E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
First Line treatment for Locally Advanced or Metastatic Non-Small Cell Lung Cancer. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10061873 |
E.1.2 | Term | Non-small cell lung cancer |
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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 |
The primary objective of this study is to establish the objective response rate (complete response [CR] + partial response [PR]) following treatment with VELCADE in combination with cisplatin plus gemcitabine in patients with locally advanced Stage IIIb not amenable to curative treatment or metastatic (stage IV) non-small cell lung cancer (NSCLC) who have not received prior antineoplastic therapy for advanced disease. |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives for this study include the assessment of the following: Time to tumor progression (TTP) Duration of response (DoR) Progression-free survival (PFS) Overall survival (OS), 6-month, and 12-month survival rates Safety will be evaluated throughout the study by assessment of adverse events, changes in physical examinations, 11-item module Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) scores, Eastern Cooperative Oncology Group (ECOG) performance scores, vital signs, and clinical laboratory findings. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients with locally advanced Stage IIIΒ (not amenable to curative treatment) or metastatic (Stage IV) NSCLC who have not received prior systemic anti-neoplastic therapy (one additional prior line is allowed if given as neo-adjuvant or adjuvant therapy to tumor resection) will be enrolled in the study. The patient population comprises of men or women, 18 years of age or older. NSCLC must be histologically or cytologically confirmed. Additional inclusion criteria include: measurable disease per RECIST criteria and ECOG performance status score of 0 to 1. |
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E.4 | Principal exclusion criteria |
Exclusion Criteria for this study include: presence of peripheral neuropathy of Grade 2 or greater intensity; significant weight loss (documented ≥10% body weight in the 6 weeks before randomization); inadequate organ function at the screening visit as defined in the protocol; cardiac disease as defined in the protocol;; active systemic infection requiring treatment; active second malignancy. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint is the objective response rate, which is defined as the proportion of response-evaluable subjects who achieve a confirmed CR or PR per RECIST guidelines.Safety will be evaluated throughout the study by assessment of the incidence, intensity, and type of clinically significant adverse events, and by changes in physical examinations, 11-item module FACT/GOG-Ntx scores, vital signs, clinical laboratory findings and ECOG status. The 11-item module FACT/GOG-Ntx scale will be used as a checklist to assist with the clinical safety evaluation of neuropathic pain and peripheral neuropathy symptoms. |
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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 | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
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 | No |
E.8.1.1 | Randomised | No |
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 | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
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 | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 18 |
E.8.9.1 | In the Member State concerned days | |