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Recruiting Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT07746388

Public ClinicalTrials.gov record NCT07746388. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Nov 6, 2026, 5:22 PM EST

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Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT07746388
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 2
Enrollment
30 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 19, 2026 (Actual)
Primary completion
Sep 1, 2030 (Estimated)
Completion
Sep 1, 2031 (Estimated)
Last update posted
Nov 4, 2026

2026 – 2031

United States locations

U.S. sites
5
U.S. states
4
U.S. cities
5
Facility City State ZIP Site status
Indiana University Indianapolis Indiana 46202 Not yet recruiting
University of Maryland Greenebaum Comprehensive Cancer Center Baltimore Maryland 21201 Recruiting
University Hospitals Seidman Cancer Center Cleveland Ohio 44106 Not yet recruiting
Ohio State University Comprehensive Cancer Center Columbus Ohio 43210 Not yet recruiting
University of Virginia Comprehensive Cancer Center Charlottesville Virginia 22903 Not yet recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07746388, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 4, 2026 · Synced Nov 6, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT07746388 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →