Cemiplimab for Clinical Stage I, 2-3.9cm, Non-Small Cell Lung Cancer

NCT07720167 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 104130
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The study will investigate the role of cemiplimab in combination with platinum doublet chemotherapy in stage I resectable non-small cell lung cancer (NSCLC). Sub-4cm NSCLC tumors are highly lethal malignancies, yet no therapies are used in these patients to improve chances of survival with surgery alone. Here will be examined the ability of 3 cycles of cemiplimab-chemotherapy to induce pathologic complete responses to treatment.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Frequency and percentage of patients with a pathologic complete response (pCR) rate

  defined as the rate of ypT0N0 stage disease based on AJCC and UICC staging systems

  5.5 years

Secondary Outcomes (5)

• Frequency and grade of adverse events and serious adverse events

  5.5 years

• Relapse-free survival

  5.5 years

• Overall survival

  5.5 years

• frequency and percentage surgical margin status based on residual (R) tumor classification (R0, R1, R2)

  5.5 years

• frequencies and percentages of delayed or cancelled surgeries

  5.5 years

Other Outcomes (4)

• summarized ctDNA, TCR repertoires, and DetermaIO assay IO scores

  5.5 years

• frequency and percentage of operative approach (minimally invasive versus open)

  5.5 years

• Post-surgical length of stay

  5.5 years

Study Arms (1)

Cemiplimab+Investigator's choice platinum doublet for clinical stage 1, 2-3.9cm, NSCLC

EXPERIMENTAL

Patients will receive carboplatin + pemetrexed/paclitaxel or cisplatin. Followed by surgery. Safety labs and physical exam 3 weeks post-surgery. Long-term follow up.

Drug: Cemiplimab; Drug: Carboplatin + Pemetrexed/Paclitaxel; Drug: Cisplatin

Interventions

Cemiplimab DRUG

administered at a dose of 350 mg as an intravenous infusion over 30 minutes

Cemiplimab+Investigator's choice platinum doublet for clinical stage 1, 2-3.9cm, NSCLC

Cisplatin DRUG

every 21 days for three cycles if not using carboplatin and pemetrexed/paclitaxel

Cemiplimab+Investigator's choice platinum doublet for clinical stage 1, 2-3.9cm, NSCLC

Carboplatin + Pemetrexed/Paclitaxel DRUG

every 21 days for three cycles if not using cisplatin

Cemiplimab+Investigator's choice platinum doublet for clinical stage 1, 2-3.9cm, NSCLC

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must have histologically proven NSCLC, clinically staged cT1c or T2a, clinically node-negative (no bronchoscopy is required for screening) using AJCC 9th Edition.
• Participants must have an SUVmax \>6.2 on standard of care staging PET scan, and/or biopsy histology must be consistent with moderate/poorly/or undifferentiated NSCLC.
• Participants must have pulmonary function study capable of tolerating the proposed lung resection according to the surgeon. This will require post-operative predicted forced expiratory volume (FEV) 1 and diffusing capacity of the lungs for carbon monoxide (DLCO) greater than 40%.
• Participants must be deemed a surgical candidate with adequate organ function, documented in the electronic medical record (EMR).
• Participants must have ECOG Performance status 0-1.
• Participants must have a signed and dated IRB approved written consent form before the performance of any protocol related procedures that are not part of the normal participant care.
• Participants must be aged \>18 years old.

You may not qualify if:

• Participants must have no known ALK driver mutations
• Participants must have no known EGFR mutations.
• Participants must not have known or suspected active autoimmune disease requiring systemic immunosuppressive treatment within the past two years. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
• Participants must not have any condition treated with chemotherapy or other cancer therapy, including anti-PD-1, anti-PD-L1, anti-PDL-2, or anti-CTLA-4 antibody (or any other antibody targeting T-cell co-regulatory pathways).
• Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
• Participants must not have history of symptomatic interstitial lung disease.
• Prisoners or subjects who are involuntarily incarcerated or compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness will be excluded from the study.
• Participants must not have previous history of bone marrow transplant.
• Participants must not have a known allergy, or history of allergy or hypersensitivity to study drug or any of the excipients.
• Presence of cardiovascular disease, as defined by:
• a) New York Heart Association heart failure classifications of Class II, III, or IV; or myocardial infarction, or acute coronary syndrome within 12 months of first dose of study medication; or b) Transient ischemic attack or stroke within 1 year.
• Any condition that requires ongoing/continuous corticosteroid or immunosuppressive therapy (\>10 mg prednisone/day or anti-inflammatory equivalent) within 1 week prior to the first dose of study medication. Participants who require a brief course of steroids (up to 2 days in the week before enrollment) or physiologic replacement are not excluded.
• Any infection requiring hospitalization or treatment with IV anti-infectives within 2 weeks of first dose of study medication.
• Known infection with HIV, hepatitis B or hepatitis C infection, diagnosis of immunodeficiency, and/or tuberculosis (active or latent).
• a) Receipt of a live vaccine within 4 weeks of start of study medication. b) Receipt of COVID-19 vaccination within 1 week of planned start of study medication or for which the planned COVID-19 vaccinations would not be completed 1 week prior to start of study medication.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina Hollings Cancer Center

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

cemiplimab; Carboplatin; Pemetrexed; Paclitaxel; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Central Study Contacts

HCC Clinical Trials Office

CONTACT

843-792-9321; hcc-clinical-trials@musc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 17, 2026
• First Posted: July 22, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2030
• Last Updated: July 22, 2026

Record last verified: 2026-07

Locations

US (1)