Thoracic Radiotherapy and Immunotherapy for Locally Advanced Lung Cancer
This study is testing a new approach for locally advanced non-small cell lung cancer (NSCLC). It combines radiation therapy (thoracic radiotherapy) with two immunotherapy drugs: cemiplimab and fianlimab. Cemiplimab is an anti-PD-1 drug, and fianlimab is an anti-LAG-3 drug. These immunotherapies work by helping your immune system better fight cancer cells. The study aims to see how well this combination shrinks tumors. You may be able to join if you have previously untreated, biopsy-proven NSCLC that is locally advanced (Stage II or III and unresectable). The study is looking for 76 participants, but its current status is unclear.
- Study design
- This is an interventional study with a planned enrollment of 76 participants. The phase of the study is not specified.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary goal is to measure how well tumors respond to the immunotherapy after about 10 weeks (following 3 cycles of treatment).
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06865339
Thoracic Radiotherapy and Inhibition of PD-1 and LAG-3 for Locally Advanced Non-Small Cell Lung Cancer
Recruiting
PHASE2Ages 18+InterventionalTreatmentMontefiore Medical CenterInvestigator-initiated
~76 participants
Updated 2026-04-13 on ClinicalTrials.gov
What's tested:CemiplimabFianlimabRadiotherapyPlatinum Doublet Chemotherapy (PDC)
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective Response Rate (ORR) to induction IO therapy
Measured over Following 3 cycles (each cycle is ~3 weeks) of induction IO therapy, approximately 10 weeks overall
Conditions
Where it's being run
1 sites across 1 statesNew York1
Study leadership
- Nitin Ohri, MD, MS · PRINCIPAL_INVESTIGATOR · Albert Einstein College of Medicine
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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))
Exclusion
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
Presence of known sensitizing epidermal growth factor (EGFR) mutation or anaplastic lymphoma kinase (ALK) fusion
Prior therapy with an anti-PD-1, anti-PD-L1, or LAG-3 inhibitor
Patient currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment
Active malignancy other than lung cancer that (1) requires active treatment other than hormonal therapy and (2) is deemed by the treating physicians to be likely to affect the patient's life expectancy
A history of (non-infectious) pneumonitis that required steroids or current pneumonitis
Known history of myocarditis
Troponin T (TnT) or troponin I (TnI) \> 2x institutional ULN at baseline. Patients with TnT or TnI levels between \> 1 to 2x ULN are permitted if repeat levels within 24 hours are ≤ 1x ULN. If TnT or TnI levels are \> 1 to 2x ULN within 24 hours, the subject may undergo a cardiac evaluation and be considered for treatment by the investigator based on the medical judgement in the patient's best interest
Known active Bacillus Tuberculosis (TB)
Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Pregnancy, assessed with urine pregnancy test within 72 hours prior to study treatment allocation. If urine pregnancy test is positive or cannot be confirmed as negative, a serum pregnancy test is required. If more than 72 hours elapse between screening pregnancy test and the first dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative
Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents. The following are non-exclusionary: vitiligo, childhood asthma that has resolved, residual hypothyroidism that requires only hormone replacement, psoriasis not requiring systemic treatment
History or current evidence of significant (CTCAE grade ≥2) local or systemic infection (e.g., cellulitis, pneumonia, septicemia) requiring systemic antibiotic treatment within 2 weeks prior to the first dose of trial medication
Active infection requiring therapy
Uncontrolled infection with HIV, Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection
Patients with known HIV who have controlled infection (undetectable viral load and CD4 count above 350 either spontaneously or on a stable antiviral regimen) are permitted. For patients with controlled HIV infection, monitoring will be performed per local standards
Patients with known hepatitis B (HepBsAg+) who have controlled infection (serum hepatitis B virus DNA PCR that is below the limit of detection AND receiving anti-viral therapy for hepatitis B) are permitted. Patients with controlled infections must undergo periodic monitoring of HBV DNA per local standards and must remain on anti-viral therapy for at least 6 months beyond the last dose of investigational study drug
Patients who are known hepatitis C virus antibody positive (HCV Ab+) who have controlled infection (undetectable HCV RNA by polymerase chain reaction (PCR) either spontaneously or in response to a successful prior course of anti-HCV therapy) are permitted
Patients with HIV or hepatitis must be reviewed by a qualified specialist (e.g., infectious disease or hepatologist) managing this disease prior to commencing and regularly throughout the duration of their participation in the trial
Diagnosis of immunodeficiency or ongoing chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug
Known hypersensitivity to the active substances or to any of the excipients
Received a live vaccine within 30 days of planned start of study medication o Live or live attenuated vaccination with replicating potential. If a patient intends to receive a COVID-19 vaccine before the start of study drug, participation in the study should be delayed at least 1 week after any COVID-19 vaccination. During the treatment period, it is recommended to delay COVID-19 vaccination until patients are receiving and tolerating a steady dose of study drug. A vaccine dose should not be less than 48 hours before or after study drug dosing
What this trial measures
- Objective Response Rate (ORR) to induction IO therapyFollowing 3 cycles (each cycle is ~3 weeks) of induction IO therapy, approximately 10 weeks overall
ORR to induction therapy will be evaluated by fluorodeoxyglucose (FDG) FDG-PET scan using Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST) criteria. Pre-and post-treatment maximum standardized uptake value (SUV) levels following PERCIST criteria will be assessed. Specifically, the percentage of patients who experience either a complete metabolic response (CMR) or partial metabolic response (PMR) based on changes in FDG uptake will be determined and quantified using the following calculation (PMR+CMR/Sample Size). All participants who initiate study therapy will be analyzed for ORR. Participants who do not undergo response rate evaluation for any reason will be categorized as non-responders. Response rates in each study cohort will be summarized and reported using counts and percentages. 95% Clopper-Pearson confidence intervals will be calculated. ORR based on PET are more accurate predictors of long-term clinical outcomes than computed tomography (CT).