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Carcinoma，Non-Small-Cell LungPhase 2BIOTECNCT01153984

A Study to Assess Biomarkers Impact on Participants Response to Erlotinib Treatment for First-line Non-Small Cell Lung Cancer With Endothelial Growth Factor Receptor (EGFR) Activating Mutations

A Phase 2 study testing Erlotinib in people with Carcinoma，Non-Small-Cell Lung, run by Hoffmann-La Roche at 9 sites in Romania.

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

This open-label, single-arm, multi-center study will evaluate the progression-free survival in participants with histologically documented, advanced and/or metastatic chemotherapy naive, non-small cell lung cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) positive mutations and receiving erlotinib… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma，Non-Small-Cell Lung
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
23 participants
Where
9 sitesRomania
Study dates
Jun 2011to Jul 2015
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

  • Histological documented adenocarcinoma, locally advanced - Stage IIIB, metastatic - Stage IV or recurrent non-squamous NSCLC
  • Activated EGFR mutation positive status (Exons 19 and 21) for treatment phase
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Life expectancy greater than or equal to (≥) 12 weeks
  • Evidence of disease with at least one measurable disease evaluation on Response Evaluation Criteria in Solid Tumors (RECIST)
  • Adequate hematological , liver and renal function

Who cannot join

  • Known hypersensitivity to erlotinib or any of its excipients
  • Squamous non-small cell or small cell tumors or absence of histological report
  • Neoadjuvant/adjuvant chemotherapy within 6 months prior to enrollment
  • Prior exposure to inhibitors of EGFR
  • Prior chemotherapy or treatment with another systemic anti-cancer agent for the treatment of the participant's current stage of disease
  • Any significant ophthalmologic abnormality, especially severe dry eye syndrome, keratoconjunctivitis sicca, Sjögren syndrome, severe exposure keratitis or any other disorder likely to increase the risk of corneal epithelial lesions
  • Radical radiotherapy with curative intent within 28 days prior to enrollment
  • Any active non-controlled systemic disease

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Romania9 sites

  • County Hospital Alba; Oncology

    Alba Iulia, 510073

  • Institut of Oncology Al. Trestioreanu Bucharest; Oncology

    Bucharest, 022328

  • Institute Of Oncology Bucharest; Medical Oncology

    Bucharest, 022338

  • Spitalul de Boli Cronice Sf. Luca

    Bucharest, 04195

  • Emergency University Bucharest Hospital; Oncology Department

    Bucharest, 050098

  • Oncology Inst. Cluj-Napoca; Cancer Dept

    Cluj-Napoca, 400015

  • Uni Hospital St. Spiridon; Clinica Oncologie-Radiotherapie

    Iași, 6600

  • S.C. Life Search S.R.L; Medical Oncology Clinic

    Timișoara, 300167

  • ONCOMED - Medical Centre

    Timișoara, 300239

Other trials in Romania

About this study

Official title: Biomarkers Impact on the Response to Treatment With Erlotinib in First Line Non-small Cell Lung Cancer With EGFR Activating Mutations - BIOTEC

This open-label, single-arm, multi-center study will evaluate the progression-free survival in participants with histologically documented, advanced and/or metastatic chemotherapy naive, non-small cell lung cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) positive mutations and receiving erlotinib treatment. The anticipated time on study treatment is until disease progression, unacceptable toxicity, withdrawal due to any reason or death.

Being tested
Erlotinib
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 150 mg oral doses will be administered daily.

Study groups in NCT01153984
Study groupRoleWhat they receive
ErlotinibExperimentalParticipants will receive 150 milligrams (mg) erlotinib orally daily until disease progression, unacceptable toxicity, withdrawal due to any reason or death.
Receives: Drug: Erlotinib

What is being measured

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

  1. Progression-Free Survival (PFS), as Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

    PFS was the time from inclusion in the study to the date of first documented PD or death from any cause, whichever occurred first. Participants without event were censored at the date of the last tumor assessment where non-progression was documented. If a participant received a second anti-cancer therapy without prior documentation of disease progression, the participant was censored at the date of last tumor assessment before starting new chemotherapy. Analysis was performed using Kaplan-Meier method. PD was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.

    Measured: Baseline up to approximately 4 years

Secondary outcomes (7)

  1. Time to Disease Progression, as Assessed by Investigator Using RECIST v1.1

    Time to disease progression was defined as the time from baseline evaluation to the first date PD was recorded. Participants without progression were censored at the date of last tumor assessment where non-progression was documented. PD was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.

    Measured: Baseline up to approximately 4 years

  2. Percentage of Participants With Complete Response (CR) And Partial Response (PR) as Assessed by the Investigator Using RECIST v1.1

    CR was defined as the disappearance of all target lesions, and PR was defined as at least a 30% decrease in the sum of the longest diameter compared to baseline.

    Measured: Baseline up to approximately 4 years

  3. Percentage of Participants Who Were Alive One Year After Study Treatment Initiation

    Measured: Year 1

  4. Percentage of Participants by Localization of PD, as Assessed by Investigator Using RECIST v1.1

    PD was assessed using RECIST v1.1. PD was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. Percentage of participants by localization of PD were reported. Localization included: Left lung inferior lobe; Para-aortic; Left lung upper lobe; Right lung inferior lobe; and Infracranial.

    Measured: Baseline up to approximately 4 years

  5. Number of EGFR Positive Participants Classified Based on Smoking Status

    Participants were asked: "Have you smoked at least 100 cigarettes in your entire life?" and "Do you now smoke cigarettes every day, some days, or not at all?" Responses were grouped into three categories: Current Smoker, Former Smoker, and Non-Smoker. Participants who reported smoking at least 100 cigarettes in their lifetime and who, at the time of survey, smoked either every day or some days were defined as 'Current smoker'. Participants who reported smoking at least 100 cigarettes in their lifetime and who, at the time of the survey, did not smoke at all were defined as 'Former smoker'. Participants who reported never having smoked 100 cigarettes were defined as 'Non-smoker'.

    Measured: Day 1

  6. Number of EGFR Positive Participants Classified Based on Type of EGFR Mutations

    Participants with NSCLC have tumor associated with EGFR mutations. These mutations occur within EGFR Exons 18-21, which encodes a portion of the EGFR kinase domain.

    Measured: Day 1

  7. Percentage of Similar EGFR Mutations Between Matched Plasma and Tumor Tissue Samples

    Measured: Baseline up to approximately 4 years

Timeline

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

  1. First posted30 Jun 2010 (estimated)
  2. Study startJun 2011
  3. Primary completionJul 2015
  4. Study completionJul 2015

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01153984
Sponsor's protocol ID
ML22606
Other IDs
2009-017063-42, 2009
Acronym
BIOTEC
Status last verified
Feb 2017
First submitted
16 Jun 2010
Last updated
13 Apr 2017
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Erlotinib in people with Carcinoma，Non-Small-Cell Lung, run by Hoffmann-La Roche at 9 sites 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 6 inclusion and 8 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 13 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites 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.

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 13 Apr 2017). 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 (PFS), as Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) (time frame: Baseline up to approximately 4 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 NCT01153984.

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 Apr 2017.

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