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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01317615
First received: March 16, 2011
Last updated: October 19, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Carcinoma, Large Cell
Neuroendocrine Tumors
Drug: RAD001 + paclitaxel/carboplatin
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • The proportion of subjects progression-free at Month 3 (C4D21) according to RECIST (Version 1.1). Time Frame [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the proportion of subjects progression-free at Month 6 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Progression Free Survival [ Time Frame: approximately 3-6 months ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: estimated 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 47
Study Start Date: April 2011
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RAD001 + paclitaxel/carboplatin Drug: RAD001 + paclitaxel/carboplatin
Other Name: Everolimus

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01317615

Contacts
Contact: Novartis Pharmaceuticals +41613241111
Contact: Novartis Pharmaceuticals

Locations
Germany
Novartis Investigative Site Recruiting
Bad Berka, Germany, 99438
Novartis Investigative Site Recruiting
Berlin, Germany, 13125
Novartis Investigative Site Recruiting
Bremen, Germany, 28177
Novartis Investigative Site Recruiting
Essen, Germany, 45147
Novartis Investigative Site Withdrawn
Hamburg, Germany, 21075
Novartis Investigative Site Recruiting
Heidelberg, Germany, 69120
Novartis Investigative Site Recruiting
Hemer, Germany, 58675
Novartis Investigative Site Recruiting
Koeln, Germany, 51109
Novartis Investigative Site Recruiting
Leipzig, Germany, 04177
Novartis Investigative Site Recruiting
Muenchen, Germany, 82131
Novartis Investigative Site Recruiting
Ulm, Germany, 89081
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01317615     History of Changes
Other Study ID Numbers: CRAD001KDE37, EudraCT 2010-022273-34, 2010-022273-34
Study First Received: March 16, 2011
Last Updated: October 19, 2014
Health Authority: United States: Food and Drug Administration
Germany: Bundesamt für Arzneimittel und Medizinprodukte (BfArM)

Keywords provided by Novartis:
Large cell carcinoma,
Lung cancer,
Neuroendocrine Tumors,
RAD001

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Large Cell
Lung Neoplasms
Neuroendocrine Tumors
Lung Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Carboplatin
Everolimus
Paclitaxel
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 20, 2014