RAD001 With Paclitaxel and Carboplatin in First Line Treatment of Patients With Advanced Large Cell Lung Cancer With Neuroendocrine Differentiation

A Multi-centric, Open-label, Phase II Study Investigating the Combination of Afinitor With Paclitaxel and Carboplatin in First Line Treatment of Patients With Advanced (Stage IV) Large Cell Lung Cancer With Neuroendocrine Differentiation (LC-NEC)

This is a multi-centric, open-label study evaluating the efficacy and safety of RAD001 in patients with advanced (stage IV) Lung Cancer (Large Cell) with neuroendocrine differentiation treated with a combination of RAD001 with paclitaxel and carboplatin.

Inclusion Criteria:

1. Patients who give a written informed consent obtained according to local guidelines

2. Histologically confirmed diagnosis of stage IV lung cancer of LC-NEC type according to WHO classification:

   1. Histolocial analysis of newly diagnosed disease must not be older than 8 weeks from signed consent
   2. Relapse must be confirmed by histology
   3. Neuroendocrine differentiation

3. World Health organisation (WHO) performance status grade ≤ 1

4. measurable disease

5. Adequate bone marrow function

6. Adequate liver function

7. Adequate renal function

Exclusion Criteria:

1. History or clinical evidence of central nervous system (CNS) metastases.
2. Presence of SCLC cells
3. Patients who have a history of another primary malignancy ≤ 3 years, with the exception of inactive basal or squamous cell carcinoma of the skin or cervical cancer in situ, early stages of breast cancer (LCIS and DCIS) and prostate cancer (stage T1a)
4. prior chemotherapy for the treatment of advanced lung cancer and/or not having recovered from the side effects of any other therapy (adjuvant treatment for earlier stages I-III is allowed if finished at least one year before study entry)
5. Patients who have received any investigational drug ≤ 28 days before starting study treatment or who have not recovered from side effects of such therapy
6. Patients who have not recovered from the side effects of any major surgery or patients that may require major surgery during the course of the study
7. Patients who have received prior therapy with RAD001 or other mTOR inhibitors
8. Having any severe and/or uncontrolled medical conditions
9. Women who are pregnant or breast feeding

Other protocol-defined inclusion/exclusion criteria may apply