Nonsquamous Nonsmall Cell Neoplasm of LungTEAMNCT01161173
An Observational Study of Tarceva (Erlotinib) in Routine Daily Clinical Practice as Second Line Treatment in Patients With Non-small Cell Lung Cancer
An observational study of Nonsquamous Nonsmall Cell Neoplasm of Lung, run by Hoffmann-La Roche at 36 sites in 2 countries.
Trial summary
This observational study will evaluate the safety and efficacy of Tarceva (erlotinib) in routine clinical practice as second-line treatment in patients with recurrent or metastatic non-small dell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nonsquamous Nonsmall Cell Neoplasm of Lung
- What is being tested?
- Erlotinib
- Type of treatment
- Pill or oral medicine
- How many people
- 347 participants
- Where
- 36 sitesin 2 countries
- Study dates
- Apr 2008to Aug 2012
- Phase
- Observational
- 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
Study population: Non-small cell lung cancer patients with progressive disease after first-line chemotherapy.
Who may be able to join
- Adult patients ≥ 18 years of age.
- Written informed consent.
- Recurrent or metastatic, Stage III or IV non-small cell lung cancer (NSCLC).
- Measurable disease (Response Evaluation Criteria In Solid Tumors).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Prior course of standard systemic chemotherapy.
Who cannot join
- Contra-indications to treatment with Tarceva.
Trial locations and contacts
36 sites in 2 countries.
36 sites in 2 countries
Belgium33 sites
Study site
Aalst, 9300
Study site
Antwerp, 2020
Study site
Arlon, 6700
Study site
Bonheiden, 2820
Study site
Bouge, 5004
Study site
Boussu, 7360
Study site
Brussels, 1020
Study site
Brussels, 1050
Study site
Brussels, 1180
Study site
Brussels, 1200
Study site
Charleroi, 6000
Study site
Chimay, 6460
Study site
Duffel, 2570
Study site
Edegem, 2650
Study site
Frameries, 7080
Study site
Genk, 3600
Study site
Gilly, 6060
Study site
Hasselt, 3500
Study site
Leuven, 3000
Study site
Liège, 4000
Study site
Marche-en-Famenne, 5411
Study site
Mons, 7000
Study site
Namur, 5000
Study site
Ostend, 8400
Study site
Ottignies, 1340
Study site
Roeselare, 8800
Study site
Seraing, 4100
Study site
Sint-Niklaas, 9100
Study site
Tournai, 7500
Study site
Turnhout, 2300
Study site
Verviers, 4800
Study site
Vilvoorde, 1800
Study site
Wilrijk, 2610
Luxembourg3 sites
Study site
Differdange, 4602
Study site
Esch-alzette
Study site
Luxembourg, 1210
About this study
Official title: A Non-interventional Study to Follow and Evaluate Patients With Advanced NSCLC Who Are Treated in Second Line Setting With Tarceva (Erlotinib) in a "Real Life" Clinical Setting
This observational study will evaluate the safety and efficacy of Tarceva (erlotinib) in routine clinical practice as second-line treatment in patients with recurrent or metastatic non-small dell lung cancer (NSCLC). Data will be collected from patients who have received 1 course of standard systemic chemotherapy, experienced disease progression, and who are receiveingTarceva in a second-line setting. Patients will also be followed through third-line treatment if there is disease progression on Tarceva therapy.
- Being tested
- Erlotinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErlotinibDrug
Also called Tarceva
Erlotinib was provided in the retail versions of the product.
| Study group | Role | What they receive |
|---|---|---|
| Erlotinib | Participants received erlotinib (Tarceva) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics. The recommended daily dose of erlotinib is 150 mg orally once daily. Receives: Drug: Erlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)
The best overall response to treatment was determined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. A CR was defined as the disappearance of all target lesions (TL) or the disappearance of all non-TLs. A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD. SD was defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since treatment started for TLs and the persistence of 1 or more non-TL(s). 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 appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. For the best overall responses of CR and PR, a response was "confirmed" if a subsequent RECIST evaluation also showed a CR or PR.
Measured: Baseline to the end of the study (up to 4 years, 4 months)
Secondary outcomes (5)
Time to Disease Progression
The time to disease progression was defined as the time from Baseline until disease progression as determined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.
Measured: Baseline to the end of the study (up to 4 years, 4 months)
Progression-free Survival
Progression-free survival was defined as the time from Baseline until disease progression or death from any cause. Progressive disease was determined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.
