Non-Small Cell Lung CancerPhase 2NCT01996332

A Study of Tarceva (Erlotinib) Monotherapy in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

A Phase 2 study testing erlotinib [Tarceva] in people with Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 94 sites in Spain.

Completed

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

Official record

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Trial summary

This study will evaluate the efficacy and safety of oral Tarceva in patients with advanced NSCLC for whom Tarceva monotherapy is considered the best therapeutic option. The anticipated time on study treatment is 3-12 months. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-Small Cell Lung Cancer
What is being tested?: erlotinib [Tarceva]
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,805 participants
Where: 94 sitesSpain
Study dates: Apr 2004to Oct 2012
Phase: Phase 2
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

Who may be able to join

adult patients >=18 years of age;
locally advanced or metastatic NSCLC (Stage IIIB or IV);
not a candidate for curative surgery or radical chemotherapy;
no brain metastases, or clinically stable metastases for >=2 months.

Who cannot join

radiotherapy over the previous 2 weeks;
weight loss >10% in the previous 6 weeks.

Trial locations and contacts

94 sites in 1 country.

City, postcode or hospital

94 sites in 1 country

Spain94 sites

Study site
A Coruña, La Coruña, 15006
Study site
A Coruña, La Coruña, 15009
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Alcorcón, Madrid, 28922
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Alcoy, Alicante, 03804
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Algeciras, Cadiz, 11207
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Alicante, Alicante, 3010
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Almería, Almeria, 04009
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Ávila, Avila, 05071
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Badajoz, Badajoz, 06080
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Badalona, Barcelona, 08911
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Barakaldo, Vizcaya, 48903
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Barcelona, Barcelona, 08003
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Barcelona, Barcelona, 08017
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Barcelona, Barcelona, 08022
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Barcelona, Barcelona, 08029
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Barcelona, Barcelona, 08036
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Barcelona, Barcelona, 08041
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Barcelona, Barcelona, 08227
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Barcelona, Barcelona, 08907
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Barcelona, Barcelona, 08916
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Baza, Granada, 18800
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Bilbao, Vizcaya, 48013
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Burgos, Burgos, 09006
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Cáceres, Caceres, 10003
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Cadiz, Cadiz, 11009
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Cartagena, Murcia, 30203
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Castellon, Castellon, 12002
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Córdoba, Cordoba, 14004
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Don Benito, Badajoz, 06400
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Donostia / San Sebastian, Guipuzcoa, 20014
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Elche, Alicante, 03203
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Ferrol, La Coruña, 15405
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Girona, Girona, 17007
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Granada, Granada, 18003
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Granada, Granada, 18014
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Granollers, Barcelona, 08400
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Huelva, Huelva, 21005
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Ibiza Town, Balearic Islands, 07800
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Jaén, Jaen, 23007
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Jerez de la Frontera, Cadiz, 11407
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Las Palmas de Gran Canaria, Las Palmas, 35016
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Las Palmas de Gran Canaria, Las Palmas, 35020
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León, Leon, 24071
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Lleida, Lerida, 25198
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Lugo, Lugo, 27004
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Madrid, Madrid, 28002
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Madrid, Madrid, 28006
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Madrid, Madrid, 28033
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Madrid, Madrid, 28034
Study site
Madrid, Madrid, 28040
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Madrid, Madrid, 28041
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Madrid, Madrid, 28046
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Madrid, Madrid, 28222
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Madrid, Madrid, 28660
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Madrid, Madrid, 28935
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Málaga, Malaga, 29010
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Manresa, Barcelona, 08243
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Mataró, Barcelona, 08304
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Mérida, Badajoz, 06800
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Murcia, Murcia, 30008
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Murcia, Murcia, 30120
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Navarra, Navarre, 31008
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Ourense, Orense, 32005
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Palencia, Palencia, 34005
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Palma de Mallorca, Balearic Islands, 07012
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Palma de Mallorca, Balearic Islands, 07014
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Palma de Mallorca, Balearic Islands, 07198
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Pamplona, Navarre, 31008
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Puerto Real, Cadiz, 11510
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Sabadell, Barcelona, Barcelona, 08208
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Sagunto, Valencia, 46520
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Salamanca, Salamanca, 37007
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San Cristóbal de La Laguna, Tenerife, 38320
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Sant Coloma Gramenet, Barcelona, 08923
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Sant Pere de Ribes, Barcelona, 08810
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Santa Cruz de Tenerife, Tenerife, 38010
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Santander, Cantabria, 39008
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Segovia, Segovia, 40002
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Seville, Sevilla, 41009
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Seville, Sevilla, 41013
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Seville, Sevilla, 41014
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Terrassa, Barcelona, 08221
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Torrevieja, Cantabria, 03180
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Valencia, Valencia, 41014
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Valencia, Valencia, 46009
Study site
Valencia, Valencia, 46010
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Valencia, Valencia, 46015
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Valencia, Valencia, 46017
Study site
Valencia, Valencia, 46026
Study site
Valladolid, Valladolid, 47010
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Vic, Barcelona, 08500
Study site
Vigo, Pontevedra, 36204
Study site
Vigo, Pontevedra, 36211
Study site
Zaragoza, Zaragoza, 50009

