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 groupsLocations
1Montefiore Einstein Comprehensive Cancer Center (MECCC)10461, The BronxNew York, United States
Sponsors 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