Carcinoma, Non-Small-Cell LungPhase 2NCT06623656
Preoperative Radioimmunotherapy Versus Chemoimmunotherapy in NSCLC
A Phase 2 study testing Cemiplimab, Platinum based chemotherapy and Stereotactic body radiation therapy in people with Carcinoma, Non-Small-Cell Lung, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if Cemiplimab with chemotherapy or Cemiplimab with stereotactic body radiation therapy (SBRT) works as treatment for stages IB, II, and III (N2) Non-Small Cell Lung Cancer (NSCLC). Before surgery to remove their lung cancer, participants will take: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Cemiplimab, Platinum based chemotherapy and Stereotactic body radiation therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2025to Jan 2032
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically or cytologically proven clinical stages IB (T2aN0), II, and III(N2) NSCLC (according to AJCC version 9) eligible for surgical resection with curative intent. Patients with 2 synchronous NSCLC are allowed.
- Measurable disease, as defined by RECIST v1.1.
- Known PD-L1 expression.
- No known EGFR mutations or ALK fusions.
- Written informed consent and HIPAA obtained from the subject prior to performing any protocol-related procedures.
- Age > 18 years at time of study entry.
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- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- No prior therapy for lung cancer
- Adequate organ and bone marrow function as defined below:
- Absolute neutrophil count (ANC) ≥1.5 x10(3)/uL
- Platelets ≥75 x10(3)/uL
- Hemoglobin ≥9 g/dL
- Serum creatinine ≤1.5 X upper limit of normal (ULN) OR calculated CrCl ≥50 ml/min (using the Cockcroft-Gault formula).
- 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
- 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.
- A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high FSH level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient to determine the occurrence of a postmenopausal state. The above definitions are according to the CTFG guidance. Pregnancy testing and contraception are not required for women who are post-menopausal or with documented permanent sterilization.
- Male study patients with WOCBP partners are required to use condoms unless they are vasectomized or practice sexual abstinence.
- Vasectomized partner or vasectomized study patient must have received medical assessment of the surgical success.
- 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.
- WOCBP must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the entire trial and until 6 months after last treatment.
- All men must agree not to donate sperm during the trial and for 6 months after receiving the last therapy dose.
Who cannot join
- -
- History of another primary malignancy except for:
- -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
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- 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).
- 2.a. Any condition that requires ongoing/continuous corticosteroid therapy (>10mg 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.
- 3. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease systemic lupus erythematosus, sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]. No active diverticulitis within the previous 3 months. The following are exceptions to this criterion:
- 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.
- 5. Interstitial lung disease (eg, idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis that requires immune-suppressive doses of glucocorticoids to assist with management. A history of radiation pneumonitis in the radiation field is permitted as long as pneumonitis is resolved ≥6 months prior to study treatment.
- 6. Receipt of a live vaccine within 30 days of the planned start of study medication.
- Note: If a patient intends to receive a COVID-19 vaccine before the start of the study drug, participation in the study should be delayed at least 4 weeks after any COVID-19 vaccination. During the neoadjuvant treatment period, it is recommended to delay any COVID-19 vaccination or any other vaccination until patients have undergone radical surgery for the lung. A vaccine dose should not be administered less than 48 hours (ideally by at least one week) before or after study drug dosing.
- 7. Prior allogeneic stem cell transplant or solid organ transplant. 8. Uncontrolled HIV, active hepatitis B or C, or diagnosis of immunodeficiency, and/or tuberculosis (active or latent).
- Participants with known controlled HIV infection (undetectable viral load or HIV RNA PCR) and CD4 count above 250 either spontaneously or on a stable antiviral regimen are eligible. For these participants monitoring will be performed per local standards.
- Participants with HBsAg positive who have controlled infection (serum HBV DNA PCR that is below the limit of detection and receiving antiviral therapy for hepatitis B) are eligible. Participants with controlled infections must undergo periodic monitoring of HBV DNA. Participants must remain on antiviral therapy for at least 6 months beyond the last dose of investigational study medication.
- Participants with HBsAg negative but total HBcAb positive are permitted with the following requirements: if HBV DNA PCR is above limit of detection at screening, initiate HBV antiviral therapy before study entry. If serum HBV DNA PCR is below the limit of detection, periodic monitoring of HBsAg must be performed.
- Participants who are HCV Ab+ who have controlled infection (undetectable HCV RNA by PCR either spontaneously or in response to successful prior course of anti-HCV therapy) are eligible.
