CEMIPLIMAB for Non-small cell lung cancer

Inclusion criteria

• {"criterion_text":"- Registration phase: Histologic or cytologic confirmation of NSCLC. If small-cell elements present, participant will be ineligible."}
• {"criterion_text":"- Registration phase: Patients of childbearing / reproductive potential should agree to use adequate birth control measures, as defined by the protocol, during the study treatment period and for: • At least 6 months after the last dose of pemetrexed-if pemetrexed was administered. • At least 6 months after the last dose of cemiplimab/placebo."}
• {"criterion_text":"- Registration phase: Women who are breast feeding should discontinue nursing prior to the first dose of study treatment and until: • At least 6 months after the last dose of pemetrexed, if pemetrexed was administered. • At least 6 months after the last dose of cemiplimab/placebo."}
• {"criterion_text":"- Registration phase: Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol."}
• {"criterion_text":"- At randomization: Stable disease, partial or complete response according to RECIST v.1.1 after 4 cycles of induction treatment and radical treatment of all residual disease (if applicable). Patients with progressive disease will be excluded."}
• {"criterion_text":"- At randomization: Anticipated life expectancy >12 weeks"}
• {"criterion_text":"- At randomization: Hepatic function: • Serum total bilirubin ≤1.5x ULN (or ≤3x ULN, if liver metastases or in patients with history of Gilbert syndrome) • AST and/or ALT ≤3x ULN (or ≤5x ULN, if liver metastases)"}
• {"criterion_text":"- At randomization: Renal function: GFR based on MDRD equation ≥30 mL/min"}
• {"criterion_text":"- At randomization: Bone marrow function: • Haemoglobin ≥9.0 g/dL • ANC ≥1.5 x 10^9/L • Platelet count ≥100 x 10^9/L"}
• {"criterion_text":"- At randomization: WOCBP must have a negative serum or highly negative urine pregnancy test within 7 days prior to the first dose of consolidation treatment."}
• {"criterion_text":"- Registration phase: Synchronous oligometastatic disease at diagnosis – and still oligometastatic at registration into the study - defined as maximum 5 metastases, in maximum 3 organs. Hilar, mediastinal and/or supraclavicular lymph nodes are not considered as metastases."}
• {"criterion_text":"- Registration phase: Measurable disease according to RECIST 1.1."}
• {"criterion_text":"- Registration phase: Age at registration ≥18 years"}
• {"criterion_text":"- Registration phase: Eastern Cooperative Oncology Group performance status (ECOG PS)/ World Health Organization (WHO) 0-1."}
• {"criterion_text":"- Registration phase: Hepatic function: • Serum total bilirubin ≤1.5x upper limit of normal (ULN), or ≤3x ULN, if liver metastases or in patients with history of Gilbert syndrome • Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≤3x ULN (or ≤5x ULN, if liver metastases)"}
• {"criterion_text":"- Registration phase: Renal function: Glomerular filtration rate (GFR) based on the modification of diet in renal disease (MDRD) equation ≥30 mL/min"}
• {"criterion_text":"- Registration phase: Bone marrow function: • Haemoglobin ≥9.0 g/dL • Absolute neutrophil count (ANC) ≥1.5 x 10^9/L • Platelet count ≥100 x 10^9/L"}
• {"criterion_text":"- Registration phase: Women of childbearing potential (WOCBP) must have a negative serum or highly sensitive urine pregnancy test within 7 days prior to the first dose of treatment."}

