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Non-Squamous Non-Small Cell Lung CancerPhase 2NCT01204697

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

A Phase 2 study testing docetaxel and erlotinib [Tarceva] in people with Non-Squamous Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 20 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Squamous Non-Small Cell Lung Cancer
What is being tested?
docetaxel and erlotinib [Tarceva]
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
20 sitesItaly
Study dates
Nov 2010to Jul 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

Italy20 sites

  • Study site

    Avellino, Campania, 83100

  • Study site

    Aviano (PN), Friuli Venezia Giulia, 33081

  • Study site

    Cremona, Lombardy, 26100

  • Study site

    Lecce, Apulia, 73100

  • Study site

    Lido di Camaiore, Tuscany, 55043

  • Study site

    Milan, Lombardy, 20142

  • Study site

    Monza, Lombardy, 20900

  • Study site

    Naples, Campania, 80131

  • Study site

    Parma, Emilia-Romagna, 43100

  • Study site

    Pavia, Lombardy, 27100

  • Study site

    Pisa, Tuscany, 56124

  • Study site

    Pontedera, Tuscany, 56025

  • Study site

    Province of Macerata, The Marches, 62100

  • Study site

    Rome, Lazio, 00152

  • Study site

    Rome, Lazio, 00157

  • Study site

    Rome, Lazio, 00168

  • Study site

    San Giovanni Rotondo, Apulia, 71013

  • Study site

    Sondalo, Lombardy, 23039

  • Study site

    Treviso, Veneto, 31100

  • Study site

    Vicenza, Veneto, 36100

Other trials in Italy

About this study

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

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.

Being tested
docetaxel, erlotinib [Tarceva]

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • docetaxelDrug

    75 mg/m2 intravenously every 3 weeks for 4 cycles

  • erlotinib [Tarceva]Drug

    150 mg/day orally, days 2-16 each 3-week cycle for 4 cycles; 150 mg/day orally thereafter

  • erlotinib [Tarceva]Drug

    150 mg/day orally as monotherapy

Study groups in NCT01204697
Study groupRoleWhat they receive
AExperimentalNot described
Receives: Drug: erlotinib [Tarceva]
BExperimentalNot described
Receives: Drug: docetaxel; Drug: erlotinib [Tarceva]

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Month 6

Secondary outcomes (5)

  1. 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.

    Measured: From randomization until progressive disease or death, assessed up to 18 months

  2. 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.

    Measured: From randomization until death, assessed up to 18 months

  3. 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.

    Measured: From randomization until progressive disease or death, assessed up to 18 months

  4. 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.

    Measured: From randomization until progressive disease or death, assessed up to 18 months

  5. 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.

    Measured: From randomization until progressive disease or death, assessed up to 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2010 (estimated)
  2. Study startNov 2010
  3. Primary completionJul 2014
  4. Study completionJul 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01204697
Sponsor's protocol ID
ML21869
Status last verified
Oct 2015
First submitted
16 Sep 2010
Last updated
16 Nov 2015

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing docetaxel and erlotinib [Tarceva] in people with Non-Squamous Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 20 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Free From Disease Progression or Death at 6 Months (time frame: Month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01204697.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2015.

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