Adaptive Chemotherapy for Pd-l1 High REsEctablE NSCLC: A Chemo-PHREE Trial

Sponsor
University of Maryland, Baltimore
Study ID
NCT07746388
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • NSCLC Stage II
  • NSCLC Stage IIIB
  • NSCLC, Stage III
  • Nsclc
  • Resectable Lung Non-Small Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cemiplimab — DRUG
    Cemiplimab 350 mg IV administered every 3 weeks

Study Details

This research study is being done to find out if a drug called cemiplimab is safe in adult patients who have non-small cell lung cancer (NSCLC) that can be surgically removed (resectable Stage II, IIIA, or select IIIB NSCLC). The purpose of this study is also to look at how well the study drug works and whether certain patients can skip chemotherapy before their surgery. The goal is to see if they can safely avoid the harsh side effects of chemo and still have a successful outcome. The investigators are doing this study because the investigators want to find out if this treatment approach is better or worse than the usual approach for early-stage NSCLC that can be surgically removed. The usual approach for the participants type of cancer is treatment with a combination of platinum-doublet chemotherapy and an immune checkpoint inhibitor (ICI) such as cemiplimab (LIBTAYO®) given before the tumor is surgically removed. (Immune checkpoint is a normal part of the immune system used to prevent an immune response from becoming so strong that it inadvertently destroys healthy cells in the body). Cemiplimab is given via infusion and will be administered at the study center. Everyone on the study will get the active study drug, cemiplimab. No one will get placebo. Placebos look like the study drug but don't have medicine in them. Infusion of cemiplimab will be given for 2 cycles followed by an evaluation. An evaluation means that participants will have imaging studies ("scans") done to see if the tumor has changed. After the scans, participants may receive one final cycle of cemiplimab followed by resection (surgery to remove the tumor) or combination chemotherapy plus cemiplimab for 2 cycles followed by resection.

Key Dates

First listed
Aug 5, 2026
Start date
Sep 1, 2026
Status verified
Aug 2026
Primary completion
Sep 1, 2030
Completion
Sep 1, 2031

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment with Cemiplimab
    Cemiplimab 350 mg IV administered every 3 weeks Will be given for at least 3 pre-operative doses, with potential 4th dose pending interim radiographic assessment after cycle 2 of treatment.

Primary Outcome Measure

Major pathologic response (MPR) [ Time Frame: At time of surgery ]

Central Contacts

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