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Non Small Cell Lung CancerPhase 2NCT00615758

Erlotinib as 1st Line Treatment in NSCLC Stage IIIB/IV

A Phase 2 study testing Erlotinib in people with Non Small Cell Lung Cancer, run by Hellenic Oncology Research Group at 5 sites in Greece.

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

To evaluate the efficacy and toxicity of erlotinib as first line treatment in patients with locally advanced/metastatic (stages IIIB/IV) NSCLC, with clinical predictors of response to tyrosine kinase inhibitors (erlotinib, gefitinib), such as female gender, never-smoking status and adenocarcinoma histology. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
Erlotinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
5 sitesGreece
Study dates
Oct 2006to Nov 2009
Phase
Phase 2
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed, unresectable locally advanced (stage IIIB with pleural effusion) and/or metastatic (stage IV) NSCLC
  • No previous therapy for advanced/metastatic NSCLC is allowed
  • age >18 years
  • bidimensionally measurable disease
  • non-smokers (or ex-smokers with less than 5 pack-years smoking history)
  • adenocarcinoma histology
Show all 11Show fewer
  • performance status (WHO) 0-3
  • adequate liver (serum bilirubin <1.5 times the upper normal limit (UNL); AST and ALT <2.5 times the UNL in the absence of demonstrable liver metastases, or <5 times the UNL in the presence of liver metastases); adequate renal function (serum creatinine <1.5 times the UNL); and bone marrow (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L) function
  • previous radiotherapy, either in the adjuvant setting or for the treatment of metastatic disease is allowed provided that the measurable lesions are outside the radiation fields
  • patient able to take oral medication
  • tissue sample for tumour mutational analysis is required

Who cannot join

  • serious chronic skin conditions (e.g. psoriasis, eczema) that would preclude study participation
  • active infection
  • history of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
  • malnutrition (loss of ≥ 20% of the original body weight)
  • performance status: 4
  • psychiatric illness or social situation that would preclude study compliance
  • pregnant or lactating women

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Greece5 sites

  • 401 Military Hospital, Medical Oncology Unit

    Athens

  • Air Forces Military Hospital, Dep of Medical Oncology

    Athens

  • IASO" General Hospital of Athens, 1st Dep of Medical Oncology

    Athens

  • Sotiria" General Hospital, 2nd Dep of Pulmonary Diseases

    Athens

  • "Diabalkaniko" Anticancer Hospital of Thessaloniki

    Thessaloniki

Other trials in Greece

About this study

Official title: ERLOTINIB, A TYROSINE KINASE INHIBITOR OF EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) AS FIRST LINE TREATMENT, IN PATIENTS WITH LOCALLY ADVANCED/METASTATIC NON SMALL CELL LUNG CANCER (NSCLC). A PHASE II STUDY

To evaluate the efficacy and toxicity of erlotinib as first line treatment in patients with locally advanced/metastatic (stages IIIB/IV) NSCLC, with clinical predictors of response to tyrosine kinase inhibitors (erlotinib, gefitinib), such as female gender, never-smoking status and adenocarcinoma histology. Furthermore, erlotinib-sensitivity will be correlated with the presence of EGFR mutations in exons 18, 19 and 21, in this population

Read the detailed description

A randomized, placebo-controlled phase III trial of erlotinib versus placebo, with more than 700 patients demonstrated that therapy with this tyrosine kinase inhibitor (TKI) prolongs survival after first or second line therapy in patients with advanced NSCLC. Statistically significant and clinically relevant differences were observed for overall and progression free survival in favour of erlotinib. Moreover, several clinical factors had been correlated with response to gefitinib or erlotinib, including never smoking status, female gender, Asian ethnicity and adenocarcinoma histology (especially bronchioalveolar carcinoma).

Being tested
Erlotinib
Keywords
Erlotinib, Biological therapy, Tyrosin Kinase Inhibitor therapy
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.

  • ErlotinibDrug

    Also called Tarceva

    Erlotinib at the dose of 150 mg orally once a day continually until progression

Study groups in NCT00615758
Study groupRoleWhat they receive
1ExperimentalTarceva
Receives: Drug: Erlotinib

What is being measured

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

  1. Overall Response Rate

    Measured: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)

Secondary outcomes (4)

  1. Overall Survival

    Measured: 1-year OS

  2. Time to Tumor Progression

    Measured: 1 year TTP

  3. Quality of life assessment

    Measured: Assessment every two cycles

  4. Toxicity assesment

    Measured: Toxicity assessment on each cycles

Timeline

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

  1. First posted14 Feb 2008 (estimated)
  2. Study startOct 2006
  3. Primary completionNov 2009
  4. Study completionNov 2009

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00615758
Sponsor's protocol ID
CT/06.03
Status last verified
Dec 2009
First submitted
1 Feb 2008
Last updated
15 Dec 2009
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Erlotinib in people with Non Small Cell Lung Cancer, run by Hellenic Oncology Research Group at 5 sites in Greece.

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 11 inclusion and 7 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 15 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Greece. 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?

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?

Overall Response Rate (time frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)). 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 NCT00615758.

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 15 Dec 2009.

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