RECRUITING

Preoperative Radioimmunotherapy Versus Chemoimmunotherapy in NSCLC

Conditions

Carcinoma, Non-Small-Cell Lung Lung neoplasms Bronchial Neoplasms Carcinoma, bronchogenic Neoplasms

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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. Cemiplimab with chemotherapy (Arm A) every 3 weeks for up to 3 doses, OR 2. 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.

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

Quick Facts

Study Start:2025-02-21

Study Completion:2032-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06623656

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Patients with histologically or cytologically proven clinical stages IB, II, and III(N2) NSCLC (according to AJCC version 8) eligible for surgical resection with curative intent. Patients with 2 synchronous NSCLC are allowed. 2. Measurable disease, as defined by RECIST v1.1. 3. Known PD-L1 expression. 4. No known EGFR mutations or ALK fusions. 5. Written informed consent and HIPAA obtained from the subject prior to performing any protocol-related procedures. 6. Age \> 18 years at time of study entry. 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 8. No prior therapy for lung cancer 9. 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 10. WOCBP\* must have a negative serum (beta-hCG) at screening. 1. \*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. 2. Male study patients with WOCBP partners are required to use condoms unless they are vasectomized or practice sexual abstinence. 3. Vasectomized partner or vasectomized study patient must have received medical assessment of the surgical success. 4. 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. 11. 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. 12. All men must agree not to donate sperm during the trial and for 6 months after receiving the last therapy dose.	1. 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 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). 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 hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement * Any chronic skin condition that does not require systemic therapy 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. 7. Prior allogeneic stem cell transplant or solid organ transplant. 8. Known HIV, active hepatitis B or C. 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: 1. 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 2. IUD; IUS 3. bilateral tubal ligation (occlusion) 4. 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 5. 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 and for women who are post-menopausal or with documented permanent sterilization. 11. Adjuvant hormonotherapy used for breast cancer or other hormone-sensitive cancers in long term remission is allowed.

Inclusion Criteria

Exclusion Criteria

1. Patients with histologically or cytologically proven clinical stages IB, II, and III(N2) NSCLC (according to AJCC version 8) eligible for surgical resection with curative intent. Patients with 2 synchronous NSCLC are allowed.
2. Measurable disease, as defined by RECIST v1.1.
3. Known PD-L1 expression.
4. No known EGFR mutations or ALK fusions.
5. Written informed consent and HIPAA obtained from the subject prior to performing any protocol-related procedures.
6. Age \> 18 years at time of study entry.
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
8. No prior therapy for lung cancer
9. 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
10. WOCBP\* must have a negative serum (beta-hCG) at screening.
1. \*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.
2. Male study patients with WOCBP partners are required to use condoms unless they are vasectomized or practice sexual abstinence.
3. Vasectomized partner or vasectomized study patient must have received medical assessment of the surgical success.
4. 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.
11. 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.
12. All men must agree not to donate sperm during the trial and for 6 months after receiving the last therapy dose.

1. 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
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).
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 hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
* Any chronic skin condition that does not require systemic therapy
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.
7. Prior allogeneic stem cell transplant or solid organ transplant.
8. Known HIV, active hepatitis B or C.
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:
1. 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
2. IUD; IUS
3. bilateral tubal ligation (occlusion)
4. 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
5. 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 and for women who are post-menopausal or with documented permanent sterilization.
11. Adjuvant hormonotherapy used for breast cancer or other hormone-sensitive cancers in long term remission is allowed.

Contacts and Locations

Study Contact

Julissa Murillo

CONTACT

2127463328

jum4020@med.cornell.edu

Julia Muuse

CONTACT

212-746-4528

jum4029@med.cornell.edu

Principal Investigator

Nasser K Altorki, MD

PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Study Locations (Sites)

Weill Cornell Medicine

New York, New York, 10065

United States

Collaborators and Investigators

Sponsor: Weill Medical College of Cornell University

Nasser K Altorki, MD, PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-21

Study Completion Date2032-01

Study Record Updates

Study Start Date2025-02-21

Study Completion Date2032-01

Terms related to this study

Keywords Provided by Researchers

Lung neoplasms
Bronchial Neoplasms
Carcinoma, bronchogenic
Neoplasms

Additional Relevant MeSH Terms

Carcinoma, Non-Small-Cell Lung