Clinical Trials List
2018-09-01 - 2019-05-20
Phase III
Not yet recruiting10
ICD-9162.9
Malignant neoplasm of bronchus and lung, unspecified
A Randomized, Phase 3, Open-Label Study of Combinations of REGN2810 (Anti-PD-1 Antibody), Ipilimumab (Anti-CTLA-4 Antibody) and Platinum-Based Doublet Chemotherapy in First-Line Treatment of Patients with Advanced or Metastatic Non-Small Cell Lung Cancer With Tumors Expressing PD-L1
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Trial Applicant
ICON Clinical Research Pte Ltd
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Sponsor
Regeneron Pharmaceuticals, Inc.
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- HsingJin Eugene Liu Division of Hematology & Oncology
- Chih-Ming Chou Division of Hematology & Oncology
- Yu-Tien Tzeng Division of Thoracic Medicine
- 方嘉郎 Division of Others
- Han-Lin Hsu Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Audit
None
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- YEN-HAN TSENG Division of Thoracic Medicine
- Tzu-Tao Chen Division of Thoracic Medicine
- Ching-Shan Luo Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Audit
CRO
Co-Principal Investigator
Audit
CRO
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Inclution Criteria
2. Patients with histologically or cytologically documented squamous or non squamous NSCLC with stage IIIB disease who are not candidates for treatment with definitive concurrent chemoradiation or patients with stage IV disease if they have not received prior systemic treatment for recurrent or metastatic NSCLC
• Patients who received adjuvant or neoadjuvant platinum based doublet chemotherapy (after surgery and/or radiation therapy) and developed recurrent or metastatic disease more than 6 months after completing therapy.
3. Availability of an archival (≤5 months) or on-study obtained formalin-fixed, paraffin-embedded tumor tissue sample from a metastatic/recurrent site, which has not previously been irradiated.
4. Expression of PD L1 in <50% of tumor cells determined by the commercially available PD-L1 IHC 22C3 pharmDx assay performed by the central laboratory.
5. At least 1 radiographically measureable lesion by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST 1.1 criteria. Target lesions may be located in a previously irradiated field if there is documented (radiographic) disease progression in that site.
6. ECOG performance status of ≤1.
7. Anticipated life expectancy of at least 3 months.
8. Adequate organ and bone marrow function as defined below:
a. Hemoglobin ≥10.0 g/dL
b. Absolute neutrophil count ≥1.5 × 109/L
c. Platelet count ≥100,000/mm3
d. Glomerular filtration rate (GFR) >30 mL/min/1.73m2
e. Total bilirubin ≤1.5 × upper limit of normal (ULN) (if liver metastases ≤3 × ULN), with the exception of patients diagnosed with clinically confirmed Gilbert’s syndrome
f. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 × ULN or ≤5 × ULN, if liver metastases
g. Alkaline phosphatase ≤2.5 × ULN (or ≤5.0 × ULN, if liver or bone metastases)
h. Not meeting criteria for Hy’s law (ALT >3 × ULN and bilirubin >2 × ULN).
9. Willing and able to comply with clinic visits and study-related procedures.
10. Provide signed informed consent.
11. Able to understand and complete study-related questionnaires
Exclusion Criteria
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 criteria 7) 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.
4. Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent.
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 ≥6months prior to enrollment.
6. Ongoing or recent evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk of immune-related treatment-emergent adverse events (irTEAEs). The following are not exclusionary: vitiligo, childhood asthma that has resolved, residual hypothyroidism that required only hormone replacement or psoriasis that does not require systemic treatment.
7. Patients with a condition requiring corticosteroid therapy (>10 mg prednisone/day or equivalent) within 14 days of randomization. Physiologic replacement doses are allowed even if they are >10 mg of prednisone/day or equivalent, as long as they are not being administered for immunosuppressive intent. Inhaled or topical steroids are permitted, provided that they are not for treatment of an autoimmune disorder.
8. Previous treatment with idelalisib at any time (ZYDELIG®).
9. Another malignancy that is progressing or requires treatment, with the exception of nonmelanomatous skin cancer that has undergone potentially curative therapy, in situ cervical carcinoma, or any other localized tumor that has been treated, and the patient is deemed to be in complete remission for at least 2 years prior to study entry, and no additional therapy is required during the study period.
10. Known active hepatitis B (known positive result) or hepatitis C (known positive result) and known quantitative HCV RNA results greater than the lower limits of detection of the assay).
11. Known history of human immunodeficiency virus or known acquired immunodeficiency syndrome indicating uncontrolled active infection. Patients on highly active antiretroviral therapy with undetectable RNA levels and CD4 counts above 350 are permitted.
12. Active infection requiring systemic therapy within 14 days prior to randomization.
13. Prior therapy with anti-PD 1 or anti-PD L1. Prior exposure to other immunomodulatory or vaccine therapies such as anti-CTLA-4 antibodies is permitted, but the last dose of such an antibody should have been at least 6 months prior to the first dose of study drug.
The Estimated Number of Participants
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Taiwan
36 participants
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Global
690 participants
