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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00456833

Enrollment

248

Registered

2007-04-05

Start date

2005-06-30

Completion date

Unknown

Last updated

2020-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Small Cell Lung Cancer

Keywords

Non Small Cell Lung Cancer, NSCLC, Advanced lung cancer, RAD, RAD001, erlotinib

Brief summary

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.

Interventions

DRUGRAD001

DRUGerlotinib

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame
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.	first 28 days of combined treatment
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	at baseline and after 8 weeks of treatment

Secondary

Measure	Time frame
Phase 1: Tumor response assessed by CT scans measured at baseline, monthly until month 4 then q2months until progression	at baseline, monthly until month 4 then q2months until progression
Phase 2: Safety and steady state drug levels evaluated monthly	Monthly
Phase 1 and 2: Exploratory Biomarker assessment from archival tumor tissue	Dec 2009

Countries

Canada, Denmark, France, Russia, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026