NCT01287754

Brief Summary

This single arm, open-label study will assess the efficacy and safety of Tarceva (erlotinib) in patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) mutations. Patients will receive Tarceva at a dose of 150 mg daily orally until disease progression or unacceptable toxicity occurs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for phase_4 nonsmall-cell-lung-cancer

Timeline
Completed

Started Oct 2011

Shorter than P25 for phase_4 nonsmall-cell-lung-cancer

Geographic Reach
1 country

5 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

First Submitted

Initial submission to the registry

January 24, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 1, 2011

Completed
8 months until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

June 2, 2015

Completed
Last Updated

June 2, 2015

Status Verified

May 1, 2015

Enrollment Period

2.1 years

First QC Date

January 24, 2011

Results QC Date

May 6, 2015

Last Update Submit

June 1, 2015

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression-Free Survival (PFS) Among Erlotinib-Treated Participants With the EGFR Mutation

    PFS was defined as the time from the first dose of erlotinib to the first documentation of disease progression or death, whichever occurred first. Tumor progression was determined using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), which defines progression as a 20 percent (%) or greater increase in the sum of diameters of target lesions with an absolute increase of at least 5 millimeters (mm), or the appearance of one or more new lesions. PFS was calculated in months as \[first event date minus first dose date plus 1\] divided by 30.44.

    Per standard of care (every 3 months) until discontinuation for up to approximately 2 years

Secondary Outcomes (4)

  • Number of Erlotinib-Treated Participants With the EGFR Mutation With an Objective Response Per RECIST v1.1

    Per standard of care (every 3 months) until discontinuation for up to approximately 2 years

  • Overall Survival (OS) Among Erlotinib-Treated and Untreated Participants

    Per standard of care (every 3 months) until discontinuation for up to approximately 2 years

  • Percentage of Participants Alive at 6 and 12 Months

    At 6 and 12 months

  • Percentage of Participants With EGFR Mutation at Screening

    Screening

Study Arms (1)

Single Arm

EXPERIMENTAL
Drug: erlotinib [Tarceva]

Interventions

erlotinib [Tarceva]DRUG

150 mg daily orally

Single Arm

Eligibility Criteria

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

You may qualify if:

  • Adult patients, \>/=18 years of age
  • Locally advanced or metastatic (stage III/IV) non-small cell lung cancer with EGFR mutations
  • Measurable disease according to RECIST criteria
  • ECOG performance status 0-2
  • Adequate haematological, renal and liver function

You may not qualify if:

  • Previous chemotherapy or therapy against EGFR for metastatic disease
  • History of another malignancy, except for in situ carcinoma of the cervix, adequately treated basal cell skin carcinoma, or radically treated prostate carcinoma with good prognosis
  • Symptomatic cerebral metastases
  • Pre-existing parenchymal lung disease such as pulmonary fibrosis
  • Concomitant use of coumarins

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unknown Facility

Helsinki, 00290, Finland

Location

Unknown Facility

Kuopio, 70211, Finland

Location

Unknown Facility

Oulu, 90029, Finland

Location

Unknown Facility

Pori, 28500, Finland

Location

Unknown Facility

Turku, 20521, Finland

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Erlotinib Hydrochloride

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 Compounds

Results Point of Contact

Title
Medical Communications
Organization
Hoffmann-LaRoche
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 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2011

First Posted

February 1, 2011

Study Start

October 1, 2011

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

June 2, 2015

Results First Posted

June 2, 2015

Record last verified: 2015-05

Locations

FI(5)