E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients > 70 years of age with locally advanced or unresectable stage III-IV NSCLC, with no prior sistemic treatment for metastatic disease. |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10059515 |
E.1.2 | Term | Non-small cell lung cancer metastatic |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To compare Progression-Free Survival (PFS) in patients > 70 years of age, PS 0-1, with advanced or metastatic NSCLC in patients treated with a first-line regimen of either sequential satraplatin and erlotinib or continuous single-agent erlotinib. |
|
E.2.2 | Secondary objectives of the trial |
- To assess Overall Survival in patients > 70 years of age, PS 0-1, with advanced or metastatic NSCLC in patients treated with a first-line regimen of either sequential satraplatin and erlotinib or continuous single-agent erlotinib. - To compare response rates. - To compare the toxicity profiles between patients treated with satraplatin and erlotinib and single-agent erlotinib. |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
- Histologically or cytologically confirmed NSCLC (squamous cell carcinoma, adenocarcinoma, or large cell carcinoma). Cytologic specimens obtained by brushings, washings or needle biopsy with aspiration are acceptable. Mixed tumors with small cell anaplastic elements are not eligible. - Patients who have unresectable stage III or stage IV disease are eligible. Patients with stage III disease should be ineligible for combined modality therapy (i.e. pleural effusions, pericardial effusions, etc.). Patients with earlier stage NSCLC that has recurred after prior surgery are eligible. - Age >= 70 years old. - ECOG performance status 0-1 - Prior treatment with systemic therapy is allowed provided the following criteria are met: ^ No EGFR targeted therapy (TKI or antibody) ^ No prior platinum agent. ^ Neoadjuvant, adjuvant, or part of a combined modality regimen (i.e., not for metastatic disease) ^ Completion > 6 months prior to enrollment onto this study. - Patients who have had previous radiation therapy (RT) as definitive therapy for locally NSCLC are eligible only if the following criteria are met: ^ Site of tumor recurrence is outside of the original RT port unless there is incontrovertible evidence of disease progression within the portal ^ All side effects from RT must have resolved prior to enrollment. ^ Completion of RT > 4 weeks prior to enrollment. ^ Previous radiation must have treated < 30% of active bone marrow. ^ Patients who have undergone thoracotomy must have fully recovered from surgery and cannot start treatment until at least three weeks after their operative procedure. - Adequate hematological function as noted by: ^ Absolute neutrophil count (ANC) > 1,500/uL ^ Platelets > 100,000/uL ^ Hemoglobin > 10 g/dl. Patients may be transfused or receive erythropoietin to maintain or exceed this level. - Adequate hepatic and renal function as noted by: ^ Bilirubin < 1.5 x ULN ^ Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) < 2.5 x ULN. ^ Serum creatinine < 1.5mg/dL or calculated (or measured) glomerular filtration rate (GFR) > 50 ml/min. - Patients with both measurable and non-measurable disease (as per Response Criteria in Solid Tumors (RECIST)) may be enrolled. |
|
E.4 | Principal exclusion criteria |
- Concurrent invasive malignancy requiring ongoing therapy. - Metastatic brain or meningeal tumors, unless the patient is > 1 month from definitive therapy, is clinically stable with respect to the tumor at the time of study entry, is not receiving steroid therapy or taper, and is not receiving anti-convulsant medications (that were started for the brain metastases). - Previous treatment with either platinum-based chemotherapy agents or prior EGFR targeting agents. - Peripheral neuropathy > grade 1. - Hearing loss or tinnitus > grade 2 - Obstructive pulmonary disease or symptoms > grade 3. - A history of cardiac disease as defined by malignant hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous six months, or symptomatic uncontrolled cardiac arrhythmias. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Progression Free Survival: Defined as the time from randomization until verification of progressive disease (as per RECIST) or death. Subjects who discontinue therapy without disease progression will be followed for evaluation of progressive disease every two months during the first year, every three months during the second year, and every six months thereafter until death. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
stratified by smoking history and by gender |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
sequential satraplatin+erlotinib vs erlotinib |
|
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |