E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Non-small Cell Lung Cancer |
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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 | 10029520 |
E.1.2 | Term | Non-small cell lung cancer stage IIIA |
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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 | 10029521 |
E.1.2 | Term | Non-small cell lung cancer stage IIIB |
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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 |
Progression free survival at 1 year |
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E.2.2 | Secondary objectives of the trial |
• Objective tumor response rate • Overall survival (OS) • Safety and tolerability (acute and late toxicity)
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
[1]Histologic or cytologic diagnosis of unresectable nonsquamous Stage IIIA or Stage IIIB NSCLC. Squamous cell and/or mixed small cell, non-small cell histology is not permitted. [2]Have an ECOG PS of 0 or 1. [3]Previous radiation therapy is allowed, but should have been limited and must not have included thoracic radiation, whole pelvis radiation, or radiation to >25% of the patient’s bone marrow. Patients must have recovered from the toxic effects of radiation treatment prior to study enrollment. Prior radiotherapy must be completed 30 days before study entry. [4]Have at least 1 unidimensionally measurable lesion meeting RECIST guidelines, version 1.0. Positron emission tomography (PET) scans and ultrasounds may not be used. [5]Estimated life expectancy of at least 12 weeks. [6]Patient compliance and geographic proximity that allow adequate follow-up. [7]Adequate organ function, including the following: Adequate bone marrow reserve, adequate hepatic, pulmonary and renal functions. [8]Patients must sign an ICD. [9]Patients must be at least 18 years of age. [10]Patients must have completed a 3-D plan, and the attending physician must have reviewed and approved the dose volume histograms with a total lung V20 < or = 35%. [11]For women: Must be surgically sterile, postmenopausal, or compliant with a medically approved contraceptive regimen during and for 6 months after the treatment period; must have a negative serum pregnancy test within 7 days before study enrollment and must not be breast-feeding. For men: Must be surgically sterile or compliant with a contraceptive regimen during and for 6 months after the treatment period. [12] Have not received prior systemic anticancer therapy for NSCLC. No prior adjuvant chemotherapy is allowed.
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E.4 | Principal exclusion criteria |
[13]Have received treatment within the last 30 days of enrollment with a drug that has not received regulatory approval for any indication at the time of study entry. [14]Have previously completed or withdrawn from this study or any other study investigating pemetrexed. [15]Have a serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient’s ability to adhere to the protocol. [16]Have a serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease, as defined by the New York Heart Association Class III or IV. [17]Have had a prior malignancy other than NSCLC, carcinoma in situ of the cervix, or non-melanoma skin cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence. Patients with a history of low-grade (Gleason score < or = 6) localized prostate cancer will be eligible even if diagnosed less than 5 years previously. [18]Are receiving concurrent administration of any other antitumor therapy. [19]Have had weight loss > 10% over the previous 3 months before study entry. [20]Are unable to interrupt aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose < or = 1.3 grams per day, for at least 2 days before (5 days for long-acting agents), the day of, and for at least 2 days after administration of pemetrexed. [21]Are unable or unwilling to take folic acid or vitamin B12 supplementation. [22]Are unable or unwilling to take corticosteroids. [23]Have received a recent yellow fever vaccination (within 30 days of enrollment) or are receiving concurrent yellow fever vaccination. [24]Have known hypersensitivity to pemetrexed, cisplatin, or any of the excipients in these medicinal products. [25]Have evidence of clinical hearing loss. [26]Have clinically significant (by physical exam) third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry.
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E.5 End points |
E.5.1 | Primary end point(s) |
1 year progression free survival |
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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 | No |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 20 |
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 | 3 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 6 |