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Non-Small Cell Lung CancerPhase 2NCT00940875

A Study of Tarceva (Erlotinib) in Sequential Combination With Gemcitabine as First Line Therapy in Patients With Advanced Non-Small Cell Lung Cancer

A Phase 2 study testing erlotinib [Tarceva] and gemcitabine in people with Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 17 sites in Australia.

Terminated

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

Official record
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Trial summary

This 2 arm study will compare the efficacy and safety of sequential treatment with Tarceva and gemcitabine, and of gemcitabine monotherapy, as first line treatment of elderly patients, or patients with ECOG performance status of 2, with advanced non-small cell lung cancer.Patients will be randomized to receive either… 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] and gemcitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
17 sitesAustralia
Study dates
Jun 2009to Sep 2011
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, >=70 years of age or with ECOG PS of 2;
  • advanced (stage IIIB or IV)non-small cell lung cancer;
  • no prior systemic chemotherapy for advanced NSCLC or prior treatment with HER-axis targeted drugs.

Who cannot join

  • active brain metastasis or spinal cord suppression;
  • unstable systemic disease.

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

Australia17 sites

  • Study site

    Bendigo, Victoria, 3550

  • Study site

    Brisbane, Queensland, 4029

  • Study site

    Fremantle, Western Australia, 6160

  • Study site

    Greenslopes, Queensland, 4120

  • Study site

    Heidelberg, Victoria, 3084

  • Study site

    Hobart, Tasmania, 7000

  • Study site

    Melbourne, Victoria, 3002

  • Study site

    Port Macquarie, New South Wales, 2444

  • Study site

    Randwick, New South Wales, 2031

  • Study site

    Richmond, South Australia, 3121

  • Study site

    Sydney, New South Wales, 2139

  • Study site

    Sydney, New South Wales, 2747

  • Study site

    Terrace Gardens, South Australia, 5065

  • Study site

    Tweed Heads, New South Wales, NSW 2485

  • Study site

    Wodonga, Victoria, 3690

  • Study site

    Wollongong, New South Wales, 2500

  • Study site

    Woolloongabba, Queensland, 4102

Other trials in Australia

About this study

Official title: A Randomized, Open-label Study of the Effect of First Line Treatment With Tarceva in Sequential Combination With Gemcitabine, Compared to Gemcitabine Monotherapy, on Progression-free Survival in Elderly or ECOG PS of 2 Patients With Advanced Non-small Cell Lung Cancer.

This 2 arm study will compare the efficacy and safety of sequential treatment with Tarceva and gemcitabine, and of gemcitabine monotherapy, as first line treatment of elderly patients, or patients with ECOG performance status of 2, with advanced non-small cell lung cancer.Patients will be randomized to receive either sequential gemcitabine 1250mg/m2/day on days 1 and 8 + Tarceva 150mg po on days 15-28 of each 4 week cycle, or gemcitabine monotherapy 1000mg/m2/day on days 1, 8 and 15 of each 4 week cycle. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Being tested
erlotinib [Tarceva], gemcitabine
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

    150mg po on days 15-28 of each 4 week cycle

  • gemcitabineDrug

    1250mg/m2/day on days 1 and 8 of each 4 week cycle

  • gemcitabineDrug

    1000mg/m2/day on days 1, 8 and 15 of each 4 week cycle

Study groups in NCT00940875
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: erlotinib [Tarceva]; Drug: gemcitabine
2Active comparatorNot described
Receives: Drug: gemcitabine

What is being measured

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

  1. Percentage of Participants With Disease Progression or Death

    Progression-free survival (PFS) was defined as the time from randomization to the date of first documentation of progressive disease (PD), according to Response Evaluation Criteria in Solid Tumors (RECIST) version (V) 1.0, or date of death from any cause. PD was defined for target lesions (TLs) as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded since the start of treatment, and for non-target lesions (NTLs) as unequivocal progression of NTLs. Participants without documented PD were censored at the date of last tumor assessment, the last date recorded in the drug log, or the last date of follow-up the participant was known to be progression free, whichever was last. Participants without a post-Baseline (BL) tumor assessment who were known to be alive were censored at the date of randomization.

