Preoperative Radioimmunotherapy Versus Chemoimmunotherapy in NSCLC (NCT06623656) | Clinical Trial Compass
RecruitingPhase 2
Preoperative Radioimmunotherapy Versus Chemoimmunotherapy in NSCLC
United States112 participantsStarted 2025-02-21
Plain-language 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. 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
✓. No prior therapy for lung cancer
Exclusion criteria
✕. 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.
What they're measuring
1
Number of participants with pathological complete response (pCR)
Timeframe: Surgical resection (Weeks 9-13).
Trial details
NCT IDNCT06623656
SponsorWeill Medical College of Cornell University
✕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).
✕.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.
✕. 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.