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Clinical Trials List

Protocol NumberR2810-ONC-2045
Completed

2024-08-01 - 2028-11-05

Phase II

Recruiting5

ICD-10C33

Malignant neoplasm of trachea

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.0

Malignant neoplasm of trachea

A Phase 2 Study of Cemiplimab (Anti-PD-1 Antibody) in Combination with BNT116 (FixVac Lung) versus Cemiplimab Monotherapy in First-Line Treatment of Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) with Tumors Expressing PD-L1 ≥50%

  • Trial Applicant

    ICON Clinical Research Pte Ltd

  • Sponsor

    Regeneron Pharmaceuticals, Inc.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Jen-Yu Hung Division of Thoracic Medicine
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 夏和雄 無
Taipei Tzu Chi Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator JIN-YUAN SHIH Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 葉人華 無
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator kang-Yun LEE
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Advanced Non-Small Cell Lung Cancer (NSCLC)

Objectives

• To assess the ORR per blinded IRC (BIRC) of combination of cemiplimab and BNT116 and cemiplimab monotherapy in the first-line treatment of patients with advanced NSCLC whose tumors express PD-L1 in ≥50% of tumor cells.

Test Drug

Solution

Active Ingredient

cemiplimab
BNT116

Dosage Form

970
970

Dosage

50 mg/mL
0.05 mg/mL

Endpoints

• ORR as assessed by BIRC using RECIST 1.1, up to 136 weeks from randomization.
ORR is defined as proportion of patients with a best overall response of confirmed
CR or PR.

Inclution Criteria

A patient must meet the following criteria to be eligible for inclusion in the study:
1. Men and women ≥18 years of age (or the legal age of adults to consent to participate in a
clinical study per country-specific regulations)
2. Patients with non-squamous or squamous histology NSCLC with stage IIIB or stage IIIC
disease who are not candidates for surgical resection or definitive chemoradiation per
investigator assessment, or stage IV (metastatic) disease who received no prior systemic
treatment for recurrent or metastatic NSCLC.
3. Availability of an archival or on-study obtained formalin-fixed, paraffin-embedded tumor
tissue sample.
Guidance on biopsy sites:
a. Archival or fresh biopsies are acceptable
b. Formalin-fixed, paraffin-embedded tissue block will be accepted without time
restriction; however unstained slides of tumor sample (archival or recent)
must be ≤10 months old for PD-L1 testing. If ALK, ROS or EGFR testing is
also needed then slides must be no more than 2 weeks old.
c. The biopsy should be from a metastatic or recurrent site which has not
previously been irradiated.
• Exception: the primary lung tumor can be used if it is still in place and
the other metastatic sites are either not accessible (brain) or cannot be
used (bone) or the biopsy would put the patient at risk
4. Expression of PD-L1 levels ≥ 50%, as determined by a locally accredited laboratory and
tested according to local regulations. If PD-L1 IHC results are not available prior to the
time the patient provides informed consent, PD-L1 IHC results will be obtained during
screening using the VENTANA PD-L1 (SP263) assay in a central laboratory designated
by the sponsor. If local results were obtained for screening, a tissue sample will be
requested to be sent for confirmatory central analysis.

Exclusion Criteria

1. Patients who have never smoked, defined as smoking ≤100 cigarettes in a lifetime.
2. Active or untreated brain metastases or spinal cord compression. Patients are eligible if
central nervous system (CNS) metastases are adequately treated, and patients have
neurologically returned to baseline (except for residual signs or symptoms related to the
CNS treatment) for at least 2 weeks prior to enrollment. Patients must be off
(immunosuppressive doses of) corticosteroid therapy (see exclusion criterion #9 for details
on timing of discontinuation of steroids).
3. Patients with tumors tested positive for EGFR gene mutations, ALK gene translocations,
or ROS1 fusions. All patients will have tumor evaluated for EGFR mutations, ALK
rearrangement, and ROS1 fusions confirmed by a central laboratory when local laboratory
results are not available.
4. Encephalitis, meningitis, or uncontrolled seizures in the year prior to enrollment.
5. History of interstitial lung disease (eg, idiopathic pulmonary fibrosis or organizing
pneumonia), of active, noninfectious pneumonitis that required immune-suppressive doses
of glucocorticoids to assist with management, or of pneumonitis within the last 5 years. A
history of radiation pneumonitis in the radiation field is permitted as long as pneumonitis
resolved ≥6 months prior to enrollment.

The Estimated Number of Participants

  • Taiwan

    4 participants

  • Global

    100 participants

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