Non-Squamous Non-Small Cell Lung CancerPhase 2NCT00518011

A Study of Tarceva (Erlotinib) and Gemcitabine in Treatment-Naive Patients With Advanced Non-Small Cell Lung Cancer.

A Phase 2 study testing Erlotinib and Gemcitabine in people with Non-Squamous Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 14 sites in Australia.

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

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 and Gemcitabine
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 17 participants
Where: 14 sitesAustralia
Study dates: Aug 2007to Feb 2009
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;
non-small cell lung cancer, stage IIIb (with effusion) or stage IV with measurable disease ;
ECOG PS 2;
adequate organ function.

Who cannot join

prior chemotherapy or systemic anti-tumor therapy;
hypersensitivity to erlotinib;
any condition contraindicating the use of the study medication and/or impairing the interpretation of results and/or leading to treatment-related complications.

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

Australia14 sites

Study site
Auchenflower, 4066
Study site
Chermside, 4032
Study site
Footscray, 3011
Study site
Greenslopes, 4120
Study site
Lismore, 2480
Study site
Melbourne, 3002
Study site
Melbourne, 3084
Study site
Parkville, 3052
Study site
Randwick, 2031
Study site
Richmond, 3121
Study site
St Leonards, 2065
Study site
Sydney, 2139
Study site
Wodonga, 3690
Study site
Wollongong, 2500

Other trials in Australia

About this study

Official title: A Randomized, Open Label Study Comparing the Effect of First-line Therapy With Tarceva + Gemcitabine Versus Gemcitabine Monotherapy on Treatment Response in Treatment-naïve Patients With Advanced Non-small Cell Lung Cancer

This 2 arm study will assess the efficacy and safety of Tarceva plus gemcitabine, compared with gemcitabine alone, in the treatment of chemotherapy-naive patients with advanced non-small cell lung cancer. Patients will be randomized to receive either Tarceva 150mg po daily plus gemcitabine on days 1, 8, 15 and every 4 weeks subsequently, or with gemcitabine monotherapy. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

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

What participants receive

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

ErlotinibDrug
150 mg po daily
GemcitabineDrug
As prescribed

Study groups in NCT00518011
Study group	Role	What they receive
Erlotinib + Gemcitabine	Experimental	Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles. Receives: Drug: Erlotinib; Drug: Gemcitabine
Gemcitabine	Active comparator	Participants received Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles. Receives: Drug: Gemcitabine

What is being measured

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

Progression Free Survival
Progression free survival was defined as the interval between the day of randomization and the date of the first documentation of disease progression or date of death (from any cause), whichever occurs first.
Measured: Up to 2 years

Secondary outcomes (7)

Objective Response Rate
Objective response rate was defined as the percentage of participants who have any evidence of confirmed objective of complete response (CR) + partial response (PR), as assessed by the Response Evaluation Criteria In Solid Tumors (RECIST version 1.0) criteria. As per the RECIST Version 1.0 CR is defined as disappearance of all target lesions and PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of the LD.
Measured: Up to 2 years
Disease Control Rate
Disease control rate was defined as the percentage of participants who have any evidence of confirmed objective CR or PR or Stable disease (SD) (where SD was maintained for 8 weeks), as assessed by the RECIST version 1.0 criteria. As per the RECIST Version 1.0 CR is defined as disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum of the LD. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum of the LD since the treatment started. PD is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum of the LD recorded since the treatment started or the appearance of one or more new lesions.
Measured: Up to 2 years
Duration of Response
Duration of response was defined as the interval between the date of CR or PR was first recorded to the date on which progressive disease was first noted or date of death.
Measured: Up to 2 years
Overall Survival
Overall survival was defined as the interval between the date of randomization to the date of death from any cause.
Measured: Up to 2 years
Mean Change in Pulse Rate From Baseline
Mean change in pulse rate from Baseline for each cycle calculated as Day 1 of each cycle value minus Baseline value
Measured: Baseline (Day -14 to Day 0), Cycle 1 (Days 1, 8, 15 and 22), Cycle 2 (Days 1, 8, 15 and 22), Cycle 3 (Days 1, 8, and 15), Cycle 4 (Days 1, 8, and 15), Cycle 5 (Days 1, 8, and 15), Cycle 6 (Days 1, 8, and 15)
Mean Change in Blood Pressure From Baseline
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were recorded as vital parameters in this study. Mean change in SBP and DBP from Baseline for each cycle calculated as Day 1 of each cycle value minus baseline value.
Measured: Baseline (Day -14 to Day 0), Cycle 1 (Days 1, 8, 15 and 22), Cycle 2 (Days 1, 8, 15 and 22), Cycle 3 (Days 1, 8, and 15), Cycle 4 (Days 1, 8, and 15), Cycle 5 (Days 1, 8, and 15), Cycle 6 (Days 1, 8, and 15)
Mean Change in Body Temperature From Baseline
Mean change in body temperature from Baseline for each cycle calculated as Day 1 of each cycle value minus baseline value.
Measured: Baseline (Day -14 to Day 0), Cycle 1 (Days 1, 8, 15 and 22), Cycle 2 (Days 1, 8, 15 and 22), Cycle 3 (Days 1, 8, and 15), Cycle 4 (Days 1, 8, and 15), Cycle 5 (Days 1, 8, and 15), Cycle 6 (Days 1, 8, and 15)

