Back to resultsA Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Following 4 Cycles of Platinum-based Chemotherapy Without Disease Progression
Primary Purpose
Non-Small Cell Lung Cancer
Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Erlotinib
Sponsored by
About this trial
This is an interventional treatment trial for Non-Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Adult patients ≥ 18 years of age.
- Histologically documented non-small cell lung cancer (NSCLC).
- Locally advanced or recurrent (Stage IIIB) or metastatic (Stage IV) disease.
- Completion of 4 cycles of an acceptable, standard, platinum-based chemotherapy doublet without progression.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Patients of reproductive potential must agree to use effective contraception.
Exclusion Criteria:
- Prior exposure to agents directed at the human epidermal growth factor receptor (HER) axis (eg, gefitinib, cetuximab, trastuzumab).
- Prior treatment with any monoclonal antibody therapy.
- Any other malignancies within the previous 5 years, except for adequately treated carcinoma in situ of the cervix or squamous cell skin cancer.
- Clinically significant cardiovascular, hepatic, renal, or metabolic disease or active infection
- Pre-existing interstitial lung disease.
- Human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection.
- Pregnant or lactating women.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Erlotinib
Arm Description
Participants received erlotinib 150 mg orally once a day for 48 weeks.
Outcomes
Primary Outcome Measures
Percentage of Participants With Progression-free Survival at Week 52
A participant had progression-free survival if they did not have disease progression and were alive. Tumor assessments were done by magnetic resonance imaging according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions. All measurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.
Secondary Outcome Measures
Progression-free Survival (PFS)
PFS was defined as the time from the date of enrolment to the date of disease progression (PD) or death, whichever occurred first. Tumor assessments were done by magnetic resonance imaging according to RECIST v1.1. PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions (TL), taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-TLs. All measurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total, representative of all involved organs, should be identified as TLs at Baseline. TLs should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all TLs will be calculated and reported as the Baseline sum longest diameter.
Overall Survival
Overall survival was defined as the time from the date of enrolment to the date of death from any cause.
Percentage of Participants With a Complete Response (CR) or a Partial Response (PR)
A CR was defined as the disappearance of all target lesions. A PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the Baseline sum longest diameter. All measurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. All other lesions (or sites of disease) should be identified as non-target lesions. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter. Tumor assessments were done by magnetic resonance imaging according to RECIST v1.1.
Percentage of Participants With Disease Control
A participant with disease control was defined as a participant with either a complete response (CR), a partial response (PR), or stable disease (SD), as determined using RECIST v1.1. A CR was defined as the disappearance of all target lesions (TL). A PR was defined as at least a 30% decrease in the sum of the longest diameter of TLs taking as reference the Baseline sum longest diameter (SLD). SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest SLD since treatment started. For non-TLs, SD was defined as the persistence of 1 or more lesions. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the unequivocal progression of existing non-TLs. A SLD for all TLs will be calculated and reported as the Baseline SLD. Tumor assessments were done by magnetic resonance imaging according to RECIST v1.1.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01230710
Brief Title
A Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Following 4 Cycles of Platinum-based Chemotherapy Without Disease Progression
Official Title
A Multi-centre, Open-label, Phase IV, Interventional Study to Evaluate the Efficacy of Erlotinib (Tarceva®) Following 4 Cycles of Platinum-based Chemotherapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Who Have Not Experienced Disease Progression or Unacceptable Toxicity During Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (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 open-label, single-arm study will evaluate the safety and efficacy of Tarceva (erlotinib) in patients with locally advanced or metastatic non-small cell lung cancer who have completed 4 cycles of standard platinum-based chemotherapy without progression. Patients will receive Tarceva at a dose of 150 mg orally daily until disease progression or unacceptable toxicity occurs.
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 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Erlotinib
Arm Type
Experimental
Arm Description
Participants received erlotinib 150 mg orally once a day for 48 weeks.
Intervention Type
Drug
Intervention Name(s)
Erlotinib
Other Intervention Name(s)
Tarceva
Intervention Description
Erlotinib was supplied as tablets.
Primary Outcome Measure Information:
Title
Percentage of Participants With Progression-free Survival at Week 52
Description
A participant had progression-free survival if they did not have disease progression and were alive. Tumor assessments were done by magnetic resonance imaging according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions. All measurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.
Time Frame
From the date of enrolment in the study until the date of disease progression or death from any cause (up to 2 years, 6 months).
Secondary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Description
PFS was defined as the time from the date of enrolment to the date of disease progression (PD) or death, whichever occurred first. Tumor assessments were done by magnetic resonance imaging according to RECIST v1.1. PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions (TL), taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-TLs. All measurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total, representative of all involved organs, should be identified as TLs at Baseline. TLs should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all TLs will be calculated and reported as the Baseline sum longest diameter.
Time Frame
From the date of enrolment until the end of the study (up to 2 years, 6 months).
Title
Overall Survival
Description
Overall survival was defined as the time from the date of enrolment to the date of death from any cause.
Time Frame
From the date of enrolment until the end of the study (up to 2 years, 6 months).
Title
Percentage of Participants With a Complete Response (CR) or a Partial Response (PR)
Description
A CR was defined as the disappearance of all target lesions. A PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the Baseline sum longest diameter. All measurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. All other lesions (or sites of disease) should be identified as non-target lesions. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter. Tumor assessments were done by magnetic resonance imaging according to RECIST v1.1.
Time Frame
From the date of enrolment until the end of the study (up to 2 years, 6 months).
Title
Percentage of Participants With Disease Control
Description
A participant with disease control was defined as a participant with either a complete response (CR), a partial response (PR), or stable disease (SD), as determined using RECIST v1.1. A CR was defined as the disappearance of all target lesions (TL). A PR was defined as at least a 30% decrease in the sum of the longest diameter of TLs taking as reference the Baseline sum longest diameter (SLD). SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest SLD since treatment started. For non-TLs, SD was defined as the persistence of 1 or more lesions. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the unequivocal progression of existing non-TLs. A SLD for all TLs will be calculated and reported as the Baseline SLD. Tumor assessments were done by magnetic resonance imaging according to RECIST v1.1.
Time Frame
From the date of enrolment until the end of the study (up to 2 years, 6 months).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients ≥ 18 years of age.
Histologically documented non-small cell lung cancer (NSCLC).
Locally advanced or recurrent (Stage IIIB) or metastatic (Stage IV) disease.
Completion of 4 cycles of an acceptable, standard, platinum-based chemotherapy doublet without progression.
Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
Patients of reproductive potential must agree to use effective contraception.
Exclusion Criteria:
Prior exposure to agents directed at the human epidermal growth factor receptor (HER) axis (eg, gefitinib, cetuximab, trastuzumab).
Prior treatment with any monoclonal antibody therapy.
Any other malignancies within the previous 5 years, except for adequately treated carcinoma in situ of the cervix or squamous cell skin cancer.
Clinically significant cardiovascular, hepatic, renal, or metabolic disease or active infection
Pre-existing interstitial lung disease.
Human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection.
Pregnant or lactating women.
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
Bangalore
ZIP/Postal Code
560027
Country
India
City
Chennai
ZIP/Postal Code
600035
Country
India
City
Delhi
ZIP/Postal Code
110085
Country
India
City
Hyderabad
ZIP/Postal Code
500 034
Country
India
City
Jaipur
ZIP/Postal Code
302 017
Country
India
City
Kolkata
ZIP/Postal Code
700026
Country
India
City
Nasik
ZIP/Postal Code
422005
Country
India
12. IPD Sharing Statement
Learn more about this trial
A Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Following 4 Cycles of Platinum-based Chemotherapy Without Disease Progression
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