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Non-Squamous Non-Small Cell Lung CancerPhase 2NCT01250119

A Study to Assess the Incidence of EGFR Mutation in Patients With Newly Diagnosed Locally Advanced or Metastatic Non-Small Cell Lung Cancer in the UK, And of Tarceva (Erlotinib) as First-Line Therapy in EGFR Mutation Positive Patients.

A Phase 2 study testing erlotinib [Tarceva] in people with Non-Squamous Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 22 sites in United Kingdom.

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 study will assess the prevalence of epidermal growth factor receptor (EGFR) mutations in newly diagnosed patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). Read more about this study

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 [Tarceva]
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
688 participants
Where
22 sitesUnited Kingdom
Study dates
Mar 2011to May 2014
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
  • Locally advanced or metastatic (stage IIIB/IV) non-small cell lung cancer (NSCLC)
  • ECOG performance status 0-3
  • Treatment phase: histologically confirmed EGFR exon 19 deletion or exon 21 mutation in the diagnostic phase of the study
  • Adequate haematological, liver and renal function
  • Female patients must be postmenopausal, surgically sterile, or agree to use a barrier method of contraception
  • Male patients must be surgically sterile or agree to use a barrier method of contraception

Who cannot join

  • Previous treatment for NSCLC with chemotherapy or therapy against EGFR, either with antibody or small molecule (tyrosine kinase inhibitor)
  • Symptomatic cerebral metastases
  • Pregnant or lactating women
  • Any other concomitant anti-cancer therapy (until disease progression and discontinuation of Tarceva therapy)

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

United Kingdom22 sites

  • Study site

    Belfast, BT47 6SB

  • Study site

    Belfast, BT9 7AB

  • Study site

    Bradford, BD9 6RJ

  • Study site

    Brighton, BN2 5BE

  • Study site

    Chelsmford, CM1 7ET

  • Study site

    Colchester, C03 3NB

  • Study site

    Dudley, DY1 2HQ

  • Study site

    Glasgow, G12 0YN

  • Study site

    Grimsby, DN33 2BA

  • Study site

    London, DD1 9SY

  • Study site

    London, N18 1QX

  • Study site

    London, NW1 2PG

  • Study site

    London, NW3 2QG

  • Study site

    London, SW17 0QT

  • Study site

    London, W6 8RF

  • Study site

    Newtownards, BT16 1RH

  • Study site

    Portadown, BT63 5QQ

  • Study site

    Rhyl, LL18 5UJ

  • Study site

    Sutton in Ashfield, NG17 4JL

  • Study site

    Truro, TR1 3LJ

  • Study site

    Westcliffe-on-sea, SS0 0RY

  • Study site

    York, BD20 6TD

Other trials in United Kingdom

About this study

Official title: Assess the Incidence of Mutations in the Tyrosine Kinase Domain of the Endothelial Growth Factor Receptor in UK Patients With Newly Diagnosed Metastatic or Recurrent Non-small Cell Lung Cancer and to Investigate the Quality of Life of These Patients Undergoing First-line Therapy With Erlotinib.

This study will assess the prevalence of epidermal growth factor receptor (EGFR) mutations in newly diagnosed patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). Patients with positive EGFR mutation results will enter an open-label, single arm study to evaluate progression-free survival and quality of life with first-line Tarceva (erlotinib) therapy. Patients will receive Tarceva at a dose of 150 mg orally daily. Anticipated time on study treatment is until progressive disease or unacceptable toxicity occurs. Patients with negative EGFR mutation results will be offered treatment as per the centre's standard of care.

Being tested
erlotinib [Tarceva]

What participants receive

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

  • erlotinib [Tarceva]Drug

    150 mg daily, orally

Study groups in NCT01250119
Study groupRoleWhat they receive
Single ArmExperimentalNot described
Receives: Drug: erlotinib [Tarceva]

What is being measured

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

  1. Percentage of Participants Who Tested Positive for EGFR Mutations

    All participants newly diagnosed with recurrent or metastatic NSCLC were tested for EGFR exon 19 deletion or exon 21 mutations.

