MedDataX Logo

A Study of Tarceva (Erlotinib) Monotherapy in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

NCT ID: NCT01996332

Last Updated: 2014-07-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

1805 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2012-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will evaluate the efficacy and safety of oral Tarceva in patients with advanced NSCLC for whom Tarceva monotherapy is considered the best therapeutic option. The anticipated time on study treatment is 3-12 months.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

An Observational Study of Tarceva (Erlotinib) in Patients With Non-Small Cell Lung Cancer

NCT01488331

Non-Squamous Non-Small Cell Lung Cancer
COMPLETED

A Study of Tarceva (Erlotinib) as First Line Therapy in Participants With Non-Small Cell Lung Cancer Harbouring Epidermal Growth Factor Receptor (EGFR) Mutations

NCT01310036

Non-Squamous Non-Small Cell Lung Cancer
COMPLETED PHASE2

An Expanded Access Program of Tarceva (Erlotinib) in Participants With Advanced Non-Small Cell Lung Cancer (NSCLC)

NCT00949910

Non-Small Cell Lung Cancer
COMPLETED PHASE4

An Observational Study of Tarceva (Erlotinib) in Routine Practice For First Line Maintenance Therapy in Patients With Non Small Cell Lung Cancer

NCT01194050

Non-Squamous Non-Small Cell Lung Cancer
COMPLETED

A Study of Erlotinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor Mutations

NCT01260181

Non-Squamous Non-Small Cell Lung Cancer
COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non-Small Cell Lung Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Tarceva Arm

Group Type EXPERIMENTAL

erlotinib [Tarceva]

Intervention Type DRUG

150 mg/day until progressive disease or unacceptable toxicity

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

erlotinib [Tarceva]

150 mg/day until progressive disease or unacceptable toxicity

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* adult patients \>=18 years of age;
* locally advanced or metastatic NSCLC (Stage IIIB or IV);
* not a candidate for curative surgery or radical chemotherapy;
* no brain metastases, or clinically stable metastases for \>=2 months.

Exclusion Criteria

* radiotherapy over the previous 2 weeks;
* weight loss \>10% in the previous 6 weeks.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clinical Trials

Role: STUDY_CHAIR

Hoffmann-La Roche

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Alcoy, Alicante, Spain

Site Status

Alicante, Alicante, Spain

Site Status

Elche, Alicante, Spain

Site Status

Almería, Almeria, Spain

Site Status

Ávila, Avila, Spain

Site Status

Badajoz, Badajoz, Spain

Site Status

Don Benito, Badajoz, Spain

Site Status

Mérida, Badajoz, Spain

Site Status

Ibiza Town, Balearic Islands, Spain

Site Status

Palma de Mallorca, Balearic Islands, Spain

Site Status

Palma de Mallorca, Balearic Islands, Spain

Site Status

Palma de Mallorca, Balearic Islands, Spain

Site Status

Badalona, Barcelona, Spain

Site Status

Barcelona, Barcelona, Spain

Site Status

Barcelona, Barcelona, Spain

Site Status

Barcelona, Barcelona, Spain

Site Status

Barcelona, Barcelona, Spain

Site Status

Barcelona, Barcelona, Spain

Site Status

Barcelona, Barcelona, Spain

Site Status

Barcelona, Barcelona, Spain

Site Status

Barcelona, Barcelona, Spain

Site Status

Barcelona, Barcelona, Spain

Site Status

Granollers, Barcelona, Spain

Site Status

Manresa, Barcelona, Spain

Site Status

Mataró, Barcelona, Spain

Site Status

Sabadell, Barcelona, Barcelona, Spain

Site Status

Sant Coloma Gramenet, Barcelona, Spain

Site Status

Sant Pere de Ribes, Barcelona, Spain

Site Status

Terrassa, Barcelona, Spain

Site Status

Vic, Barcelona, Spain

Site Status

Burgos, Burgos, Spain

Site Status

Cáceres, Caceres, Spain

Site Status

Algeciras, Cadiz, Spain

Site Status

Cadiz, Cadiz, Spain

Site Status

Jerez de la Frontera, Cadiz, Spain

Site Status

Puerto Real, Cadiz, Spain

Site Status

Santander, Cantabria, Spain

Site Status

Torrevieja, Cantabria, Spain

Site Status

Castellon, Castellon, Spain

Site Status

Córdoba, Cordoba, Spain

Site Status

Girona, Girona, Spain

Site Status

Baza, Granada, Spain

Site Status

Granada, Granada, Spain

Site Status

Granada, Granada, Spain

Site Status

Donostia / San Sebastian, Guipuzcoa, Spain

Site Status

Huelva, Huelva, Spain

Site Status

Jaén, Jaen, Spain

Site Status

A Coruña, La Coruña, Spain

Site Status

A Coruña, La Coruña, Spain

Site Status

Ferrol, La Coruña, Spain

Site Status

Las Palmas de Gran Canaria, Las Palmas, Spain

Site Status

Las Palmas de Gran Canaria, Las Palmas, Spain

Site Status

León, Leon, Spain

Site Status

Lleida, Lerida, Spain

Site Status

Lugo, Lugo, Spain

Site Status

Alcorcón, Madrid, Spain

Site Status

Madrid, Madrid, Spain

Site Status

Madrid, Madrid, Spain

Site Status

Madrid, Madrid, Spain

Site Status

Madrid, Madrid, Spain

Site Status

Madrid, Madrid, Spain

Site Status

Madrid, Madrid, Spain

Site Status

Madrid, Madrid, Spain

Site Status

Madrid, Madrid, Spain

Site Status

Madrid, Madrid, Spain

Site Status

Madrid, Madrid, Spain

Site Status

Málaga, Malaga, Spain

Site Status

Cartagena, Murcia, Spain

Site Status

Murcia, Murcia, Spain

Site Status

Murcia, Murcia, Spain

Site Status

Navarra, Navarre, Spain

Site Status

Pamplona, Navarre, Spain

Site Status

Ourense, Orense, Spain

Site Status

Palencia, Palencia, Spain

Site Status

Vigo, Pontevedra, Spain

Site Status

Vigo, Pontevedra, Spain

Site Status

Salamanca, Salamanca, Spain

Site Status

Segovia, Segovia, Spain

Site Status

Seville, Sevilla, Spain

Site Status

Seville, Sevilla, Spain

Site Status

Seville, Sevilla, Spain

Site Status

San Cristóbal de La Laguna, Tenerife, Spain

Site Status

Santa Cruz de Tenerife, Tenerife, Spain

Site Status

Sagunto, Valencia, Spain

Site Status

Valencia, Valencia, Spain

Site Status

Valencia, Valencia, Spain

Site Status

Valencia, Valencia, Spain

Site Status

Valencia, Valencia, Spain

Site Status

Valencia, Valencia, Spain

Site Status

Valencia, Valencia, Spain

Site Status

Valladolid, Valladolid, Spain

Site Status

Barakaldo, Vizcaya, Spain

Site Status

Bilbao, Vizcaya, Spain

Site Status

Zaragoza, Zaragoza, Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ML17915

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

An Observational Study of Tarceva (Erlotinib) in Elderly Patients With Advanced Non-Small Cell Lung Cancer
NCT01535729 COMPLETED
A Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (TRIGGER)
NCT01378962 COMPLETED PHASE2
A Study of First or Second Line Treatment With Tarceva (Erlotinib) in Patients With Advanced Non-Small Cell Lung Cancer
NCT01066884 COMPLETED PHASE4
A Study Examining Long Response in Lung Cancer Patients Treated With Tarceva (Erlotinib)
NCT02133508 COMPLETED
A Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Following 4 Cycles of Platinum-based Chemotherapy Without Disease Progression
NCT01230710 COMPLETED PHASE4
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 COMPLETED PHASE2
A Study of Tarceva (Erlotinib) in First Line in Patients With Locally Advanced or Metastatic Lung Adenocarcinoma With EGFR Mutations
NCT01609543 COMPLETED PHASE4
A Study of Erlotinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
NCT01667562 COMPLETED PHASE3
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 COMPLETED PHASE3
A Study of Tarceva (Erlotinib) to Compare Two Different Doses in in Currently Smoking Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (CURRENTS)
NCT01183858 COMPLETED PHASE3
A Study of the Effect of R1507 in Combination With Tarceva (Erlotinib) on Progression-Free Survival in Patients With Stage IIIb/IV Non-Small Cell Lung Cancer (NSCLC) Having Received Tarceva Monotherapy.
NCT00773383 TERMINATED PHASE2
A Non-interventional Trial of Erlotinib (Tarceva) Metastatic Non-small Cell Lung Cancer
NCT02595450 COMPLETED
A Study of Tarceva (Erlotinib) in Patients With Locally Advanced, Metastatic or Recurrent Non-Small Cell Cancer Who Present Epidermal Growth Factor Receptor Mutations
NCT01372384 COMPLETED PHASE2
A Study on the Correlation Between Tarceva (Erlotinib) - Induced Rash and Efficacy in EGFR Mutated Participants With Advanced Non-Small Cell Lung Cancer Receiving First-Line Therapy
NCT01174563 COMPLETED PHASE2
A Study to Assess the Incidence of EGFR Mutation in Patients With Newly Diagnosed Locally Advanced or Metastatic Non-Small Cell Lung Cancer in the UK, And of Tarceva (Erlotinib) as First-Line Therapy in EGFR Mutation Positive Patients.
NCT01250119 COMPLETED PHASE2
Erlotinib as First-line Treatment of Advanced Non-small Cell Lung Cancer (NSCLC) for Patients Unfit for Chemotherapy
NCT00452075 TERMINATED PHASE2
Study of Erlotinib (Tarceva®) in Combination With OSI-906 in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) With Activating Mutations of the Epidermal Growth Factor Receptor (EGFR) Gene
NCT01221077 COMPLETED PHASE2
A Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Who Present EGFR Mutations
NCT01287754 COMPLETED PHASE4
An Observational Study of Tarceva (Erlotinib) in Previously Treated Patients With Advanced Non-Small Cell Lung Cancer With Wild-Type Epidermal Growth Factor Receptor (EGFR) Gene (WILT)
NCT01512420 COMPLETED
Erlotinib (Tarceva) as a Single Agent or Intercalated With Combination Chemotherapy in Patients With EGFR Positive NSCLC
NCT00294762 COMPLETED PHASE2
A Pharmacokinetic Study of Erlotinib in Cancer Patients With Advanced Solid Tumors, With Adequate and Moderately Impaired Hepatic Function
NCT00139620 COMPLETED PHASE1
A Phase 2 Study of Tarceva for Untreated, Good Prognosis Patients With Advanced Non-Small Cell Lung Cancer
NCT00585533 COMPLETED PHASE2
An Observational Study of Tarceva (Erlotinib) in First Line in Patients With Advanced EGFR Mutation-Positive Non-Small Cell Lung Cancer (GERTAC)
NCT01790217 COMPLETED
A Study of Erlotinib (Tarceva) Versus Gemcitabine/Cisplatin as First-line Treatment in Patients With Non-small Cell Lung Cancer With EGFR Mutations
NCT01342965 COMPLETED PHASE3
A Study of First Line Treatment With Tarceva (Erlotinib) in Combination With Gemcitabine in Patients With Unresectable Advanced and/or Metastatic Non-Small Cell Lung Cancer
NCT00701558 COMPLETED PHASE2