Thoracic Radiotherapy and Inhibition of PD-1 and LAG-3 for Locally Advanced Non-Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMontefiore Medical Center
About this trial
Determine anti-tumor efficacy by characterizing response rates on positron emission tomography (PET) following three cycles of induction immunotherapy with cemiplimab and fianlimab without chemotherapy for locally advanced non-small cell lung cancer (LA-NSCLC).
Eligibility criteria
Qualifiers
Previously untreated and biopsy-proven NSCLC, with measurable disease (at least 1 unidimensional, radiographically measurable lesion based on RECIST v1.1) and one of the following stages: (prior resection or stereotactic radiotherapy for early-stage disease is allowed)
AJCC version 8 Stage II disease, medically or technically unresectable
AJCC version 8 Stage III disease, eligible for non-surgical treatment
Determination of PD-L1 expression on pretreatment tumor specimen using a clinically validated assay
Disqualifiers
Not a woman of childbearing potential (WOCBP) as defined in the Appendix
A WOCBP who agrees to follow the contraceptive guidance in the Appendix during the treatment period and for at least 6 months (180 days) after the last dose of study treatment with cemiplimab and fianlimab
A WOCBP who agrees to follow the contraceptive guidance in the Appendix and for at least 6 months after the last dose of chemotherapy or as specified in FDA prescribing labels (e.g. 14 months after the last dose of cisplatin)
A male participant must agree to use contraception during the treatment period and for at least 6 months after the last dose of study treatment and refrain from donating sperm during this period
Trial design
Treatments tested in this trial
- Cemiplimab
- Fianlimab
- Radiotherapy
- Platinum Doublet Chemotherapy (PDC)
Treatment groups
76 Participants
are divided into 2 treatment groupsSponsors and collaborators
Montefiore Medical Center
Lead sponsor
Regeneron Pharmaceuticals
Collaborator
Henry Ford Health System
Collaborator
NYU Langone Health
Collaborator
University of Michigan
Collaborator
Source ClinicalTrials.gov