Clinical trial NCT00556712: A Study of Tarceva (Erlotinib) Following Platinum-Based Chemotherapy in Patients With Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Official title: A Randomized, Double-blind Study to Evaluate the Effect of Tarceva or Placebo Following Platinum-based CT on Overall Survival and Disease Progression in Patients With Advanced, Recurrent or Metastatic NSCLS Who Have Not Experienced Disease Progression or Unacceptable Toxicity During 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: 889
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, compared with placebo, following platinum-based chemotherapy in patients with advanced, recurrent, or metastatic NSCLC who have not had disease progression or unacceptable toxicity during chemotherapy. Following 4 cycles of platinum-based chemotherapy, eligible patients will be randomized to receive either Tarceva 150mg po daily, or placebo daily. The anticipated time on study treatment is until disease progression; the target sample size is 500+ individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients \>=18 years of age;
* histologically documented, locally advanced , recurrent or metastatic NSCLC;
* measurable disease;
* no disease progression after 4 cycles of platinum-based chemotherapy.

Exclusion Criteria:

* unstable systemic disease;
* any other malignancies in the last 5 years.

Primary outcomes:
measure: Percentage of Participants With PD According to Response Evaluation Criteria in Solid Tumors (RECIST) or Death (Data Cutoff 17 May 2008)
timeFrame: Screening, BL [≤21 days after randomization], every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
measure: PFS in All Participants (Data Cutoff 17 May 2008)
timeFrame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
measure: Probable Percentage of Participants Remaining Alive and Free of Disease Progression at 6 Months (Data Cutoff 17 May 2008)
timeFrame: 6 months
measure: Percentage of Epidermal Growth Factor Receptor (EGFR) Immunohistochemistry (IHC) Positive Participants With PD or Death (Data Cutoff 17 May 2008)
timeFrame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
measure: PFS in EGFR IHC Positive Population (Data Cutoff 17 May 2008)
timeFrame: Screening, BL (≤ 21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
measure: Probable Percentage of Participants in the EGFR IHC Positive Population Remaining Alive and Progression Free at 6 Months (Data Cutoff 17 May 2008)
timeFrame: 6 months
Secondary outcomes:
measure: Percentage of All Participants Who Died (Data Cutoff 12 January 2012)
timeFrame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months).
measure: Overall Survival (OS) in All Participants (Data Cutoff 12 January 2012)
timeFrame: Screening, BL (≤ 21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months)
measure: Probable Percentage of Participants Remaining Alive at 1 Year (Data Cutoff 12 January 2012)
timeFrame: 1 year
measure: Percentage of EGFR IHC Positive Participants Who Died (Data Cutoff 12 January 2012)
timeFrame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months)
measure: OS in EGFR IHC Positive Population (Data Cutoff 12 January 2012)
timeFrame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months)
measure: Probable Percentage of Participants in the EGFR IHC Positive Population Remaining Alive at 1 Year (Data Cutoff 12 January 2012)
timeFrame: 1 year
measure: Percentage of EGFR IHC Negative Participants With PD or Death (Data Cutoff 17 May 2008)
timeFrame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 71 months)
measure: PFS in EGFR IHC Negative Participants (Data Cutoff 17 May 2008)
timeFrame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
measure: Probable Percentage of Participants in the EGFR IHC Negative Population Remaining Alive and Free of Disease Progression at 6 Months (Data Cutoff 17 May 2008)
timeFrame: 6 months
measure: Percentage of EGFR IHC Negative Participants Who Died (Data Cutoff 17 May 2008)
timeFrame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
measure: OS in EGFR IHC Negative Participants (Data Cutoff 17 May 2008)
timeFrame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
measure: Probable Percentage of Participants in the EGFR IHC Negative Population Remaining Alive at 1 Year (Data Cutoff 17 May 2008)
timeFrame: 1 year
measure: Time to Progression (Data Cutoff 17 May 2008)
timeFrame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
measure: Probable Percentage of Participants Remaining Progression-Free in the TTP Analysis at 6 Months (Data Cutoff 17 May 2008)
timeFrame: 6 months
measure: Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST (Data Cutoff 17 May 2008)
timeFrame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
measure: Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST (Data Cutoff 17 May 2008)
timeFrame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
measure: Percentage of Participants With a Response Upgrade From BL According to RECIST (Data Cutoff 17 May 2008)
timeFrame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
measure: Percentage of Participants With a Change of PR to CR or SD to PR or CR From BL to End of Treatment According to RECIST (Data Cutoff 17 May 2008)
timeFrame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
measure: Percentage of Participants With CR, PR, or SD or With SD [Maintained For Greater Than (>) 12 Weeks] or CR or PR (Data Cutoff 17 May 2008)
timeFrame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
measure: Percentage of Participants With Symptom Progression Assessed Using the Lung Cancer Subscale (LCS) (Data Cutoff 17 May 2008)
timeFrame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
measure: Time to Symptom Progression (Data Cutoff 17 May 2008)
timeFrame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
measure: Probable Percentage of Participants Remaining Without Symptom Progression at 6 Months (Data Cutoff 17 May 2008)
timeFrame: 6 months
measure: Percentage of Participants With Deterioration Assessed Using the Trial Outcome Index (Data Cutoff 17 May 2008)
timeFrame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
measure: Time to Deterioration in TOI (Data Cutoff 17 May 2008)
timeFrame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
measure: Probable Percentage of Participants Remaining Without Deterioration in TOI at 6 Months (Data Cutoff 17 May 2008)
timeFrame: 6 months
measure: Percentage of Participants With Deterioration in Quality of Life Assessed Using TOI, SWB, and EWB (Data Cutoff 17 May 2008)
timeFrame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
measure: Time to Deterioration in QoL (Data Cutoff 17 May 2008)
timeFrame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
measure: Probable Percentage of Participants Remaining Without Deterioration in QoL at 6 Months (Data Cutoff 17 May 2008)
timeFrame: 6 months
measure: Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008)
timeFrame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
measure: Change From BL in FACT-L Scores (Data Cutoff 17 May 2008)
timeFrame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
Other outcomes:
Locations:
city: St. Leonards
country: Australia
state: New South Wales
city: Waratah
country: Australia
state: New South Wales
city: Brisbane
country: Australia
state: Queensland
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: Edegem
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: 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: 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: Amsterdam
country: Netherlands
city: Heerlen
country: Netherlands
city: Nieuwegein
country: Netherlands
city: Vlissingen
country: Netherlands
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: 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: Valencia
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: Cappuzzo F, Ciuleanu T, Stelmakh L, Cicenas S, Szczesna A, Juhasz E, Esteban E, Molinier O, Brugger W, Melezinek I, Klingelschmitt G, Klughammer B, Giaccone G; SATURN investigators. Erlotinib as maintenance treatment in advanced non-small-cell lung cancer: a multicentre, randomised, placebo-controlled phase 3 study. Lancet Oncol. 2010 Jun;11(6):521-9. doi: 10.1016/S1470-2045(10)70112-1. Epub 2010 May 20.