TARCEVA (erlotinib) is a Human Epidermal Growth Factor Receptor Type 1/Epidermal Growth Factor Receptor (HER1/EGFR) tyrosine kinase inhibitor.
TARCEVA (erlotinib) is indicated for the following:
Non-Small Cell Lung Cancer
TARCEVA monotherapy is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen.
Results from two, multicenter, placebo-controlled, randomized, Phase 3 trials conducted in first-line patients with locally advanced or metastatic NSCLC showed no clinical benefit with the concurrent administration of TARCEVA with platinum-based chemotherapy [carboplatin and paclitaxel or gemcitabine and cisplatin] and its use is not recommended in that setting.
TARCEVA in combination with gemcitabine is indicated for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.
Published Studies Related to Tarceva (Erlotinib)
Sunitinib plus erlotinib for the treatment of advanced/metastatic non-small-cell
lung cancer: a lead-in study. 
combination of sunitinib and erlotinib... CONCLUSION: A dosage of sunitinib 37.5 mg/d concurrently with erlotinib 150 mg/d
Afatinib versus placebo for patients with advanced, metastatic non-small-cell
lung cancer after failure of erlotinib, gefitinib, or both, and one or two lines
of chemotherapy (LUX-Lung 1): a phase 2b/3 randomised trial. 
tyrosine-kinase inhibitors... INTERPRETATION: Although we recorded no benefit in terms of overall survival with
Rationale and design of MARQUEE: a phase III, randomized, double-blind study of
tivantinib plus erlotinib versus placebo plus erlotinib in previously treated
patients with locally advanced or metastatic, nonsquamous, non-small-cell lung
We present the rationale and design for MARQUEE, a phase III, randomized,
double-blind, placebo-controlled study of ARQ 197 plus erlotinib versus placebo
plus erlotinib in previously treated subjects with locally advanced or
metastatic, nonsquamous, non-small-cell lung cancer (NSCLC)... All
patients will be tested for biomarkers, and the results will provide a wealth of
information on the role of tivantinib in treating nonsquamous NSCLC.
Pharmacogenetic analysis of BR.21, a placebo-controlled randomized phase III
clinical trial of erlotinib in advanced non-small cell lung cancer. 
(EGFR), ABCG2, and AKT1 genetic polymorphisms were performed... CONCLUSIONS: In contrast to previous publications, carrying shorter alleles of
A randomized, phase II, biomarker-selected study comparing erlotinib to erlotinib intercalated with chemotherapy in first-line therapy for advanced non-small-cell lung cancer. [2011.09.10]
PURPOSE: Erlotinib prolongs survival in patients with advanced non-small-cell lung cancer (NSCLC). We report the results of a randomized, phase II study of erlotinib alone or intercalated with chemotherapy (CT + erlotinib) in chemotherapy-naive patients with advanced NSCLC who were positive for epidermal growth factor receptor (EGFR) protein expression and/or with high EGFR gene copy number... CONCLUSION: The feasibility of a multicenter biomarker-driven study was demonstrated, but neither treatment arms exceeded historical controls. This study does not support combined chemotherapy and erlotinib in first-line treatment of EGFR-selected advanced NSCLC, and the patients with tumors harboring EGFR mutations had a better outcome on erlotinib alone.
Clinical Trials Related to Tarceva (Erlotinib)
Erlotinib (Tarceva) vs. Standard Chemotherapy (Paclitaxel and Carboplatin) in Patients With Advanced NSCLC and ECOG PS 2 [Active, not recruiting]
The purpose of this study is to obtain preliminary estimates of the efficacy of erlotinib and standard chemotherapy in patients with advanced, previously untreated NSCLC and an ECOG PS of 2. The study will also evaluate the safety of single-agent erlotnib in this patient population.
Study of OSI-774 (Tarceva) in Previously Untreated Elderly Lung Cancer Patients [Active, not recruiting]
The primary purpose of this study is to determine whether the drug OSI-774 is less toxic and potentially as good as or better than standard chemotherapy drugs, when given to subjects with non-small cell lung cancer, who are 70 years of age or older.
Safety Study of Radiotherapy and Concurrent Erlotinib (TarcevaŽ) for Brain Metastases From a Non-Small Cell Lung Cancer [Recruiting]
Lung cancer is a leading cause of death worldwide. Brain metastases manifest as the first site of disease failure in between 15-30% of patients with non-small cell lung cancer (NSCLC). The standard treatment for patients with multiple brain metastases is whole brain radiotherapy but this results in only a modest survival of 3-6 months. Drugs that can enhance the effect of cranial irradiation (radiosensitizers) may improve the the response rates. Erlotinib (Tarceva) is an oral agent that has been registered for treatment in patients with metastatic NSCLC. Erlotinib has shown tumor activity in patients presenting with brain metastases, and preclinical studies show that it may be a radiosensitizer. As a prelude to studies investigating the combination of Erlotinib and cranial radiotherapy, the present study will be performed to evaluate the safety of combining both these treatments.
Study of Biological Effect of Tarceva (OSI-774) for Patients Stricken by ENT Epidermoid Carcinoma [Recruiting]
The purpose of this study is to evaluate the biological effect of Tarceva (OSI-774) from an inhibition of EGF tumor receptor tyrosine kinase activity's point of view, for patients who are carriers of head and neck epidermoid carcinoma.
OSI-774 (Tarceva) in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer [Completed]
The purpose of this study is to determine if OSI-774 will improve overall survival of
patients with incurable stage IIIB/IV non-small cell lung cancer compared to standard of
care. OSI-774 is a new type of drug under evaluation called an epidermal growth factor
receptor (EGFR). OSI-774 is an investigational drug that has not yet been approved by the
U. S. Food and Drug Administration (FDA).
Reports of Suspected Tarceva (Erlotinib) Side Effects
Disease Progression (66),
Neoplasm Malignant (66),
Incorrect Dose Administered (53),
Decreased Appetite (52),
Dyspnoea (52), more >>
Page last updated: 2013-02-10