[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07720167":3,"trial-entities:NCT07720167":98,"trial-summary:NCT07720167":102},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":43,"secondary_outcomes":48,"sex":64,"minimum_age":65,"maximum_age":66,"healthy_volunteers":67,"eligibility_criteria":68,"std_ages":74,"locations":77,"central_contacts":93,"overall_officials":95,"references":96,"see_also_links":97},"NCT07720167","104130","Cemiplimab for Clinical Stage I, 2-3.9cm, Non-Small Cell Lung Cancer","Neoadjuvant Chemo-Cemiplimab for Clinical Stage I, 2-3.9cm, Non-Small Cell Lung Cancer","NOT_YET_RECRUITING","2030-11-01","2026-07","2026-07-22","2026-11-01","Medical University of South Carolina","OTHER",true,"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.",null,[19],"Non-Small Cell Lung Cancer",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE2",{"count":26,"type":27},38,"ESTIMATED",[29,35,39],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DRUG","Cemiplimab","administered at a dose of 350 mg as an intravenous infusion over 30 minutes",[34],"Cemiplimab+Investigator's choice platinum doublet for clinical stage 1, 2-3.9cm, NSCLC",{"type":30,"name":36,"description":37,"armGroupLabels":38},"Carboplatin + Pemetrexed\u002FPaclitaxel","every 21 days for three cycles if not using cisplatin",[34],{"type":30,"name":40,"description":41,"armGroupLabels":42},"Cisplatin","every 21 days for three cycles if not using carboplatin and pemetrexed\u002Fpaclitaxel",[34],[44],{"measure":45,"description":46,"timeFrame":47},"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",[49,52,55,58,61],{"measure":50,"description":51,"timeFrame":47},"Frequency and grade of adverse events and serious adverse events","based on CTCAE v5.0",{"measure":53,"description":54,"timeFrame":47},"Relapse-free survival","defined as the time interval from date of surgery until disease recurrence or death due to any cause.",{"measure":56,"description":57,"timeFrame":47},"Overall survival","defined as the time interval from C1D1 of treatment with the investigational intervention to death due to any cause.",{"measure":59,"description":60,"timeFrame":47},"frequency and percentage surgical margin status based on residual (R) tumor classification (R0, R1, R2)","will be summarized by the frequency and percentage of patients classified as R0, R1, and R2 based on residual tumor classification",{"measure":62,"description":63,"timeFrame":47},"frequencies and percentages of delayed or cancelled surgeries","Number and proportion of delayed or cancelled surgeries","ALL","18 Years","80 Years",false,{"inclusion":69,"exclusion":70,"raw_text":73},[],[71,72],"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.","Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea method are not acceptable methods of contraception. Female condom and male condom should not be used together.","Inclusion Criteria:\n\n1. Participants must have histologically proven NSCLC, clinically staged cT1c or T2a, clinically node-negative (no bronchoscopy is required for screening) using AJCC 9th Edition.\n2. Participants must have an SUVmax \\>6.2 on standard of care staging PET scan, and\u002For biopsy histology must be consistent with moderate\u002Fpoorly\u002For undifferentiated NSCLC.\n3. 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%.\n4. Participants must be deemed a surgical candidate with adequate organ function, documented in the electronic medical record (EMR).\n5. Participants must have ECOG Performance status 0-1.\n6. 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.\n7. Participants must be aged \\>18 years old.\n\nExclusion Criteria:\n\n1. Participants must have no known ALK driver mutations\n2. Participants must have no known EGFR mutations.\n3. 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.\n4. 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).\n5. 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.\n6. Participants must not have history of symptomatic interstitial lung disease.\n7. 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.\n8. Participants must not have previous history of bone marrow transplant.\n9. Participants must not have a known allergy, or history of allergy or hypersensitivity to study drug or any of the excipients.\n10. Presence of cardiovascular disease, as defined by:\n\n    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.\n11. Any condition that requires ongoing\u002Fcontinuous corticosteroid or immunosuppressive therapy (\\>10 mg prednisone\u002Fday 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.\n12. Any infection requiring hospitalization or treatment with IV anti-infectives within 2 weeks of first dose of study medication.\n13. Known infection with HIV, hepatitis B or hepatitis C infection, diagnosis of immunodeficiency, and\u002For tuberculosis (active or latent).\n14. Exclusions relating to vaccines:\n\n    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.\n15. Exclusions and information relating to pregnancy\u002Fcontraception:\n\n    1. WOCBP\\* and men\\*\\* who are unwilling to practice highly effective contraception prior to the initial dose\u002Fstart of the first treatment, during the study, and for at least 6 months after the last dose. Highly effective contraceptive measures include:\n\n    i. 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; ii. Intrauterine device; intrauterine hormone-releasing system; iii. Bilateral tubal occlusion\u002Fligation; iv. Vasectomized partner (provided that the male vasectomized partner is the sole sexual partner of the WOCBP study participant and that the vasectomized partner has obtained medical assessment of surgical success for the procedure); and\u002For v. Sexual abstinence†,‡.\n\n    Note: Pregnancy testing and contraception are required for WOCBP. Pregnancy testing and contraception are not required for women who are postmenopausal or permanently sterile.\n    * 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.\n\n    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 with documented hysterectomy or tubal ligation.\n\n    \\*\\*Male participants: A male participant 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\u002Fstart of study medication, during the study, and for at least 6 months after the last dose. Sperm donation is also prohibited during the same period. Vasectomy success must be confirmed by semen analysis.\n\n    †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 drugs. 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 participant.\n    * Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea method are not acceptable methods of contraception. Female condom and male condom should not be used together.",[75,76],"ADULT","OLDER_ADULT",[78],{"facility":79,"city":80,"state":81,"zip":82,"country":83,"contacts":84,"geoPoint":90},"Medical University of South Carolina Hollings Cancer Center","Charleston","South Carolina","29425","United States",[85],{"name":86,"role":87,"phone":88,"email":89},"HCC Clinical Trials Office","CONTACT","843-792-9321","hcc-clinical-trials@musc.edu",{"lat":91,"lon":92},32.77632,-79.93275,[94],{"name":86,"role":87,"phone":88,"email":89},[],[],[],{"nct_id":4,"conditions":99,"biomarkers":101},[100],"Lung Non-Small Cell Carcinoma",[],{"nct_id":4,"found":15,"summary":103,"prompt_version":113},{"design":104,"status":105,"heading":106,"summary":107,"follow_up":108,"word_count":109,"commitments":110,"compensation":111,"drugs_mentioned":112},"This is an interventional study planning to enroll 38 participants. It will investigate the ability of cemiplimab-chemotherapy to induce pathologic complete responses.","completed","Cemiplimab for Early-Stage Non-Small Cell Lung Cancer","This study is looking into a new way to treat early-stage non-small cell lung cancer (NSCLC) that is 2 to 3.9 centimeters in size. Researchers are testing a drug called cemiplimab along with standard chemotherapy (carboplatin + pemetrexed\u002Fpaclitaxel, or cisplatin). The goal is to see if this combination can completely get rid of the cancer before surgery. You might be able to join if you are between 18 and 80 years old, have NSCLC that meets specific size and other criteria, and have certain markers like PD-1 or PD-L1. The study will measure how many patients have a complete response to treatment over 5.5 years. The current enrollment status is unclear.","Participants will be followed to measure the pathologic complete response rate for 5.5 years.",111,"Participants will receive 3 cycles of cemiplimab and chemotherapy, administered every 21 days as an intravenous infusion.","Not stated in the trial record.",[31,36,40],"v2"]