Preoperative Cemiplimab with Chemo or Radiation for Lung Cancer
This study is looking at two different treatments before surgery for stages IB, II, and III (N2) non-small cell lung cancer (NSCLC). You would receive either Cemiplimab with chemotherapy, or Cemiplimab with stereotactic body radiation therapy (SBRT), a type of targeted radiation. Researchers want to see how many participants have a complete disappearance of cancer cells in the removed tissue after these treatments. This study is for adults aged 18 and older with measurable lung cancer, known PD-L1 expression, and no specific EGFR or ALK mutations. The study plans to enroll 112 participants.
- Study design
- This study will involve 112 participants. It compares two different treatment approaches before surgery for lung cancer.
- What's involved
- You would receive treatment every 3 weeks for up to 3 doses before surgery. After surgery, you would receive Cemiplimab for one year.
- Compensation
- Not stated in the trial record.
- Follow-up
- The main goal of the study is measured at surgical resection, which happens 9-13 weeks after starting treatment.
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NCT06623656
Preoperative Radioimmunotherapy Versus Chemoimmunotherapy in NSCLC
Recruiting
PHASE2Ages 18+InterventionalTreatmentWeill Medical College of Cornell UniversityInvestigator-initiated
~112 participants
Updated 2026-04-21 on ClinicalTrials.gov
What's tested:CemiplimabPlatinum based chemotherapyStereotactic body radiation therapy
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with pathological complete response (pCR)
Measured over Surgical resection (Weeks 9-13).
Conditions
Where it's being run
1 sites across 1 statesNew York1
Study leadership
- Nasser K Altorki, MD · PRINCIPAL_INVESTIGATOR · Weill Medical College of Cornell University
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Serum total bilirubin ≤1.5 X ULN, except in patients with clinically documented Gilbert's Syndrome where ≤3x the ULN is permitted
Aspartate aminotransferase (AST)/ Alanine aminotransferase (ALT) ≤3 X ULN 10. WOCBP\* must have a negative serum (beta-hCG) at screening. a) \*WOCBP are defined as women who are fertile following menarche until becoming postmenopausal, unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy.
Exclusion
Malignancy treated with curative intent and with no known active disease ≥2 years before the first dose of the study drug and of low potential risk for recurrence.
Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
Adequately treated carcinoma in situ without evidence of disease e.g., cervical cancer in situ, in-situ urinary bladder cancer, treated localized prostate cancer, and ductal carcinoma in-situ.
Indolent hematological malignancies 2. Current or prior use of immunosuppressive medication within 14 days before the first dose of cemiplimab, with the exceptions of intranasal, inhaled, topical steroids, or local steroid injections (e.g.intra articular injection), corticosteroids or systemic corticosteroids at physiological doses which are not to exceed 10 mg/day of prednisone or an equivalent corticosteroid, and steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
Patients with vitiligo or alopecia
Patients with endocrinopathies (such as hypothyroidism or type 1 diabetes (e.g., following Hashimoto syndrome) stable on hormone replacement, or psoriasis that does not require systemic treatment.
Any chronic skin condition that does not require systemic therapy
Patients with childhood asthma that has resolved 4. Uncontrolled, intercurrent illness including, but not limited to: ongoing or active infection requiring antibiotics (exception is a brief (≤10 days) course of antibiotics to be completed before initiation of treatment), symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements as determined by the Investigator.
Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject.
Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and LAM are not acceptable methods of contraception. Female condom and male condom should not be used together.
Sexually active men and their partners must use highly effective contraception as described above. Contraception is not required for men with documented vasectomy. Pregnancy testing and contraception are not required for women who are post-menopausal or with documented permanent sterilization.
Male participants: a male participants will be excluded from the study if that participant does not agree to use condoms or practice sexual abstinence, unless vasectomized, prior to the initial dose/start of study medication, during the study, and for at least 4 months after the last dose. Sperm donation is also prohibited during the same period. Vasectomy success must be confirmed by semen analysis.
What this trial measures
- Number of participants with pathological complete response (pCR)Surgical resection (Weeks 9-13).
pCR is defined as the absence of viable tumor in the tumor bed and the draining lymph nodes upon pathological review of the tissue.