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Non-small Cell Lung Cancer MetastaticPhase 4REALMENCT01320501

Experience of Erlotinib in Patients With Advanced Non-Small Cell Lung Cancer

A Phase 4 study testing Erlotinib in people with Non-small Cell Lung Cancer Metastatic, run by National Guard Health Affairs at 1 site in Saudi Arabia.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial summary

An open-label, prospective, single-arm, multi-center phase IV clinical trial of TarcevaTM as single agent Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer Metastatic
What is being tested?
Erlotinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteSaudi Arabia
Study dates
Oct 2009to Aug 2016
Phase
Phase 4
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histological or cytological documented diagnosis of inoperable, locally advanced, recurrent or metastatic (Stage IIIB or Stage IV) NSCLC.
  • Patients must have evidence of disease but measurable disease is not mandatory.
  • 18 years of age or older.
  • ECOG performance status of 0 - 3.
  • Life expectancy of at least 12 weeks.
  • Patients who received one or two previous line of systemic chemotherapy irrespective of EGFR mutation status.
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  • No more than 2 prior chemotherapy regimens are permissible. Patients must have recovered from any toxic effects and at least 3-4 weeks must have elapsed from the last dose and prior to registration (14 days for vinorelbine or other vinca alkaloids or gemcitabine). Patients who, in the opinion of the investigator, have fully recovered from surgery in less than 4 weeks may also be considered for the study. Patients must have recovered (CTC < 1) from acute toxicities of any previous therapy.
  • Patients are eligible to receive Erlotinib (TarcevaTM) as first line if they met one of the following criteria:
  • Positive EGFR mutation tested in certified lab (although EGFR test is not mandatory only if available).
  • Poor performance status of 3
  • Severe co morbidities and illness which make the patient not candidate for standard systemic chemotherapy .
  • .Patient with negative EGFR mutation are still candidate for 2nd and 3rd line therapy (although EGFR test is not mandatory only if available).
  • Prior radiotherapy is allowed.
  • Granulocyte count > 1.5 x 109/L and platelet count > 100 x 109/L.
  • Serum bilirubin must be < 1.5 upper limit of normal (ULN).
  • AST and ALT < 2 x ULN (or < 5 x ULN if clearly attributable to liver metastasis).
  • Serum creatinine < 1.5 ULN or creatinine clearance > 60 ml/min.
  • Able to comply with study and follow-up procedures.
  • For all females of childbearing potential a negative pregnancy test must be obtained within 72 hours before starting therapy. Patients with reproductive potential must use effective contraception.
  • Signed Informed Consent to participate in the study.

Who cannot join

  • Any unstable systemic disease (including active infection, grade 4 hypertension, unstable angina, congestive heart failure, hepatic, renal or metabolic disease).
  • Prior therapy with systemic anti-tumor therapy with HER1/EGFR inhibitors (as small molecule or monoclonal antibody therapy).
  • Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer).
  • Patients are excluded if they have brain metastasis or spinal cord compression that is newly diagnosed and/or has not yet been definitively treated with surgery and/or radiation; previously diagnosed and treated CNS metastases or spinal cord compression with evidence of stable disease (clinically stable imaging) for at least 2 months is permitted.
  • Any significant ophthalmologic abnormality, especially severe dry eye syndrome, keratoconjunctivitis sicca, Sjogren syndrome, severe exposure keratitis or any other disorder likely to increase the risk of corneal epithelial lesions. The use of contact lenses is not recommended during the study. The decision to continue to wear contact lenses should be discussed with the patient's treating Oncologist and the ophthalmologist.
  • Patients who cannot take oral medication, who require intravenous alimentation, have had prior surgical procedures affecting absorption, or have active peptic ulcer disease.
  • Nursing mothers.

Trial locations and contacts

1 site in 1 country.

