E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with a histologic and/or cytologic diagnosis of LS-SCLC who are naïve to prior chemotherapy and/or thoracic radiotherapy |
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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 | 10041069 |
E.1.2 | Term | Small cell lung cancer limited stage |
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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 |
Estimate the overall response rate after treatment with pemetrexed + carboplatin (at doses of 500 mg/m2 and target AUC of 5, respectively) and concurrent radiation (up to a cumulative dose of 50 Gy) in patients with limited stage of small cell lung cancer |
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E.2.2 | Secondary objectives of the trial |
Assess time-to-event for: - Progression Free Survival - 1-year Overall Survival - duration of response Determine Complete Response rate. Evaluate safety and further characterize acute and late toxicities.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
[1] Histologic and/or cytologic diagnosis of Limited Stage of Small Cell Lung Cancer, without cytological proven malignant pleural effusion and confined to 1 hemithorax. [2] Performance status of 0 to 1 on the ECOG performance status schedule [3] At least one unidimensionally measurable lesion meeting Response Evaluation Criteria in Solid Tumours criteria (at least 10 mm in longest diameter by spiral computerized tomography [CT] scan, or at least 20 mm by standard techniques). [4] Adequate organ function, including the following: • Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) ≥1.5 x 109/L, platelets ≥100 x 109/L, and haemoglobin ≥ 9 g/dL. • Hepatic: bilirubin ≤1.5 times the upper limit of normal (ULN); alkaline phosphatase (AP), aspartate aminotransferase (AST), and alanine aminotransaminase (ALT) ≤ 3.0 x ULN. • Renal: calculated creatinine clearance (CrCl)≥ 45 mL/min based on the standard Cockcroft and Gault formula. [5] Adequate pulmonary function as defined as a forced expiratory volume in 1 sec (FEV1) >30% predicted normal value and diffusion capacity (DLCO) >40% predicted normal value. [6] Signed informed consent document from patient. [7] Males or females at least 18 years of age. [8] For women: must be surgically sterile, postmenopausal, or compliant with a medically approved contraceptive regimen (for example, intrauterine device, birth control pills, or barrier device) during and for 6 months after the treatment period; must have a negative serum or urine pregnancy test within 7 days before study enrolment 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. [9] Patient compliance and geographic proximity that allows for adequate follow-up. [10] Estimated life expectancy of at least 12 weeks.
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E.4 | Principal exclusion criteria |
[11] Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry. [12] 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. [13] Diagnosis of a serious concomitant systemic disorder (for example, active infection including HIV) that, in the opinion of the investigator, would compromise the patient’s ability to complete the study. [14] Have had a recent (within 30 days of study treatment) or concurrent yellow fever vaccination. [15] Have had a prior malignancy other than Small Cell Lung Cancer, carcinoma in situ of the cervix, or nonmelanoma 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 ≤ 6) localized prostate cancer will be eligible even if diagnosed less than 5 years previously. [16] Prior chemotherapy for this cancer and/or prior TRT [17] Pregnancy/breast-feeding. [18] Significant weight loss (that is ≥ 10%) over the previous 6 weeks before study entry. [19] Concurrent administration of any other anti-tumour therapy. [20] Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other than an aspirin dose ≤ 1.3 grams per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam). [21] Inability or unwillingness to take folic acid or vitamin B12 supplementation. [22] Inability to take corticosteroids. [23] Completion or withdrawal from this study or any other study investigating pemetrexed, carboplatin, and/or Thoracic Radiotherapy. [24] Inability or unwillingness to comply with the protocol or study procedures.
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E.5 End points |
E.5.1 | Primary end point(s) |
Overall response rate of pemetrexed and carboplatin combination therapy with concurrent Thoracic Radiotherapy |
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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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 15 |
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 | Yes |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |