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

Gemcitabine

Carboplatin

Docetaxel

Cisplatin

Mitogens

Erlotinib Hydrochloride

Tubulin Modulators

Antimitotic Agents

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Antimetabolites

Tyrosine

Erlotinib (Tarceva)150 mg /day

Patients will receive treatment until disease progression or unacceptable toxicity.

For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib

4 cycles of Chemotherapy:

Cisplatin / Gemcitabine; Cisplatin /Docetaxel; Carboplatin / Gemcitabine; Carboplatin / Docetaxel.

- Cisplatin plus docetaxel: cisplatin 75 mg/m2 i.v. day 1 and docetaxel 75 mg/m2 i.v.

day 1. Repeat cycles every 3 weeks.

- Cisplatin plus gemcitabine: Cisplatin 75 mg/m2 i.v. on day 1 and gemcitabine 1250 mg/m2 on days 1 and 8. Repeat cycles every 3 weeks.

In the case of patients not eligible for treatment with cisplatin, cisplatin can be replaced by carboplatin. The schedules will be the following:

Docetaxel 75 mg/m2 day 1 and carboplatin AUC = 6 day 1, every 21 days.

Gemcitabine 1000 mg/m2 days 1 and 8 and carboplatin AUC = 5 day 1, every 21 days.

Patients in the chemotherapy arm will receive the treatment until disease progression or unacceptable toxicity occurs, or until a maximum of 4 treatment cycles are given.

150 mg/day Patients will receive treatment until disease progression or unacceptable toxicity.

For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib

Erlotinib

Gemcitabine 1000 mg/m2 days 1 and 8 and Carboplatin AUC = 5 day 1, every 21 days.

Docetaxel (75 mg/m2) /carboplatin (AUC=6); Gemcitabine (1000 mg/m2; day 1 and 8) / Carboplatin (AUC=5)

Patients in the chemotherapy arm will receive the treatment until disease progression or unacceptable toxicity occurs, or until a maximum of 4 treatment cycles are given.

Cisplatin (75 mg/m2) / Gemcitabine (1250 mg/m2; day 1 and 8) Patients in the chemotherapy arm will receive the treatment until disease progression or unacceptable toxicity occurs, or until a maximum of 4 treatment cycles are given.

Gemcitabin

Cisplatin (75 mg/m2) / Docetaxel (75 mg/m2) Patients in the chemotherapy arm will receive the treatment until disease progression or unacceptable toxicity occurs, or until a maximum of 4 treatment cycles are given.

Rafael Rosell i Costa, MD

Luis Paz-Ares, MD

A Phase III, multicenter, open-label, randomized trial of Erlotinib (Tarceva®) versus chemotherapy in patients with advanced NSCLC with mutations in the Tyrosine Kinase (TK) domain of the EGFR.

This is a multicenter, phase III, randomized, open-label clinical trial.

146 patients with a diagnosis of advanced (stage IIIB and stage IV), non-squamous-cell, non-small-cell pulmonary carcinoma not treated previously for their disease with chemotherapy who present mutation in the tyrosine kinase domain of the epidermal growth factor receptor, EGFR will be recluted.

The primary objective is to compare the progression-free survival in both treatment arms of the study (conventional chemotherapy vs. erlotinib) in patients with non-squamous-cell, non-small-cell lung cancer (NSCLC) in advanced stage (stages IIIB and stage IV) who have not received previous chemotherapy for their disease and who present mutations in the tyrosine kinase domain of the epidermal growth factor receptor (EGFR).

Phase III Study (Tarceva®) vs Chemotherapy to Treat Advanced Non-Small Cell Lung Cancer in Patients With Mutations in the TK Domain of EGFR

Phase III, Multicenter, Open-label, Randomized Trial of Tarceva® vs Chemotherapy in Patients With Advanced NSCLC With Mutations in the TK Domain of the EGFR

The time from enrollment in the study to tumor progression or death from any cause (whichever occurs first)

The objective response rate is defined as the percentage of patients who attain complete response (CR) or partial response (PR); response will be evaluated following RECIST criteria.

Proportion of patients who are still alive one year after enrollment in the study.

Overall survival will be assessed from the date of enrollment in the study until the date of death from any cause. Patients lost to follow-up will be censured on the date of the last follow-up visit.

Occurrence and severity of adverse events, with severity determined by NCI CTCAE v3.0 criteria

Changes in the scores obtained with the LCSS validated questionnaire throughout the course of the study will be analyzed to assess change in the patient's quality of life.

The study of mutations in serum (serum DNA)

Spanish Lung Cancer Group

Concentrations of erlotinib were measured from the samples collected over a 72 hour interval after receiving either Erotinib generic or Tarceva original. Later, after 14 days, a crossover was took place with the same measures.

dosing in each period.

Erlotinib HCl 150 mg

Tarceva®

Theobjectiveofthisstudyistoevaluatethecomparativebioavailabilitybetween:

* ErlotinibHCl150mgTablets(Novopharm Limited,Canada)and
* Tarceva® 150mgTablets(Hoffmann-LaRocheLimited,Canada) afterasingle-doseinhealthysubjectsunderfastingconditions.

This is a blinded,single-dose,randomized,two-period,two-sequence,two-treatment,cross over study, designed to evaluate the comparative bioavailability of two formulations of erlotinib HCl 150mg tablets administered to healthy male and female subjects under fasting conditions.

• SubjectswererandomlyassignedtooneofthetwodosingsequencesABorBA underfasting conditions.

Based on the log-transformed parameters, the following criteria were used to evaluate the bioequivalence between the test and reference products:

* The 90% confidence interval of the relative mean AUCt of the test to reference products should be between80% and125%.
* TherelativemeanCmaxofthetesttoreferenceproductsshouldbebetween80% and125%

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase III Study (Tarceva®) vs Chemotherapy to Treat Advanced Non-Small Cell Lung Cancer in Patients With Mutations in the TK Domain of EGFR	NCT00446225	Non-Small Cell ...	Erlotinib Carboplatin Gemcitabin Docetaxel Cisplatin	18 Years -	Spanish Lung Cancer Group
A Single-Dose,ComparativeBioavailability Study ofTwo Formulations ofErlotinib150mgTabletsunderFastingConditions	NCT04145570	Lung Cancer	Erlotinib HCl 1... Tarceva®	18 Years - 55 Years	Quadras Scientific Solutions
A Single-Dose,ComparativeBioavailability Study ofTwo Formulations ofErlotinib150mgTabletsunderFastingConditions	NCT04145570	Lung Cancer	Erlotinib HCl 1... Tarceva®	18 Years - 55 Years	Quadras Scientific Solutions

Spots Global Cancer Trial Database for tarceva®

Every month we try and update this database with for tarceva® cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for tarceva®

Every month we try and update this database with for tarceva® cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for tarceva® cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.