Non-Squamous Non-Small Cell Lung CancerNCT01659970

PEPITA Study: An Observational Study of Tarceva (Erlotinib) in Second Line in Patients With Locally Advanced or Metastatic Squamous Non-Small Cell Lung Cancer

An observational study of Non-Squamous Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 110 sites in France.

Completed

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

Trial summary

This observational study will evaluate the efficacy and safety of Tarceva (erlotinib) in second line in patients with locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) after failure of first line platinum-based chemotherapy. Eligible patients will be followed for 12 months. 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: 152 participants
Where: 110 sitesFrance
Study dates: Jun 2012to Apr 2014
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 locally advanced or metastatic squamous NSCLC initiating 2nd line treatment with Tarceva

Who may be able to join

Adult patients, >/= 18 years of age
Histologically or cytologically confirmed advanced (Stage IIIB) or metastatic (Stage IV) squamous non-small cell lung cancer after failure of first-line platinum-based chemotherapy
Patients for whom the treating physician has decided to initiate treatment with Tarceva

Who cannot join

Mixed non-small cell and small-cell lung carcinoma or mixed squamous cell carcinoma with predominant adenocarcinoma component
Current participation in a clinical trial evaluating an anticancer treatment

Trial locations and contacts

110 sites in 1 country.

City, postcode or hospital

110 sites in 1 country

France110 sites

Study site
Abbeville, 80142
Study site
Agen, 47000
Study site
Aix-en-Provence, 13616
Study site
Aix-en-Provence, 13617
Study site
Amiens, 80090
Study site
Angers, 49933
Study site
Antibes, 06600
Study site
Armentières, 59421
Study site
Aulnay-sous-Bois, 93602
Study site
Bar-le-Duc, 55012
Study site
Bayonne, 64100
Study site
Beuvry, 62660
Study site
Bordeaux, 33000
Study site
Boulogne-Billancourt, 92100
Study site
Bourg-en-Bresse, 01012
Study site
Brive-la-Gaillarde, 19312
Study site
Bron, 69677
Study site
Bry-sur-Marne, 94366
Study site
Carcassonne, 11890
Study site
Castres, 81108
Study site
Chalon-sur-Saône, 71100
Study site
Chambéry, 73011
Study site
Charleville-Mézières, 08011
Study site
Chaumont, 52014
Study site
Chauny, 02303
Study site
Clamart, 92141
Study site
Clermont-Ferrand, 63003
Study site
Colmar, 68024
Study site
Compiègne, 60321
Study site
Créteil, 94010
Study site
Dijon, 21000
Study site
Dijon, 21079
Study site
Draguignan, 83007
Study site
Dunkirk, 59240
Study site
Épernay, 51205
Study site
Ermont, 95120
Study site
Férolles-Attilly, 77150
Study site
Forbach, 57604
Study site
Gap, 05007
Study site
Gleizé, 69400
Study site
Gonesse, 95503
Study site
La Rochelle, 17019
Study site
La Source, 45100
Study site
La Tronche, 38700
Study site
Lagny-sur-Marne, 77405
Study site
Le Mans, 72015
Study site
Le Mans, 72037
Study site
Le Puy-en-Velay, 43012
Study site
Lille, 59000
Study site
Lille, 59037
Study site
Lille, 59042
Study site
Limoges, 87042
Study site
Lisieux, 14107
Study site
Longjumeau, 91161
Study site
Lorient, 56322
Study site
Lyon, 69275
Study site
Lyon, 69365
Study site
Manosque, 04101
Study site
Mantes-la-Jolie, 78200
Study site
Mareuil-lès-Meaux, 77100
Study site
Marseille, 13291
Study site
Meaux, 77104
Study site
Metz, 57038
Study site
Metz-Tessy, 74370
Study site
Mont-de-Marsan, 40024
Study site
Montpellier, 34070
Study site
Nancy, 54100
Study site
Nantes, 44202
Study site
Narbonne, 11780
Study site
Neuilly-sur-Seine, 92200
Study site
Paris, 75231
Study site
Paris, 75475
Study site
Paris, 75908
Study site
Paris, 75970
Study site
Perpignan, 66000
Study site
Perpignan, 66046
Study site
Pierre-Bénite, 69495
Study site
Poitiers, 86021
Study site
Pontoise, 95300
Study site
Quimper, 29000
Study site
Rambouillet, 78514
Study site
Reims, 51056
Study site
Reims, 51100
Study site
Rennes, 35033
Study site
Rouen, 76000
Study site
Rouen, 76031
Study site
Saint-Dié, 88187
Study site
Saint-Dizier, 52115
Study site
Saint-Jean, 31240
Study site
Saint-Laurent-du-Var, 06700
Study site
Saint-Omer, 62500
Study site
Saint-Priest-en-Jarez, 42271
Study site
Saint-Priest-en-Jarez, 42770
Study site
Saint-Quentin, 02321
Study site
Saintes, 17108
Study site
Strasbourg, 67000
Study site
Strasbourg, 67010
Study site
Strasbourg, 67065
Study site
Strasbourg, 67091
Study site
Thionville, 57126
Study site
Thonon-les-Bains, 74203
Study site
Toulon, 83041
Study site
Toulon, 83056
Study site
Toulouse, 31076
Study site
Tours, 37000
Study site
Valence, 26000
Study site
Vandœuvre-lès-Nancy, 54511
Study site
Vannes, 56017
Study site
Vénissieux, 69200
Study site
Verdun, 55107