    Measured: BL, Day 22 of Cycles 2, 4, and 6 (28-day cycles), every 2 months thereafter until disease progression, participant withdrawal, or study termination (12 months after randomization of the last participant).

  2. PFS

    The median time, in weeks, between randomization and PFS event. Participants without documented PD were censored at the date of last tumor assessment, the last date recorded in the drug log, or the last date of follow-up the participant was known to be progression free, whichever was last. Participants without a post-BL tumor assessment who were known to be alive were censored at the date of randomization. PFS was estimated by using Kaplan-Meier methodology.

    Measured: BL, Day 22 of Cycles 2, 4, and 6 (28-day cycles), every 2 months thereafter until disease progression, participant withdrawal, or study termination (up to 2 years)

Secondary outcomes (5)

  1. Percentage of Participants Who Achieved Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST V 1.0

    As per RECIST V 1.0: for TLs, CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the SLD of TLs taking as reference the BL SLD. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. The 95% confidence interval (CI) for one-sample binomial was determined using the Pearson-Clopper Method.

    Measured: BL, Day 22 of Cycle 2, 4, and 6 (28-day cycles), every 2 months thereafter until disease progression, participant withdrawal, or study termination (12 months after randomization of the last participant).

  2. Percentage of Participants With Non-Progression at Weeks 8 and 16

    Non-progression was defined as CR, PR, or stable disease according to RECIST V 1.0: for TLs, CR was defined as the disappearance of all TLs, PR was defined as at least a 30% decrease in the SLD of TLs taking as reference the BL SLD, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD recorded since the start of treatment. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels, and SD was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above the normal limits. The 95% CI for one-sample binomial was determined using the Pearson-Clopper method.

    Measured: Weeks 8 and 16

  3. Percentage of Participants Who Died

    Measured: BL, Days 1, 8, and 15 of Cycles 1-6 (28-day cycles), every 28 days thereafter until death, participant withdrawal, or study termination up to 2 years.

  4. Overall Survival (OS)

    OS was defined as the median time, in weeks, between randomization and death due to any cause. Participants without documented death were censored at the last date recorded in the drug log, or the last date of follow-up the participant was known to be alive, whichever was last. Participants without a post-BL assessment who were known to be alive were censored at the date of randomization. OS was estimated using Kaplan-Meier methodology.

    Measured: BL, Days 1, 8, and 15 of Cycles 1-6 (28-day cycles), every 28 days thereafter until death, participant withdrawal, or study termination up to 2 years.

  5. Duration of Response

    Duration of response was defined as the time between the first documentation of CR or PR (whichever status was recorded first as assessed by the RECIST V 1.0) until the date of documented disease progression or death. Participants with no documented disease progression or death after confirmed CR or PR were censored at the date of the last tumor assessment or last date of follow-up when the participant was known to be progression free, whichever was last.

    Measured: BL, Days 1, 8, and 15 of Cycles 1-6 (28-day cycles), every 28 days thereafter until death, participant withdrawal, or study termination up to 2 years.

Timeline

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

  1. First posted16 Jul 2009 (estimated)
  2. Study startJun 2009
  3. Primary completionSep 2011
  4. Study completionSep 2011

Why it stopped: Study was stopped due to slower than expected recruitment.

Resources

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
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00940875
Sponsor's protocol ID
ML22429
Status last verified
Apr 2015
First submitted
6 Jul 2009
Last updated
2 Apr 2015

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing erlotinib [Tarceva] and gemcitabine in people with Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 17 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 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: stopped early, as of the sponsor's last update on 2 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 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 2 Apr 2015). 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 Disease Progression or Death (time frame: BL, Day 22 of Cycles 2, 4, and 6 (28-day cycles), every 2 months thereafter until disease progression, participant withdrawal, or study termination (12 months after randomization of the last participant).). 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?

On the ClinicalTrials.gov record for NCT00940875.

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 Apr 2015.

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