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

Neuroendocrine Tumors Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01317615
• Other study ID #: CRAD001KDE37
• Secondary ID: EudraCT 2010-022
• Status: Completed
• Phase: Phase 4
• First received: March 16, 2011
• Last updated: April 16, 2015
• Start date: April 2011
• Est. completion date: March 2015

Study information

• Verified date: April 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Bundesamt für Arzneimittel und Medizinprodukte (BfArM)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Carcinoid Tumor
• Carcinoma, Large Cell
• Neuroendocrine Tumors

Intervention

Drug:
• RAD001 + paclitaxel/carboplatin

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Bremen
Germany	Novartis Investigative Site	Essen
Germany	Novartis Investigative Site	Heidelberg
Germany	Novartis Investigative Site	Hemer
Germany	Novartis Investigative Site	Koeln
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Muenchen
Germany	Novartis Investigative Site	Ulm

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of subjects progression-free at Month 3 (C4D21) according to RECIST (Version 1.1). Time Frame		3 months	No
Secondary	the proportion of subjects progression-free at Month 6		6 months	No
Secondary	Overall response rate (ORR) is the proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR) at Month 3 (C4D21)		3 months	No
Secondary	Disease control rate (DCR) is the proportion of patients with a best overall response of CR or PR or Stable Disease (SD) at Month 3 (C4D21)		3 months	No
Secondary	Progression Free Survival		approximately 3-6 months	No
Secondary	Overall Survival		estimated 12 months	No