NCT01372384

Brief Summary

This open-label study will assess the efficacy and safety of Tarceva (Erlotinib) in patients with locally advanced, metastatic or recurrent non-small cell lung cancer who have not received previous chemotherapy for their disease and who present epidermal growth factor receptor mutations. Patients will receive Tarceva 150 mg orally daily 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
6

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

9 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

June 10, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 13, 2011

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

November 16, 2015

Completed
Last Updated

February 2, 2016

Status Verified

January 1, 2016

Enrollment Period

2 years

First QC Date

June 10, 2011

Results QC Date

October 16, 2015

Last Update Submit

January 3, 2016

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression-free Survival (Tumour Assessments According to RECIST Criteria)

    Progression free survival is (PFS) defined as the time from the first dose of Erlotinib to the date of first occurrence of disease progression or death.

    Until participants had disease progression, unacceptable toxicity or died; approximately 24 months.

Secondary Outcomes (3)

  • Objective Response Rate (Investigator Assessed)

    Visit 4, Visit 6, Visit 10 and Visit 22; (up to approximately 24 months)

  • Safety: Incidence of Adverse Events

    Until participants had disease progression, unacceptable toxicity, or died; approximately 24 months.

  • Overall Survival

    Until participants had disease progression, unacceptable toxicity, or died; approximately 24 months.

Study Arms (1)

Single Arm

EXPERIMENTAL
Drug: erlotinib [Tarceva]

Interventions

erlotinib [Tarceva]DRUG

150 mg orally daily

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 (Stage IIIB), metastatic (Stage IV) or recurrent non-small cell lung cancer with mutations in the tyrosine kinase domain of the epidermal growth factor receptor (EGFR)
  • At least one measurable lesion according to RECIST criteria
  • European Cooperative Oncology Group (ECOG) performance status 0-2
  • Adequate hematological, liver and renal function
  • Patients with stable cerebral metastases who have received surgical or radiotherapy will be eligible

You may not qualify if:

  • Previous chemotherapy or therapy against EGFR for metastatic disease (neoadjuvant or adjuvant therapy after radical surgery is allowed if finalized \>/= 6 months before entering the study)
  • History of another neoplasm except for carcinoma in situ of the cervix, adequately treated basal cell skin carcinoma, radically treated prostate carcinoma with good prognosis (Gleason \</= 6), or another curatively treated neoplasm without evidence of disease in the last 5 years
  • Symptomatic cerebral metastases
  • Any significant ophthalmologic abnormality
  • Use of coumarins
  • Pregnant or breast-feeding women
  • Pre-existing parenchymal lung disease such as pulmonary fibrosis, lymphangiosis and carcinomatosis (if this is the only presence of the disease)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Unknown Facility

Plovdiv, 4004, Bulgaria

Location

Unknown Facility

Sofia, 1404, Bulgaria

Location

Unknown Facility

Sofia, 1431, Bulgaria

Location

Unknown Facility

Sofia, 1527, Bulgaria

Location

Unknown Facility

Sofia, 1756, Bulgaria

Location

Unknown Facility

Stara Zagora, 8000, Bulgaria

Location

Unknown Facility

Varna, 9002, Bulgaria

Location

Unknown Facility

Varna, 9010, Bulgaria

Location

Unknown Facility

Veliko Tarnovo, 5000, Bulgaria

Location

MeSH Terms

Interventions

Erlotinib Hydrochloride

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title
Roche Trial Information Hotline
Organization
F. Hoffmann-La Roche AG
global.trial_information@roche.com
+41 61 6878333

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 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2011

First Posted

June 13, 2011

Study Start

January 1, 2012

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

February 2, 2016

Results First Posted

November 16, 2015

Record last verified: 2016-01

Locations

BU(9)