Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

Erlotinib Hydrochloride

Tubulin Modulators

Antimitotic Agents

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Erlotinib tablets administered orally, 150 mg/day (starting dose) or 100 mg/day (reduced dose), continuous therapy

Paclitaxel 200 mg/m\^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 - 30 minutes, both given on Day 1 every 21 days for 4 cycles

Tarceva (Trademark) (erlotinib HCl, OSI-774)

Combination carboplatin and paclitaxel

The purpose of this noncomparative study is to obtain preliminary estimates of the efficacy of erlotinib and standard chemotherapy in patients with advanced, previously untreated nonsmall cell lung cancer (NSCLC) and an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 2. The study will also evaluate the safety of single-agent erlotinib in this patient population.

Erlotinib vs. Standard Chemotherapy in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) and Eastern Cooperative Oncology Group (ECOG)Performance Status (PS) 2

A Randomized Phase II Study of Single Agent Erlotinib [Tarceva (TM), OSI-774] Versus Standard Chemotherapy in Patients With Previously Untreated Advanced NSCLC and a Poor Performance Status

Median time until disease progression. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression.

Median number of months from first study treatment until time of death

Change in size of tumor: Complete Response (CR) = no measurable tumor; Partial Response (PR) = 30% decrease in size of measurable tumor; Stable Disease (SD) = measurable tumor size has not changed; Progressive Disease (PD) = measurable tumor 20% larger than at baseline.

OSI Pharmaceuticals

Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.

Erlotinib

Standard Chemotherapy

Total

Age Continuous

Sex: Female, Male

White

Black

Hispanic

Asian

Race/Ethnicity, Customized

Medical Monitor

All patients who received at least 1 dose of study drug and who had both a baseline and at least one on-treatment tumor assessment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Erlotinib vs. Standard Chemotherapy in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) and Eastern Cooperative Oncology Group (ECOG)Performance Status (PS) 2	NCT00085839	Non-Small Cell ...	Tarceva (Tradem... Combination car...	18 Years -	Astellas Pharma Inc
Erlotinib vs. Standard Chemotherapy in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) and Eastern Cooperative Oncology Group (ECOG)Performance Status (PS) 2	NCT00085839	Non-Small Cell ...	Tarceva (Tradem... Combination car...	18 Years -	Astellas Pharma Inc

Spots Global Cancer Trial Database for ecog performance status 2