Cemiplimab for Clinical Stage I, 2-3.9cm, Non-Small Cell Lung Cancer (NCT07720167) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Cemiplimab for Clinical Stage I, 2-3.9cm, Non-Small Cell Lung Cancer
United States38 participantsStarted 2026-11-01
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Frequency and percentage of patients with a pathologic complete response (pCR) rate
. 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.
Exclusion criteria
. 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.