Non-small cell lung cancer (NSCLC) MedDRA version: 14.1 Level: PT Classification code 10029520 Term: Non-small cell lung cancer stage IIIA System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: TAXOTERE*INFUS FL 80MG/4ML
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: DOCETAXEL
CAS Number: 114977-28-5
Current Sponsor code: NA
Other descriptive name
Sponsors
IST - ISTITUTO NAZIONALE PER LA RICERCA SUL CANCRO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed NSCLC. For the purpose of randomization/stratification, the histologic subtype of NSCLC must be documented, preferably by World Health Organization/International Association for Study of Lung Cancer Histologic Classification of Lung Cancer criteria; however, the diagnosis of undifferentiated NSCLC or not otherwise specified (NOS) NSCLC are sufficient for enrollment and will be stratified as non-squamous. 2. Specimen tumor tissue obtained from mediastinoscopy is required, and will be sent to the IST laboratory for molecular testing of tumor tissue. ECOG Performance status (PS) 0-1. 3. Stage IIIA(N2) patients with technical operable disease limited to T1a,b, T2a,b N2 M0; T3 (>7 cm) N2 M0 are eligible. 4. Medically fit for resection by lobectomy or pneumonectomy. 5. Radiologically measurable disease by RECIST v1.1 criteria. 6. Prior surgery for NSCLC permitted if resected =5 years prior. 7. No prior chemotherapy, targeted-therapy, investigational therapy or radiation for NSCLC. 8. No uncontrolled medical problems. 9. No superior vena cava syndrome. 10. Peripheral neuropathy must be = grade 1. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 118 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: 1. Any evidence of mixed histology that includes elements of small cell or carcinoid lung cancer. 2. Stage IIIA patients limited to T3 N1 M0; T3 (invasion) N2 M0; T4 N0, N1 M0. 3. Patients with known diffuse interstitial lung disease. 4. Uncontrolled or significant cardiovascular disease, including: a. Myocardial infarction within 12 months; b. Uncontrolled angina within 6 months; c. Congestive heart failure within 6 months; d. Diagnosed or suspected congenital long QT syndrome; e. Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes); f. Prolonged QTc interval on pre entry electrocardiogram. QTc must be less than CTC Grade 2 (=480 msec) using Fredricia’s correction formula with manual read by investigator if required. The ECG may be repeated for evaluation of eligibility after management of correctable causes for observed QTc prolongation; g. Any history of second or third degree heart block (may be eligible if currently have a pacemaker); h. Heart rate <50/minute on baseline electrocardiogram; i. Uncontrolled hypertension. 5. Prior malignancy: Patients will not be eligible if they have evidence of other malignancy (other than non melanoma skin cancer or in situ cervical cancer, or localized and presumed cured prostate cancer with PSA < ULN) within the last 3 years. 6. Patients in whom corticosteroid premedication was contraindicated. 7. HIV-positive patients on active treatment. 8. Medications are prohibited at baseline and prior to randomization if they affect the pharmacokinetics of gefitinib, cisplatin, docetaxel, gemcitabine, vinorelbine and pemetrexed or if they are mainly metabolized by CYP3A4. Patients who are otherwise eligible can be enrolled only if drug substitution is performed with acceptable clinical outcome prior to enrollment. These are described below.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare pathological complete response (PCR) of all subjects randomized, by treatment arm;Secondary Objective: To compare all randomized subjects by treatment arm for: • Response rate (RR) • Disease-free survival (DFS) • Overall Survival and one, two and five year • Safety profile;Primary end point(s): Pathologic Complete Response (PCR) per Independent Pathology Review;Timepoint(s) of evaluation of this end point: After surgical resection (24 months post study initiation) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Overall Survival (OS) • Disease-Free Survival (DFS) • Overall Survival at 1, 2 and 5 years • Overall Response (OR) per RECIST v1.1 • Overall safety profile as characterized by type, frequency, severity of adverse events as graded by NCI Common Toxicity Criteria for Adverse Events version 4, timing and relationship to treatment on each arm, laboratory abnormalities observed.;Timepoint(s) of evaluation of this end point: • Overall Survival (OS : at 1, 2 and 5 years • Disease-Free Survival (DFS): at 1, 2 and 5 years • Overall Response (OR) per RECIST v1.1 : at the end of treatment (25 months post study initiation). | — |
Countries
Italy
Contacts
Public ContactCentro Clinical Trials
Istituto Nazionale per la Ricerca sul Cancro
Outcome results
None listed