A study of REGN2810 (Cemiplimab,Anti-PD-1 Antibody), Ipilimumab (Anti-CTLA-4 Antibody), and Platinum-based Doublet Chemotherapy versus pembrolizumab in patients with lung cancer

• Register: EUCTR
• Last refreshed on: 8 October 2021
• Main ID: EUCTR2017-001041-27-LT
• Date of registration: 17/04/2018
• Prospective Registration: Yes
• Primary sponsor: Regeneron Pharmaceuticals, Inc.
• Public title: A study of REGN2810 (Cemiplimab,Anti-PD-1 Antibody), Ipilimumab (Anti-CTLA-4 Antibody), and Platinum-based Doublet Chemotherapy versus pembrolizumab in patients with lung cancer
• Scientific title: A Randomized, Phase 3, Open-Label Study of Combinations of REGN2810 (Cemiplimab, Anti-PD-1 Antibody), Platinum based Doublet Chemotherapy, and Ipilimumab (Anti-CTLA-4 Antibody) Versus Pembrolizumab Monotherapy in First-Line Treatment of Patients With Advanced or Metastatic Non-Small Cell Lung Cancer With Tumors Expressing PD-L1 =50%
• Date of first enrolment: 24/05/2018
• Target sample size: 585
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-001041-27
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: yes; Single blind: no; Double blind: no; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: no; Other: no; Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Austria, Belgium, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Ireland, Israel, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Netherlands, New Zealand, Serbia, Slovakia, South Africa, Sweden, Switzerland, United Kingdom, United States

Contacts

• Name: Clinical Trial Information
• Affiliation: Regeneron Pharmaceuticals, Inc.

• Name: Clinical Trial Information
• Affiliation: Regeneron Pharmaceuticals, Inc.

Key inclusion & exclusion criteria

Inclusion criteria:
1. Men and women =18 years of age.
2. Patients with histologically or cytologically documented squamous or non-squamous NSCLC with stage IIIB, or IIIC disease who are not candidates for treatment with definitive concurrent chemo/radiation or patients with stage IV disease if they have not received prior systemic treatment for recurrent or metastatic NSCLC. The histologic diagnosis of NSCLC may be confirmed by the central laboratory.
3. Availability of an archival or on-study obtained formalin-fixed, paraffin embedded tumor tissue sample
4. Expression of PD L1 in =50% of tumor cells determined by a commercially available assay.
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.

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 410
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 175

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 7 for details on timing of discontinuation of corticosteroid therapy).
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.
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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Cancer [C04]

Non-Small Cell Lung Cancer

Intervention(s)

Product Name: cemiplimab
Product Code: REGN2810
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: cemiplimab
Other descriptive name: REGN2810
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 350-

Product Name: Carboplatin
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: carboplatin
Other descriptive name: CARBOPLATIN
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-

Product Name: Cisplatin
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: CISPLATIN
Current Sponsor code: Cisplatin
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 1-

Product Name: PACLITAXEL
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: PACLITAXEL
CAS Number: 33069-62-4
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 6-

Product Name: Armisarte (Pemetrexed)
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: PEMETREXED
CAS Number: 137281-23-3
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-

Trade Name: Yervoy
Product Name: ipilimumab
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: IPILIMUMAB
Other descriptive name: ipilimumab
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-

Trade Name: Keytruda
Product Name: pembrolizumab
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: PEMBROLIZUMAB
Other descriptive name: PEMBROLIZUMAB
Concentration unit: mg/l milligram(s)/litre
Concentration type: equal
Concentration numb

Primary Outcome(s)

Primary end point(s): The primary endpoint is PFS as assessed by a blinded Independent Review Committee (IRC) based on RECIST (Response assessment in solid tumours) 1.1 assessments.

Secondary Objective: The key secondary objectives of the study are the following:
•To compare the overall survival (OS) of cemiplimab/ipi and cemiplimab/chemo/ipi with pembrolizumab monotherapy in the first line treatment of patients with advanced squamous or non squamous NSCLC whose tumors express PD L1 in =50% of tumor cells
•To compare the objective response rate (ORR) of cemiplimab/ipi and cemiplimab/chemo/ipi with pembrolizumab monotherapy in the first line treatment of patients with advanced squamous or non-squamous NSCLC whose tumors express PD L1 in =50% of tumor cells

Timepoint(s) of evaluation of this end point: Through 108 weeks of treatment plus a follow up period.

Main Objective: The primary objective of the study is to compare the progression-free survival (PFS) of cemiplimab plus ipilimumab combination therapy (hereinafter referred to as cemiplimab/ipi) and cemiplimab plus 2 cycles only of platinum-based doublet chemotherapy plus ipilimumab combination therapy (hereinafter referred to as “cemiplimab/chemo/ipi”) with standard-of-care pembrolizumab monotherapy in the first line treatment of patients with advanced squamous or non-squamous non-small cell lung cancer (NSCLC) whose tumors express programmed death ligand 1 (PD L1) in =50% of tumor cells.

Secondary Outcome(s)

Secondary end point(s): The key secondary endpoints in the study are OS and ORR.

Timepoint(s) of evaluation of this end point: Through 108 weeks of treatment plus a follow up period.

Secondary ID(s)

2017-001041-27-NL

R2810-ONC-16111

Source(s) of Monetary Support

Regeneron Pharmaceuticals, Inc.

Sanofi Aventis

Ethics review

Status: Approved
Approval date: 16/05/2018
Contact: