Non-Squamous Non-Small Cell Lung CancerNCT01512420
An Observational Study of Tarceva (Erlotinib) in Previously Treated Patients With Advanced Non-Small Cell Lung Cancer With Wild-Type Epidermal Growth Factor Receptor (EGFR) Gene (WILT)
An observational study of Non-Squamous Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 41 sites in Spain.
Trial summary
This prospective observational study will evaluate the efficacy and safety of second-line Tarceva (erlotinib) in patients with previously treated advanced non-small cell lung cancer with confirmed wild-type epidermal growth factor receptor (EGFR) gene. 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
- How many people
- 355 participants
- Where
- 41 sitesSpain
- Study dates
- Nov 2011to Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients with previously treated advanced NSCLC, with wild-type EGFR gene or squamous cell carcinoma histology
Who may be able to join
- Adult patients, >/= 18 years of age
- Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC)
- Patients with known wild-type EGFR gene; patients with unknown EGFR mutation status are allowed if they fulfil the following criteria:
- squamous cell carcinoma lung cancer histology, and
- current smoker, or former smoker who has stopped smoking less than 10 years ago and has had a total of >15 pack-years of smoking
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Patients having failed one prior chemotherapy regimen and eligible for a second-line treatment with Tarceva
Who cannot join
- Current treatment with an investigational drug or participation in another investigational study
- Severe or uncontrolled systemic disease, active infection, concomitant malignancy or a second primary malignancy except for in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin
- Clinically active interstitial lung disease
- Recent myocardial infarction or unstable angina
- Progressive or uncontrolled brain metastases
Trial locations and contacts
41 sites in 1 country.
41 sites in 1 country
Spain41 sites
Study site
A Coruña, La Coruña, 15006
Study site
Alcalá de Henares, Madrid, 28805
Study site
Barbastro, Huesca, 22300
Study site
Barcelona, Barcelona, 08006
Study site
Barcelona, Barcelona, 08036
Study site
Barcelona, Barcelona, 08041
Study site
Barcelona, Barcelona, 08916
Study site
Bilbao, Vizcaya, 48013
Study site
Cáceres, Caceres, 10003
Study site
Donostia / San Sebastian, Guipuzcoa, 20080
Study site
Elda, Alicante, 03600
Study site
Girona, Girona, 17007
Study site
Huesca, Huesca, 22004
Study site
Las Palmas de Gran Canaria, Las Palmas, 35020
Study site
León, Leon, 24071
Study site
Logroño, La Rioja, 26006
Study site
Lugo, Lugo, 27003
Study site
Madrid, Madrid, 28007
Study site
Madrid, Madrid, 28040
Study site
Madrid, Madrid, 28046
Study site
Madrid, Madrid, 28905
Study site
Mahon, Balearic Islands, 07703
Study site
Melilla, Malaga, 52005
Study site
Oviedo, Principality of Asturias, 33011
Study site
Palma de Mallorca, Balearic Islands, 07014
Study site
Reus, Tarragona, 43204
Study site
Salamanca, Salamanca, 37007
Study site
San Cristóbal de La Laguna, Tenerife, 38320
Study site
Santander, Cantabria, 39008
Study site
Santiago de Compostela, La Coruña, 15706
Study site
Teruel, Teruel, 44002
Study site
Toledo, Toledo, 45004
Study site
Valencia, Valencia, 41014
Study site
Valencia, Valencia, 46015
Study site
Valencia, Valencia, 46017
Study site
Valencia, Valencia, 46026
Study site
Valladolid, Valladolid, 47005
Study site
Vitoria-Gasteiz, Alava, 01009
Study site
Xàtiva, Valencia, 46800
Study site
Zamora, Zamora, 49021
Study site
Zaragoza, Zaragoza, 50009
About this study
Official title: A Multicenter, Prospective, Observational Study to Identify Different Prognostic Factors Related to Survival in Patients With Previously Treated Advanced NSCLC With Wild-type Epidermal Growth Factor Receptor (EGFR) Gene.
This prospective observational study will evaluate the efficacy and safety of second-line Tarceva (erlotinib) in patients with previously treated advanced non-small cell lung cancer with confirmed wild-type epidermal growth factor receptor (EGFR) gene. The aim of the study is to identify from baseline clinical and demographic patient characteristics prognostic factors related to overall survival with second-line Tarceva treatment. Data will be collected from eligible patients for up to 2 years.
- Conditions
- Non-Squamous Non-Small Cell Lung Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of overall survival with baseline clinical/demographic patient characteristics
Measured: approximately 2 years
Correlation of overall survival with baseline tumour characteristics
Measured: approximately 2 years
Correlation of overall survival with previous treatment regimens
Measured: approximately 2 years
Secondary outcomes (4)
Objective response rate (ORR), tumour assessments according to RECIST criteria
Measured: approximately 2 years
Disease control rate
Measured: approximately 2 years
Progression-free survival
Measured: approximately 2 years
Safety: Incidence of adverse events
Measured: approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2012 (estimated)
- Study startNov 2011
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Squamous Non-Small Cell Lung CancerStudies 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
- 355 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
- NCT01512420
- Sponsor's protocol ID
- ML27773
- Status last verified
- Nov 2016
- First submitted
- 19 Dec 2011
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Observational Study to Identify Different Prognostic Factors Related to Survival in Patients With Previously Treated Advanced NSCLC With Wild-type Epidermal Growth Factor Receptor (EGFR) Gene.
- ClinicalTrials.gov ID
- NCT01512420
- Acronym / sponsor ID
- ML27773
- Conditions
- Non-Squamous Non-Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 355 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 19 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective observational study will evaluate the efficacy and safety of second-line Tarceva (erlotinib) in patients with previously treated advanced non-small cell lung cancer with confirmed wild-type epidermal growth factor receptor (EGFR) gene. The aim of the study is to identify from baseline clinical and demographic patient characteristics prognostic factors related to overall survival with second-line Tarceva treatment. Data will be collected from eligible patients for up to 2 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with previously treated advanced NSCLC, with wild-type EGFR gene or squamous cell carcinoma histology
Key inclusion criteria (7 listed)
- Adult patients, >/= 18 years of age
- Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC)
- Patients with known wild-type EGFR gene; patients with unknown EGFR mutation status are allowed if they fulfil the following criteria:
- squamous cell carcinoma lung cancer histology, and
- current smoker, or former smoker who has stopped smoking less than 10 years ago and has had a total of >15 pack-years of smoking
Key exclusion criteria (5 listed)
- Current treatment with an investigational drug or participation in another investigational study
- Severe or uncontrolled systemic disease, active infection, concomitant malignancy or a second primary malignancy except for in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin
- Clinically active interstitial lung disease
- Recent myocardial infarction or unstable angina
- Progressive or uncontrolled brain metastases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation of overall survival with baseline clinical/demographic patient characteristics
Time frame: approximately 2 years
Correlation of overall survival with baseline tumour characteristics
Time frame: approximately 2 years
Correlation of overall survival with previous treatment regimens
Time frame: approximately 2 years
4 secondary outcomes
Objective response rate (ORR), tumour assessments according to RECIST criteria
Time frame: approximately 2 years
Disease control rate
Time frame: approximately 2 years
Progression-free survival
Time frame: approximately 2 years
Safety: Incidence of adverse events
Time frame: approximately 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
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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
41 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Squamous Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 41 sites in Spain.
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 7 inclusion and 5 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 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Correlation of overall survival with baseline clinical/demographic patient characteristics (time frame: approximately 2 years). The study lists 3 primary outcomes in all. 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 2 Nov 2016.