before lung cancer surgery: 1. Cemiplimab 350 mg intravenously every 3 weeks up to 3 cycles. 2. Platinum-based chemotherapy intravenously every 3 weeks up to 3 cycles. After lung cancer surgery, cemiplimab 350 mg intravenously every 3 weeks for 4 treatments followed by 700 mg every 6 weeks for one year (11 treatments).

Group II: Cemiplimab with SBRT (Arm B)Experimental Treatment2 Interventions

Before lung cancer surgery: 1. Cemiplimab 350 mg intravenously every 3 weeks up to 3 cycles. 2. SBRT on days 1, 2, and 3. After lung cancer surgery, cemiplimab 350 mg intravenously every 3 weeks for 4 treatments followed by 700 mg every 6 weeks for one year (11 treatments).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Stereotactic body radiation therapy

2017

Completed Phase 1

~30

Cemiplimab

2015

Completed Phase 3

~1470