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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)


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Carcinoma, Large Cell, Neuroendocrine Tumors

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Trial Information

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)


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The proportion of subjects progression-free at Month 3 (C4D21) according to RECIST (Version 1.1). Time Frame

Outcome Time Frame:

3 months

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CRAD001KDE37

NCT ID:

NCT01317615

Start Date:

April 2011

Completion Date:

November 2015

Related Keywords:

  • Carcinoma, Large Cell
  • Neuroendocrine Tumors
  • Large cell carcinoma,
  • Lung cancer,
  • Neuroendocrine Tumors,
  • RAD001
  • Carcinoma
  • Lung Neoplasms
  • Carcinoma, Large Cell
  • Neuroendocrine Tumors

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