Back to resultsA Study of Erlotinib [Tarceva] as Monotherapy or Intermittent Dosing With Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer. (TALISMAN)
Primary Purpose
Non-Squamous Non-Small Cell Lung Cancer
Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
docetaxel
erlotinib [Tarceva]
erlotinib [Tarceva]
Sponsored by
About this trial
This is an interventional treatment trial for Non-Squamous Non-Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- male patients, >/=18 years of age
- former smoker (smoked >/= 100 cigarettes in his lifetime and quit >12 months before enrollment)
- locally advanced (stage IIIb), metastatic (stage IV) or recurrent squamous non-small cell lung cancer
- prior platinum-based therapy for advanced NSCLC
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Exclusion Criteria:
- uncontrolled symptomatic central nervous system (CNS) metastases
- prior therapy against epidermal growth factor receptor (EGFR)
- >1 prior chemotherapy for advanced/metastatic NSCLC
- radiotherapy <28 days prior to enrollment
- history of melanoma at any time, or another malignancy in the last 5 years except for carcinoma in situ of the cervix, basal or squamous cell carcinoma of the skin, or surgically cured malignant neoplasias with a disease-free interval of >5 years
- not fully treated eye inflammation or infection, or predisposing conditions
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
A
B
Arm Description
Outcomes
Primary Outcome Measures
Percentage of Participants Free From Disease Progression or Death at 6 Months
According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1, progressive Disease (PD) is defined as: for Target Lesions - At least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). (Note: the appearance of one or more new lesions is also considered progression). For Non-Target Lesions - Unequivocal progression of existing non-target lesions. (Note: the appearance of one or more new lesions is also considered progression).
Secondary Outcome Measures
Progression-free Survival (PFS)
Progression-free Survival (PFS) was defined as the interval (in days) between the date of randomization and the first documentation of progressive disease or death from any cause. Participants alive and progression-free were considered as censored at the date of the last tumor assessment when the participant was known to be progression-free. Participants without post-baseline tumor assessment, but known to be alive, were censored at the time of randomization. PFS (days) = (Date of Event - Date of Randomization) + 1. PFS was assessed using the Kaplan-Meier method. Detailed definition of PD is provided in Outcome Measure 1.
Overall Survival (OS)
Overall survival (OS) was defined as the interval (in days) between the date of randomization and death from any cause. Participants alive at the time of the analysis were censored at the date they were last known to be alive. OS was assessed using the Kaplan-Meier method.
Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR)
Best overall response (complete response [CR]/partial response [PR]) was defined as the best response recorded from the start of the treatment until disease progression (PD). Best response in this trial was defined as the best response observed at any post-treatment visits. According to RECIST Version 1.1, CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 mm). No new lesions. PR was defined as greater than or equal to [>=] 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.
Percentage of Participants With Disease Control
Disease control was defined as PR, CR, or SD. Participants who did not achieve a CR or PR or SD were counted as non-responders in the analysis of disease control. According to RECIST Version 1.1, SD was defined as not qualifying for CR, PR, and PD. Detailed definitions of CR and PR are provided in Outcome Measure 4.
Duration of Response (DoR)
Duration of response (DoR) was defined as the interval (in days) from first documentation of a response (CR/PR depending on which occurred first) to the date of the first documentation of disease progression or death from any cause. Participants presenting a response were considered as censored at the date of the last assessment with a documentation of non-progression. DoR (days) = (Date of PD/death - Date of CR/PR) + 1. Assessments were performed according to RECIST Version 1.1. DoR was assessed using the Kaplan-Meier method. Detailed definitions of CR and PR are provided in Outcome Measure 4.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01204697
Brief Title
A Study of Erlotinib [Tarceva] as Monotherapy or Intermittent Dosing With Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer. (TALISMAN)
Official Title
A Randomized Phase II Trial of Erlotinib or Intermittent Dosing of Erlotinib and Docetaxel in Male Former-smokers With Locally Advanced or Metastatic Squamous NSCLC in Second-line Setting After Failure on Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 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 randomized parallel group study will assess the efficacy and safety of erlotinib [Tarceva], as monotherapy or intermittent dosing with docetaxel, in second-line setting in former-smoker male patients with advanced or metastatic squamous non-small cell lung cancer. Patients will be randomized to receive either Tarceva (150 mg/day orally) as monotherapy or 4 cycles of docetaxel (75 mg/m2 intravenously every 3 weeks) plus Tarceva (150 mg/day orally, days 2-16 each cycle) followed by Tarceva monotherapy. Anticipated time on study treatment is until disease progression.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Squamous Non-Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Description
75 mg/m2 intravenously every 3 weeks for 4 cycles
Intervention Type
Drug
Intervention Name(s)
erlotinib [Tarceva]
Intervention Description
150 mg/day orally, days 2-16 each 3-week cycle for 4 cycles; 150 mg/day orally thereafter
Intervention Type
Drug
Intervention Name(s)
erlotinib [Tarceva]
Intervention Description
150 mg/day orally as monotherapy
Primary Outcome Measure Information:
Title
Percentage of Participants Free From Disease Progression or Death at 6 Months
Description
According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1, progressive Disease (PD) is defined as: for Target Lesions - At least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). (Note: the appearance of one or more new lesions is also considered progression). For Non-Target Lesions - Unequivocal progression of existing non-target lesions. (Note: the appearance of one or more new lesions is also considered progression).
