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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|ClinicalTrials.gov Identifier: NCT01204697|
Recruitment Status : Completed
First Posted : September 17, 2010
Results First Posted : November 16, 2015
Last Update Posted : November 16, 2015
|Condition or disease||Intervention/treatment||Phase|
|Non-Squamous Non-Small Cell Lung Cancer||Drug: docetaxel Drug: erlotinib [Tarceva]||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||74 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||November 2010|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
Drug: erlotinib [Tarceva]
150 mg/day orally as monotherapy
75 mg/m2 intravenously every 3 weeks for 4 cyclesDrug: erlotinib [Tarceva]
150 mg/day orally, days 2-16 each 3-week cycle for 4 cycles; 150 mg/day orally thereafter
- Percentage of Participants Free From Disease Progression or Death at 6 Months [ Time Frame: Month 6 ]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).
- Progression-free Survival (PFS) [ Time Frame: From randomization until progressive disease or death, assessed up to 18 months ]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) [ Time Frame: From randomization until death, assessed up to 18 months ]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) [ Time Frame: From randomization until progressive disease or death, assessed up to 18 months ]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 [ Time Frame: From randomization until progressive disease or death, assessed up to 18 months ]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) [ Time Frame: From randomization until progressive disease or death, assessed up to 18 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01204697
|Avellino, Campania, Italy, 83100|
|Napoli, Campania, Italy, 80131|
|Parma, Emilia-Romagna, Italy, 43100|
|Aviano (PN), Friuli-Venezia Giulia, Italy, 33081|
|Roma, Lazio, Italy, 00152|
|Roma, Lazio, Italy, 00157|
|Roma, Lazio, Italy, 00168|
|Cremona, Lombardia, Italy, 26100|
|Milano, Lombardia, Italy, 20142|
|Monza, Lombardia, Italy, 20900|
|Pavia, Lombardia, Italy, 27100|
|Sondalo, Lombardia, Italy, 23039|
|Macerata, Marche, Italy, 62100|
|Lecce, Puglia, Italy, 73100|
|San Giovanni Rotondo, Puglia, Italy, 71013|
|Lido Di Camaiore, Toscana, Italy, 55043|
|Pisa, Toscana, Italy, 56124|
|Pontedera, Toscana, Italy, 56025|
|Treviso, Veneto, Italy, 31100|
|Vicenza, Veneto, Italy, 36100|
|Study Director:||Clinical Trials||Hoffmann-La Roche|