Timeline

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

Aug 2007Feb 2009

First posted17 Aug 2007 (estimated)
Study startAug 2007
Primary completionFeb 2009
Study completionFeb 2009

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: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00518011
Sponsor's protocol ID: ML20063
Status last verified: Apr 2016
First submitted: 16 Aug 2007
Last updated: 16 May 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

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All Non-Squamous Non-Small Cell Lung Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 16 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open Label Study Comparing the Effect of First-line Therapy With Tarceva + Gemcitabine Versus Gemcitabine Monotherapy on Treatment Response in Treatment-naïve Patients With Advanced Non-small Cell Lung Cancer
ClinicalTrials.gov ID: NCT00518011
Acronym / sponsor ID: ML20063
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Aug 2007
Primary completion: Feb 2009 (actual)
Study completion: Feb 2009 (actual)
First posted: 17 Aug 2007 (estimated)
Results: Posted 1 Apr 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

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Erlotinib + Gemcitabine	Experimental	Drug: Erlotinib, Drug: GemcitabineParticipants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles.
Gemcitabine	Active comparator	Drug: GemcitabineParticipants received Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles.

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;
non-small cell lung cancer, stage IIIb (with effusion) or stage IV with measurable disease ;
ECOG PS 2;
adequate organ function.

Key exclusion criteria (3 listed)

prior chemotherapy or systemic anti-tumor therapy;
hypersensitivity to erlotinib;
any condition contraindicating the use of the study medication and/or impairing the interpretation of results and/or leading to treatment-related complications.

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
Erlotinib150 mg po daily	Drug	Erlotinib + Gemcitabine
GemcitabineAs prescribed	Drug	Erlotinib + Gemcitabine, Gemcitabine

Primary outcome

Progression Free Survival
Time frame: Up to 2 years
Progression free survival was defined as the interval between the day of randomization and the date of the first documentation of disease progression or date of death (from any cause), whichever occurs first.

7 secondary outcomes

Objective Response Rate
Time frame: Up to 2 years
Disease Control Rate
Time frame: Up to 2 years
Duration of Response
Time frame: Up to 2 years
Overall Survival
Time frame: Up to 2 years
Mean Change in Pulse Rate From Baseline
Time frame: Baseline (Day -14 to Day 0), Cycle 1 (Days 1, 8, 15 and 22), Cycle 2 (Days 1, 8, 15 and 22), Cycle 3 (Days 1, 8, and 15), Cycle 4 (Days 1, 8, and 15), Cycle 5 (Days 1, 8, and 15), Cycle 6 (Days 1, 8, and 15)
Mean Change in Blood Pressure From Baseline
Time frame: Baseline (Day -14 to Day 0), Cycle 1 (Days 1, 8, 15 and 22), Cycle 2 (Days 1, 8, 15 and 22), Cycle 3 (Days 1, 8, and 15), Cycle 4 (Days 1, 8, and 15), Cycle 5 (Days 1, 8, and 15), Cycle 6 (Days 1, 8, and 15)
Mean Change in Body Temperature From Baseline
Time frame: Baseline (Day -14 to Day 0), Cycle 1 (Days 1, 8, 15 and 22), Cycle 2 (Days 1, 8, 15 and 22), Cycle 3 (Days 1, 8, and 15), Cycle 4 (Days 1, 8, and 15), Cycle 5 (Days 1, 8, and 15), Cycle 6 (Days 1, 8, and 15)

Results and safety

Results posted to the registry on 1 Apr 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
Gemcitabine	9	0
Erlotinib + Gemcitabine	8	0

Primary outcome: Progression Free Survival

Time frame: Up to 2 years. Median (95% Confidence Interval). Unit: Week

Measure	Gemcitabine n = 8	Erlotinib + Gemcitabine n = 7
Value	23.3 (7.1 to 24.9)	24.4 (6.9 to NA)

Gemcitabine vs Erlotinib + Gemcitabine: Hazard Ratio (HR): 1.842 (95% CI 0.483 to 7.027), p = 0.3644, Log Rank

Population analysed: Per protocol (PP) population included all randomized participants who received at least one dose of study medication and had at least one post baseline tumor assessment or record of death.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 2 years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Gemcitabine	5 of 8 (62.5%)	7 of 8 (87.5%)	Not reported
Erlotinib + Gemcitabine	6 of 8 (75%)	8 of 8 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 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)
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RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
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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
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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

14 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 and Gemcitabine in people with Non-Squamous Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 14 sites in Australia.

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 16 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Australia. 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 1 Apr 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?

Progression Free Survival (time frame: Up to 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 NCT00518011.

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 May 2016; AzTrials last refreshed its copy on 8 Nov 2026.