cemiplimab for Non-small cell lung cancer stage III (unresectable)

Inclusion criteria

• {"criterion_text":"-Patients must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care."}
• {"criterion_text":"-Measurable disease according to RECIST 1.1 per investigator assessment. The radiological assessment has to be done within the timelines indicated"}
• {"criterion_text":"-Respiratory function: FEV1 ≥ 40% of theoretical value, DLCO ≥ 40%."}
• {"criterion_text":"-Bone marrow function: absolute neutrophil count (ANC) ≥ 1.5.109/L, platelets ≥ 100.109/L, hemoglobin ≥ 9 g/dl."}
• {"criterion_text":"-Expression of PD-L1 as assessed locally by the investigator center."}
• {"criterion_text":"-Renal and hepatic function: estimated creatinine clearance ≥ 45 ml/min, bilirubin ≤1.5xULN, AST ALT ≤3xULN, Albumin ≥28g/dl."}
• {"criterion_text":"-Participant has national health insurance coverage."}
• {"criterion_text":"-Effective method of contraception during the treatment and during the 6 months following the last dose for patients of childbearing potential and for male subjects who are sexually active with a woman of childbearing potential."}
• {"criterion_text":"-Patients must be willing and able to comply with scheduled visits, treatment schedule, and laboratory testing."}
• {"criterion_text":"-Age ≥ 18 years."}
• {"criterion_text":"-Histologically or cytologically confirmed locally advanced NSCLC stage IIIA non resectable, IIIB or IIIC accordingly to 8th classification TNM, UICC 2015."}
• {"criterion_text":"-Unfit or elderly patients as defined below: ≥ 70 years ; PS 0 to 1 ; Charlson sccore : watever OR < 70 years ; PS 0 to 1 ; Charslon score ≥ 3 OR < 70 years ; PS 2 ; Charlson sccore : watever"}
• {"criterion_text":"-Patients eligible for treatment with sequential radio-chemotherapy validated by multidisciplinary committee."}

Exclusion criteria

• {"criterion_text":"-Immunotherapy or chemotherapy contra-indicated."}
• {"criterion_text":"-Weight loss ≥15% of total body weight in the last 6 months."}
• {"criterion_text":"-ECOG PS upper 2"}
• {"criterion_text":"-Active autoimmune pathology. History of autoimmune pathology including myasthenia, Guillain-Barre syndrome, lupus erythematosus, antiphospholipid syndrome, Wegener's granulomatosis, glomerulonephritis, inflammatory bowel disease, vasculitis, sarcoidosis, uveitis. Autoimmune thyroid pathologies under replacement therapy as well as type 1 diabetes under insulin are authorized."}
• {"criterion_text":"-History of idiopathic pulmonary fibrosis, organized pneumopathy or signs of active interstitial pulmonary pathology on CT scan."}
• {"criterion_text":"-Any immunosuppressive therapy received within 28 days and corticosteroids > 10mg/day of prednisone or equivalent received within 7 days prior the start of chemotherapy excepted hydrocortisone replacement for adrenal insufficiency or pituitary disease not considered immunosuppressive therapy."}
• {"criterion_text":"-Chronic active infection including tuberculosis, HIV, hepatitis B (HBsAg positive) or C. Patients with a history of cured hepatitis B (anti HBc and absence of negative HBs antigen) are eligible. In case of hepatitis C (anti HCV Ac) patients are eligible if the HCV PCR is negative."}
• {"criterion_text":"-Severe infections (including covid-19 infection) within 4 weeks prior to initiation of study treatment, including but not limited to hospitalization for complications of infection, bacteraemia, or severe pneumonia."}
• {"criterion_text":"-History of neoplastic disease (other than NSCLC) less than 3 years old or progressive (except basal cell carcinoma of the skin and carcinoma in situ of the cervix)."}
• {"criterion_text":"-History of thoracic radiotherapy."}
• {"criterion_text":"-Live attenuated vaccine received within 28 days of starting chemotherapy"}
• {"criterion_text":"-Patients eligible for treatment with concomitant radio-chemotherapy validated by multidisciplinary committee."}
• {"criterion_text":"-History of organ or bone marrow transplantation."}
• {"criterion_text":"-Major surgery within 4 weeks of starting treatment."}
• {"criterion_text":"-Patient already included in another therapeutic trial."}
• {"criterion_text":"-Positive pregnancy test or breastfeeding woman."}
• {"criterion_text":"-Protected adults (under guardianship or curatorship)."}
• {"criterion_text":"-Inability to undergo medical monitoring of the study (for geographical, social and/or physical reasons)."}
• {"criterion_text":"-Patients unable to understand the study."}
• {"criterion_text":"-Stage I or II NSCLC."}
• {"criterion_text":"-Previously received a treatment with anti-PD1/PDL1, anti-CTLA, or other antineoplastic immunotherapy or chemotherapy for NSCLC."}
• {"criterion_text":"-Histology other than primary non-small cell lung cancer."}
• {"criterion_text":"-Known activating EGFR mutation or ALK or ROS1 translocation."}
• {"criterion_text":"-Metastatic NSCLC including brain metastasis."}
• {"criterion_text":"-Patients not eligible for curative radiotherapy (tumor extension, predictable dose constraints that cannot be met)."}
• {"criterion_text":"-Severe uncontrolled comorbidities or severe intercurrent disease: acute coronary syndrome less than 3 months old, unstable angina, heart failure with LVEF ≤30%, uncontrolled hypertension, Child B or C cirrhosis, severe sepsis, myocarditis or any other active conditions that would contraindicate chemotherapy, immunotherapy, or radiotherapy in the opinion of the investigator."}