    Measured: 14 days

  2. Percentage of Participants With EGFR Mutations by Subgroup

    Incidence of EGFR mutations were summarized with respect to different subgroups as follows: (1) equals (=) Histopathology, (2) = Stage of disease, (3) = Age at consent, (4) = Gender, (5) = Race, (6) = Smoking history.

    Measured: 14 Days

Secondary outcomes (9)

  1. Percentage of Participants With a Response by Best Objective Tumor Response

    Best objective response was defined as the best response recorded from the start of treatment until disease progression/recurrence. Tumor response was assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1". Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeters (mm). Partial Response (PR): At least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this may include the baseline sum). The sum must also demonstrate an absolute increase of at least 5 mm. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.

    Measured: Screening, Day 1 of each 6 week visit starting from Visit 3 until PD, Death, Unacceptable Toxicity or Withdrawal of Consent up to 34 months

  2. Probability of Being Alive and Free of Progression by Timepoint

    Progression Free Survival (PFS) was defined as the interval (number of days) from the trial treatment start date to the earlier of the date of the first tumor response assessment of PD or the date of death by any cause. Participants who experienced neither of these events or who were lost to followup at the time of the analysis were censored at date of last contact. PFS was summarized according to the Kaplan-Meier method.

    Measured: Months 0, 3, 6, 9, 12, 15, and 18

  3. Survival Time in Months

    Duration of time in months from Screening until Death due to any cause.

    Measured: Baseline, Day 1 of each 6-week visit starting from Visit 3 until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months

  4. Quality of Life Assessment Using EuroQol(EQ) 5D Visual Analog Score (VAS) Instrument

    The EQ-5D contains a descriptive system that measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The EQ-5D also contains a visual analog scale (EQ-VAS), which records the respondent's self-rated health status on a vertical graduated visual analog scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). A negative change indicates improvement.

    Measured: Screening, Baseline and Final or Withdrawal Visit up to 34 months

  5. Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D

    The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The participants were required to rate their mobility as the following categories: Category 1. I have no problems in walking about; Category 2. I have some problems in walking about; Category 3. I am confined to bed.

    Measured: Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months

  6. Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D

    The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The participants were required to rate their self-care as the following categories: Category 1. I have no problems with self-care; Category 2. I have some problems washing or dressing myself; Category 3. I am unable to wash or dress myself.

    Measured: Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months

  7. Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D

    The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The participants were required to rate their ability to perform usual activities as the following categories: Category 1. I have no problems with performing my usual activities; Category 2. I have some problems with performing my usual activities; Category 3. I am unable to perform my usual activities.

    Measured: Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months

  8. Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D

    The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The participants were required to rate their pain as the following categories: Category 1. I have no pain or discomfort; Category 2. I have moderate pain or discomfort; Category 3. I have extreme pain or discomfort.

    Measured: Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months

  9. Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D

    The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The participants were required to rate their pain as the following categories: Category 1. I am not anxious or depressed; Category 2. I am moderately anxious or depressed; Category 3.I am extremely anxious or depressed.

    Measured: Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months

Timeline

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

  1. First posted30 Nov 2010 (estimated)
  2. Study startMar 2011
  3. Primary completionMay 2014
  4. Study completionMay 2014

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
688 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01250119
Sponsor's protocol ID
ML25279
Other IDs
2010-021120-96
Status last verified
Feb 2016
First submitted
29 Nov 2010
Last updated
14 Mar 2016

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing erlotinib [Tarceva] in people with Non-Squamous Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 22 sites in United Kingdom.

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 7 inclusion and 4 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 14 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in United Kingdom. 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 5 Oct 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 Who Tested Positive for EGFR Mutations (time frame: 14 days). 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 NCT01250119.

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 14 Mar 2016.

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