A Study of Erlotinib [Tarceva] as Monotherapy or Intermittent Dosing With Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer. (TALISMAN)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01204697
First received: September 16, 2010
Last updated: October 15, 2015
Last verified: October 2015
  Purpose
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.

Condition Intervention Phase
Non-Squamous Non-Small Cell Lung Cancer
Drug: docetaxel
Drug: erlotinib [Tarceva]
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants Free From Disease Progression or Death at 6 Months [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    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) [ Time Frame: From randomization until progressive disease or death, assessed up to 18 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 74
Study Start Date: November 2010
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: erlotinib [Tarceva]
150 mg/day orally as monotherapy
Experimental: B Drug: docetaxel
75 mg/m2 intravenously every 3 weeks for 4 cycles
Drug: erlotinib [Tarceva]
150 mg/day orally, days 2-16 each 3-week cycle for 4 cycles; 150 mg/day orally thereafter

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01204697

Locations
Italy
Avellino, Campania, Italy, 83100
Napoli, Campania, Italy, 80131
Parma, Emilia-Romagna, Italy, 43100
Aviano (PN), Friuli-Venezia Giulia, Italy, 33081
Roma, Lazio, Italy, 00168
Roma, Lazio, Italy, 00152
Roma, Lazio, Italy, 00157
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
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01204697     History of Changes
Other Study ID Numbers: ML21869 
Study First Received: September 16, 2010
Results First Received: October 15, 2015
Last Updated: October 15, 2015
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Lung Neoplasms
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Docetaxel
Erlotinib
Antimitotic Agents
Antineoplastic Agents
Enzyme Inhibitors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on February 11, 2016