- 9. Female patients who are pregnant or breastfeeding. 10. Sexually active men and WOCBP who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 6 months after the last dose. Highly effective contraceptive measures include:
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- stable use of combined (estrogen and progestogen-containing) hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation initiated 2 or more menstrual cycles prior to screening
- IUD; IUS
- bilateral tubal ligation (occlusion)
- vasectomized partner (provided that the male vasectomized partner is the sole sexual partner of the WOCBP study patient and that the vasectomized partner has obtained medical assessment of surgical success for the procedure); and or
- sexual abstinence
- 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.
- 11. Adjuvant hormonotherapy used for breast cancer or other hormone-sensitive cancers in long term remission is allowed.
- 12. Presence of cardiovascular disease, as defined by:
- 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 13. Known hypersensitivity to the active substances or to any of the excipients.
- 14. Any infection requiring hospitalization or treatment with IV anti-infectives within 2 weeks of first dose of study medication.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Weill Cornell Medicine
New York, New York, 10065
Julissa Murillo, 2127463328, jum4020@med.cornell.edu
Julia Muuse, 2127464528, jum4029@med.cornell.edu
About this study
Official title: Multicenter Randomized Phase II Trial of Neoadjuvant Radioimmunotherapy Versus Chemoimmunotherapy in Patients With Clinical Stages IB-III (N2) Non-small Cell Lung Cancer
The goal of this clinical trial is to learn if Cemiplimab with chemotherapy or Cemiplimab with stereotactic body radiation therapy (SBRT) works as treatment for stages IB, II, and III (N2) Non-Small Cell Lung Cancer (NSCLC).
Before surgery to remove their lung cancer, participants will take:
- Cemiplimab with chemotherapy (Arm A) every 3 weeks for up to 3 doses, OR
- Cemiplimab every 3 weeks for up to 3 doses with SBRT (Arm B). SBRT will be given on day 1 before taking cemiplimab, then SBRT alone on day 2 and day 3.
Four to 12 weeks following surgery, participants in both Arm A and Arm B will receive treatment with cemiplimab for one year.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- Cemiplimab, Platinum based chemotherapy, Stereotactic body radiation therapy
- Keywords
- Lung neoplasms, Bronchial Neoplasms, Carcinoma, bronchogenic, Neoplasms
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Bronchial Neoplasms, Carcinoma, Bronchogenic, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CemiplimabDrug
Also called Libtayo, REGN2810
Intravenously
Platinum based chemotherapyDrug
Also called Cisplatin, pemetrexed, gemcitabine, carboplatin, paclitaxel, docetaxel
Intravenously
Stereotactic body radiation therapyRadiation
8 Gy times 3 treatment days (Days 1-3)
| Study group | Role | What they receive |
|---|---|---|
| Cemiplimab with chemotherapy (Arm A) | Experimental | Before lung cancer surgery:
1. Cemiplimab 350 mg intravenously every 3 weeks up to 3 cycles.
2. Platinum-based chemotherapy intravenously every 3 weeks up to 3 cycles.
After lung cancer surgery, cemiplimab 350 mg intravenously every 3 weeks for 4 treatments followed by 700 mg every 6 weeks for one year (11 treatments). Receives: Drug: Cemiplimab; Drug: Platinum based chemotherapy |
| Cemiplimab with SBRT (Arm B) | Experimental | Before lung cancer surgery:
1. Cemiplimab 350 mg intravenously every 3 weeks up to 3 cycles.
2. SBRT on days 1, 2, and 3.
After lung cancer surgery, cemiplimab 350 mg intravenously every 3 weeks for 4 treatments followed by 700 mg every 6 weeks for one year (11 treatments). Receives: Drug: Cemiplimab; Radiation: Stereotactic body radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with pathological complete response (pCR)
pCR is defined as the absence of viable tumor in the tumor bed and the draining lymph nodes upon pathological review of the tissue.
Measured: Surgical resection (Weeks 9-13).
Secondary outcomes (14)
Number of participants with Major Pathological Response (MPR)
MPR is defines as is defined as ≤10% residual viable tumor in the resected specimen on histopathological examination.
Measured: Surgical resection (Weeks 9-13).
Number of participants with neoadjuvant treatment-related adverse events as assessed by CTCAE v5.0
Defined as grade 3-4 toxicities determined to be related to the study drug and are assessed and graded according to CTCAE v. 5.0
Measured: From cemiplimab with chemotherapy and cemiplimab with SBRT treatment start date (Day 1) to prior to surgical resection (Weeks 9-13).
Surgical delay, mean/standard deviation
Defined as a delay in surgery beyond 6 weeks from the last dose of neoadjuvant cemiplimab
Measured: From the date of the last dose of neoadjuvant cemiplimab treatment (Week 7) to surgical resection (Weeks 9-13).
