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Non-Small Cell Lung CancerPhase 3NCT01342965

A Study of Erlotinib (Tarceva) Versus Gemcitabine/Cisplatin as First-line Treatment in Patients With Non-small Cell Lung Cancer With EGFR Mutations

A Phase 3 study testing Erlotinib and Chemotherapy in people with Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 28 sites in 3 countries.

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, randomized, parallel arm study assessed the efficacy and safety of Tarceva (erlotinib) versus gemcitabine/cisplatin combination chemotherapy as first-line treatment in patients with stage IIIB/IV non-small cell lung cancer with epidermal growth factor receptor (EGFR) mutations in their tumours. 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 and Chemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
217 participants
Where
28 sitesin 3 countries
Study dates
Mar 2011to Apr 2014
Phase
Phase 3
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 participants, ≥ 18 years of age.
  • Locally advanced or recurrent (stage IIIB) or metastatic (stage IV) non-small cell lung cancer.
  • Presence of epidermal growth factor receptor (EGFR) mutations in tumours.
  • Measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 criteria.
  • European Cooperative Oncology Group (ECOG) performance status ≤ 2.

Who cannot join

  • Prior exposure to agents directed at the human epidermal receptor (HER) axis (eg, but not limited to erlotinib, gefitinib, cetuximab, or trastuzumab).
  • Prior chemotherapy or systemic anti-neoplastic therapy for advanced disease.
  • Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or active gastroduodenal ulcer disease.
  • Any inflammatory changes of the surface of the eye.
  • ≥ Grade 2 peripheral neuropathy.
  • History of any other malignancies within 5 years, except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer.
Show all 9Show fewer
  • Brain metastasis or spinal cord compression that has not yet been definitely treated with surgery and/or radiation, or treated but without evidence of stable disease for at least 2 months.
  • Human immunodeficiency virus (HIV) infection.
  • Pregnant, nursing, or lactating women.

Trial locations and contacts

28 sites in 3 countries.

28 sites in 3 countries

China15 sites

  • Study site

    Beijing, 100071

  • Study site

    Beijing, 101149

  • Study site

    Changchun, 130012

  • Study site

    Chongqing, 400038

  • Study site

    Chongqing, 400042

  • Study site

    Fuzhou, 350014

  • Study site

    Guangzhou, 510080

  • Study site

    Hangzhou, 310016

  • Study site

    Nanjing, 210002

  • Study site

    Shanghai, 200030

  • Study site

    Shanghai, 200032

  • Study site

    Shanghai, 200433

  • Study site

    Shantou, 515041

  • Study site

    Wuhan, 430023

  • Study site

    Xi'an, 710061

Other trials in China

Malaysia8 sites

  • Study site

    Kampung Baharu Nilai, 71800

  • Study site

    Kelantan, 16150

  • Study site

    Kuala Lumpur, 50603

  • Study site

    Kuala Lumpur, 59100

  • Study site

    Kuala Pahang, 25100

  • Study site

    Petaling Jaya, 46150

  • Study site

    Petaling Jaya, Selangor, 46050

  • Study site

    Pulau Pinang, 11600

Other trials in Malaysia

Philippines5 sites

  • Study site

    Davao City, 8000

  • Study site

    Desmarinas City, 4114

  • Study site

    Manila, 1000

  • Study site

    Quezon City, 1104

  • Study site

    San Juan City, 1500

Other trials in Philippines

About this study

Official title: A Multicenter, Open-label, Randomized Phase III Study to Evaluate the Efficacy and Safety of Erlotinib (Tarceva®) Versus Gemcitabine/Cisplatin as the First-line Treatment for Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC) Patients With Mutations in the Tyrosine Kinase Domain of Epidermal Growth Factor Receptor (EGFR) in Their Tumors

This open-label, randomized, parallel arm study assessed the efficacy and safety of Tarceva (erlotinib) versus gemcitabine/cisplatin combination chemotherapy as first-line treatment in patients with stage IIIB/IV non-small cell lung cancer with epidermal growth factor receptor (EGFR) mutations in their tumours. Patients were randomized to receive either Tarceva 150 mg orally daily or 3-week cycles of gemcitabine 1250 mg/m^2 intravenously (iv) on Days 1 and 8 plus cisplatin 75 mg/m^2 iv on Day 1.

Being tested
Erlotinib, Chemotherapy
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 was supplied as tablets.

  • ChemotherapyDrug

    Cisplatin and gemcitabine were locally sourced with commercial products.

