Back to resultsA Study of Tarceva (Erlotinib) to Compare Two Different Doses in in Currently Smoking Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (CURRENTS)
Primary Purpose
Non-Small Cell Lung Cancer
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Erlotinib [Tarceva]
Sponsored by
About this trial
This is an interventional treatment trial for Non-Small Cell Lung Cancer
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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Erlotinib 150 mg
Erlotinib 300 mg
Arm Description
Erlotinib 150 mg single daily oral dose until disease progression.
Erlotinib 300 mg single daily oral dose until disease progression.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Overall Survival (OS)
OS defined as the time from randomization to the date of death due to any cause.
Overall Response Rate (ORR)
Tumor response was assessed by the investigator using computer tomography (CT) or magnetic resonance imaging (MRI) scans according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. A participant was defined as a responder if they sustained a complete response (CR) or partial response (PR) for at least 4 weeks during randomized treatment (confirmed response). Patients with no tumor assessment after the start of study treatment were to be considered as non-responders. The percentage of participants in each best response category is presented.
Disease Control Rate (DCR)
Tumor response was assessed by the investigator using computer tomography (CT) or magnetic resonance imaging (MRI) scans. Disease control rates were measured according to RECIST version 1.1 criteria. A participant was defined as having controlled disease if they sustained a Complete Response (CR) or Partial Response (PR) for at least 4 weeks during randomized treatment (confirmed response), or Stable Disease (SD) for at least 6 weeks. Patients with no tumor assessment after the start of study treatment were considered as having uncontrolled disease. The percentage of participants with Disease Control is presented.
Time to Progression (TTP)
Tumor response was assessed by the investigator using computer tomography (CT) or magnetic resonance imaging (MRI) scans according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria. Time to progression (TTP) in weeks was defined as the time from randomization to the date of disease progression. Participants without event were censored at the date of the last tumor assessment when the patient was known to be progression free.
Number of Participants With Adverse Events (AEs) at the End of the Study
An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events.
A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
Adverse Events in the following categories are presented: Adverse Events, Serious Adverse Events, AEs leading to withdrawal from treatment and AEs leading to death.
Overall Survival (OS) at the End of Study
OS defined as the time from randomization to the date of death due to any cause.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01183858
Brief Title
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
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
315 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Erlotinib 150 mg
Arm Type
Experimental
Arm Description
Erlotinib 150 mg single daily oral dose until disease progression.
Arm Title
Erlotinib 300 mg
Arm Type
Experimental
Arm Description
Erlotinib 300 mg single daily oral dose until disease progression.
Intervention Type
Drug
Intervention Name(s)
Erlotinib [Tarceva]
Other Intervention Name(s)
Tarceva
Intervention Description
Single daily oral dose
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
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.
Time Frame
Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 Months)
Title
Progression-Free Survival (PFS) at the End of Study
Description
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.
Time Frame
Randomization to End of Study: 14 October 2010 - 7 February 2014 (Up to 39.8 months)
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS defined as the time from randomization to the date of death due to any cause.
Time Frame
Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)
Title
Overall Response Rate (ORR)
Description
Tumor response was assessed by the investigator using computer tomography (CT) or magnetic resonance imaging (MRI) scans according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. A participant was defined as a responder if they sustained a complete response (CR) or partial response (PR) for at least 4 weeks during randomized treatment (confirmed response). Patients with no tumor assessment after the start of study treatment were to be considered as non-responders. The percentage of participants in each best response category is presented.
Time Frame
Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)
Title
Disease Control Rate (DCR)
Description
Tumor response was assessed by the investigator using computer tomography (CT) or magnetic resonance imaging (MRI) scans. Disease control rates were measured according to RECIST version 1.1 criteria. A participant was defined as having controlled disease if they sustained a Complete Response (CR) or Partial Response (PR) for at least 4 weeks during randomized treatment (confirmed response), or Stable Disease (SD) for at least 6 weeks. Patients with no tumor assessment after the start of study treatment were considered as having uncontrolled disease. The percentage of participants with Disease Control is presented.
Time Frame
Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)
Title
Time to Progression (TTP)
Description
Tumor response was assessed by the investigator using computer tomography (CT) or magnetic resonance imaging (MRI) scans according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria. Time to progression (TTP) in weeks was defined as the time from randomization to the date of disease progression. Participants without event were censored at the date of the last tumor assessment when the patient was known to be progression free.
Time Frame
Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)
Title
Number of Participants With Adverse Events (AEs) at the End of the Study
Description
An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events.
