Thoracic Radiotherapy and Inhibition of PD-1 and LAG-3 for Locally Advanced Non-Small Cell Lung Cancer
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).
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 2 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Apr 13, 2026 · Source: ClinicalTrials.gov
The study is currently accepting participants.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Montefiore Medical Center
- Interventions being studied
- Drug: Cemiplimab; Drug: Fianlimab; Radiation: Radiotherapy; Drug: Platinum Doublet Chemotherapy (PDC)
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
- Eligible for standard nonsurgical treatment for Stage III NSCLC, i.e., chemotherapy and concurrent RT followed by adjuvant durvalumab
- Whole body PET/CT within 42 days prior to study entry demonstrating hypermetabolic pulmonary lesion(s) and/or thoracic lymph node(s)
- MRI of the brain or head CT with contrast within 42 days prior to study entry
- PFTs within 42 days of study entry
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Adequate end-organ function for study therapy, as per clinician assessment and including:
- Hemoglobin ≥ 9.0 g/dL
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L (\> 1500 per mm3)
- Platelet count ≥ 100 x 109/L (\>100,000 per mm3)
- Serum bilirubin ≤ 1.5 x institutional upper limit of normal (ULN). This will not apply to subjects with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician
- AST (SGOT)/ALT (SGPT), and alkaline phosphatase ≤ 2.5 x institutional upper limit of normal (ULN)
- Serum creatinine clearance \>30 mL/min by the Cockcroft-Gault formula (as below) or by 24-hour urine collection for determination of creatinine clearance: (except for patients planned to receive pemetrexed, in which case serum creatinine clearance needs to \>45 ml/min)
- Males: Weight (kg) x (140 - Age) ÷ (72 x serum creatinine (mg/dL))
- Females: 0.85 x Weight (kg) x (140 - Age) ÷ (72 x serum creatinine (mg/dL))
- A female participant is eligible to participate if she is not pregnant (see
- ), not breastfeeding, and at least one of the following conditions applies:
- 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
- The participant (or legally acceptable representative if applicable) provides written informed consent for the trial
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Montefiore Einstein Comprehensive Cancer Center (MECCC)The Bronx, New York
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 13, 2026. Always confirm current availability with the study team.