Study groups in NCT01342965
Study groupRoleWhat they receive
ErlotinibExperimentalParticipants received erlotinib 150 mg orally once daily until progressive disease or unacceptable toxicity.
Receives: Drug: Erlotinib
ChemotherapyActive comparatorParticipants received gemcitabine 1250 mg/m^2 intravenously (IV) on Days 1 and 8 and cisplatin 75 mg/m^2 IV on Day 1 of every 3 week cycle until disease progression, unacceptable toxicity, or a total of 4 cycles, whichever came first.
Receives: Drug: Chemotherapy

What is being measured

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

  1. Investigator-assessed Duration of Progression-free Survival

    The duration of progression-free survival was defined as the time from randomization to disease progression (PD) or death from any cause, whichever occurs first. PD was defined as: (1) 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. (2) An unequivocal progression of existing non-target lesions. When the patient has measurable disease, the overall tumor burden must have increased sufficiently to merit discontinuation of therapy. When the patient has only non-measurable disease, the increase in overall disease burden should be comparable in magnitude to the increase that would be required to declare PD for measurable disease. (3) The appearance of new malignant lesions.

    Measured: Baseline to the data cut-off date of 20 Jul 2012 (1 year, 4 months)

Secondary outcomes (6)

  1. Percentage of Responders as Assessed by the Investigator

    A responder was defined as a participant with either a complete response (CR) or a partial response (PR), as determined using the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. A CR was defined as: (1) The disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to < 10 mm. (2) The disappearance of all non-target lesions and normalization of tumor marker levels. All lymph nodes must be non-pathological in size (< 10 mm in the short axis). A PR was defined as: (1) At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. (2) The persistence of 1 or more non-target lesion(s) and/or maintenance of tumor marker levels above normal limits.

    Measured: Baseline to the data cut-off date of 19 Nov 2012 (1 year, 8 months)

  2. Percentage of Participants With Disease Control

    A participant with disease control was defined as a participant with either a complete response (CR), a partial response (PR), or stable disease (SD), as determined using RECIST v1.1. A CR was defined as the disappearance of all target lesions (TL). A PR was defined as at least a 30% decrease in the sum of the longest diameter of TLs taking as reference the Baseline sum longest diameter (SLD). SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest SLD since treatment started. For non-TLs, SD was defined as the persistence of 1 or more lesions. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the unequivocal progression of existing non-TLs. A SLD for all TLs will be calculated and reported as the Baseline SLD.

    Measured: Baseline to the data cut-off date of 19 Nov 2012 (1 year, 8 months)

  3. Duration of Response

    Duration of response was defined as the time from the first documented complete response (CR) or partial response (PR) to the first documented disease progression (PD) or death, whichever occurs first. A CR was defined as the disappearance of all target lesions (TL). A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs taking as reference the Baseline SLD. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the unequivocal progression of existing non-TLs.

    Measured: Baseline to the data cut-off date of 19 Nov 2012 (1 year, 8 months)

  4. Overall Survival

    Overall survival was defined as the time from the date of randomization to the date of death from any cause.

    Measured: Baseline to the end of the study (3 years, 1 month)

  5. Safety: Incidence of Adverse Events

    Measured: 36 months

  6. Quality of Life: Functional Assessment of Chronic Illness Therapy - Lung (FACIT-L) Questionnaire

    Measured: approximately 21 months

Timeline

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

  1. First posted27 Apr 2011 (estimated)
  2. Study startMar 2011
  3. Primary completionJul 2012
  4. Study completionApr 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
217 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01342965
Sponsor's protocol ID
YO25121
Status last verified
Feb 2015
First submitted
26 Apr 2011
Last updated
24 Feb 2015

Publications

  • Wen F, Zheng H, Zhang P, Hutton D, Li Q. OPTIMAL and ENSURE trials-based combined cost-effectiveness analysis of erlotinib versus chemotherapy for the first-line treatment of Asian patients with non-squamous non-small-cell lung cancer. BMJ Open. 2018 Apr 13;8(4):e020128. doi: 10.1136/bmjopen-2017-020128.

    PubMed 29654023

  • Wu YL, Zhou C, Liam CK, Wu G, Liu X, Zhong Z, Lu S, Cheng Y, Han B, Chen L, Huang C, Qin S, Zhu Y, Pan H, Liang H, Li E, Jiang G, How SH, Fernando MCL, Zhang Y, Xia F, Zuo Y. First-line erlotinib versus gemcitabine/cisplatin in patients with advanced EGFR mutation-positive non-small-cell lung cancer: analyses from the phase III, randomized, open-label, ENSURE study. Ann Oncol. 2015 Sep;26(9):1883-1889. doi: 10.1093/annonc/mdv270. Epub 2015 Jun 23.

    PubMed 26105600

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Erlotinib and Chemotherapy in people with Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 28 sites in 3 countries.

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 5 inclusion and 9 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 24 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in China, Malaysia, Philippines. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 24 Feb 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?

Investigator-assessed Duration of Progression-free Survival (time frame: Baseline to the data cut-off date of 20 Jul 2012 (1 year, 4 months)). 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 NCT01342965, which also lists 2 linked publications.

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 24 Feb 2015.

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