A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
Adverse Events in the following categories are presented: Adverse Events, Serious Adverse Events, AEs leading to withdrawal from treatment and AEs leading to death.
Time Frame
Randomization to End of Study: 14 October 2010 - 7 February 2014 (Up to 39.8 months)
Title
Overall Survival (OS) at the End of Study
Description
OS defined as the time from randomization to the date of death due to any cause.
Time Frame
Randomization to End of Study: 14 October 2010 - 7 February 2014 (Up to 39.8 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Beijing
ZIP/Postal Code
100071
Country
China
City
Changchun
ZIP/Postal Code
130012
Country
China
City
Chengdu
ZIP/Postal Code
610041
Country
China
City
Fuzhou
ZIP/Postal Code
350014
Country
China
City
Guangzhou
ZIP/Postal Code
510030
Country
China
City
Nanjing
ZIP/Postal Code
210009
Country
China
City
Nanning
ZIP/Postal Code
530021
Country
China
City
Shanghai
ZIP/Postal Code
200030
Country
China
City
Shanghai
ZIP/Postal Code
200433
Country
China
City
Shenyang
ZIP/Postal Code
110001
Country
China
City
Tianjin
ZIP/Postal Code
300060
Country
China
City
Wuhan
ZIP/Postal Code
430030
Country
China
City
Hillerod
ZIP/Postal Code
3400
Country
Denmark
City
København
ZIP/Postal Code
2100
Country
Denmark
City
Naestved
ZIP/Postal Code
4700
Country
Denmark
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
City
Cairo
ZIP/Postal Code
11796
Country
Egypt
City
Cairo
Country
Egypt
City
Caen
ZIP/Postal Code
14076
Country
France
City
Limoges
ZIP/Postal Code
87042
Country
France
City
Marseille
ZIP/Postal Code
13915
Country
France
City
Paris
ZIP/Postal Code
75014
Country
France
City
Paris
ZIP/Postal Code
75674
Country
France
City
Paris
ZIP/Postal Code
75908
Country
France
City
Pontoise
ZIP/Postal Code
95300
Country
France
City
Berlin
ZIP/Postal Code
13125
Country
Germany
City
Berlin
ZIP/Postal Code
14165
Country
Germany
City
Essen
ZIP/Postal Code
45122
Country
Germany
City
Gauting
ZIP/Postal Code
82131
Country
Germany
City
Grosshansdorf
ZIP/Postal Code
22927
Country
Germany
City
Hannover
ZIP/Postal Code
30625
Country
Germany
City
Hannover
ZIP/Postal Code
30659
Country
Germany
City
Immenhausen
ZIP/Postal Code
34376
Country
Germany
City
Lostau
ZIP/Postal Code
39291
Country
Germany
City
München
ZIP/Postal Code
81925
Country
Germany
City
Nürnberg
ZIP/Postal Code
90419
Country
Germany
City
Rheine
ZIP/Postal Code
48431
Country
Germany
City
Villingen-Schwenningen
ZIP/Postal Code
78052
Country
Germany
City
Wuerselen
ZIP/Postal Code
52146
Country
Germany
City
Wuppertal
ZIP/Postal Code
42283
Country
Germany
City
Amsterdam
ZIP/Postal Code
1007 MB
Country
Netherlands
City
Breda
ZIP/Postal Code
4818 CK
Country
Netherlands
City
Nieuwegein
ZIP/Postal Code
3435 CM
Country
Netherlands
City
Zwolle
ZIP/Postal Code
8011 JW
Country
Netherlands
City
Sabadell, Barcelona
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
City
Madrid
ZIP/Postal Code
28040
Country
Spain
City
Madrid
ZIP/Postal Code
28041
Country
Spain
City
Malaga
ZIP/Postal Code
29010
Country
Spain
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
City
Valencia
ZIP/Postal Code
46009
Country
Spain
City
Baden
ZIP/Postal Code
5404
Country
Switzerland
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
City
Bern
ZIP/Postal Code
3011
Country
Switzerland
City
Fribourg
ZIP/Postal Code
1708
Country
Switzerland
City
Ankara
ZIP/Postal Code
06000
Country
Turkey
City
Ankara
ZIP/Postal Code
06200
Country
Turkey
City
Eskisehir
ZIP/Postal Code
26480
Country
Turkey
City
Gaziantep
ZIP/Postal Code
27310
Country
Turkey
City
Izmir
ZIP/Postal Code
35110
Country
Turkey
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
City
Konya
ZIP/Postal Code
42050
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
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)
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