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

Novartis

Status and phase: Completed; Phase 4

Conditions: Carcinoma, Large Cell; Neuroendocrine Tumors

Treatments: Drug: Carboplatin; Drug: RAD001; Drug: Paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT01317615

2010-022273-34

EudraCT 2010-022273-34 (Registry Identifier)

CRAD001KDE37

Details and patient eligibility

About

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.

Enrollment: 49 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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49 participants in 1 patient group

RAD001 plus paclitaxel/carboplatin

Experimental group

Description:

Participants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation.

Treatment:

Drug: Paclitaxel

Drug: Carboplatin

Drug: RAD001