NCT01342965

Brief 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. 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
217

participants targeted

Target at below P25 for phase_3 nonsmall-cell-lung-cancer

Timeline
Completed

Started Mar 2011

Shorter than P25 for phase_3 nonsmall-cell-lung-cancer

Geographic Reach
3 countries

28 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 27, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
11 months until next milestone

Results Posted

Study results publicly available

February 24, 2015

Completed
Last Updated

February 24, 2015

Status Verified

February 1, 2015

Enrollment Period

1.3 years

First QC Date

April 26, 2011

Results QC Date

February 5, 2015

Last Update Submit

February 5, 2015

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (6)

  • Percentage of Responders as Assessed by the Investigator

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

  • Percentage of Participants With Disease Control

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

  • Duration of Response

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

  • Overall Survival

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

  • Safety: Incidence of Adverse Events

    36 months

  • +1 more secondary outcomes

Study Arms (2)

Erlotinib

EXPERIMENTAL

Participants received erlotinib 150 mg orally once daily until progressive disease or unacceptable toxicity.

Drug: Erlotinib

Chemotherapy

ACTIVE COMPARATOR

Participants 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.

Drug: Chemotherapy

Interventions

ErlotinibDRUG

Erlotinib was supplied as tablets.

Also known as: Tarceva
Erlotinib
ChemotherapyDRUG

Cisplatin and gemcitabine were locally sourced with commercial products.

Chemotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (28)

Unknown Facility

Beijing, 100071, China

Location

Unknown Facility

Beijing, 101149, China

Location

Unknown Facility

Changchun, 130012, China

Location

Unknown Facility

Chongqing, 400038, China

Location

Unknown Facility

Chongqing, 400042, China

Location

Unknown Facility

Fuzhou, 350014, China

Location

Unknown Facility

Guangzhou, 510080, China

Location

Unknown Facility

Hangzhou, 310016, China

Location

Unknown Facility

Nanjing, 210002, China

Location

Unknown Facility

Shanghai, 200030, China

Location

Unknown Facility

Shanghai, 200032, China

Location

Unknown Facility

Shanghai, 200433, China

Location

Unknown Facility

Shantou, 515041, China

Location

Unknown Facility

Wuhan, 430023, China

Location

Unknown Facility

Xi'an, 710061, China

Location

Unknown Facility

Kampung Baharu Nilai, 71800, Malaysia

Location

Unknown Facility

Kelantan, 16150, Malaysia

Location

Unknown Facility

Kuala Lumpur, 50603, Malaysia

Location

Unknown Facility

Kuala Lumpur, 59100, Malaysia

Location

Unknown Facility

Kuala Pahang, 25100, Malaysia

Location

Unknown Facility

Petaling Jaya, 46150, Malaysia

Location

Unknown Facility

Petaling Jaya, Selangor, 46050, Malaysia

Location

Unknown Facility

Pulau Pinang, 11600, Malaysia

Location

Unknown Facility

Davao City, 8000, Philippines

Location

Unknown Facility

Desmarinas City, 4114, Philippines

Location

Unknown Facility

Manila, 1000, Philippines

Location

Unknown Facility

Quezon City, 1104, Philippines

Location

Unknown Facility

San Juan City, 1500, Philippines

Location

Related Publications (2)

  • 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.

    PMID: 29654023DERIVED

  • 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.

    PMID: 26105600DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Erlotinib HydrochlorideDrug Therapy

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsTherapeutics

Results Point of Contact

Title
Medical Communications
Organization
Hoffmann-La Roche
genentech@druginfo.com
800 821-8590

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2011

First Posted

April 27, 2011

Study Start

March 1, 2011

Primary Completion

July 1, 2012

Study Completion

April 1, 2014

Last Updated

February 24, 2015

Results First Posted

February 24, 2015

Record last verified: 2015-02

Locations

CN(15)MY(8)PH(5)