Other trials in France

About this study

Official title: A Prospective Cohort Study Assessing the Efficacy and Safety of Tarceva in 2nd Line in Patients With Locally Advanced or Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)

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 groups in NCT01659970
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
Measured: 2 years

Secondary outcomes (5)

Clinical/demographic patients characteristics at baseline
Measured: 2 years
Treatment schedules: Dose/duration/modifications/interruptions
Measured: 2 years
Overall survival
Measured: 2 years
Safety: Incidence of adverse events
Measured: 2 years
Quality of life: FACT-L version 4 questionnaire
Measured: 2 years

Timeline

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

Jun 2012Apr 2014

First posted8 Aug 2012 (estimated)
Study startJun 2012
Primary completionApr 2014
Study completionApr 2014

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: 152 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01659970
Sponsor's protocol ID: ML28195
Status last verified: Nov 2016
First submitted: 6 Aug 2012
Last updated: 2 Nov 2016
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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

All Non-Squamous Non-Small Cell Lung Cancer trials

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 Prospective Cohort Study Assessing the Efficacy and Safety of Tarceva in 2nd Line in Patients With Locally Advanced or Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)
ClinicalTrials.gov ID: NCT01659970
Acronym / sponsor ID: ML28195
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Study type: Observational
Recruitment status: Completed
Enrolment: 152 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Jun 2012
Primary completion: Apr 2014 (actual)
Study completion: Apr 2014 (actual)
First posted: 8 Aug 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.

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 locally advanced or metastatic squamous NSCLC initiating 2nd line treatment with Tarceva

Key inclusion criteria (3 listed)

Adult patients, >/= 18 years of age
Histologically or cytologically confirmed advanced (Stage IIIB) or metastatic (Stage IV) squamous non-small cell lung cancer after failure of first-line platinum-based chemotherapy
Patients for whom the treating physician has decided to initiate treatment with Tarceva

Key exclusion criteria (2 listed)

Mixed non-small cell and small-cell lung carcinoma or mixed squamous cell carcinoma with predominant adenocarcinoma component
Current participation in a clinical trial evaluating an anticancer 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 frame: 2 years

5 secondary outcomes

Clinical/demographic patients characteristics at baseline
Time frame: 2 years
Treatment schedules: Dose/duration/modifications/interruptions
Time frame: 2 years
Overall survival
Time frame: 2 years
Safety: Incidence of adverse events
Time frame: 2 years
Quality of life: FACT-L version 4 questionnaire
Time frame: 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.

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

110 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 110 sites in France.

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 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 110 sites in France. 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 frame: 2 years). 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 NCT01659970.

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.