Number of participants with minimal access surgery
Defined as the confirmation of a minimal access surgical procedure
Measured: Time of surgical resection (Week 9-13), after the last preoperative dose of cemiplimab.
Change in number of participants with distant recurrence
Distant recurrence rate is defined as confirmed distant disease recurrence
Measured: From cemiplimab with chemotherapy and cemiplimab with SBRT treatment start date (Day 1) to recurrence (Every 6 months for 3 years, then yearly for year 4-5).
Change in number of participants with local recurrence
Local recurrence rate is defined as confirmed local disease recurrence
Measured: From cemiplimab with chemotherapy and cemiplimab with SBRT treatment start date (Day 1) to recurrence (Every 6 months for 3 years, then yearly for year 4-5).
Change from baseline in health-related quality of life, as measured by the European Organization for Research and Treatment of Cancer-Core Quality of Life Questionnaire (EORTC QLQ-C30)
The EORTC scores range from 0 to 100; a higher score represents a higher level of functioning, or a higher level of symptoms.
Measured: From baseline (Day 1), Post Treatment (Weeks 9-10), to 6 months post operatively.
Change from baseline in health-related quality of life, as measured by the European Organization for Research and Treatment of Cancer-Core Quality of Life Questionnaire (EORTC QLQ-LC13)
The EORTC scores range from 0 to 100; a higher score represents a higher level of functioning, or a higher level of symptoms.
Measured: Baseline (Day 1), Post Treatment (Weeks 9-10), to 6 months post operatively.
Event Free Survival (EFS) in months
EFS is defined as the time from randomization to the first documentation of disease recurrence, disease progression, or death without documented recurrence/progression.
Measured: From randomization (day 1) up to 2 years.
Number of days spent in the ICU (Intensive care unit)
Measured: From the time of admission (Week 9-13) to the ICU (approximately 1 day after surgical resection) to discharge (approximately 2-5 days after surgical resection)
Number of participants with surgical adverse events as assessed by CTCAE v5.0
Defined as grade 3-4 toxicities assessed and graded according to CTCAE v. 5.0
Measured: From the time of surgical resection (Weeks 9-13) until hospital discharge, approximately 2-5 days after surgical resection.
Number of days spent in the hospital
Measured: From the date of surgery (Weeks 9-13) to discharge from the hospital (approximately 2-5 days after surgical resection)
Number of participants with negative surgical resection margins (R-0)
Defined as no gross or microscopic tumor remaining in the primary tumor site as determined by the pathologist.
Measured: Time of surgical resection (Weeks 9-13), after the last preoperative dose of cemiplimab.
Progression Free Survival (PFS) in months
PFS is defined as the time from randomization to the first documentation of evidence of disease progression or death from disease.
Measured: From randomization (day 1) up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start21 Feb 2025
- Primary completionDec 2026 (estimated)
- Study completionJan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Nasser K Altorki, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06623656
- Sponsor's protocol ID
- 24-02027124
- Status last verified
- Apr 2026
- First submitted
- 30 Sep 2024
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Phase II Trial of Neoadjuvant Radioimmunotherapy Versus Chemoimmunotherapy in Patients With Clinical Stages IB-III (N2) Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06623656
- Acronym / sponsor ID
- 24-02027124
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Lung neoplasms, Bronchial Neoplasms, Carcinoma, bronchogenic, Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 21 Feb 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2032 (estimated)
- First posted
- 2 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if Cemiplimab with chemotherapy or Cemiplimab with stereotactic body radiation therapy (SBRT) works as treatment for stages IB, II, and III (N2) Non-Small Cell Lung Cancer (NSCLC).
Before surgery to remove their lung cancer, participants will take:
- Cemiplimab with chemotherapy (Arm A) every 3 weeks for up to 3 doses, OR
- Cemiplimab every 3 weeks for up to 3 doses with SBRT (Arm B). SBRT will be given on day 1 before taking cemiplimab, then SBRT alone on day 2 and day 3.
