Non-Small Cell Lung CancerNCT02133508
A Study Examining Long Response in Lung Cancer Patients Treated With Tarceva (Erlotinib)
An observational study of Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 39 sites in Italy.
Trial summary
This multicenter, retrospective and prospective observational, cohort study will examine the effect of second-line Tarceva treatment on long response in non-small cell lung cancer (NSCLC) participants with wild type or unknown EGFR status. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- How many people
- 172 participants
- Where
- 39 sitesItaly
- Study dates
- 30 Apr 2014to 10 Jun 2016
- 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: Adult participants with non-small cell lung cancer (NSCLC)
Who may be able to join
- Participants with stage IIIb or IV NSCLC
- Participants aged >/= 18 years
- Second-line treatment with Tarceva started before study inclusion and SD response, or CR/PR according to RECIST v1.1, lasting for at least 4 weeks
Who cannot join
- Known presence of epidermal growth factor receptor (EGFR) mutation
- Participation in a clinical trial with Tarceva during the study observation period
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
Italy39 sites
Azienda Ospedaliera San Giuseppe Moscati
Avellino, Campania, 83100
Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica
Bari, Apulia, 70124
Ospedale Di Bolzano; Dept. Di Oncologia
Bolzano, Trentino-Alto Adige, 39100
Ospedale Oncologico A.Businco; Div. Oncologia Medica II
Cagliari, Sardinia, 09121
Az Ospedaliera Nuovo Garibaldi Quartiere Nesima; Oncologia Medica
Catania, Sicily, 95122
Policlinico Ospedaliero Ss Annunziata; U.O. Di Clinica Oncologica
Chieti, Abruzzo, 66100
Ospedale Valduce;U.O.S. Oncologia Ed Ematologia
Como, Lombardy, 22100
Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1
Florence, Tuscany, 50139
IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A
Genoa, Liguria, 16132
A.O. Villa Scassi; Oncologia Medica
Genoa, Liguria, 16149
Ospedale Vito Fazzi; Div. Oncoematologia
Lecce, Apulia, 73100
Ospedale Nuovo Della Versilia; Divisione Di Oncologia Medica
Lido di Camaiore, Tuscany, 55043
Ospedale Civile; Unita Operativa Di Oncologia Medica
Livorno, Tuscany, 57100
Az. Osp. Carlo Poma; Divisione Di Oncologia Medica
Mantua, Lombardy, 46100
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
Meldola, Emilia-Romagna, 47014
A.O. Universitaria Policlinico Di Modena; Ematologia
Modena, Emilia-Romagna, 41100
ASST DI MONZA; Oncologia Medica
Monza, Lombardy, 20900
Az. Osp. Monaldi; 1 Pneumologia Oncologica
Naples, Campania, 80131
Az. Osp. Monaldi; 2 Pneumologia-Chemioterapia E Day Hospital-Pneumoncologia
Naples, Campania, 80131
Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli; U.O.C. di Oncologia Medica
Naples, Campania, 80131
IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica A
Naples, Campania, 80131
Ospedale Maggiore Della Carita; Oncologia Medica
Novara, Piedmont, 28100
IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda
Padova, Veneto, 35128
Casa Di Cura Di Alta Specialita La Maddalena; Dept. Oncologico Di Iii Livello
Palermo, Sicily, 90146
A.O. Universitaria Di Parma; Oncologia Medica
Parma, Emilia-Romagna, 43100
Ospedale Civile; Divisione Di Oncologia
Pescara, Abruzzo, 65124
A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii
Pisa, Tuscany, 56124
Ospedale Di Macerata; Oncologia
Province of Macerata, The Marches, 62100
Ospedale Provinciale Santa Maria delle Croci
Ravenna, Emilia-Romagna, 48100
Arcispedale Santa Maria Nuova; Oncologia
Reggio Emilia, Emilia-Romagna, 42100
Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica
Rome, Lazio, 00128
Fondazione Ptv Policlinico Tor Vergata
Rome, Lazio, 00133
Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica
Rome, Lazio, 00152
Azienda Ospedaliera San Camillo Forlanini; U.O.C. Pneumologia Ad Indirizzo Oncologico 1
Rome, Lazio, 00152
Policlinico Umberto i di Roma; dip. Scienze Radiologiche, Oncologiche, Anatomopatologiche
Rome, Lazio, 00161
IFO - Istituto Regina Elena; Oncologia Medica
Rome, Lazio, 00168
Casa Sollievo della Sofferenza - Medicina Interna
San Giovanni Rotondo, Apulia, 71013
Ospedale Cà Foncello - Divisione di Oncologia Medica
Treviso, Veneto, 31100
A.O.U.I. VERONA-OSPEDALE BORGO TRENTO; ONCOLODIA MEDICA-d.O.
Verona, Veneto, 37126
About this study
Official title: Observational Trial on Long Responses in Patients With Advanced Non-Small Cell Lung Cancer Treated in Second-Line With Erlotinib
This multicenter, retrospective and prospective observational, cohort study will examine the effect of second-line Tarceva treatment on long response in non-small cell lung cancer (NSCLC) participants with wild type or unknown EGFR status. Participants will be observed from the start of treatment for 8 months or until death. The extension of the retrospective versus prospective observation will depend on the lag between the date of the participant enrollment and the date of beginning of erlotinib therapy.
