Advanced Non Small Cell Lung Cancer MedDRA version: 16.0 Level: LLT Classification code 10025052 Term: Lung cancer non-small cell stage III System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 16.0 Level: PT Classification code 10029522 Term: Non-small cell lung cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Carboplatin
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Carboplatin
Other descriptive name: CARBOPLATIN
Concentration unit: IU international unit(s)
Concentration typ
Sponsors
IFCT
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histologically or cytologically documented Non Small Cell Lung Cancer non resecable or non irradiable stage III or stage IV EGFR wild type or non feasible EGFR 89 >Age = 70 ECOG Performance status : 0, 1 or 2 Mini-Mental Test Status (MMS) > 23 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 546
Exclusion criteria
Exclusion criteria: Mixed non-small cell and small cell tumors Patients with EGFR mutated tumor Patient with EML4-ALK translocation Evolutive or symptomatic metastasis of central nervous system Superior vena cava syndrome Calcemia > 2,70 mmol/L
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Overall Survival;Secondary Objective: Feasability of treatment Progression free survival Response or stabilisation duration Safety Quality of life Percentage of patient who had the 2nd line treatment Efficacy of 2nd line treatment Identify prognostic and predictive survey factor;Primary end point(s): Overall Survival;Timepoint(s) of evaluation of this end point: Time between randomisation and death | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Median number of cycles of maintenance Time between randomisation and progression Time between the EVA3 evaluation and progression Number of patient with at least one undesirable effect, number of undesirable effects Duration of treatment Percentage of patient who had the 2nd line treatment Response rate;Timepoint(s) of evaluation of this end point: No timepoint | — |
Countries
France
Contacts
Public ContactContact
IFCT
Outcome results
None listed