Four to 12 weeks following surgery, participants in both Arm A and Arm B will receive treatment with cemiplimab for one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cemiplimab with chemotherapy (Arm A) | Experimental | Drug: Cemiplimab, Drug: Platinum based chemotherapyBefore lung cancer surgery: 1. Cemiplimab 350 mg intravenously every 3 weeks up to 3 cycles. 2. Platinum-based chemotherapy intravenously every 3 weeks up to 3 cycles. After lung cancer surgery, cemiplimab 350 mg intravenously every 3 weeks for 4 treatments followed by 700 mg every 6 weeks for one year (11 treatments). |
| Cemiplimab with SBRT (Arm B) | Experimental | Drug: Cemiplimab, Radiation: Stereotactic body radiation therapyBefore lung cancer surgery: 1. Cemiplimab 350 mg intravenously every 3 weeks up to 3 cycles. 2. SBRT on days 1, 2, and 3. After lung cancer surgery, cemiplimab 350 mg intravenously every 3 weeks for 4 treatments followed by 700 mg every 6 weeks for one year (11 treatments). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Patients with histologically or cytologically proven clinical stages IB (T2aN0), II, and III(N2) NSCLC (according to AJCC version 9) eligible for surgical resection with curative intent. Patients with 2 synchronous NSCLC are allowed.
- Measurable disease, as defined by RECIST v1.1.
- Known PD-L1 expression.
- No known EGFR mutations or ALK fusions.
- Written informed consent and HIPAA obtained from the subject prior to performing any protocol-related procedures.
Key exclusion criteria (36 listed)
- -
- History of another primary malignancy except for:
- -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.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CemiplimabAlso: Libtayo, REGN2810Intravenously | Drug | Cemiplimab with SBRT (Arm B), Cemiplimab with chemotherapy (Arm A) |
| Platinum based chemotherapyAlso: Cisplatin, pemetrexed, gemcitabine, carboplatin, paclitaxel, docetaxelIntravenously | Drug | Cemiplimab with chemotherapy (Arm A) |
| Stereotactic body radiation therapy8 Gy times 3 treatment days (Days 1-3) | Radiation | Cemiplimab with SBRT (Arm B) |
Primary outcome
Number of participants with pathological complete response (pCR)
Time frame: 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.
14 secondary outcomes
Number of participants with Major Pathological Response (MPR)
Time frame: Surgical resection (Weeks 9-13).
Number of participants with neoadjuvant treatment-related adverse events as assessed by CTCAE v5.0
Time frame: From cemiplimab with chemotherapy and cemiplimab with SBRT treatment start date (Day 1) to prior to surgical resection (Weeks 9-13).
Surgical delay, mean/standard deviation
Time frame: From the date of the last dose of neoadjuvant cemiplimab treatment (Week 7) to surgical resection (Weeks 9-13).
Number of participants with minimal access surgery
Time frame: Time of surgical resection (Week 9-13), after the last preoperative dose of cemiplimab.
Change in number of participants with distant recurrence
Time frame: From cemiplimab with chemotherapy and cemiplimab with SBRT treatment start date (Day 1) to recurrence (Every 6 months for 3 years, then yearly for year 4-5).
Change in number of participants with local recurrence
Time frame: From cemiplimab with chemotherapy and cemiplimab with SBRT treatment start date (Day 1) to recurrence (Every 6 months for 3 years, then yearly for year 4-5).
Change from baseline in health-related quality of life, as measured by the European Organization for Research and Treatment of Cancer-Core Quality of Life Questionnaire (EORTC QLQ-C30)
Time frame: From baseline (Day 1), Post Treatment (Weeks 9-10), to 6 months post operatively.
Change from baseline in health-related quality of life, as measured by the European Organization for Research and Treatment of Cancer-Core Quality of Life Questionnaire (EORTC QLQ-LC13)
Time frame: Baseline (Day 1), Post Treatment (Weeks 9-10), to 6 months post operatively.
Event Free Survival (EFS) in months
Time frame: From randomization (day 1) up to 2 years.
Number of days spent in the ICU (Intensive care unit)
Time frame: From the time of admission (Week 9-13) to the ICU (approximately 1 day after surgical resection) to discharge (approximately 2-5 days after surgical resection)
Number of participants with surgical adverse events as assessed by CTCAE v5.0
Time frame: From the time of surgical resection (Weeks 9-13) until hospital discharge, approximately 2-5 days after surgical resection.
Number of days spent in the hospital
Time frame: From the date of surgery (Weeks 9-13) to discharge from the hospital (approximately 2-5 days after surgical resection)
Number of participants with negative surgical resection margins (R-0)
Time frame: Time of surgical resection (Weeks 9-13), after the last preoperative dose of cemiplimab.
Progression Free Survival (PFS) in months
Time frame: From randomization (day 1) up to 2 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nasser K Altorki, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cemiplimab, Platinum based chemotherapy and Stereotactic body radiation therapy in people with Carcinoma, Non-Small-Cell Lung, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julissa Murillo (2127463328, jum4020@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with pathological complete response (pCR) (time frame: Surgical resection (Weeks 9-13).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.