- Conditions
- Non-Small Cell Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
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 |
|---|---|---|
| NSCLC Participants | Participants with advanced non-small cell lung cancer (NSCLC), treated in second-line with erlotinib, presenting wild-type, not tested or unknown Epidermal Growth Factor Receptor (EGFR) status, and with stable disease at the first revaluation after start of erlotinib therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Stable Disease (SD) or Objective Response (Complete and Partial Response [CR + PR] According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. Objective response was defined as having a CR or PR. CR was defined as disappearance of all target and non-target lesions and no new lesions, and all pathological lymph nodes must have decreased to <10 millimeters (mm) in short axis. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. PD was defined as at least a 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and an absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.
Measured: Up to 8 months
Duration of SD or Objective Response According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
The duration of SD or objective response (CR+PR) was defined as the time from first occurrence of SD or objective response to the time of PD, or death for any cause. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Objective response was defined as having a CR or PR. CR was defined as disappearance of all target and non-target lesions and no new lesions, and all pathological lymph nodes must have decreased to <10 mm in short axis. PR was defined as at least 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. PD was defined as at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and an absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.
Measured: Up to 8 months
Secondary outcomes (3)
Progression-free Survival (PFS) According to RECIST v1.1
PFS was defined as the time from the beginning of therapy with erlotinib to the first occurrence of disease progression, as determined by the investigator using RECIST v1.1 criteria, or death from any cause. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.
Measured: Up to 8 months
Overall Survival
Overall survival was defined as the time from the beginning of therapy with erlotinib to death from any cause.
Measured: Up to 8 months
Percentage of Participants With Adverse Events (AEs)
An AE is an unfavorable and unintended sign, symptom, or disease temporally associated with a clinical study, regardless of causality.
Measured: Up to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2014 (estimated)
- Study start30 Apr 2014
- Primary completion10 Jun 2016
- Study completion10 Jun 2016
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 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
- Case only
- Time perspective
- Other
- Enrolment
- 172 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
- NCT02133508
- Sponsor's protocol ID
- ML28891
- Status last verified
- May 2017
- First submitted
- 7 May 2014
- Last updated
- 24 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Trial on Long Responses in Patients With Advanced Non-Small Cell Lung Cancer Treated in Second-Line With Erlotinib
- ClinicalTrials.gov ID
- NCT02133508
- Acronym / sponsor ID
- ML28891
- Conditions
- Non-Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2014 (actual)
- Primary completion
- 10 Jun 2016 (actual)
- Study completion
- 10 Jun 2016 (actual)
- First posted
- 8 May 2014 (estimated)
- Results
- Posted 24 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multicenter, retrospective and prospective observational, cohort study will examine the effect of second-line Tarceva treatment on long response in non-small cell lung cancer (NSCLC) participants with wild type or unknown EGFR status. Participants will be observed from the start of treatment for 8 months or until death. The extension of the retrospective versus prospective observation will depend on the lag between the date of the participant enrollment and the date of beginning of erlotinib therapy.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NSCLC Participants | – | –Participants with advanced non-small cell lung cancer (NSCLC), treated in second-line with erlotinib, presenting wild-type, not tested or unknown Epidermal Growth Factor Receptor (EGFR) status, and with stable disease at the first revaluation after start of erlotinib therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants with non-small cell lung cancer (NSCLC)
Key inclusion criteria (3 listed)
- Participants with stage IIIb or IV NSCLC
- Participants aged >/= 18 years
- Second-line treatment with Tarceva started before study inclusion and SD response, or CR/PR according to RECIST v1.1, lasting for at least 4 weeks
Key exclusion criteria (2 listed)
- Known presence of epidermal growth factor receptor (EGFR) mutation
- Participation in a clinical trial with Tarceva during the study observation period
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
Percentage of Participants With Stable Disease (SD) or Objective Response (Complete and Partial Response [CR + PR] According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: Up to 8 months
SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. Objective response was defined as having a CR or PR. CR was defined as disappearance of all target and non-target lesions and no new lesions, and all pathological lymph nodes must have decreased to <10 millimeters (mm) in short axis. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. PD was defined as at least a 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and an absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.
Duration of SD or Objective Response According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: Up to 8 months
The duration of SD or objective response (CR+PR) was defined as the time from first occurrence of SD or objective response to the time of PD, or death for any cause. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Objective response was defined as having a CR or PR. CR was defined as disappearance of all target and non-target lesions and no new lesions, and all pathological lymph nodes must have decreased to <10 mm in short axis. PR was defined as at least 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. PD was defined as at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and an absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.
3 secondary outcomes
Progression-free Survival (PFS) According to RECIST v1.1
Time frame: Up to 8 months
Overall Survival
Time frame: Up to 8 months
Percentage of Participants With Adverse Events (AEs)
Time frame: Up to 8 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2017.
- 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
39 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-Small Cell Lung Cancer, run by Hoffmann-La Roche at 39 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 3 inclusion and 2 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 24 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Oct 2017). 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 Stable Disease (SD) or Objective Response (Complete and Partial Response [CR + PR] According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (time frame: Up to 8 months). The study lists 2 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 24 Oct 2017.