Clinical trial NCT00949910: An Expanded Access Program of Tarceva (Erlotinib) in Participants With Advanced Non-Small Cell Lung Cancer (NSCLC)
Official title: An Expanded Access Program of Tarceva (Erlotinib) in Patients With Advanced Stage IIIB/IV Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2009-07-31
Enrollment: 6586
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will provide treatment with erlotinib to participants with advanced NSCLC who have received at least one course of standard chemotherapy or radiation therapy, or who are not medically suitable for either. Efficacy and safety will be monitored throughout the study.


Eligibility criteria: Inclusion Criteria:

* Adults greater than or equal to (≥) 18 years of age
* Histologically or cytologically documented inoperable, locally advanced, metastatic, or recurrent NSCLC
* Previous treatment with no more than 2 prior chemotherapy regimens

Exclusion Criteria:

* Previous systemic anti-cancer therapy with human epidermal growth factor receptor 1 (HER1)/epidermal growth factor receptor (EGFR) inhibitors
* Inability to take oral medication
* Any other malignancies within 5 years

Primary outcomes:
measure: Percentage of Participants With Objective Response According to Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter
Secondary outcomes:
measure: Percentage of Participants With Disease Control According to RECIST
timeFrame: Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter
measure: Percentage of Participants by Best Overall Response According to RECIST
timeFrame: Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter
measure: Percentage of Participants With Death or Disease Progression According to RECIST
timeFrame: Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter
measure: Progression-Free Survival (PFS) According to RECIST
timeFrame: Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter
measure: Percentage of Participants Who Died
timeFrame: Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter
measure: Overall Survival (OS)
timeFrame: Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter
Other outcomes:
Locations:
city: Tirana
country: Albania
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Córdoba
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city: La Plata
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city: Salta
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city: Santa Fe
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city: Adelaide
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city: Camperdown
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city: Chermside
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city: Fremantle
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city: Kurralta Park
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city: Waratah
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city: Wodonga
country: Australia
city: Wollongong
country: Australia
city: Bludesch
country: Austria
city: Grimmenstein
country: Austria
city: Innsbruck
country: Austria
city: Klagenfurt
country: Austria
city: Kufstein
country: Austria
city: Leoben
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city: Linz
country: Austria
city: Linz
country: Austria
city: Natters
country: Austria
city: Oberpullendorf
country: Austria
city: Salzburg
country: Austria
city: Wels
country: Austria
city: Wien
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city: Wien
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city: Wien
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city: Wien
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city: Wien
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city: Zams
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city: Antwerpen
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city: Antwerpen
country: Belgium
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city: Baudour
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city: Boussu
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city: Incheon
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city: Kyunggi-do
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city: Seoul
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city: 's Hertogenbosch
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city: Bucharest
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city: Bucharest
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city: Kazan
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city: Krasnodar
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city: Krasnodar
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Obninsk
country: Russian Federation
city: Samara
country: Russian Federation
city: Smolensk
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: Stavropol
country: Russian Federation
city: Tumen
country: Russian Federation
city: Ufa
country: Russian Federation
city: Volgograd
country: Russian Federation
city: Riyadh
country: Saudi Arabia
city: Belgrade
country: Serbia
city: Novi Sad
country: Serbia
city: Banska Bystrica
country: Slovakia
city: Bratislava
country: Slovakia
city: Kosice
country: Slovakia
city: Nitra
country: Slovakia
city: Poprad
country: Slovakia
city: Ljubljana
country: Slovenia
city: Falun
country: Sweden
city: Goeteborg
country: Sweden
city: Göteborg
country: Sweden
city: Linkoeping
country: Sweden
city: Lund
country: Sweden
city: Malmoe
country: Sweden
city: Stockholm
country: Sweden
city: Uppsala
country: Sweden
city: Aarau
country: Switzerland
city: Aarau
country: Switzerland
city: Baden
country: Switzerland
city: Chur
country: Switzerland
city: Locarno
country: Switzerland
city: Luzern
country: Switzerland
city: Zürich
country: Switzerland
city: Changhua
country: Taiwan
city: Kaohsiung
country: Taiwan
city: Kaohsiung
country: Taiwan
city: Kaohsiung
country: Taiwan
city: Taichung
country: Taiwan
city: Taichung
country: Taiwan
city: Tainan
country: Taiwan
city: Tainan
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Taoyuan
country: Taiwan
city: Bangkok
country: Thailand
city: Bangkok
country: Thailand
city: Bangkok
country: Thailand
city: Ankara
country: Turkey
city: Ankara
country: Turkey
city: Ankara
country: Turkey
city: Ankara
country: Turkey
city: Istanbul
country: Turkey
city: Istanbul
country: Turkey
city: Istanbul
country: Turkey
city: Izmir
country: Turkey
city: Izmir
country: Turkey
city: Shhiye, Ankara
country: Turkey
city: Montevideo
country: Uruguay
city: Caracas
country: Venezuela
city: Caracas
country: Venezuela
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References:
citation: Huang Y, Zhang L, Shi Y, Ma S, Liao M, Bai C, Zhang Q, Wang C, Luo F, Yu S, Qin S, Zhi X, Zhou C. Efficacy of erlotinib in previously treated patients with advanced non-small cell lung cancer: analysis of the Chinese subpopulation in the TRUST study. Jpn J Clin Oncol. 2015 Jun;45(6):569-75. doi: 10.1093/jjco/hyv036. Epub 2015 Apr 7.
citation: Heigener DF, Wu YL, van Zandwijk N, Mali P, Horwood K, Reck M. Second-line erlotinib in patients with advanced non-small-cell lung cancer: subgroup analyses from the TRUST study. Lung Cancer. 2011 Nov;74(2):274-9. doi: 10.1016/j.lungcan.2011.02.017. Epub 2011 Mar 24.