Cemiplimab for Non-Small Cell Lung Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Henry Ford Health System

Must not be taking: Corticosteroids, Live vaccines

Disqualifiers: Metastases, EGFR mutations, Cardiovascular disease, Autoimmune disease, Infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 14

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a single arm phase II trial enrolling patients with stage II-IIIA non-small cell lung cancer whose disease is deemed amenable for surgical resection and has a PD-L1 level of ≥50%. Patients will receive cemiplimab for 3 cycles followed by surgical resection. The primary endpoint evaluated by the study is the amount of residual tumor in the resected tissue after 3 cycles of cemiplimab. After surgery, all patients will receive additional 10 cycles of cemiplimab and the treating oncologist will decide on the need of administering chemotherapy prior to that.

Are You a Good Fit for This Trial?

Inclusion Criteria

1. AST/ALT for adults: AST ≤3x ULN, ALT ≤3x ULN

2. Serum bilirubin ≤1.5x ULN, except in patients with clinically documented Gilbert's Syndrome where ≤3x the ULN is permitted

I have early-stage, operable NSCLC with PD-L1 levels of 50% or higher and have not started treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Treatment

Participants receive neoadjuvant cemiplimab 350 mg IV every 3 weeks for 3 cycles

9 weeks

3 visits (in-person)

Surgical Resection

Participants undergo surgical resection to remove the tumor

1 week

1 visit (in-person)

Adjuvant Treatment

Participants receive adjuvant cemiplimab 350 mg IV every 3 weeks for 10 cycles, with optional chemotherapy

30 weeks

10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cemiplimab

How Is the Trial Designed?

Group I: Perioperative Cemiplimab Experimental Treatment 2 Interventions

Patients receive neoadjuvant cemiplimab 350 mg IV every 3 weeks for 3 cycles, followed by surgical resection, then adjuvant cemiplimab 350 mg IV every 3 weeks for 10 cycles. Treating oncologists may administer histology-matched adjuvant chemotherapy (up to 4 cycles) before adjuvant cemiplimab per investigator discretion.

Who Is Running the Clinical Trial?

Henry Ford Health System

Lead Sponsor

Trials

334

Recruited

2,197,000+

Regeneron Pharmaceuticals

Industry Sponsor

Trials

690

Recruited

948,000+

Founded

1988

Headquarters

Tarrytown, USA

Known For

Precision medicine

Top Products

Dupixent, EYLEA, Libtayo, Praluent

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School