RAD001 With Paclitaxel and Carboplatin in First Line Treatment of Patients With Advanced Large Cell Lung Cancer With Neuroendocrine Differentiation
Condition: Carcinoma, Large Cell; Neuroendocrine Tumors
MeSH terms: Lung Neoplasms; Neuroendocrine Tumors; Carcinoma, Large Cell
Intervention: RAD001; Paclitaxel; Carboplatin
Intervention description: Participants started RAD001 treatment with a dose of 5 mg/day once daily. A dose decrease to 5 mg every other day was allowed if tolerability issues arose.; Paclitaxel was started at doses of 175 mg/m². Dose reductions of Paclitaxel to 135 mg/m2 was permitted if tolerability issues arose.; Carboplatin was started at doses of Area under the Curve 5 (AUC 5). Dose reductions of carboplatin to AUC 4 was permitted if tolerability issues arose.
Intervention MeSH terms: Paclitaxel; Carboplatin; Everolimus
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Large cell carcinoma,; Lung cancer,; Neuroendocrine Tumors,; RAD001

Summary:

      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.
    

Eligibility criteria:

        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