Clinical trial NCT01183858: A Study of Tarceva (Erlotinib) to Compare Two Different Doses in in Currently Smoking Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (CURRENTS)
Official title: A Prospective, Double-blind Randomized Phase III Study of 300 mg Versus 150 mg Erlotinib in Current Smokers With Locally Advanced or Metastatic NSCLC in Second-line Setting After Failure on Chemotherapy (CURRENTS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-08-18
Enrollment: 315
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 prospective, double-blind, randomized study will evaluate the safety and efficacy of two dose levels of erlotinib \[Tarceva\] on progression-free survival, response and disease control rates and overall survival in patients with advanced or metastatic non-small cell lung cancer (NSCLC) after failure of first-line platinum-based chemotherapy. Patients must be current smokers and not intending to stop smoking during the study. Patients will be randomized to receive either 150 mg or 300 mg of study drug as single daily oral doses. Treatment will continue until disease progression.


Eligibility criteria: Inclusion Criteria:

* Adult patients aged ≥18 years
* inoperable, locally advanced (stage IIIB/IV) with supraclavicular lymph node metastases or malignant pleural or pericardial effusion) or metastatic (stage IV) non-small cell lung cancer (NSCLC)
* Disease must be characterized according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria
* Patients have received one prior platinum-based chemotherapy regimen for advanced NSCLC, but must have recovered from any treatment-related toxicity
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Life expectancy ≥12 weeks
* Current cigarette smoker (having smoked \>100 cigarettes in entire lifetime and currently smoking on average ≥1 cigarette per day), not intending to stop during the study

Exclusion Criteria:

* Prior antibody or small molecule therapy against Epidermal growth factor receptor (EGFR)
* Radiotherapy within 28 days prior to enrollment
* Received more than one line of chemotherapy for locally advanced/metastatic NSCLC (first-line maintenance chemotherapy after first-line platinum-based chemotherapy is allowed)

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 Months)
measure: Progression-Free Survival (PFS) at the End of Study
timeFrame: Randomization to End of Study: 14 October 2010 - 7 February 2014 (Up to 39.8 months)
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)
measure: Overall Response Rate (ORR)
timeFrame: Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)
measure: Disease Control Rate (DCR)
timeFrame: Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)
measure: Time to Progression (TTP)
timeFrame: Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)
measure: Number of Participants With Adverse Events (AEs) at the End of the Study
timeFrame: Randomization to End of Study: 14 October 2010 - 7 February 2014 (Up to 39.8 months)
measure: Overall Survival (OS) at the End of Study
timeFrame: Randomization to End of Study: 14 October 2010 - 7 February 2014 (Up to 39.8 months)
Other outcomes:
Locations:
city: Beijing
country: China
city: Changchun
country: China
city: Chengdu
country: China
city: Fuzhou
country: China
city: Guangzhou
country: China
city: Nanjing
country: China
city: Nanning
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Shenyang
country: China
city: Tianjin
country: China
city: Wuhan
country: China
city: Hillerod
country: Denmark
city: København
country: Denmark
city: Naestved
country: Denmark
city: Roskilde
country: Denmark
city: Cairo
country: Egypt
city: Cairo
country: Egypt
city: Caen
country: France
city: Limoges
country: France
city: Marseille
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Pontoise
country: France
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Essen
country: Germany
city: Gauting
country: Germany
city: Grosshansdorf
country: Germany
city: Hannover
country: Germany
city: Hannover
country: Germany
city: Immenhausen
country: Germany
city: Lostau
country: Germany
city: München
country: Germany
city: Nürnberg
country: Germany
city: Rheine
country: Germany
city: Villingen-Schwenningen
country: Germany
city: Wuerselen
country: Germany
city: Wuppertal
country: Germany
city: Amsterdam
country: Netherlands
city: Breda
country: Netherlands
city: Nieuwegein
country: Netherlands
city: Zwolle
country: Netherlands
city: Sabadell, Barcelona
country: Spain
state: Barcelona
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Malaga
country: Spain
city: Sevilla
country: Spain
city: Valencia
country: Spain
city: Baden
country: Switzerland
city: Basel
country: Switzerland
city: Bern
country: Switzerland
city: Fribourg
country: Switzerland
city: Ankara
country: Turkey
city: Ankara
country: Turkey
city: Eskisehir
country: Turkey
city: Gaziantep
country: Turkey
city: Izmir
country: Turkey
city: Izmir
country: Turkey
city: Konya
country: Turkey
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: