Non-Squamous Non-Small Cell Lung CancerNCT01723878
ASPET Study: An Observational Study of Tarceva (Erlotinib) in First Line in Patients With Advanced Non-Small Cell Lung Cancer Harbouring EGFR Activating Mutations
An observational study of Non-Squamous Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 43 sites in Spain.
Trial summary
This observational study will evaluate the patterns of disease progression in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring EGFR activating mutations receiving Tarceva (erlotinib) as first-line treatment. 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
- 144 participants
- Where
- 43 sitesSpain
- Study dates
- 30 Dec 2013to 20 Jun 2017
- 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 advanced non-small cell lung cancer (NSCLC) with EGFR activating mutations receiving first-line treatment with Tarceva
Who may be able to join
- Adult patients, >/= 18 years of age
- Histologically or cytologically confirmed locally advanced or metastatic (IIIB/IV) non-squamous non-small cell lung cancer (NSCLC) which is routinely evaluated in clinical practice according to RECIST criteria
- EGFR mutation-positive disease according to local laboratory testing
- Patients on treatment with Tarceva monotherapy as first-line treatment according to the physician's usual practice
Who cannot join
- Prior systemic therapy for advanced NSCLC. The administration of neoadjuvant or adjuvant chemotherapy is allowed as long as it was finalized >6 months prior to receiving Tarceva
- Participation in another clinical study
- Patients could have received radiotherapy as long as the irradiated lesion was not the only lesion for evaluating response and a long as the radiotherapy was completed before initiating Tarceva treatment
Trial locations and contacts
43 sites in 1 country.
43 sites in 1 country
Spain43 sites
Hospital Universitario Principe de Asturias; Servicio de Oncologia
Alcalá de Henares, Madrid, 28805
Fundacion Hospital de Alcorcon; Servicio de Oncologia
Alcorcón, Madrid, 28922
Hospital Virgen de los Lirios; Servicio de Oncologia
Alcoy, Alicante, 03804
Hospital de Cruces; Servicio de Oncologia
Barakaldo, Vizcaya, 48903
Hospital Clinic de Barcelona
Barcelona, 08036
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
Barcelona, 08041
Hospital Universitario Puerta del Mar; Servicio de Oncologia
Cadiz, Cadiz, 11009
Hospital Universitario Reina Sofia; Servicio de Oncologia
Córdoba, 14004
Hospital del Henares; Servicio de Oncologia
Coslada, Madrid, 28822
Hospital de Donostia; Servicio de Oncologia Medica
Donostia / San Sebastian, Guipuzcoa, 20080
Hospital Universitario San Cecilio; Servicio de Oncologia
Granada, 18003
Hospital General de Granollers; Servicio de Oncologia
Granollers, Barcelona, 08400
Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
Jaén, 23007
Hospital Universitario de Canarias (HUC)
La Laguna (Tenerife), Tenerife, 38320
Hospital General de Lanzarote
Lanzarote, Las Palmas
Hospital de Gran Canaria Dr. Negrin; Servicio de Oncologia
Las Palmas de Gran Canaria, Las Palmas, 35020
Complejo Asistencial Universitario de Leon; Servicio de Oncologia
León, 24071
Complejo Hospitalario Xeral-Cies
Lugo, 27004
Hospital Universitario La Paz; Servicio de Oncologia
Madrid, 28046
Hospital Universitario Puerta de Hierro; Servicio de Oncologia
Madrid, 28222
Hospital Universitario de Mostoles;Servicio de Oncologia
Madrid, 28935
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Hematologia
Málaga, 29010
Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia
Murcia, 30120
Complejo Hospitalario de Orense; Servicio de Oncologia
Ourense, Orense, 32005
Hospital Univ. Central de Asturias
Oviedo, Principality of Asturias, 33006
Hospital Universitario Son Espases; Servicio de Oncologia
Palma de Mallorca, Balearic Islands, 07014
Hospital Son Llatzer; Servicio de Oncologia
Palma de Mallorca, Balearic Islands, 07198
Hospital de Sagunto; Servicio de Oncologia
Sagunto, Valencia, 46520
Hospital Clinico Universitario de Salamanca; Servicio de Oncologia
Salamanca, 37007
Hospital Infanta Sofia; Servico de Oncologia
San Sebastián de los Reyes, Guipuzcoa, 28702
Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Oncologia
Santa Cruz de Tenerife, Tenerife, 38010
Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
Santander, Cantabria, 39008
Hospital General de Segovia; Servicio de Oncologia
Segovia, 40002
Hospital Universitario Virgen Macarena; Servicio de Oncologia
Seville, 41009
Hospital Mutua de Terrassa; Servicio de Oncologia
Terrassa, Barcelona, 08221
Hospital General de Teruel Obispo Polanco; Servicio Oncologia
Teruel, 44002
Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia
Valencia, 46015
Hospital Universitario Dr. Peset; Servicio de Oncologia
Valencia, 46017
Hospital Clinico Universitario de Valladolid; Servicio de Oncologia
Valladolid, 47005
Hospital Meixoeiro
Vigo, Pontevedra, 36214
Hospital Lluis Alcanys; Servicio de Oncologia
Xàtiva, Valencia, 46800
Complejo Hospitalario Zamora- H. Virgen de la Concha; Servicio Oncologia
Zamora, 49021
Hospital Universitario Miguel Servet; Servicio Oncologia
Zaragoza, 50009
About this study
Official title: Observational, Post-authorization, Prospective Study for Evaluating Patterns of Disease Progression in Patients With Advanced Non-small-cell Lung Carcinoma (NSCLC) Harbouring EGFR Activating Mutations Treated With Erlotinib in First Line.
This observational study will evaluate the patterns of disease progression in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring EGFR activating mutations receiving Tarceva (erlotinib) as first-line treatment. Patients will be followed for up to 12 months after progression of disease.
- 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.
Progression-free survival (time from initiation of treatment to disease progression or death of any cause) in correlation with localization of progression and clinical tumor characteristics
Measured: 3 years
Secondary outcomes (7)
Objective response rate, tumor assessments according to RECIST v1.1 criteria
Measured: 3 years
One-year overall survival (from initiation of treatment to 12 months after disease progression)
Measured: 3 years
Time to progression
Measured: 3 years
Exposure (dosage/duration) with first-line Tarceva in clinical practice
Measured: 3 years
Safety: Incidence of adverse events
Measured: 3 years
Velocity of progression (disease flares) after cessation of treatment with Tarceva following disease progression
Measured: 3 years
Treatments used after disease progression in clinical practice
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2012 (estimated)
- Study start30 Dec 2013
- Primary completion20 Jun 2017
- Study completion20 Jun 2017
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
- 144 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
- NCT01723878
- Sponsor's protocol ID
- ML28361
- Status last verified
- Sep 2017
- First submitted
- 6 Nov 2012
- Last updated
- 11 Sep 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational, Post-authorization, Prospective Study for Evaluating Patterns of Disease Progression in Patients With Advanced Non-small-cell Lung Carcinoma (NSCLC) Harbouring EGFR Activating Mutations Treated With Erlotinib in First Line.
- ClinicalTrials.gov ID
- NCT01723878
- Acronym / sponsor ID
- ML28361
- Conditions
- Non-Squamous Non-Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 30 Dec 2013 (actual)
- Primary completion
- 20 Jun 2017 (actual)
- Study completion
- 20 Jun 2017 (actual)
- First posted
- 8 Nov 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 observational study will evaluate the patterns of disease progression in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring EGFR activating mutations receiving Tarceva (erlotinib) as first-line treatment. Patients will be followed for up to 12 months after progression of disease.
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 advanced non-small cell lung cancer (NSCLC) with EGFR activating mutations receiving first-line treatment with Tarceva
Key inclusion criteria (4 listed)
- Adult patients, >/= 18 years of age
- Histologically or cytologically confirmed locally advanced or metastatic (IIIB/IV) non-squamous non-small cell lung cancer (NSCLC) which is routinely evaluated in clinical practice according to RECIST criteria
- EGFR mutation-positive disease according to local laboratory testing
- Patients on treatment with Tarceva monotherapy as first-line treatment according to the physician's usual practice
Key exclusion criteria (3 listed)
- Prior systemic therapy for advanced NSCLC. The administration of neoadjuvant or adjuvant chemotherapy is allowed as long as it was finalized >6 months prior to receiving Tarceva
- Participation in another clinical study
- Patients could have received radiotherapy as long as the irradiated lesion was not the only lesion for evaluating response and a long as the radiotherapy was completed before initiating Tarceva treatment
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
Progression-free survival (time from initiation of treatment to disease progression or death of any cause) in correlation with localization of progression and clinical tumor characteristics
Time frame: 3 years
7 secondary outcomes
Objective response rate, tumor assessments according to RECIST v1.1 criteria
Time frame: 3 years
One-year overall survival (from initiation of treatment to 12 months after disease progression)
Time frame: 3 years
Time to progression
Time frame: 3 years
Exposure (dosage/duration) with first-line Tarceva in clinical practice
Time frame: 3 years
Safety: Incidence of adverse events
Time frame: 3 years
Velocity of progression (disease flares) after cessation of treatment with Tarceva following disease progression
Time frame: 3 years
Treatments used after disease progression in clinical practice
Time frame: 3 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 11 Sep 2017.
Related trials for Non-Squamous Non-Small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Not yet recruitingPhase 2
Phase II Study to Evaluate Telisotuzumab Adizutecan in Combination With RC148(ABBV-1480) as First-Line Treatment for Patients With Non-Squamous Non-Small-Cell Lung Cancer
Patients With Locally Advanced or Metastatic Non-Squamous NSCLC Requiring First-Line Treatment and no Driver Gene Alterations Confirmed by Histology or Cytology
Active, not recruitingPhase 2
Carboplatin, Taxane And Ramucirumab for Patients With NSCLC After Pemetrexed or Pembrolizumab Maintenance
Non-small Cell Lung Cancer
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
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
43 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 43 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 4 inclusion and 3 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 11 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 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?
Progression-free survival (time from initiation of treatment to disease progression or death of any cause) in correlation with localization of progression and clinical tumor characteristics (time frame: 3 years). 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 11 Sep 2017.