E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Previously treated patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). |
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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 | 10059515 |
E.1.2 | Term | Non-small cell lung cancer metastatic |
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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 |
To compare time to progression between the combination pemetrexed-carboplatin and pemetrexed alone in previously treated patients with locally advanced or metastatic NSCLC. |
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E.2.2 | Secondary objectives of the trial |
To assess differences in terms of response rate between the combination pemetrexed-carboplatin and pemetrexed alone.
To assess differences in terms of duration of response between the combination pemetrexed-carboplatin and pemetrexed alone.
To assess differences in terms of toxicity between the combination pemetrexed-carboplatin and pemetrexed alone.
To assess differences in terms of survival between the combination pemetrexed-carboplatin and pemetrexed alone. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
The patient must give written (personally signed and dated) informed consent before completing any study related procedure.
Males or females >=18 years.
Histologically or cytologically confirmed non-small-cell lung cancer (NSCLC).
Unresectable stage IIIB, stage IV and unresectable local relapse or metastatic disease, with evidence of disease progression after first line chemotherapy which should have included a platinum agent.
ECOG performance status <=2.
Life expectancy >= 12 weeks.
Adequate hematological, hepatic and renal functions.
Prior treatment with only 1 chemotherapy regimen for the treatment of advanced disease which should have included a platinum agent (prior treatment with gefitinib/erlotinib as maintenance after 1st line chemotherapy is allowed and not considered as a chemotherapy regimen).
At least 4 weeks from prior chemotherapy with complete recovery from first line chemotherapy side effects to < Grade 2.
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. All radiology studies must be performed within 28 days prior to randomization.
Absence of any psychological, familial, sociological or geographical conditions potentially hampering compliance with the study protocol and follow-up schedule. |
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E.4 | Principal exclusion criteria |
Prior treatment with pemetrexed.
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.
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.
Inability to interrupt aspirin or other non-steroidal anti-inflammatory agents 2 days before, the day of, and 2 days after the dose of pemetrexed single agent or pemetrexed plus carboplatin. If a patient is taking an NSAID (COX-2 inhibitors included) or salicylate with a long half-life (for example, naproxen, piroxicam, diflunisal, nabumetone, rofecoxib or celecoxib) it should not be taken 5 days before the dose of pemetrexed (8-day period for long-acting agents such as piroxicam), the day of, and 2 days after the dose of pemetrexed single agent or pemetrexed plus carboplatin. |
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E.5 End points |
E.5.1 | Primary end point(s) |
To compare time to progression between the combination pemetrexed-carboplatin and pemetrexed alone in previously treated patients with locally advanced or metastatic NSCLC |
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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 | 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 | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
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.8.5 | 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 | 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
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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 | 0 |
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 | 0 |