Time Frame
Month 6
Secondary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Description
Progression-free Survival (PFS) was defined as the interval (in days) between the date of randomization and the first documentation of progressive disease or death from any cause. Participants alive and progression-free were considered as censored at the date of the last tumor assessment when the participant was known to be progression-free. Participants without post-baseline tumor assessment, but known to be alive, were censored at the time of randomization. PFS (days) = (Date of Event - Date of Randomization) + 1. PFS was assessed using the Kaplan-Meier method. Detailed definition of PD is provided in Outcome Measure 1.
Time Frame
From randomization until progressive disease or death, assessed up to 18 months
Title
Overall Survival (OS)
Description
Overall survival (OS) was defined as the interval (in days) between the date of randomization and death from any cause. Participants alive at the time of the analysis were censored at the date they were last known to be alive. OS was assessed using the Kaplan-Meier method.
Time Frame
From randomization until death, assessed up to 18 months
Title
Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR)
Description
Best overall response (complete response [CR]/partial response [PR]) was defined as the best response recorded from the start of the treatment until disease progression (PD). Best response in this trial was defined as the best response observed at any post-treatment visits. According to RECIST Version 1.1, CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 mm). No new lesions. PR was defined as greater than or equal to [>=] 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.
Time Frame
From randomization until progressive disease or death, assessed up to 18 months
Title
Percentage of Participants With Disease Control
Description
Disease control was defined as PR, CR, or SD. Participants who did not achieve a CR or PR or SD were counted as non-responders in the analysis of disease control. According to RECIST Version 1.1, SD was defined as not qualifying for CR, PR, and PD. Detailed definitions of CR and PR are provided in Outcome Measure 4.
Time Frame
From randomization until progressive disease or death, assessed up to 18 months
Title
Duration of Response (DoR)
Description
Duration of response (DoR) was defined as the interval (in days) from first documentation of a response (CR/PR depending on which occurred first) to the date of the first documentation of disease progression or death from any cause. Participants presenting a response were considered as censored at the date of the last assessment with a documentation of non-progression. DoR (days) = (Date of PD/death - Date of CR/PR) + 1. Assessments were performed according to RECIST Version 1.1. DoR was assessed using the Kaplan-Meier method. Detailed definitions of CR and PR are provided in Outcome Measure 4.
Time Frame
From randomization until progressive disease or death, assessed up to 18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
male patients, >/=18 years of age
former smoker (smoked >/= 100 cigarettes in his lifetime and quit >12 months before enrollment)
locally advanced (stage IIIb), metastatic (stage IV) or recurrent squamous non-small cell lung cancer
prior platinum-based therapy for advanced NSCLC
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Exclusion Criteria:
uncontrolled symptomatic central nervous system (CNS) metastases
prior therapy against epidermal growth factor receptor (EGFR)
>1 prior chemotherapy for advanced/metastatic NSCLC
radiotherapy <28 days prior to enrollment
history of melanoma at any time, or another malignancy in the last 5 years except for carcinoma in situ of the cervix, basal or squamous cell carcinoma of the skin, or surgically cured malignant neoplasias with a disease-free interval of >5 years
not fully treated eye inflammation or infection, or predisposing conditions
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
Avellino
State/Province
Campania
ZIP/Postal Code
83100
Country
Italy
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
City
Parma
State/Province
Emilia-Romagna
ZIP/Postal Code
43100
Country
Italy
City
Aviano (PN)
State/Province
Friuli-Venezia Giulia
ZIP/Postal Code
33081
Country
Italy
City
Roma
State/Province
Lazio
ZIP/Postal Code
00152
Country
Italy
City
Roma
State/Province
Lazio
ZIP/Postal Code
00157
Country
Italy
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
City
Cremona
State/Province
Lombardia
ZIP/Postal Code
26100
Country
Italy
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20142
Country
Italy
City
Monza
State/Province
Lombardia
ZIP/Postal Code
20900
Country
Italy
City
Pavia
State/Province
Lombardia
ZIP/Postal Code
27100
Country
Italy
City
Sondalo
State/Province
Lombardia
ZIP/Postal Code
23039
Country
Italy
City
Macerata
State/Province
Marche
ZIP/Postal Code
62100
Country
Italy
City
Lecce
State/Province
Puglia
ZIP/Postal Code
73100
Country
Italy
City
San Giovanni Rotondo
State/Province
Puglia
ZIP/Postal Code
71013
Country
Italy
City
Lido Di Camaiore
State/Province
Toscana
ZIP/Postal Code
55043
Country
Italy
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56124
Country
Italy
City
Pontedera
State/Province
Toscana
ZIP/Postal Code
56025
Country
Italy
City
Treviso
State/Province
Veneto
ZIP/Postal Code
31100
Country
Italy
City
Vicenza
State/Province
Veneto
ZIP/Postal Code
36100
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
A Study of Erlotinib [Tarceva] as Monotherapy or Intermittent Dosing With Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer. (TALISMAN)
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