Exclusion criteria

• {"criterion_text":"- Registration phase: Presence of malignant pleural, pericardial and/or peritoneal effusion."}
• {"criterion_text":"- Registration phase: History of any solid or haematological malignancy in the past 3 years before registration. Exceptions include patients who underwent successful definitive treatment of basal or squamous cell carcinoma of the skin, or any in-situ carcinoma(s)."}
• {"criterion_text":"- Registration phase: Any uncontrolled, intercurrent illness or clinical situation that would, in the judgment of investigator, limit compliance with study requirements."}
• {"criterion_text":"- Registration phase: Any uncontrolled active infection, defined as an infection ≥ grade 3 according to CTCAE version 5.0."}
• {"criterion_text":"- Registration phase: Any autoimmune disease that has required systemic treatment in the past 2 years (defined as any use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine for hypothyroidism or insulin for type I diabetes) is not considered a form of systemic treatment. The following treatments are allowed: • Intranasal, inhaled and topical steroids as well as local steroid injections (e.g., intra articular injection). • Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent. • Systemic corticosteroid replacement therapy for adrenal or pituitary insufficiency. • Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)"}
• {"criterion_text":"- Registration phase: Receipt of live vaccines (including attenuated) within 30 days of first study treatment."}
• {"criterion_text":"- Registration phase: Participation in any other clinical study involving an investigational drug or device within 4 weeks before registration."}
• {"criterion_text":"- Registration phase: History of documented allergic reaction or acute hypersensitivity reaction attributed to antibody treatments."}
• {"criterion_text":"- Registration phase: Sensitivity to any of the study interventions, or components thereof, or other allergy that, in the opinion of the investigator, contraindicates participation in the study."}
• {"criterion_text":"- Registration phase: Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol, understanding and completion of questionnaires and followup schedule; those conditions should be assessed and discussed with the patient before the enrolment in the trial"}
• {"criterion_text":"- At randomization: Use of immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 2 weeks prior to the first dose of cemiplimab/placebo. Patients who require brief courses of steroids (e.g., as prophylaxis for imaging studies due to hypersensitivity to contrast agents) can be included."}
• {"criterion_text":"- Registration phase: Known active hepatitis B or C, defined as a positive HBV surface antigen (HBsAg) result or positive HCV RNA."}
• {"criterion_text":"- Registration phase: Known active HIV infection, defined as >200 copies of HIV per ml of blood."}
• {"criterion_text":"- Registration phase: History of interstitial lung disease (e.g., idiopathic pulmonary fibrosis, organizing pneumonia) or history of non-infectious pneumonitis that required systemic glucocorticoids to assist with management. A history of radiation pneumonitis in the radiation field is permitted as long as pneumonitis resolved ≥12 months prior to registration."}
• {"criterion_text":"- Registration phase: Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 2 weeks prior to the first dose of cemiplimab. Patients who require brief courses of steroids (e.g., as prophylaxis for imaging studies due to hypersensitivity to contrast agents) can be included."}
• {"criterion_text":"- Registration phase: Presence of leptomeningeal carcinomatosis."}
• {"criterion_text":"- Registration phase: Tumour known to be positive for EGFR exon 19 or 21 mutations, ALK translocations or ROS1 fusions."}
• {"criterion_text":"- Registration phase: Prior pneumonectomy, radiotherapy (including mediastinal radiotherapy), chemotherapy, immune-check inhibitors or targeted therapy for lung cancer within the last 3 years before registration."}
• {"criterion_text":"- Registration phase: Previously treated brain metastases that are radiologically non-stable."}

Primary endpoints

• {"endpoint_text":"- Progression Free Survival according to RECIST 1.1","definition_or_measurement_approach":"Measured as progression-free survival according to RECIST v1.1"}

Secondary endpoints

• {"endpoint_text":"- Overall survival","definition_or_measurement_approach":"Measured as overall survival (OS)"}
• {"endpoint_text":"- Time to disease progression","definition_or_measurement_approach":"Measured as time to disease progression"}
• {"endpoint_text":"- Time to development of new metastatic lesions","definition_or_measurement_approach":"Measured as time to development of new metastatic lesions"}
• {"endpoint_text":"- Time to progression in oligometastatic lesions initially present at registration","definition_or_measurement_approach":"Measured as time to progression in initially present oligometastatic lesions"}
• {"endpoint_text":"- AEs according to NCI-CTCAE v5.0 and SAEs","definition_or_measurement_approach":"Adverse events graded according to NCI-CTCAE v5.0; SAEs recorded per standard definitions"}
• {"endpoint_text":"- Patient-reported symptoms and treatment side-effects as measured by the EORTC QLQ-C30 and IL316 questionnaires.","definition_or_measurement_approach":"Patient-reported outcomes collected using EORTC QLQ-C30 and IL316 questionnaires"}

France

Earliest CTIS Part Ii Submission Date

20-09-2024

Latest Decision Or Authorization Date

08-10-2024

Processing Time Days

18

Number Of Sites

3

Number Of Participants

26

Italy

Earliest CTIS Part Ii Submission Date

04-09-2024

Latest Decision Or Authorization Date

11-10-2024

Processing Time Days

37

Number Of Sites

6

Number Of Participants

32

Spain

Earliest CTIS Part Ii Submission Date

05-09-2024

Latest Decision Or Authorization Date

08-10-2024

Processing Time Days

33

Number Of Sites

5

Number Of Participants

65

Netherlands

Earliest CTIS Part Ii Submission Date

20-09-2024

Latest Decision Or Authorization Date

07-10-2024

Processing Time Days

17

Number Of Sites

1

Number Of Participants

3

Belgium

Earliest CTIS Part Ii Submission Date

28-08-2024

Latest Decision Or Authorization Date

08-01-2025

Processing Time Days

133

Number Of Sites

3

Number Of Participants

16

Primary sponsor

Full Name

European Organisation For Research And Treatment Of Cancer

Organisation Type

Patient organisation/association

Country Of Registered Address

Belgium

Third parties

• {"country":"Spain","full_name":"Lodilat Logistica S.L.","duties_or_roles":"IMP Labelling, release and distribution to sites","organisation_type":"Pharmaceutical company"}
• {"country":"Luxembourg","full_name":"Luxembourg Institute Of Health","duties_or_roles":"Sample storage","organisation_type":"Laboratory/Research/Testing facility"}