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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00556322
First received: November 9, 2007
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: Alimta or Taxotere
Drug: erlotinib [Tarceva]
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Randomized Study to Evaluate the Effect of Tarceva, Compared With Alimta (Pemetrexed) or Taxotere (Docetaxel),on Survival in Patients With Advanced, Recurrent or Metastatic Non-small Cell Lung Cancer Who Have Experienced Disease Progression During Platinum-based Chemotherapy

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Overall survival [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PFS, time to progression, objective response, duration of response [ Time Frame: Event driven ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 417
Study Start Date: March 2006
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: erlotinib [Tarceva]
150mg po daily
Active Comparator: 2 Drug: Alimta or Taxotere
500mg/m2 / 3 weeks (Alimta) or 75mg/m2 / 3 weeks (Taxotere)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00556322

  Hide Study Locations
Locations
Australia, New South Wales
St. Leonards, New South Wales, Australia, 2065
Waratah, New South Wales, Australia, 2298
Australia, South Australia
Adelaide, South Australia, Australia, 5041
Australia, Victoria
East Bentleigh, Victoria, Australia, VIC 3165
Fitzroy, Victoria, Australia, 3065
Geelong, Victoria, Australia, 3220
Melbourne, Victoria, Australia, 3084
Austria
Innsbruck, Austria, 6020
Klagenfurt, Austria, 9010
Wien, Austria, 1140
Wien, Austria, 1145
Belgium
Antwerpen, Belgium, 2020
Canada, Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Ontario
Oshawa, Ontario, Canada, L1G 2B9
Sault Ste Marie, Ontario, Canada, P6A 2C4
Toronto, Ontario, Canada, M4C 3E7
Canada, Quebec
Laval, Quebec, Canada, H7M 3L9
Montreal, Quebec, Canada, H4J 1C5
Chile
Santiago, Chile, 0000
China
Beijing, China, 100730
Guangzhou, China, 510060
Guangzhou, China, 510080
Shanghai, China, 200032
Czech Republic
Ceské Budejovice, Czech Republic, 370 87
Olomouc, Czech Republic, 775 20
Plzen, Czech Republic, 305 99
Denmark
Herlev, Denmark, 2730
Odense, Denmark, 5000
France
Bayonne, France, 64100
Brest, France, 29200
Clermont-ferrand, France, 63003
Dijon, France, 21079
Le Mans, France, 72037
Lille, France, 59020
Limoges, France, 87042
Paris, France, 75674
PAU, France, 64046
Toulouse, France, 31400
Vandoeuvre-les-nancy, France, 54511
Germany
Bad Berka, Germany, 99437
Bochum, Germany, 44791
Halle (Saale), Germany, 06120
Herne, Germany, 44625
Neuruppin, Germany, 16816
Villingen-Schwenningen, Germany, 78052
Greece
Athens, Greece, 14564
Athens, Greece, 11527
Heraklion, Greece, 71110
Hungary
Budapest, Hungary, 1529
Budapest, Hungary, 1125
Deszk, Hungary, 6772
Nyíregyháza, Hungary, 4400
Pecs, Hungary, 7635
Szombathely, Hungary, 9700
Torokbalint, Hungary, 2045
Italy
Bologna, Emilia-Romagna, Italy, 40139
Roma, Lazio, Italy, 00168
Ancona, Marche, Italy
Korea, Republic of
Daegu, Korea, Republic of, 700-712
Seoul, Korea, Republic of, 135-710
Seoul, Korea, Republic of, 120-752
Seoul, Korea, Republic of, 110-744
Seoul, Korea, Republic of, 138-736
Seoul, Korea, Republic of, 139-709
Suwon, Korea, Republic of
Lithuania
Kaunas, Lithuania
Klaipeda, Lithuania, 92288
Vilnius, Lithuania, 08660
Malaysia
Kuala Lumpur, Malaysia, 59100
Penang, Malaysia, 11200
New Zealand
Auckland, New Zealand, 1009
Christchurch, New Zealand
Poland
Lodz, Poland, 91-520
Lodz, Poland, 94-306
Otwock, Poland, 05-400
Romania
Bucuresti, Romania, 022328
Cluj Napoca, Romania, 400015
Iasi, Romania, 6600
Timisoara, Romania, 1900
Russian Federation
Arkhangelsk, Russian Federation, 163045
Balashikha, Russian Federation, 143900
Chelyabinsk, Russian Federation, 454 087
Kazan, Russian Federation, 420111
Kazan, Russian Federation, 420029
Kirov, Russian Federation
Krasnodar, Russian Federation, 350040
Krasnodar, Russian Federation
Kuzmolovo, Russian Federation, 188663
Moscow, Russian Federation, 117837
Moscow, Russian Federation, 105203
Moscow, Russian Federation, 115478
Moscow, Russian Federation, 105229
Nizhny Novgorod, Russian Federation, 603000
Perm, Russian Federation, 614 066
Smolensk, Russian Federation
Soshi, Russian Federation, 354057
St Petersburg, Russian Federation, 197022
St Petersburg, Russian Federation
St Petersburg, Russian Federation, 191015
St Petersburg, Russian Federation, 195067
Yaroslavl, Russian Federation, 150054
Slovakia
Banska Bystrica, Slovakia, 975 17
Bratislava, Slovakia, 825 56
Nitra, Slovakia, 949 88
Poprad, Slovakia, 058 87
Slovenia
Golnik, Slovenia
Ljubljana, Slovenia, 1000
Maribor, Slovenia
South Africa
Durban, South Africa, 4091
Johannesburg, South Africa, 2196
Pretoria, South Africa, 0001
Spain
Oviedo, Asturias, Spain, 33006
Santander, Cantabria, Spain, 39008
La Coruña, Spain, 15006
Zaragoza, Spain, 50009
Ukraine
Kharkov, Ukraine, 61024
Uzhgorod, Ukraine, 88000
Zaporozhye, Ukraine, 69104
United Kingdom
Chelmsford, United Kingdom, CM1 7ET
Dundee, United Kingdom, DD1 9SY
Leicester, United Kingdom, LE1 5WW
Plymouth, United Kingdom, PL6 8DH
Venezuela
Caracas, Venezuela, 1062
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00556322     History of Changes
Other Study ID Numbers: BO18602
Study First Received: November 9, 2007
Last Updated: March 3, 2014
Health Authority: Slovenia: Ministry of Health

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Erlotinib
Docetaxel
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on September 16, 2014