Advanced non small cell lung cancer MedDRA version: 19.0 Level: LLT Classification code 10007050 Term: Cancer System Organ Class: 100000004864
Conditions
Interventions
Trade Name: OPDIVO
Product Name: nivolumab
Pharmaceutical Form: Solution for infusion
Product Name: carboplatin
Pharmaceutical Form: Solution for injection
Product Name: pemetrexed
Pharmaceutical Fo
Sponsors
CHU Rennes
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Signed written informed consent • Cytologically or histologically proven NSCLC (adenocarcinoma, squamous cell carcinoma, large-cell carcinoma) • Stage IV or non-treatable by radiotherapy stage III (7th classification) • No previous systemic chemotherapy for lung cancer, except in case of relapse after adjuvant treatment for localized disease with 6 months or more between end of previous chemotherapy and relapse • Patients less than 70 years old and PS 2 or 70 years older PS 0 to 2 • Judged fit enough to receive chemotherapy according to ESMO guidelines • Presence of at least one measurable target lesion (RECIST 1.1 rules) in a non-irradiated region and analysable by CT • Life expectancy >12 weeks • Prior radiation therapy is authorized if it involved less than 25% of the total bone marrow volume and finished 14 days before D1 of planned treatment • Screening laboratory values must meet the following criteria and should be obtained within 14 days prior to randomization/registration ? WBC = 2000/µL ? Neutrophils = 1500/µL ? Platelets = 100 x103/µL ? Hemoglobin > 10.0 g/dL ? Serum creatinine = 1.5 x ULN or creatinine clearance (CrCl) = 45 mL/min (if using the Cockcroft-Gault formula below): Female CrCl = (140 - age in years) x weight in kg x 0.85 72 x serum creatinine in mg/dL Male CrCl = (140 - age in years) x weight in kg x 1.00 72 x serum creatinine in mg/dL ? AST/ALT = 3 x ULN ? Total Bilirubin = 1.5 x ULN (except Patients with Gilbert Syndrome, who can have total bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Patients with other severe concurrent disorders that occurred during the prior six months before enrollment (myocardial infection, severe or unstable angor, coronarian or peripheric arterial bypass operation, NYHA class 3 or 4 congestive heart failure, transient or constituted cerebral ischemic attack, at least grade 2 peripheral neuropathy, psychiatric or neurological disorders preventing the patient from understanding the trial, uncontrolled infections) are not eligible. • Serious or uncontrolled systemic disease judged as incompatible with the protocol by the investigator • Another previous or concomitant cancer, except for basocellular cancer of the skin or treated cervical cancer in situ, or appropriately treated localized low-grade prostate cancer (Gleason score 10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration. • Patients should be excluded if they have an active, known or suspected autoimmune disease. Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger • Patients should be excluded if they have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. • As there is potential for hepatic toxicity with nivolumab, drugs with a predisposition to hepatoxicity should be used with caution in patients treated with nivolumab. • Patients should be excluded if they are positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection • Patients should be excluded if they have known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) • Allergies and Adverse Drug Reaction • History of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare overall survival of patients in experimental arm versus chemotherapy;Secondary Objective: To evaluate : • survival at one year of patients treated with nivolumab versus patients treated with chemotherapy, • the objective response rate, • the progression free survival, • the QOL (EQ5D) assessed every 6 weeks, • the safety and the tolerability of nivolumab versus chemotherapy, • the prognostic impact of PD-L1 expression by immunochemistery (IHC) on OS and PFS.;Primary end point(s): Overall survival;Timepoint(s) of evaluation of this end point: 42 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Percentage of patients alive one year after inclusion in the trial, • Objective response rate according to Recist 1.1, • Progression free survival time, • Safety tolerability according to CTCAE 4.0, • QOL evaluated by EQ5D every 6 weeks, • PD-L1 testing by immunochemistery (IHC).;Timepoint(s) of evaluation of this end point: • Percentage of patients alive one year after inclusion in the trial, • Objective response rate according to Recist 1.1, • Progression free survival time, • Safety tolerability according to CTCAE 4.0, • QOL evaluated by EQ5D every 6 weeks, • PD-L1 testing by immunochemistery (IHC). | — |
Countries
France
Contacts
Public ContactGanivet
CHU Rennes
Outcome results
None listed