CEMIPLIMAB for Non-small cell lung cancer

Inclusion criteria

• {"criterion_text":"- 1. Histologically confirmed stage IV or stage IIIB/C not candidates for definitive chemo/radiotherapy or surgical resection non-small cell lung cancer (NSCLC) per the 8th edition TNM with no prior systemic anti-cancer therapy\n- 10. Patient consent must be obtained in the appropriate manner as established in the applicable local and regulatory requirements\n- 11. Patients must be accessible for treatment and follow-up\n- 12. Women of childbearing potential, including women who had their last menstrual period in the last 2 years, must have a negative serum or urine pregnancy test within 3 days before enrolment\n- 13. All sexually active men and women of childbearing potential must use a highly effective contraceptive method (<1% failure rate) during the study treatment and for a period of at least 5 months for females and 7 months for males following the last administration of trial drugs\n- 2. PDL1 ≥ 50%\n- 3. ECOG performance status 0-1\n- 4. Patients aged ≥ 18 years\n- 5. Prior definitive chemoradiation for locally advanced disease is permitted as long as the last administration of chemotherapy or radiotherapy occurred at least 6 months prior to enrolment. Also, patients treated with immunotherapy or chemo-immunotherapy Combinations at least 6 months prior to enrollment can be included in the study\n- 6. Prior adjuvant or neoadjuvant chemotherapy or chemo-immunotherapy for early stage is permitted if completed at least 6 months prior to enrolment\n- 7. Presence of at least one measurable lesion by computed tomography (CT-scan) per response evaluation criteria in solid tumors (RECIST) version 1.1\n- 8. Anticipated life expectancy >12 weeks\n- 9. Correct hematological, hepatic and renal function"}

Exclusion criteria

• {"criterion_text":"- 1. Patients whose tumors harbor an activating mutation in epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK) translocation, or ROS Proto-Oncogene 1 (ROS1) rearrangements sensitive to available targeted inhibitor therapy\n- 18. Uncontrolled infection with HIV, hepatitis B or hepatitis C, diagnosis of immunodeficiency and/or tuberculosis (active or latent)\n- 19. 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 inclusion\n- 2. Patients with grade ≥2 neuropathy\n- 20. History of documented allergic reactions or acute hypersensitivity reactions attributed to antibody treatments\n- 21. Presence of cardiovascular disease, as defined by: a. New York Heart Association heart failure classifications of Class II, III, or IV; or myocardial infarction, or acute coronary syndrome within 12 months of first dose of study medication; or b. Transient ischemic attack or stroke within 1 year\n- 22. Patients with a history of solid organ transplant (patients with prior corneal transplants may be allowed to enroll after discussion with and approval from the medical monitor)\n- 3. Pregnant or breastfeeding women\n- 4. Patients with a weight loss >10% within the previous 3 months\n- 5. Patients with carcinomatous meningitis\n- 6. Patients with a history of other malignant diseases within the past 3 years, with the exception of the following: - properly treated non-melanotic skin cancer - cancer in situ treated with curative intent - nonmuscularis propia invasive carcinoma of the bladder - or other malignancies treated with curative intent and without signs of disease for a period of > 3 years after the end of the treatment and which, in the opinion of the physician in charge of their treatment, do not present a substantial risk of relapse of the previous malignant disease\n- 10. Patients who have received prior neo-adjuvant, adjuvant chemotherapy, radiotherapy, chemo-radiotherapy or chemo-immunotherapy with curative intent for non-metastatic disease less than 6 months before enrollment since the last chemotherapy, radiotherapy, or chemo-radiotherapy\n- 7. Patients must have recovered from a major surgery at least 14 days prior to enrolment\n- 8. Patients with active or uncontrolled infections or with serious medical conditions or disorders that may not allow patient management as established in the protocol\n- 9. Prior treatment with antineoplasic drugs or thoracic radiotherapy for any reason different from the ones specific in the inclusion criteria\n- 23. Receipt of live vaccines (including attenuated) within 30 days of first study treatment. Receipt of COVID-19 vaccination within 1 week of planned start of study medication or for which the planned COVID-19 vaccinations would not be completed 1 week prior to start of study medication.\n- 24. Women of childbearing potential (WOCBP), or sexually active men, who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment prior to the start of the first treatment, during the study, and for at least 4 months after the last dose\n- 11. Patients with a combination of small cell lung cancer and non-small cell lung cancer, a carcinoid lung tumor or large cell neuroendocrine carcinoma\n- 12. Has known allergy or hypersensitivity to components of study drug\n- 13. Significant comorbidities that preclude the administration of chemotherapy according to the investigator’s criteria\n- 14. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-mediated adverse events (imAEs). The following are not exclusionary: vitiligo, childhood asthma that has resolved, type 1 diabetes, residual hypothyroidism requiring only hormone replacement, or psoriasis that does not require systemic treatment\n- 15. Untreated brain metastasis(es) that may be considered active or symptomatic. Note in clarification: Patients with previously treated brain metastases may participate provided that the lesion(s) is (are) stable (without evidence of progression for at least 6 weeks on imaging obtained in the screening period)and there is no evidence of new or enlarging brain metastases and the patients do not require any immunosuppressive doses of systemic corticosteroids for management of brain metastasis(es) within 28 days of the first dose of REGN2810cemiplimab\n- 16. Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of REGN2810cemiplimab. Note in clarification: Patients who require brief courses of steroids (eg, as prophylaxis for imaging studies due to hypersensitivity to contrast agents) are not excluded\n- 17. Any infection requiring hospitalization or treatment with IV anti-infectives within 2 weeks of first dose of study medication"}

Primary endpoints

• {"endpoint_text":"- OS at 24 months in the intention to treat (ITT) population","definition_or_measurement_approach":"Overall survival at 24 months measured in the intention-to-treat (ITT) population (OS at 24 months)."}

Secondary endpoints

• {"endpoint_text":"- 1. Duration of response (DOR)","definition_or_measurement_approach":"Duration of response as defined in the protocol (DOR)."}
• {"endpoint_text":"- 2. Overall survival (OS) at 12, 36 and 48 months","definition_or_measurement_approach":"Overall survival measured at 12, 36 and 48 months."}
• {"endpoint_text":"- 3. Progression free survival (PFS) at 12, 24, 36 and 48 months","definition_or_measurement_approach":"Progression-free survival assessed at 12, 24, 36 and 48 months per RECIST v1.1."}
• {"endpoint_text":"- 4. Sites of first failure","definition_or_measurement_approach":"Anatomical sites of first disease progression/recurrence as recorded in trial assessments."}
• {"endpoint_text":"- 5. Overall response rate (ORR)","definition_or_measurement_approach":"Overall response rate per RECIST v1.1."}
• {"endpoint_text":"- 6. Toxicity profile","definition_or_measurement_approach":"Adverse events and toxicity profile collected and graded per CTCAE as specified in the protocol."}

Spain

Earliest CTIS Part Ii Submission Date

30-01-2025

Latest Decision Or Authorization Date

31-07-2025

Processing Time Days

182

Number Of Sites

20

Number Of Participants

63

Primary sponsor

Full Name

Fundacion GECP

Organisation Type

Patient organisation/association

Country Of Registered Address

Spain