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Non-Squamous Non-Small Cell Lung CancerPhase 2NCT01310036

A Study of Tarceva (Erlotinib) as First Line Therapy in Participants With Non-Small Cell Lung Cancer Harbouring Epidermal Growth Factor Receptor (EGFR) Mutations

A Phase 2 study testing Erlotinib in people with Non-Squamous Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 22 sites in 4 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, single arm study will evaluate the safety and efficacy of Tarceva (erlotinib) as first-line therapy in participants with stage IV or recurrent non-small cell lung cancer who harbour epidermal growth factor receptor (EGFR) mutations. 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
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
208 participants
Where
22 sitesin 4 countries
Study dates
30 Apr 2011to 30 Dec 2016
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 participants, >/= 18 years of age
  • Stage IV or recurrent non-small cell lung cancer (NSCLC)
  • Presence of mutation(s) in exon 18 through exon 21 of epidermal growth factor receptor (EGFR), (except T790M single mutation only)
  • Measurable disease (at least one lesion >= 10 mm in longest diameter)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Adequate hematological, renal and liver function

Who cannot join

  • Patients with T790M single mutation only
  • Prior exposure to agents directed at the human epidermal receptor (HER) axis, e.g. erlotinib, gefitinib, cetuximab, trastuzumab
  • Prior chemotherapy or systemic anti-cancer therapy for advanced NSCLC disease
  • Symptomatic or uncontrolled central nervous system (CNS) metastases
  • Other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal or squamous cell carcinoma of the skin, or surgically treated localized prostate cancer, or surgically treated ductal cell carcinoma in situ of the breast
  • Any significant ophthalmologic abnormality
  • Pre-existing parenchymal lung disease such as pulmonary fibrosis
  • Use of coumarins (for anti-coagulation therapy the use of low molecular weight heparin is recommended instead)

Trial locations and contacts

22 sites in 4 countries.

22 sites in 4 countries

Taiwan10 sites

  • Changhua Christian Hospital; Internal Medicine

    Changhua, 500

  • Kaohsiung Chang Gung Memorial Hospital; Dept of Internal Medicine

    Kaohsiung City, 00833

  • Veterans General Hospital; Internal Medicine

    Kaohsiung City, 813

  • China Medical University Hospital; Pulmonary and Critical Care Medicine

    Taichung, 40447

  • Taichung Veterans General Hospital; Dept of Internal Medicine

    Taichung, 407

  • National Cheng Kung Uni Hospital; Dept of Hematology and Oncology

    Tainan, 704

  • Chi-Mei Medical Centre; Hematology & Oncology

    Tainan, 710

  • National Taiwan Uni Hospital; Internal Medicine

    Taipei, 100

  • Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology

    Taipei, 112

  • Chang Gung Medical Foundation - Linkou; Chest Dept

    Taoyuan, 333

Other trials in Taiwan

South Korea6 sites

  • Seoul National University Bundang Hospital

    Gyeonggi-do, 13620

  • Gil Hospital. Gachon University

    Incheon, 405-760

  • Asan Medical Center; Medical Oncology

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

  • Seoul St Mary's Hospital

    Seoul, 06591

  • Yonsei University Severance Hospital; Medical Oncology

    Seoul, 120-752

Other trials in South Korea

Hong Kong3 sites

  • Princess Margaret Hospital; Oncology

    Hong Kong

  • Queen Elizabeth Hospital; Clinical Oncology

    Hong Kong

  • Prince of Wales Hosp; Dept. Of Clinical Onc

    Shatin

Other trials in Hong Kong

Thailand3 sites

  • Chulalongkorn Hospital; Medical Oncology

    Bangkok, 10330

  • Pramongkutklao Hospital; Medicine - Medical Oncology Unit

    Bangkok, 10400

  • Songklanagarind Hospital; Department of Internal Medicine, Division of Respiratory

    Songkhla, 90110

Other trials in Thailand

About this study

Official title: An Open-Label Multicenter Study of Erlotinib (Tarceva®) as First Line Therapy Until and Beyond RECIST Progression in NSCLC Patients Who Harbour EGFR Mutations

This open-label, single arm study will evaluate the safety and efficacy of Tarceva (erlotinib) as first-line therapy in participants with stage IV or recurrent non-small cell lung cancer who harbour epidermal growth factor receptor (EGFR) mutations. All participants will receive Tarceva 150 mg daily orally until disease progression or unacceptable toxicity occurs. At the investigator's discretion, participants may receive Tarceva beyond disease progression.