Saudi Arabia1 site

  • King Abdul Aziz Medical City for National Guard Health Affairs

    Riyadh, 11426

Other trials in Saudi Arabia

About this study

Official title: Real Life Experience of Erlotinib in Patients With Advanced Non-Small Cell Lung Cancer in the Middle Eastern Countries (REALME)

An open-label, prospective, single-arm, multi-center phase IV clinical trial of TarcevaTM as single agent

Read the detailed description

Advanced NSCLC remains largely fatal, with the positive impact of chemotherapy limited by intrinsic and acquired resistance, manifested clinically by early progression and transient responses. Current chemotherapy regimens have limited efficacy with a magnitude of survival benefit that is still modest, and lead to significant toxicity, with many patients unable to receive this kind of treatment, even in first line setting. There is, therefore, a great need to provide patients with less toxic agents such as the novel targeted therapies, with the potential to improve the efficacy and maintain a good quality of life with little associated toxicity. TarcevaTM has shown benefit as single agent in pretreated patients who have progressed despite platinum-based chemotherapy as summarized in section 1.2 with minimal toxicity compared to chemotherapy, and also is currently assessed as first line treatment in advanced NSCLC with promising preliminary efficacy results.

As previously described, TarcevaTM has recently been shown to prolong survival in a large, randomized, placebo-controlled Phase III trial including 731 NSCLC patients no longer candidates for further chemotherapy. This is the first and so far the only evidence of definitive clinical benefit provided by an EGFR inhibitor in cancer patients. TarcevaTM is the standard of care for second and third line treatment for lung cancer in USA and Europe. However, the experience with this agent in the Middle Eastern population is very limited. The rationale for this program is to evaluate the pattern of TarcevaTM use in patients with advanced (inoperable stage III or IV) NSCLC who have failed standard treatment, or patients who can not receive other systemic anticancer therapy, or patients who are not medically suitable for chemotherapy (e.g., poor performance status). This will also enable us to study the efficacy and safety of TarcevaTM in this population, as there may be differences in the pharmacogenomic of this population and the previously studied population.

Being tested
Erlotinib
Keywords
Lung Cancer
Medical subject headings
Lung Neoplasms

What participants receive

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

  • ErlotinibDrug

    All patients will receive: TarcevaTM 150mg/day PO.

Study groups in NCT01320501
Study groupRoleWhat they receive
ErlotinibExperimental150 mg PO daily
Receives: Drug: Erlotinib

What is being measured

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

  1. To evaluate the pattern of use of TarcevaTM in Middle Eastern patients with advanced NSCLC

    Measured: 3 years

Secondary outcomes (1)

  1. To evaluate the activity and tolerability of TarcevaTM in this patient population

    To evaluate the activity and tolerability of TarcevaTM in this patient population, assessing:

    • Best response (as per investigator's assessment).
    • Progression-Free Survival (PFS).
    • Overall Survival (OS).
    • Safety (Serious Adverse Events (SAEs), AEs leading to premature withdrawal, unexpected and expected TarcevaTM related AEs).
    • To assess the degree of association (correlation) of EGFR expression rate (HER1) and other markers potentially predictive for response.

    Measured: 3 years

Timeline

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

  1. First posted22 Mar 2011 (estimated)
  2. Study startOct 2009
  3. Primary completionAug 2016 (estimated)
  4. Study completionAug 2016 (estimated)

Why it stopped: Difficulty in enrolling patients

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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01320501
Sponsor's protocol ID
RC08/29
Acronym
REALME
Status last verified
May 2016
First submitted
19 Mar 2011
Last updated
13 May 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Erlotinib in people with Non-small Cell Lung Cancer Metastatic, run by National Guard Health Affairs at 1 site in Saudi Arabia.

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 20 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: paused, as of the sponsor's last update on 13 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 1 site in Saudi Arabia. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

Results are not available in the source record.

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?

To evaluate the pattern of use of TarcevaTM in Middle Eastern patients with advanced NSCLC (time frame: 3 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 NCT01320501.

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 13 May 2016.

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