Other trials in Spain

About this study

Official title: An Open-label Study of the Effect of Tarceva Monotherapy on Treatment Response in Patients With Advanced Non-small Cell Lung Cancer for Whom Tarceva Monotherapy is Considered the Best Option

Conditions: Non-Small Cell Lung Cancer
Being tested: erlotinib [Tarceva]
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.

erlotinib [Tarceva]Drug
150 mg/day until progressive disease or unacceptable toxicity

Study groups in NCT01996332
Study group	Role	What they receive
Tarceva Arm	Experimental	Not described Receives: Drug: erlotinib [Tarceva]

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to Disease Progression or Death by Line of Treatment
Time to progression or death was defined as the time from inclusion to the date of disease progression or death, whichever occurred first.
Measured: Baseline, every 6-8 weeks up to 3 years until disease progression or death

Secondary outcomes (2)

Percentage of Participants Achieving Clinical Benefit by Line of Treatment
Efficacy was analyzed in terms of clinical benefit, defined as the sum of the number of participants achieving complete response [CR], partial response [PR], or stable disease [SD]. Tumor response was evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.0. CR was defined as disappearance of all target and non-target lesions. PR was defined as greater than or equal to (≥)30 percent (%) decrease in sum of longest diameters of target lesions taking as reference baseline sum longest diameters associated to non-progressive disease response for non target lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of longest dimensions since treatment started associated to non-progressive disease response for non target lesions.
Measured: Baseline, every 6-8 weeks up to 3 years or until death
Overall Survival (OS) by Line of Treatment
Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date or last known alive date [if death date was unavailable] minus the date of first dose of study medication plus 1 divided by 30.44).
Measured: Baseline, every 6-8 weeks up to 3 years, or until death

Timeline

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

Apr 2004Oct 2012

First posted27 Nov 2013 (estimated)
Study startApr 2004
Primary completionOct 2012
Study completionOct 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 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: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 1,805 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01996332
Sponsor's protocol ID: ML17915
Status last verified: Jun 2014
First submitted: 22 Nov 2013
Last updated: 10 Jul 2014
Results posted: Yes, on ClinicalTrials.gov

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
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer

All Non-Small Cell Lung Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label Study of the Effect of Tarceva Monotherapy on Treatment Response in Patients With Advanced Non-small Cell Lung Cancer for Whom Tarceva Monotherapy is Considered the Best Option
ClinicalTrials.gov ID: NCT01996332
Acronym / sponsor ID: ML17915
Conditions: Non-Small Cell Lung Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,805 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Apr 2004
Primary completion: Oct 2012 (actual)
Study completion: Oct 2012 (actual)
First posted: 27 Nov 2013 (estimated)
Results: Posted 10 Jul 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Tarceva Arm	Experimental	Drug: erlotinib [Tarceva]

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

adult patients >=18 years of age;
locally advanced or metastatic NSCLC (Stage IIIB or IV);
not a candidate for curative surgery or radical chemotherapy;
no brain metastases, or clinically stable metastases for >=2 months.

Key exclusion criteria (2 listed)

radiotherapy over the previous 2 weeks;
weight loss >10% in the previous 6 weeks.

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
erlotinib [Tarceva]150 mg/day until progressive disease or unacceptable toxicity	Drug	Tarceva Arm

Primary outcome

Time to Disease Progression or Death by Line of Treatment
Time frame: Baseline, every 6-8 weeks up to 3 years until disease progression or death
Time to progression or death was defined as the time from inclusion to the date of disease progression or death, whichever occurred first.

2 secondary outcomes

Percentage of Participants Achieving Clinical Benefit by Line of Treatment
Time frame: Baseline, every 6-8 weeks up to 3 years or until death
Overall Survival (OS) by Line of Treatment
Time frame: Baseline, every 6-8 weeks up to 3 years, or until death

Results and safety

Results posted to the registry on 10 Jul 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Erlotinib 150 Milligrams Per Day (mg/Day)	1,805	0

Primary outcome: Time to Disease Progression or Death by Line of Treatment

Time frame: Baseline, every 6-8 weeks up to 3 years until disease progression or death. Median (95% Confidence Interval). Unit: months

Measure	Erlotinib 150 mg/Day n = 1805
1st Line	3.4 (2.9 to 4.1)
Maintenance after 1st Line	4.7 (3.0 to 6.6)
2nd Line	2.7 (2.5 to 2.9)
Maintenance after 2nd Line	3.9 (1.2 to 6.8)
3rd or Subsequent Line	2.4 (2.2 to 2.7)
Maintenance after 3rd Line	2.8 (1.8 to 5.0)

Population analysed: ITT Population; data were analyzed in 6 cohorts, with erlotinib treatment as: 1) first line; 2) maintenance after first line; 3) second line; 4) maintenance after second line; 5) third or subsequent line; or 6) maintenance after third line

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the administration of first dose of study medication to the end of study or until death.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Erlotinib 150 mg/Day	566 of 1,805 (31.4%)	1,695 of 1,797 (94.3%)	Not reported

Limitations and caveats (from the sponsor): Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for 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
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung 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 chair

Hoffmann-La Roche

94 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing erlotinib [Tarceva] in people with Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 94 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 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 10 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 94 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jul 2014). 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?

Time to Disease Progression or Death by Line of Treatment (time frame: Baseline, every 6-8 weeks up to 3 years until disease progression or death). 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 NCT01996332.

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 10 Jul 2014.