E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Non-small cell lung cancer stage IV. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10029522 |
E.1.2 | Term | Non-small cell lung cancer stage IV |
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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 |
Primary objective is to assess the objective response rate (ORR) of SAR240550 administered as a 60-min intravenous infusion twice weekly, when combined to gemcitabine/cisplatin chemotherapy regimen (GCS) as well as with the standard regimen of gemcitabin/cisplatin (GC) in patients with stage IV non small cell lung cancer. |
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E.2.2 | Secondary objectives of the trial |
- To assess the safety profiles of the study combination gemcitabine/cisplatin/SAR240550 (GCS) and of the standard regimen gemcitabine/cisplatin (GC) alone - To assess the progression free survival and the overall survival in both arms. - To assess the relationship between DNA repair pathway characteristics of tumors at baseline and clinical outcome of disease. - To assess the effect of SAR240550 on PAR level in peripheral blood mononuclear cells (PBMC).
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Molecular biological sub-study population
A subset of randomized and treated patients with available biomarkers analyses parameters before first study drug administration (from tumor tissue collected within 6 months prior to the study entry and no prior exposure to anti-cancer therapy for the advanced disease or fresh tissue from the current relapse [lung or metastasis]). All analyses using this population will be based on the treatment received |
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E.3 | Principal inclusion criteria |
- Stage IV disease (including stage IIIB with pleural effusion) with no prior systemic therapy. Adjuvant therapy is allowed if ended more than 1 year before inclusion in the study. - Histologically confirmed squamous cell bronchogenic carcinoma OR non squamous cell carcinoma. - Patients with previous radiotherapy as definitive therapy for locally advanced non-small cell lung cancer are eligible, as long as the selected measurable lesions are outside the original radiation therapy port. Radiation therapy must have been completed >4 weeks prior to study treatment. - At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. - Adequate bone marrow reserve. - Adequate liver and renal function. - Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to start of treatment.
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E.4 | Principal exclusion criteria |
- Prior treatment with gemcitabine, platinum salts or any PARP inhibitor class compound. - Past or current history of neoplasm other than the entry diagnosis, with the exception of treated non-melanoma skin cancer or carcinoma in-situ of the cervix, or other cancers cured by local therapy alone and with an expected disease-free survival of ≥5 years. - Major medical conditions that might affect study participation e.g. cardiac disease, uncontrolled infection (>Grade 2). - Presence of active brain metastases. - A major surgical procedure, open biopsy, or significant traumatic injury within 28 days of beginning treatment, or anticipation of the need for major surgery during the course of the study. - Any history of medical or psychiatric condition or laboratory abnormality that, in the opinion of the investigator, may increase the risks associated with the study participation or administration of the investigational products, or that may interfere with the interpretation of the results - Grade 2 or higher ear and labyrinth disorders. - Known or suspected allergy/hypersensitivity to any agent given in the course of this trial.
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E.5 End points |
E.5.1 | Primary end point(s) |
Overall response rate (ORR) that is defined in the RECIST 1.1 version, as: complete response rate + partial response rate. |
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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 | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | Yes |
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 | 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.8.4.1 | 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 | 12 |
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 | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |