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NCT Number: NCT00456833

Combination of RAD001 and Erlotinib in Patients With Advanced Non Small Cell Lung Cancer Previously Treated Only With Chemotherapy

This study aims to assess the value of combined treatment with RAD001 and erlotinib in patients with advanced Non Small Cell Lung Cancer treated only with chemotherapy as systemic therapy.

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Key information

Conditions

Non Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site, Richmond, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age over 18 years
  • Advanced Non Small Cell Lung Cancer which is not responding to chemotherapy treatment including either cisplatin or carboplatin
  • Only 1-2 previous chemotherapy regimens for advanced disease
  • More than 2 weeks from previous surgery, radiation or chemotherapy
  • Ability to perform normal daily functions

Exclusion criteria

  • Chronic steroid treatment
  • Prior treatment with EGFR inhibitors
  • Active bleeding conditions, skin conditions, gastrointestinal disorders, mouth ulcers, eye conditions or other severe medical conditions
  • Other cancers within the past 2 years
  • Pregnant or breastfeeding women Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

RAD001

Drug

Erlotinib

Drug

Primary outcomes

  1. Phase 1: Dose limiting toxicities (DLT) and PK drug-drug interaction (DDI) measured during first 28 days of combined treatment for each treatment regimen and dose.

    Time frame: first 28 days of combined treatment

  2. Phase 2: Tumor response assessed by CT scans measured at baseline and after 8 weeks of treatment for each feasible dose/regimen determined in phase 1

    Time frame: at baseline and after 8 weeks of treatment

Secondary outcomes

  1. Phase 1: Tumor response assessed by CT scans measured at baseline, monthly until month 4 then q2months until progression

    Time frame: at baseline, monthly until month 4 then q2months until progression

  2. Phase 2: Safety and steady state drug levels evaluated monthly

    Time frame: Monthly

  3. Phase 1 and 2: Exploratory Biomarker assessment from archival tumor tissue

    Time frame: Dec 2009

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Combined Phase 1 and 2 Study Investigating the Combination of RAD001 and Erlotinib in Patients With Advanced NSCLC Previously Treated Only With Chemotherapy

Important dates

Study start
2005
Primary completion
2011
First posted
Apr 5, 2007
Registry last updated
Dec 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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