Actively Recruiting
Thoracic Radiotherapy and Inhibition of PD-1 and LAG-3 for Locally Advanced Non-Small Cell Lung Cancer
Led by Montefiore Medical Center · Updated on 2026-04-13
76
Participants Needed
1
Research Sites
103 weeks
Total Duration
On this page
Sponsors
M
Montefiore Medical Center
Lead Sponsor
R
Regeneron Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Thoracic Radiotherapy and Inhibition of PD-1 and LAG-3 for Locally Advanced Non-Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Previously untreated and biopsy-proven non-small cell lung cancer (NSCLC) with measurable disease
- AJCC version 8 Stage II disease that is medically or technically unresectable, or Stage III disease eligible for non-surgical treatment
- PD-L1 expression determined on pretreatment tumor specimen using a validated assay
- Eligible for standard nonsurgical treatment including chemotherapy and radiotherapy followed by adjuvant durvalumab
- Whole body PET/CT within 42 days before study entry showing hypermetabolic pulmonary lesion(s) and/or thoracic lymph node(s)
- MRI of the brain or head CT with contrast within 42 days before study entry
- Pulmonary function tests within 42 days of study entry
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Adequate organ function as assessed by hemoglobin, neutrophil count, platelet count, liver enzymes, and creatinine clearance within specified limits
- Female participants must not be pregnant or breastfeeding and must meet contraception requirements if of childbearing potential
- Male participants must agree to use contraception during treatment and for 6 months after last study dose
- Written informed consent provided
You will not qualify if you...
- Known sensitizing EGFR mutation or ALK fusion (testing required for non-squamous histologies)
- Prior therapy with anti-PD-1, anti-PD-L1, or LAG-3 inhibitors
- Participation in another investigational study or use of investigational device within 4 weeks prior to study treatment
- Active malignancy other than lung cancer requiring treatment likely to affect life expectancy
- History of pneumonitis requiring steroids or current pneumonitis
- Known history of myocarditis
- Troponin T or I levels greater than two times institutional upper limit of normal at baseline
- Active tuberculosis infection
- Psychiatric or substance abuse disorders interfering with trial cooperation
- Pregnancy confirmed by urine or serum test
- Recent or ongoing autoimmune disease requiring systemic immunosuppressive treatment (with some exceptions)
- Recent significant infection requiring systemic antibiotics within 2 weeks before study treatment
- Active infection requiring therapy
- Uncontrolled HIV, hepatitis B or C infections, or immunodeficiency conditions
- Ongoing chronic systemic steroid or immunosuppressive therapy exceeding specified doses
- Known hypersensitivity to study drugs or their excipients
- Receipt of live vaccine within 30 days before planned study medication start
- COVID-19 vaccination timing restrictions relative to study drug dosing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Montefiore Einstein Comprehensive Cancer Center (MECCC)
The Bronx, New York, United States, 10461
Actively Recruiting
Research Team
N
Nitin Ohri, MD, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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