Non-Squamous Non-Small Cell Lung CancerSTARNCT01990261

A Study to Assess the Survival of Non-small Cell Lung Cancer Patients Treated With Tarceva After Failed Chemotherapy Treatment

An observational study of Non-Squamous Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 1 site in Romania.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

This study will evaluate the survival of non-small cell lung cancer (wild-type EGFR) participants treated with Tarceva after at least one failed chemotherapy treatment, and the impact of prior chemotherapy treatments. 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
What is being tested?: Erlotinib
How many people: 33 participants
Where: 1 siteRomania
Study dates: May 2013to Sep 2014
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 diagnosed with locally advanced, metastatic or recurrent non-small cell lung carcinoma with wild-type EGFR.

Who may be able to join

Adults >/= 18 years
Histologically documented locally advanced, metastatic, or recurrent non-small cell lung carcinoma with wild-type EGFR eligible for Tarceva treatment.
At least one failed chemotherapy treatment.

Who cannot join

Unknown EGFR mutation status

Trial locations and contacts

1 site in 1 country.

Romania1 site

Study site
Bucharest, 022338

Other trials in Romania

About this study

Official title: The Survival of Non-Small Cell Lung Carcinoma EGFR Non-mutated (Wild Type) Patients Treated With Erlotinib (TARceva) After the Failure of at Least One Chemotherapy Regimen

Conditions: Non-Squamous Non-Small Cell Lung Cancer
Being tested: Erlotinib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ErlotinibDrug
Also called Tarceva
Erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.

Study groups in NCT01990261
Study group	Role	What they receive
Erlotinib		Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics. Receives: Drug: Erlotinib

What is being measured

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

Survival Rate at Month 6
Measured: Month 6
Survival Rate at Month 12
Measured: Month 12
Progression Free Survival (PFS) at Month 6
PFS is defined as the time from inclusion in the study to the disease progression or death whichever occurs first. Disease progression was determined according to local treatment guidelines.
Measured: From inclusion up to disease progression or death whichever occurs first (up to 6 months)
Progression Free Survival (PFS) at Month 12
PFS is defined as the time from inclusion in the study to the disease progression or death whichever occurs first. Disease progression was determined according to local treatment guidelines.
Measured: From inclusion up to disease progression or death whichever occurs first (up to 12 months)

Secondary outcomes (3)

Overall Survival (OS)
OS is defined as time from first administration of study drug until death from any cause.
Measured: Up to 12 months
Percentage of Participants With Adverse Events (AEs)
An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Measured: Up to 12 months
Overall Survival According to Prior Chemotherapy Treatment.
Prior chemotherapy treatment is presented as reported by the investigators.
Measured: Up to 12 months

Timeline

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

May 2013Sep 2014

First posted21 Nov 2013 (estimated)
Study startMay 2013
Primary completionSep 2014
Study completionSep 2014

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-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: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01990261
Sponsor's protocol ID: ML28496
Acronym: STAR
Status last verified: Jun 2016
First submitted: 31 Oct 2013
Last updated: 16 Sep 2016
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
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 16 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Survival of Non-Small Cell Lung Carcinoma EGFR Non-mutated (Wild Type) Patients Treated With Erlotinib (TARceva) After the Failure of at Least One Chemotherapy Regimen
ClinicalTrials.gov ID: NCT01990261
Acronym / sponsor ID: STAR / ML28496
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Study type: Observational
Recruitment status: Terminated
Enrolment: 33 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: May 2013
Primary completion: Sep 2014 (actual)
Study completion: Sep 2014 (actual)
First posted: 21 Nov 2013 (estimated)
Results: Posted 28 Jul 2016

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
Erlotinib	–	Drug: ErlotinibParticipants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Adult participants diagnosed with locally advanced, metastatic or recurrent non-small cell lung carcinoma with wild-type EGFR.

Key inclusion criteria (3 listed)

Adults >/= 18 years
Histologically documented locally advanced, metastatic, or recurrent non-small cell lung carcinoma with wild-type EGFR eligible for Tarceva treatment.
At least one failed chemotherapy treatment.

Key exclusion criteria (1 listed)

Unknown EGFR mutation status

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
ErlotinibAlso: TarcevaErlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.	Drug	Erlotinib

Primary outcome

Survival Rate at Month 6
Time frame: Month 6
Survival Rate at Month 12
Time frame: Month 12
Progression Free Survival (PFS) at Month 6
Time frame: From inclusion up to disease progression or death whichever occurs first (up to 6 months)
PFS is defined as the time from inclusion in the study to the disease progression or death whichever occurs first. Disease progression was determined according to local treatment guidelines.
Progression Free Survival (PFS) at Month 12
Time frame: From inclusion up to disease progression or death whichever occurs first (up to 12 months)
PFS is defined as the time from inclusion in the study to the disease progression or death whichever occurs first. Disease progression was determined according to local treatment guidelines.

3 secondary outcomes

Overall Survival (OS)
Time frame: Up to 12 months
Percentage of Participants With Adverse Events (AEs)
Time frame: Up to 12 months
Overall Survival According to Prior Chemotherapy Treatment.
Time frame: Up to 12 months

Results and safety

Results posted to the registry on 28 Jul 2016, 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	33	8

Primary outcome: Survival Rate at Month 6

Time frame: Month 6. Number. Unit: percentage of participants

Measure	Erlotinib n = 33
Value	33.3

Population analysed: Analysis was performed on all enrolled participants.

Primary outcome: Survival Rate at Month 12

Time frame: Month 12. Number. Unit: percentage of participants

Measure	Erlotinib n = 33
Value	15.2

Population analysed: Analysis was performed on all enrolled participants.

Primary outcome: Progression Free Survival (PFS) at Month 6

Time frame: From inclusion up to disease progression or death whichever occurs first (up to 6 months). Median (95% Confidence Interval). Unit: days

Measure	Erlotinib n = 33
Value	101.0 (55.194 to 146.806)

Population analysed: Analysis was performed on all enrolled participants.

Primary outcome: Progression Free Survival (PFS) at Month 12

Time frame: From inclusion up to disease progression or death whichever occurs first (up to 12 months). Median (95% Confidence Interval). Unit: days

Measure	Erlotinib n = 33
Value	121.0 (62.862 to 179.138)

Population analysed: Analysis was performed on all enrolled participants.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 12 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Erlotinib	7 of 33 (21.2%)	3 of 33 (9.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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

1 site 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 1 site in Romania.

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 1 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: stopped early, as of the sponsor's last update on 16 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Romania. 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 28 Jul 2016). 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?

Survival Rate at Month 6 (time frame: Month 6). The study lists 4 primary outcomes in all. 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 NCT01990261.

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 16 Sep 2016.