A STUDY OF REGN2810 (ANTI-PD 1 ANTIBODY) VERSUS STANDARD OF CARE IN PATIENTS WITH LUNG CANCER

Phase 1

Conditions: on-Small Cell Lung Cancer
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2016-004407-31-GR

Lead Sponsor: Regeneron Pharmaceuticals, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 700

Inclusion Criteria

1.Men and women =18 years of age (=20 years of age in Japan)
2.Patients with histologically or cytologically documented squamous or non squamous NSCLC with stage IIIB or stage IIIC disease who are not
candidates for treatment with definitive concurrent chemoradiation or
patients with stage IV disease who received no prior systemic treatment for recurrent or metastatic NSCLC
a.Patients who received adjuvant or neoadjuvant platinum-doublet chemotherapy (after surgery and/or radiation therapy) and developed recurrent or metastatic disease more than 6 months after completing therapy are eligible
3.Archival or newly obtained formalin-fixed tumor tissue from a metastatic/recurrent site, which has not previously been irradiated
a.Tissue may be obtained from the primary site if it is still in place and
the other metastatic sites are either not accessible (ie, brain), cannot be used (ie, bone), or the biopsy would put the patient at undue risk.
b.If an archival biopsy is used, it must be less than 5 months old
4.Tumor cells expressing PD L1 in =50% of tumor cells by IHC 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 (see Appendix 4). 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 =9.0 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 490
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 210

Exclusion Criteria

1. Patients that 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 randomization. Patients must be off (immunosuppressive doses of) corticosteroid therapy.
3. Patients with tumors tested positive for EGFR gene mutations, ALK
gene translocations, or ROS1 fusions
4. Encephalitis, meningitis, or uncontrolled seizures in the year prior to randomization
5. History of interstitial lung disease (eg, idiopathic pulmonary fibrosis,
organizing pneumonia) or active, noninfectious pneumonitis that
required immune-suppressive doses of glucocorticoids to assist with
management. A history of radiation pneumonitis in the radiation field is permitted as long as pneumonitis resolved =6 months prior to
randomization.
6. Patients with active, known, or suspected autoimmune disease that
has required systemic therapy in the past 2 years. Patients with vitiligo, type I diabetes mellitus, and hypothyroidism (including hypothyroidism due to autoimmune thyroiditis) only requiring hormone replacement are permitted to be randomized.
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. Another malignancy that is progressing or requires treatment, with
the exception of nonmelanomatous skin cancer that has undergone
potentially curative therapy, or in situ cervical carcinoma or any other
tumor that has been treated, and the patient is deemed to be in
complete remission for at least 2 years prior to randomization, and no
additional therapy is required during the study period.
9. Uncontrolled infection with hepatitis B or hepatitis C or human
immunodeficiency virus; or diagnosis of immunodeficiency
10. Exclusion criterion removed
11. Active infection requiring systemic therapy within 14 days prior to
randomization
12. Prior therapy with anti-PD 1 or anti-PD L1. Prior exposure to other
immunomodulatory or vaccine therapy such as anti-cytotoxic Tlymphocyte- associated antigen 4 (CTLA-4) antibodies is permitted, but the last dose of such an antibody should have been at least 3 months prior to the first dose of study drug.
13. Treatment-related immune-mediated AEs from immune-modulatory agents (including but not limited to anti-PD1/PD-L1 mAbs, anti-CTLA4 mAbs, and phosphoinositol 3-kinase [PI 3-K]-d inhibitors) that have not resolved to baseline at least 3 months prior to initiation of treatment with study therapy. Patients are excluded from treatment with cemiplimab if they experienced immune-mediated AEs related to prior treatment with a blocker of the PD-1/PD-L1 pathway that were grade 3 or 4 in severity and/or required discontinuation of the agent, regardless of time of occurrence.
14. Receipt of an investigational drug or device within 30 days of
screening or within 5 half lives of the investigational drug (whichever is longer)
15. Receipt of a live vaccine within 30 days of planned star

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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