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NSCLC Stage Ii / Cemiplimab / Nsclc · Phase 2 Trial
ClinicalTrials.gov · August 7, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 2 registry record for an ongoing, uncontrolled trial of cemiplimab monotherapy in resectable PD-L1–high NSCLC (Stage II, IIIA, select IIIB), with adaptive assignment to either additional cemiplimab or chemotherapy plus cemiplimab before surgery based on radiological response. No results have been posted; this record documents planned enrollment and primary endpoint (major pathologic response at surgery) only.
Phase 2, Interventional, Single Group, Open label, Treatment purpose. Nsclc, NSCLC Stage II, NSCLC, Stage III, NSCLC Stage IIIB, Resectable Lung Non-Small Cell Carcinoma; age from 18 Years. Intervention: Treatment with Cemiplimab. n = 30. University of Maryland, Baltimore (lead sponsor); specific trial sites not listed in registry record..
This is a Phase 2 registry record for an ongoing, uncontrolled trial of cemiplimab monotherapy in resectable PD-L1–high NSCLC (Stage II, IIIA, select IIIB), with adaptive assignment to either additional cemiplimab or chemotherapy plus cemiplimab before surgery based on radiological response. No results have been posted; this record documents planned enrollment and primary endpoint (major pathologic response at surgery) only.
No efficacy, safety, or pathologic response data reported.
If completed and positive, this trial may support a chemotherapy-sparing approach in PD-L1–high early-stage NSCLC; however, the single-arm design and small sample limit the strength of any future conclusion. Results are not yet available.
This is a Phase 2, single-arm registry record with no reported results; it describes an adaptive design testing whether PD-L1–high resectable NSCLC patients can omit chemotherapy, but outcomes are not yet posted.
As stated by the source record.
Quoted from the source exactly as published.
If completed and positive, this trial may support a chemotherapy-sparing approach in PD-L1–high early-stage NSCLC; however, the single-arm design and small sample limit the strength of any future conclusion. Results are not yet available.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07746388). This is a study registration, not published results. Lead sponsor: University of Maryland, Baltimore. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 30 participants (ESTIMATED). Conditions: Nsclc, NSCLC Stage II, NSCLC, Stage III, NSCLC Stage IIIB, Resectable Lung Non-Small Cell Carcinoma. Interventions: DRUG: Cemiplimab. Primary outcome measures: Major pathologic response (MPR) , At time of surgery. Brief summary: 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.