Non small cell lung cancer MedDRA version: 9.1 Level: LLT Classification code 10001183 MedDRA version: 9.1 Level: LLT Classification code 10025038
Conditions
Interventions
Trade Name: PLATAMINE
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Cisplatin
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: .5-
T
Sponsors
GRUPPO ONCOLOGICO ITALIANO DI RICERCA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The patient must give written (personally signed and dated) informed consent before completing any study related procedure. Males or females >= 18 years and = 12 weeks. Adequate hematological, hepatic and renal functions. Prior radiotherapy allowed, only in case of presence of at least one measurable lesion outside an irradiated area. Radiotherapy must have been completed at least 2 weeks before registration. At baseline, presence of at least one measurable target lesion according to RECIST criteria Absence of any psychological, familial, sociological or geographical conditions potentially hampering compliance with the study protocol and follow-up schedule. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Any prior systemic anticancer therapy including cytotoxic therapy, targeted agents and experimental therapy for advanced disease; The administration of neoadjuvant or adjuvant chemotherapy is allowed as long as it has finalized within 6 months before entering the study. Patients who are: pregnant or lactating;at risk of pregnancy during the study. This must be checked by pregnancy test at study entry. The patient must be receiving a medically accepted contraceptive regimen. Patients with any underlying medical condition that might be aggravated by treatment or which cannot be controlled i.e. patients with active serious infection, diabetes mellitus, patients with concurrent heart failure [New York Heart Association (NYHA) class II-III-IV], or with progressive or unstable angina, patients who have had myocardial infarction within 6 months, and/or poorly controlled hypertension, or pericardial effusion. Documented brain metastases unless the patient has completed local therapy for central nervous system metastases and has been off corticosteroids for at least two weeks before enrollment. History of another malignancy within the past five years except basal cell carcinoma of the skin or carcinoma in situ of the cervix. Treatment with any investigational drug within the 30 days prior to registration. Concomitant treatment with any other anticancer drug. Known hypersensitivity to the study drugs or to drugs with similar chemical structures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess response rate (RR) obtained with cetuximab-cisplatin-docetaxel in previously untreated patients with locally advanced or metastatic NSCLC with favorable vs unfavorable FcgammaR genotypes.;Secondary Objective: -To assess time to progression (TTP) obtained with cetuximab-cisplatin-docetaxel in untreated patients with locally advanced or metastatic NSCLC with favorable vs unfavorable FcgammaR genotypes and EGFR Intron-1 genotypes. - To assess toxicity obtained with cetuximab-cisplatin-docetaxel in patients with locally advanced or metastatic NSCLC with favorable vs unfavorable FcgammaR genotypes and EGFR Intron-1 genotypes. - To assess overall survival (OS) obtained with cetuximab-cisplatin-docetaxel in previously untreated patients with locally advanced or metastatic NSCLC with favorable vs unfavorable FcgammaR genotypes and EGFR Intron-1 genotypes.;Primary end point(s): Response rate (RR) obtained with cetuximab-cisplatin-docetaxel in previously untreated patients with locally advanced or metastatic NSCLC with favorable vs unfavorable FcgammaR genotypes. | — |
Countries
Italy
Outcome results
None listed