Primary endpoints

• {"endpoint_text":"-Progression-free survival (PFS)","definition_or_measurement_approach":"Measured as progression-free survival (PFS)."}

Secondary endpoints

• {"endpoint_text":"-Objective response (ORR) and disease control (DCR) rates according to RECIST 1.1 criteria.","definition_or_measurement_approach":"Response rates assessed according to RECIST 1.1 criteria (as stated)."}
• {"endpoint_text":"-PFS rate at 12 months, 18 months and 3 years by treatment arm.","definition_or_measurement_approach":"PFS rates at specified time points by treatment arm."}
• {"endpoint_text":"-OS curve and OS rate at 12 months, 18 months and 3 years by treatment arm.","definition_or_measurement_approach":"Overall survival (OS) curve and OS rates at specified time points by treatment arm."}
• {"endpoint_text":"-Neoadjuvant chemoimmunotherapy : Grade 3-4 toxicity rates by treatment arm according to CTCAE v5.0 up to 90 days after the end of immunotherapy","definition_or_measurement_approach":"Grade 3-4 toxicity rates graded per CTCAE v5.0 up to 90 days after end of immunotherapy, by treatment arm."}
• {"endpoint_text":"-Percentage of discontinuation after two cycles of systemic therapy.","definition_or_measurement_approach":"Proportion of participants discontinuing treatment after two cycles."}
• {"endpoint_text":"-Toxic death rate.","definition_or_measurement_approach":"Rate of deaths attributed to toxicity."}
• {"endpoint_text":"-Variation of respiratory function tests before neoadjuvant therapy and after neoadjuvant therapy (just before radiation) and after, at 3, 6 and 12 months.","definition_or_measurement_approach":"Serial respiratory function tests measured baseline, pre-radiation, and at 3, 6 and 12 months."}
• {"endpoint_text":"-Global and specific quality of life questionnaire QLQ-C30 QLQ-LC29.","definition_or_measurement_approach":"Health-related quality of life assessed using QLQ-C30 and QLQ-LC29 questionnaires."}
• {"endpoint_text":"-Consolidation immunotherapy : Acute and late grade 3-4 toxicity rates by treatment arm according to CTCAE v5.0 up to 90 days after the end of immunotherapy.","definition_or_measurement_approach":"Grade 3-4 toxicity rates for consolidation immunotherapy per CTCAE v5.0 up to 90 days after end of immunotherapy, by arm."}

France

Earliest CTIS Part Ii Submission Date

27-11-2024

Latest Decision Or Authorization Date

13-05-2026

Processing Time Days

532

Number Of Sites

32

Number Of Participants

152

Primary sponsor

Full Name

Intergroupe Francophone De Cancerologie Thoracique

Organisation Type

Patient organisation/association

Country Of Registered Address

France

Contract research organisations

Name

EvidentIQ Germany GmbH

Responsibilities

sponsorDuties codes 3,7; contact: info@evidentiq.com

Third parties

• {"country":"Germany","full_name":"EvidentIQ Germany GmbH","duties_or_roles":"sponsorDuties codes 3,7 (contact: info@evidentiq.com)","organisation_type":"Industry"}