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

NCT00556322 | Completed Phase 3 Results

• 1 other identifier: BO18602
• Study Type: interventional
• Target: 424
• Locations: 25 countries
• Sites: 112

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

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants Who Died (All Participants; Data Cutoff: 07 September 2010)

  Overall survival (OS) was determined from the date of randomization to the date of death irrespective of the cause of death.

  Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 or Death and Every 12 Weeks until Death or Data Cut off (07 September 2010) up to 52 months

• Duration of Overall Survival in All Participants (Data Cutoff 07 September 2010)

  OS was determined from the date of randomization to the date of death irrespective of the cause of death. Kaplan-Meier estimates were used for analysis.

  Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Death or Until Data Cut off (07 September 2010) up to 52 months

• Probable Percentage of Participants Remaining Alive at 1 Year

  OS was determined from the date of randomization to the date of death irrespective of the cause of death. Kaplan-Meier estimates were used for analysis.

  1 Year

Secondary Outcomes (19)

• Percentage of Participants Who Died in Epidermal Growth Factor Receptor (EGFR) Positive and Negative Population

  Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Death or Until Data Cut off (07 September 2010) up to 52 months

• Duration of OS in EGFR Positive and Negative Population

  Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Death or Until Data Cut off (07 September 2010) up to 52 months

• Probable Percentage of Participants Remaining Alive at 1 Year in the EGFR Positive and Negative Population

  1 Year

• Percentage of Participants With Disease Progression or Death (All Participants; Data Cut Off 07 September 2010)

  Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity or Until Data Cut off (07 September 2010) up to 52 months

• Progression-Free Survival (PFS) in All Participants (Data Cutoff 07 September 2010)

  Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity or Until Data Cut off (07 September 2010) up to 52 months

Study Arms (2)

1

EXPERIMENTAL

Drug: erlotinib [Tarceva]

2

ACTIVE COMPARATOR

Drug: Alimta or Taxotere

Interventions

Alimta or Taxotere DRUG

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

2

erlotinib [Tarceva] DRUG

150mg po daily

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (123)

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St Leonards, New South Wales, 2065, Australia

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Waratah, New South Wales, 2298, Australia

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Adelaide, South Australia, 5041, Australia

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East Bentleigh, Victoria, VIC 3165, Australia

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Fitzroy, Victoria, 3065, Australia

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Geelong, Victoria, 3220, Australia

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Melbourne, Victoria, 3084, Australia

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Innsbruck, 6020, Austria

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Klagenfurt, 9010, Austria

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Vienna, 1140, Austria

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Vienna, 1145, Austria

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Antwerp, 2020, Belgium

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Winnipeg, Manitoba, R3E 0V9, Canada

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Oshawa, Ontario, L1G 2B9, Canada

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Sault Ste. Marie, Ontario, P6A 2C4, Canada

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Toronto, Ontario, M4C 3E7, Canada

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Laval, Quebec, H7M 3L9, Canada

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Montreal, Quebec, H4J 1C5, Canada

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Santiago, 0000, Chile

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Beijing, 100730, China

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Guangzhou, 510060, China

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Guangzhou, 510080, China

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Shanghai, 200032, China

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České Budějovice, 370 87, Czechia

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Olomouc, 775 20, Czechia

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Pilsen, 305 99, Czechia

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Herlev, 2730, Denmark

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Odense, 5000, Denmark

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Bayonne, 64100, France

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Brest, 29200, France

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Clermont-Ferrand, 63003, France

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Dijon, 21079, France

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Le Mans, 72037, France

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Lille, 59020, France

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Limoges, 87042, France

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Paris, 75674, France

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Pau, 64046, France

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Toulouse, 31400, France

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Vandœuvre-lès-Nancy, 54511, France

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Bad Berka, 99437, Germany

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Bochum, 44791, Germany

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Halle, 06120, Germany

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Herne, 44625, Germany

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Neuruppin, 16816, Germany

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Villingen-Schwenningen, 78052, Germany

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Athens, 11527, Greece

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Athens, 14564, Greece

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Heraklion, 71110, Greece

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Budapest, 1125, Hungary

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Budapest, 1529, Hungary

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Deszk, 6772, Hungary

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Nyíregyháza, 4400, Hungary

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Pécs, 7635, Hungary

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Szombathely, 9700, Hungary

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Törökbálint, 2045, Hungary

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Bologna, Emilia-Romagna, 40139, Italy

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Rome, Lazio, 00168, Italy

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Ancona, The Marches, Italy

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Kaunas, Lithuania

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Klaipėda, 92288, Lithuania

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Vilnius, 08660, Lithuania

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George Town, 11200, Malaysia

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Kuala Lumpur, 59100, Malaysia

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Auckland, 1009, New Zealand

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Christchurch, New Zealand

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Lodz, 91-520, Poland

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Lodz, 94-306, Poland

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Otwock, 05-400, Poland

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Bucharest, 022328, Romania

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Cluj-Napoca, 400015, Romania

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Iași, 6600, Romania

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Timișoara, 1900, Romania

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Arkhangelsk, 163045, Russia

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Balashikha, 143900, Russia

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Chelyabinsk, 454 087, Russia

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Kazan', 420029, Russia

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Kazan', 420111, Russia

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Kirov, Russia

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Krasnodar, 350040, Russia

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Krasnodar, Russia

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Kuzmolovo, 188663, Russia

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Moscow, 105203, Russia

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Moscow, 105229, Russia

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Moscow, 115478, Russia

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Moscow, 117837, Russia

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Nizhny Novgorod, 603000, Russia

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Perm, 614 066, Russia

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Saint Petersburg, 191015, Russia

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Saint Petersburg, 195067, Russia

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Saint Petersburg, 197022, Russia

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Saint Petersburg, Russia

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Sashi, 354057, Russia

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Smolensk, Russia

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Yaroslavl, 150054, Russia

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Banská Bystrica, 975 17, Slovakia

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Bratislava, 825 56, Slovakia

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Nitra, 949 88, Slovakia

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Poprad, 058 87, Slovakia

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Golnik, Slovenia

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Ljubljana, 1000, Slovenia

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Maribor, Slovenia

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Durban, 4091, South Africa

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Johannesburg, 2196, South Africa

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Pretoria, 0001, South Africa

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Daegu, 700-712, South Korea

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Seoul, 110-744, South Korea

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Seoul, 120-752, South Korea

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Seoul, 135-710, South Korea

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Seoul, 138-736, South Korea

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Seoul, 139-709, South Korea

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Suwon, South Korea

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Santander, Cantabria, 39008, Spain

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A Coruña, La Coruña, 15006, Spain

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Oviedo, Principality of Asturias, 33006, Spain

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Zaragoza, Zaragoza, 50009, Spain

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Kharkiv, 61024, Ukraine

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Uzhhorod, 88000, Ukraine

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Zaporizhzhya, 69104, Ukraine

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Chelmsford, CM1 7ET, United Kingdom

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Dundee, DD1 9SY, United Kingdom

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Leicester, LE1 5WW, United Kingdom

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Plymouth, PL6 8DH, United Kingdom

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Caracas, 1062, Venezuela

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Related Publications (1)

• 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.

  PMID: 22277837 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Pemetrexed; Docetaxel; Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Quinazolines

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann- LaRoche

genentech@druginfo.com

1-800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2007
• First Posted: November 12, 2007
• Study Start: March 1, 2006
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: February 23, 2015
• Results First Posted: February 23, 2015

Record last verified: 2015-02

Locations

RU (22); CZ (3); DK (2); MY (2); SL (3); AU (4); ES (4); FR (11); DE (6); KR (7); RO (4); UA (3); GR (3); BE (1); GB (4); CA (6); NZ (2); PL (3); CL (1); HU (7); ZA (3); VE (1); IT (3); LI (3); CN (4)