Status and phase
Conditions
Treatments
About
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:
Four to 12 weeks following surgery, participants in both Arm A and Arm B will receive treatment with cemiplimab for one year.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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.
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.
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:
WOCBP* must have a negative serum (beta-hCG) at screening.
*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.
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.
Exclusion criteria
History of another primary malignancy except for:
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).
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:
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.
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.
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.
Prior allogeneic stem cell transplant or solid organ transplant.
Known HIV, active hepatitis B or C.
Female patients who are pregnant or breastfeeding.
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:
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
Adjuvant hormonotherapy used for breast cancer or other hormone-sensitive cancers in long term remission is allowed.
Primary purpose
Allocation
Interventional model
Masking
112 participants in 2 patient groups
Loading...
Central trial contact
Cathy Spinelli, RN BSN; Julissa Murillo
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal