Clinical trial NCT00556322: A Study of Tarceva (Erlotinib) and Standard of Care Chemotherapy in Patients With Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer (NSCLC)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-11-12
Enrollment: 424
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of Participants Who Died (All Participants; Data Cutoff: 07 September 2010)
timeFrame: 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
measure: Duration of Overall Survival in All Participants (Data Cutoff 07 September 2010)
timeFrame: 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
measure: Probable Percentage of Participants Remaining Alive at 1 Year
timeFrame: 1 Year
Secondary outcomes:
measure: Percentage of Participants Who Died in Epidermal Growth Factor Receptor (EGFR) Positive and Negative Population
timeFrame: 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
measure: Duration of OS in EGFR Positive and Negative Population
timeFrame: 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
measure: Probable Percentage of Participants Remaining Alive at 1 Year in the EGFR Positive and Negative Population
timeFrame: 1 Year
measure: Percentage of Participants With Disease Progression or Death (All Participants; Data Cut Off 07 September 2010)
timeFrame: 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
measure: Progression-Free Survival (PFS) in All Participants (Data Cutoff 07 September 2010)
timeFrame: 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
measure: Probable Percentage of Participants Remaining Alive and Progression Free at 6 Months
timeFrame: 6 Months
measure: Percentage of Participants With Disease Progression or Death in EGFR Positive and Negative Population (Data Cut Off 07 September 2010)
timeFrame: Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months
measure: PFS in EGFR Positive and Negative Population (Data Cutoff 07 September 2010)
timeFrame: 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
measure: Probable Percentage of Participants Remaining Alive and Progression Free at 6 Months in EGFR Positive and Negative Population
timeFrame: 6 Months
measure: Percentage of Participants Achieving a Best Overall Response of Confirmed Complete Response (CR) or Partial Response (PR) as Assessed by the Investigator Using RECIST
timeFrame: Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity or Death or up to 52 months
measure: Percentage of Participants With Deterioration in Quality of Life Determined Using Functional Assessment of Cancer Therapy - Lung (FACT-L)
timeFrame: Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months
measure: Time to Deterioration in Quality of Life Using FACT-L
timeFrame: Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months
measure: Probable Percentage of Participants Remaining Without Deterioration in Quality of Life at 6 Months as Assessed by FACT-L
timeFrame: 6 Months
measure: Percentage of Participants With Symptomatic Progression Using FACT-L
timeFrame: Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months
measure: Time to Symptomatic Progression Using FACT-L
timeFrame: Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months
measure: Probable Percentage of Participants With Symptomatic Progression at 6 Months as Assessed by FACT-L
timeFrame: 6 Months
measure: Percentage of Participants With Deterioration in the Trial Outcome Index (TOI)
timeFrame: Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months
measure: Time to Deterioration in the TOI
timeFrame: Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months
measure: Probable Percentage of Participants With Deterioration in the TOI at 6 Months as Assessed by FACT-L
timeFrame: 6 Months
Other outcomes:
Locations:
city: St. Leonards
country: Australia
state: New South Wales
city: Waratah
country: Australia
state: New South Wales
city: Adelaide
country: Australia
state: South Australia
city: East Bentleigh
country: Australia
state: Victoria
city: Fitzroy
country: Australia
state: Victoria
city: Geelong
country: Australia
state: Victoria
city: Melbourne
country: Australia
state: Victoria
city: Innsbruck
country: Austria
city: Klagenfurt
country: Austria
city: Wien
country: Austria
city: Wien
country: Austria
city: Antwerpen
country: Belgium
city: Winnipeg
country: Canada
state: Manitoba
city: Oshawa
country: Canada
state: Ontario
city: Sault Ste Marie
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Laval
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Santiago
country: Chile
city: Beijing
country: China
city: Guangzhou
country: China
city: Guangzhou
country: China
city: Shanghai
country: China
city: Ceské Budejovice
country: Czech Republic
city: Olomouc
country: Czech Republic
city: Plzen
country: Czech Republic
city: Herlev
country: Denmark
city: Odense
country: Denmark
city: Bayonne
country: France
city: Brest
country: France
city: Clermont-ferrand
country: France
city: Dijon
country: France
city: Le Mans
country: France
city: Lille
country: France
city: Limoges
country: France
city: Paris
country: France
city: PAU
country: France
city: Toulouse
country: France
city: Vandoeuvre-les-nancy
country: France
city: Bad Berka
country: Germany
city: Bochum
country: Germany
city: Halle (Saale)
country: Germany
city: Herne
country: Germany
city: Neuruppin
country: Germany
city: Villingen-Schwenningen
country: Germany
city: Athens
country: Greece
city: Athens
country: Greece
city: Heraklion
country: Greece
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Deszk
country: Hungary
city: Nyíregyháza
country: Hungary
city: Pecs
country: Hungary
city: Szombathely
country: Hungary
city: Torokbalint
country: Hungary
city: Bologna
country: Italy
state: Emilia-Romagna
city: Roma
country: Italy
state: Lazio
city: Ancona
country: Italy
state: Marche
city: Daegu
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Suwon
country: Korea, Republic of
city: Kaunas
country: Lithuania
city: Klaipeda
country: Lithuania
city: Vilnius
country: Lithuania
city: Kuala Lumpur
country: Malaysia
city: Penang
country: Malaysia
city: Auckland
country: New Zealand
city: Christchurch
country: New Zealand
city: Lodz
country: Poland
city: Lodz
country: Poland
city: Otwock
country: Poland
city: Bucuresti
country: Romania
city: Cluj Napoca
country: Romania
city: Iasi
country: Romania
city: Timisoara
country: Romania
city: Arkhangelsk
country: Russian Federation
city: Balashikha
country: Russian Federation
city: Chelyabinsk
country: Russian Federation
city: Kazan
country: Russian Federation
city: Kazan
country: Russian Federation
city: Kirov
country: Russian Federation
city: Krasnodar
country: Russian Federation
city: Krasnodar
country: Russian Federation
city: Kuzmolovo
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Nizhny Novgorod
country: Russian Federation
city: Perm
country: Russian Federation
city: Smolensk
country: Russian Federation
city: Soshi
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: Yaroslavl
country: Russian Federation
city: Banska Bystrica
country: Slovakia
city: Bratislava
country: Slovakia
city: Nitra
country: Slovakia
city: Poprad
country: Slovakia
city: Golnik
country: Slovenia
city: Ljubljana
country: Slovenia
city: Maribor
country: Slovenia
city: Durban
country: South Africa
city: Johannesburg
country: South Africa
city: Pretoria
country: South Africa
city: Oviedo
country: Spain
state: Asturias
city: Santander
country: Spain
state: Cantabria
city: La Coruña
country: Spain
city: Zaragoza
country: Spain
city: Kharkov
country: Ukraine
city: Uzhgorod
country: Ukraine
city: Zaporozhye
country: Ukraine
city: Chelmsford
country: United Kingdom
city: Dundee
country: United Kingdom
city: Leicester
country: United Kingdom
city: Plymouth
country: United Kingdom
city: Caracas
country: Venezuela
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.