Measured: Baseline to the end of the study (up to 4 years, 4 months)
Overall Survival
Overall survival was defined as the time from Baseline until or death from any cause
Measured: Baseline to the end of the study (up to 4 years, 4 months)
Change From Baseline in the Lung Cancer Symptom Scale (LCSS) Scores
Study participants and treating physicians completed the LCSS, a measure of Quality of Life (QoL), at Baseline and throughout the study. The patient LCSS measures 6 major symptoms, the Symptom Burden Index (SBI), associated with lung malignancies (3 thoracic [cough, dyspnea, haemoptysis] and 3 general symptoms [loss of appetite, fatigue, pain]) and 3 additional scores (overall symptomatic distress, interference with daily activities, global QoL), each on a 100 mm visual analogue scale (0=no impairment, 100=maximum impairment). The physician LCSS evaluates the 6 lung malignancy associated symptoms, the SBI, on an ordinal scale (100=none, 75=mild, 50=moderate, 25=marked, 0=severe). The average of the patient and physician SBI scores (6 symptoms) and the average of the patient total score (9 symptoms) ranged from 0 to 100, with a higher patient and a lower physician score indicating more impairment. A negative patient and a positive physician change score indicates improvement.
Measured: Baseline to the end of the study (up to 4 years, 4 months)
Percentage of Participants Who Developed Rash
At each study visit, the presence of skin rash was graded using the Common Toxicity Criteria (CTC), with grade 0 = no rash, grade 1 = mild, grade 2 = moderate, grade 3 = severe, and grade 4 = life threatening or disabling rash. Reported is the percentage of participants who developed a grade ≥ 1 rash.
Measured: Baseline to the end of the study (up to 4 years, 4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2010 (estimated)
- Study startApr 2008
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nonsquamous Nonsmall Cell Neoplasm of LungStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 347 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01161173
- Sponsor's protocol ID
- ML21474
- Acronym
- TEAM
- Status last verified
- Feb 2016
- First submitted
- 12 Jul 2010
- Last updated
- 28 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional Study to Follow and Evaluate Patients With Advanced NSCLC Who Are Treated in Second Line Setting With Tarceva (Erlotinib) in a "Real Life" Clinical Setting
- ClinicalTrials.gov ID
- NCT01161173
- Acronym / sponsor ID
- TEAM / ML21474
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 347 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 13 Jul 2010 (estimated)
- Results
- Posted 28 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This observational study will evaluate the safety and efficacy of Tarceva (erlotinib) in routine clinical practice as second-line treatment in patients with recurrent or metastatic non-small dell lung cancer (NSCLC). Data will be collected from patients who have received 1 course of standard systemic chemotherapy, experienced disease progression, and who are receiveingTarceva in a second-line setting. Patients will also be followed through third-line treatment if there is disease progression on Tarceva therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Erlotinib | – | Drug: ErlotinibParticipants received erlotinib (Tarceva) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics. The recommended daily dose of erlotinib is 150 mg orally once daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Non-small cell lung cancer patients with progressive disease after first-line chemotherapy.
Key inclusion criteria (6 listed)
- Adult patients ≥ 18 years of age.
- Written informed consent.
- Recurrent or metastatic, Stage III or IV non-small cell lung cancer (NSCLC).
- Measurable disease (Response Evaluation Criteria In Solid Tumors).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Key exclusion criteria (1 listed)
- Contra-indications to treatment with Tarceva.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ErlotinibAlso: TarcevaErlotinib was provided in the retail versions of the product. | Drug | Erlotinib |
Primary outcome
Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)
Time frame: Baseline to the end of the study (up to 4 years, 4 months)
The best overall response to treatment was determined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. A CR was defined as the disappearance of all target lesions (TL) or the disappearance of all non-TLs. A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD. SD was defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since treatment started for TLs and the persistence of 1 or more non-TL(s). 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 appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. For the best overall responses of CR and PR, a response was "confirmed" if a subsequent RECIST evaluation also showed a CR or PR.
5 secondary outcomes
Time to Disease Progression
Time frame: Baseline to the end of the study (up to 4 years, 4 months)
Progression-free Survival
Time frame: Baseline to the end of the study (up to 4 years, 4 months)
Overall Survival
Time frame: Baseline to the end of the study (up to 4 years, 4 months)
Change From Baseline in the Lung Cancer Symptom Scale (LCSS) Scores
Time frame: Baseline to the end of the study (up to 4 years, 4 months)
Percentage of Participants Who Developed Rash
Time frame: Baseline to the end of the study (up to 4 years, 4 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
36 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nonsquamous Nonsmall Cell Neoplasm of Lung, run by Hoffmann-La Roche at 36 sites in 2 countries.
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 6 inclusion and 1 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 28 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in Belgium, Luxembourg. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Mar 2016). 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 With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD) (time frame: Baseline to the end of the study (up to 4 years, 4 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Mar 2016.