Patient having locally Advanced Non-Small Cell Lung Cancer MedDRA version: 21.1 Level: PT Classification code 10029519 Term: Non-small cell lung cancer stage III System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Opdivo (TM)
Product Name: Nivolumab- CLINICAL
Product Code: BMS-936558
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Nivolumab
CAS Number: 946414-94-4
Current Sponsor co
Nivolumab
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Sponsors
Centre Régional de lutte contre le Cancer Eugène Marquis
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Stage III non-small lung cancer (AJCC 8th edition); • Non-eligible to chemoradiotherapy, defined by multidisciplinary tumor board; • Eligible to radiotherapy, defined by multidisciplinary tumor board; • Performance Status ECOG 0-2; • Age = 18 years; • M0 based on clinical, MRI of brain and FDG/PET-CT examinations; • Written informed consent 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: • Patients eligible to surgery • Any prior or current treatment for invasive lung cancer • History of other malignancy within the last 3 years (exception of skin carcinomas, localized prostate carcinoma Gleason 6 and in situ breast carcinoma) • Significant disease which, in the judgment of the investigator, as a result of the medical interview, physical examinations, or screening investigations would make the patient inappropriate for entry into the trial • Known hypersensitivity reaction to nivolumab • Prior organ transplantation including allogenic stem-cell transplantation • Any social, personal, medical and/or psychologic factor(s) that could interfere with the observance of the patient to the protocol and/or the follow-up and/or the signature of the informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy (disease control rate) of accelerated IMRT combined with nivolumab for patients with a locally advanced non-small cell lung cancer unfit for concomitant or sequential chemoradiotherapy.;Secondary Objective: To evaluate the efficacy (recurrence free survival, overall survival, objective response rate) of accelerated IMRT combined with nivolumab for patients with a locally advanced non-small cell lung cancer unfit for concomitant or sequential chemoradiotherapy. To evaluate the tolerance of accelerated IMRT combined with nivolumab for patients with a locally advanced non-small cell lung cancer unfit for concomitant or sequential chemoradiotherapy ;Primary end point(s): Disease control;Timepoint(s) of evaluation of this end point: 12 months after treatment start | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Overall survival time Progression free survival time Tumor response Early and late treatment-related adverse events of grade = 2 according to the NCI CTCAE V5.0 ;Timepoint(s) of evaluation of this end point: Overall survival time : up to 12 months after start treatment initiation of the last patient Progression free survival time : 12 months after treatment start Tumor response : 12 months after treatment start Early and late treatment-related adverse events of grade = 2 : 3 months after treatment (early) start and 5 months (late) after treatment stop | — |
Countries
France
Contacts
Public ContactCellule Promotion de la DRC
Centre Régional de lutte contre le cancer Eugène Marquis
Outcome results
None listed