Chemo-Immunotherapy for Lung Cancer
(NEO-SURG Trial)

Recruiting in Palo Alto (17 mi)

Overseen byJoshua Reuss, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Georgetown University

Stay on Your Current Meds

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?The goal of this clinical trial is to learn about neoadjuvant cemiplimab with histology-specific chemotherapy followed by resection and adjuvant cemiplimab in stage 3 non-small cell lung cancer (NSCLC) with contralateral mediastinal or ipsilateral supraclavicular lymph node (N3) involvement.. The main question it aims to answer is whether patients with stage 3 NSCLC with involvement of lymph nodes can undergo surgery to remove the cancer after receiving treatment with chemotherapy + immunotherapy. Participants will receive FDA-approved chemotherapy called platinum-doublet chemotherapy together with an immunotherapy drug targeting the immune marker PD-1 called cemiplimab. Patients will receive a 3 drug combination for 4 total treatments given every 3 weeks before surgery. After surgery, patients will have the option to undergo radiation therapy if it is recommended by their treatment team. After this, they will receive cemiplimab every 3 weeks for one year.

Eligibility Criteria

This trial is for individuals with stage III non-small cell lung cancer (NSCLC) that has spread to certain lymph nodes. Candidates must be eligible for surgery after receiving chemotherapy and immunotherapy. Details on specific inclusion or exclusion criteria are not provided.

Inclusion Criteria

I am 18 years old or older.

My surgeon believes my tumor can be surgically removed with the goal of curing me.

My surgeon has cleared me for surgery without major health risks.

+5 more

Exclusion Criteria

I have active tuberculosis.

I have a history of uncontrolled HIV or hepatitis.

I have not had a severe infection in the last 3 weeks.

+15 more

Participant Groups

The study tests if patients can have successful surgery to remove NSCLC after treatment with platinum-doublet chemotherapy and cemiplimab, an immunotherapy drug targeting PD-1. Post-surgery, optional radiation therapy and additional cemiplimab treatments for one year are considered.

1Treatment groups

Experimental Treatment

Group I: Cemiplimab plus chemotherapyExperimental Treatment1 Intervention

cemiplimab given with standard of care chemotherapy for 4 treatments/cycles before surgery and then every 3 weeks for 1 year after surgery.

Cemiplimab is already approved in European Union, United States, Canada, Brazil for the following indications:

🇪🇺 Approved in European Union as Libtayo for: