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)
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)
2 other identifiers
interventional
315
9 countries
63
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 nonsmall-cell-lung-cancer
Started Oct 2010
63 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 16, 2010
CompletedFirst Posted
Study publicly available on registry
August 18, 2010
CompletedStudy Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedResults Posted
Study results publicly available
February 23, 2015
CompletedAugust 19, 2015
July 1, 2015
3 years
August 16, 2010
February 5, 2015
July 23, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
Progression-Free Survival (PFS)
PFS is defined as the time from randomization to the date of first occurrence of disease progression or death. For target lesions, Progressive Disease (PD) was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.
Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 Months)
Progression-Free Survival (PFS) at the End of Study
PFS is defined as the time from randomization to the date of first occurrence of disease progression or death. For target lesions, Progressive Disease (PD) was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.
Randomization to End of Study: 14 October 2010 - 7 February 2014 (Up to 39.8 months)
Secondary Outcomes (6)
Overall Survival (OS)
Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)
Overall Response Rate (ORR)
Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)
Disease Control Rate (DCR)
Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)
Time to Progression (TTP)
Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)
Number of Participants With Adverse Events (AEs) at the End of the Study
Randomization to End of Study: 14 October 2010 - 7 February 2014 (Up to 39.8 months)
- +1 more secondary outcomes
Study Arms (2)
Erlotinib 150 mg
EXPERIMENTALErlotinib 150 mg single daily oral dose until disease progression.
Erlotinib 300 mg
EXPERIMENTALErlotinib 300 mg single daily oral dose until disease progression.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (63)
Unknown Facility
Beijing, 100071, China
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Changchun, 130012, China
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Chengdu, 610041, China
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Fuzhou, 350014, China
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Guangzhou, 510030, China
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Nanjing, 210009, China
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Nanning, 530021, China
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Shanghai, 200030, China
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Shanghai, 200433, China
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Shenyang, 110001, China
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Tianjin, 300060, China
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Wuhan, 430030, China
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Copenhagen, 2100, Denmark
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Hillerød, 3400, Denmark
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Næstved, 4700, Denmark
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Roskilde, 4000, Denmark
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Cairo, 11796, Egypt
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Cairo, Egypt
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Caen, 14076, France
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Limoges, 87042, France
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Marseille, 13915, France
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Paris, 75014, France
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Paris, 75674, France
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Paris, 75908, France
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Pontoise, 95300, France
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Berlin, 13125, Germany
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Berlin, 14165, Germany
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Essen, 45122, Germany
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Gauting, 82131, Germany
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Großhansdorf, 22927, Germany
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Hanover, 30625, Germany
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Hanover, 30659, Germany
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Immenhausen, 34376, Germany
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Lostau, 39291, Germany
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München, 81925, Germany
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Nuremberg, 90419, Germany
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Rheine, 48431, Germany
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Villingen-Schwenningen, 78052, Germany
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Wuppertal, 42283, Germany
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Würselen, 52146, Germany
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Amsterdam, 1007 MB, Netherlands
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Breda, 4818 CK, Netherlands
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Nieuwegein, 3435 CM, Netherlands
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Zwolle, 8011 JW, Netherlands
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Barcelona, Barcelona, 08035, Spain
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Barcelona, Barcelona, 08041, Spain
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Sabadell, Barcelona, Barcelona, 08208, Spain
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Madrid, Madrid, 28040, Spain
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Madrid, Madrid, 28041, Spain
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Málaga, Malaga, 29010, Spain
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Seville, Sevilla, 41013, Spain
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Valencia, Valencia, 46009, Spain
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Baden, 5404, Switzerland
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Basel, 4031, Switzerland
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Bern, 3011, Switzerland
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Fribourg, 1708, Switzerland
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Ankara, 06000, Turkey (Türkiye)
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Ankara, 06200, Turkey (Türkiye)
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Eskişehir, 26480, Turkey (Türkiye)
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Gaziantep, 27310, Turkey (Türkiye)
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Izmir, 35110, Turkey (Türkiye)
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Izmir, 35340, Turkey (Türkiye)
Unknown Facility
Konya, 42050, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 16, 2010
First Posted
August 18, 2010
Study Start
October 1, 2010
Primary Completion
October 1, 2013
Study Completion
February 1, 2014
Last Updated
August 19, 2015
Results First Posted
February 23, 2015
Record last verified: 2015-07