A Study of Tarceva (Erlotinib) and Standard of Care Chemotherapy in Patients With Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer (NSCLC)

NCT ID: NCT00556322

Last Updated: 2015-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 424 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2012-06-30

Brief Summary

This 2 arm study will evaluate the efficacy, safety, and pharmacokinetics of Tarceva and that of standard of care chemotherapy in patients with advanced, recurrent, or metastatic NSCLC experiencing disease progression after failure of platinum-based chemotherapy.Eligible patients will be randomized to receive either Tarceva 150mg po daily, or comparator (either Alimta 500mg/m2 every 3 weeks, or Taxotere 75mg/m2 every 3 weeks). The anticipated time on study treatment is until disease progression ,and the target sample size is 500+ individuals.

Conditions

Non-Small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

erlotinib [Tarceva]

Intervention Type: DRUG

150mg po daily

2

Group Type: ACTIVE_COMPARATOR

Alimta or Taxotere

Intervention Type: DRUG

500mg/m2 / 3 weeks (Alimta) or 75mg/m2 / 3 weeks (Taxotere)

Interventions

erlotinib [Tarceva]

150mg po daily

Intervention Type: DRUG

Alimta or Taxotere

500mg/m2 / 3 weeks (Alimta) or 75mg/m2 / 3 weeks (Taxotere)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• adult patients >=18 years of age;
• histologically documented, locally advanced or recurrent or metastatic NSCLC;
• measurable disease;
• disease progression during 1-4 cycles of platinum-based chemotherapy.

Exclusion Criteria

• any other malignancies within the last 5 years;
• unstable systemic disease.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

St Leonards, New South Wales, Australia

Waratah, New South Wales, Australia

Adelaide, South Australia, Australia

East Bentleigh, Victoria, Australia

Fitzroy, Victoria, Australia

Geelong, Victoria, Australia

Melbourne, Victoria, Australia

Innsbruck, , Austria

Klagenfurt, , Austria

Vienna, , Austria

Vienna, , Austria

Antwerp, , Belgium

Winnipeg, Manitoba, Canada

Oshawa, Ontario, Canada

Sault Ste. Marie, Ontario, Canada

Toronto, Ontario, Canada

Laval, Quebec, Canada

Montreal, Quebec, Canada

Santiago, , Chile

Beijing, , China

Guangzhou, , China

Guangzhou, , China

Shanghai, , China

České Budějovice, , Czechia

Olomouc, , Czechia

Pilsen, , Czechia

Herlev, , Denmark

Odense, , Denmark

Bayonne, , France

Brest, , France

Clermont-Ferrand, , France

Dijon, , France

Le Mans, , France

Lille, , France

Limoges, , France

Paris, , France

Pau, , France

Toulouse, , France

Vandœuvre-lès-Nancy, , France

Bad Berka, , Germany

Bochum, , Germany

Halle, , Germany

Herne, , Germany

Neuruppin, , Germany

Villingen-Schwenningen, , Germany

Athens, , Greece

Athens, , Greece

Heraklion, , Greece

Budapest, , Hungary

Budapest, , Hungary

Deszk, , Hungary

Nyíregyháza, , Hungary

Pécs, , Hungary

Szombathely, , Hungary

Törökbálint, , Hungary

Bologna, Emilia-Romagna, Italy

Rome, Lazio, Italy

Ancona, The Marches, Italy

Kaunas, , Lithuania

Klaipėda, , Lithuania

Vilnius, , Lithuania

George Town, , Malaysia

Kuala Lumpur, , Malaysia

Auckland, , New Zealand

Christchurch, , New Zealand

Lodz, , Poland

Lodz, , Poland

Otwock, , Poland

Bucharest, , Romania

Cluj-Napoca, , Romania

Iași, , Romania

Timișoara, , Romania

Arkhangelsk, , Russia

Balashikha, , Russia

Chelyabinsk, , Russia

Kazan', , Russia

Kazan', , Russia

Kirov, , Russia

Krasnodar, , Russia

Krasnodar, , Russia

Kuzmolovo, , Russia

Moscow, , Russia

Moscow, , Russia

Moscow, , Russia

Moscow, , Russia

Nizhny Novgorod, , Russia

Perm, , Russia

Saint Petersburg, , Russia

Saint Petersburg, , Russia

Saint Petersburg, , Russia

Saint Petersburg, , Russia

Sashi, , Russia

Smolensk, , Russia

Yaroslavl, , Russia

Banská Bystrica, , Slovakia

Bratislava, , Slovakia

Nitra, , Slovakia

Poprad, , Slovakia

Golnik, , Slovenia

Ljubljana, , Slovenia

Maribor, , Slovenia

Durban, , South Africa

Johannesburg, , South Africa

Pretoria, , South Africa

Daegu, , South Korea

Seoul, , South Korea

Seoul, , South Korea

Seoul, , South Korea

Seoul, , South Korea

Seoul, , South Korea

Suwon, , South Korea

Santander, Cantabria, Spain

A Coruña, La Coruña, Spain

Oviedo, Principality of Asturias, Spain

Zaragoza, Zaragoza, Spain

Kharkiv, , Ukraine

Uzhhorod, , Ukraine

Zaporizhzhya, , Ukraine

Chelmsford, , United Kingdom

Dundee, , United Kingdom

Leicester, , United Kingdom

Plymouth, , United Kingdom

Caracas, , Venezuela

Countries

Australia; Austria; Belgium; Canada; Chile; China; Czechia; Denmark; France; Germany; Greece; Hungary; Italy; Lithuania; Malaysia; New Zealand; Poland; Romania; Russia; Slovakia; Slovenia; South Africa; South Korea; Spain; Ukraine; United Kingdom; Venezuela

References

Ciuleanu T, Stelmakh L, Cicenas S, Miliauskas S, Grigorescu AC, Hillenbach C, Johannsdottir HK, Klughammer B, Gonzalez EE. Efficacy and safety of erlotinib versus chemotherapy in second-line treatment of patients with advanced, non-small-cell lung cancer with poor prognosis (TITAN): a randomised multicentre, open-label, phase 3 study. Lancet Oncol. 2012 Mar;13(3):300-8. doi: 10.1016/S1470-2045(11)70385-0. Epub 2012 Jan 24.

Reference Type: DERIVED

PMID: 22277837 (View on PubMed)

Other Identifiers

BO18602

Identifier Type: -

Identifier Source: org_study_id