Being tested
Erlotinib

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 was administered orally daily until disease progression or unacceptable toxicity.

Study groups in NCT01310036
Study groupRoleWhat they receive
ErlotinibExperimentalErlotinib 150 mg daily
Receives: Drug: Erlotinib

What is being measured

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

  1. Progression-free Survival Per RECIST, v. 1.1 (PFS1)

    PFS1 was defined as time from first dose until documented progressive disease (PD), assessed per Response Evaluation Criteria in Solid Tumors RECIST, v. 1.1, or death from any cause, whichever occurred first. PD was defined as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; and the appearance of one or more new lesions.

    Measured: Approximately 68 months

Secondary outcomes (7)

  1. Progression-free Survival Per Investigator (PFS2)

    PFS2 was defined as time from first study dose to off-erlotinib progressive disease (PD), assessed by the investigator based on overall clinical evaluation.

    Measured: Approximately 68 months

  2. Objective Response Rate (ORR) for All Participants and Participants With EGFR Mutation E19del or L858R

    ORR was defined as the occurrence of either a confirmed complete (CR) or a partial response (PR, as a best overall response), as determined by RECIST, v. 1.1 criteria. CR was defined as disappearance of all target lesions. PR was defined as least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.

    Measured: Approximately 68 months

  3. Disease Control Rate (DCR) for All Participants and Participants With EGFR Mutation E19del or L858R

    DCR was defined as CR + PR + Stable disease (SD). CR was defined as disappearance of all target lesions. PR was defined as least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. 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 sum diameters while on study. PD was defined as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; and the appearance of one or more new lesions.

    Measured: Approximately 68 months

  4. Progression-free Survival for Participants With EGFR Mutation E19del or L858R Per RECIST, v. 1.1 (PFS1)

    PFS1 was defined as time from first dose until documented progressive disease (PD), assessed per Response Evaluation Criteria in Solid Tumors RECIST, v. 1.1, or death from any cause, whichever occurred first. PD was defined as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; and the appearance of one or more new lesions.

    Measured: Approximately 68 months

  5. Overall Survival (OS) for All Participants and Participants With EGFR Mutation E19del or L858R

    OS was defined as the time from baseline to the date of death from any cause.

    Measured: Approximately 68 months

  6. Number of Participants With Adverse Events

    An adverse event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug.

    Measured: Approximately 68 months

  7. Correlation Between EGFR Mutations in Plasma and Clinical Outcome (ORR/PFS/OS)

    This outcome measure was not assessed.

    Measured: Approximately 68 months

Timeline

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

  1. First posted7 Mar 2011 (estimated)
  2. Study start30 Apr 2011
  3. Primary completion14 Feb 2014
  4. Study completion30 Dec 2016

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
208 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01310036
Sponsor's protocol ID
ML25637
Status last verified
Sep 2018
First submitted
18 Feb 2011
Last updated
12 Sep 2018

Publications

  • Park K, Yu CJ, Kim SW, Lin MC, Sriuranpong V, Tsai CM, Lee JS, Kang JH, Chan KC, Perez-Moreno P, Button P, Ahn MJ, Mok T. First-Line Erlotinib Therapy Until and Beyond Response Evaluation Criteria in Solid Tumors Progression in Asian Patients With Epidermal Growth Factor Receptor Mutation-Positive Non-Small-Cell Lung Cancer: The ASPIRATION Study. JAMA Oncol. 2016 Mar;2(3):305-12. doi: 10.1001/jamaoncol.2015.4921.

    PubMed 26720423

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Erlotinib in people with Non-Squamous Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 22 sites in 4 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 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 12 Sep 2018. 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 Taiwan, South Korea, Hong Kong, Thailand. 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 12 Sep 2018). 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 Per RECIST, v. 1.1 (PFS1) (time frame: Approximately 68 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 NCT01310036, which also lists 1 linked publication.

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 12 Sep 2018.

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