NCT01378962

Brief Summary

This single-arm, open-label study evaluated the efficacy and safety of Tarceva (erlotinib) in participants with locally advanced or metastatic non-small cell lung cancer. Participants received daily oral doses of 150 mg Tarceva. The anticipated time on study treatment was 12 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2011

Longer than P75 for phase_2

Geographic Reach
1 country

10 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 31, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 23, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2013

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

October 29, 2015

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2017

Completed
Last Updated

January 23, 2018

Status Verified

December 1, 2017

Enrollment Period

2.3 years

First QC Date

June 21, 2011

Results QC Date

September 30, 2015

Last Update Submit

December 21, 2017

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (3)

  • Percentage of Participants With Disease Progression or Death at 12 Months After Baseline

    According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), progressive disease (PD) was defined as at least a 20 percent (%) increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.

    12 months

  • Progression-Free Survival (PFS)

    PFS was defined as the time from baseline to the date of first occurrence of disease progression or death. According to RECIST v1.1, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. PFS was assessed using Kaplan-Meier method.

    Up to 1 year after enrollment of the last participant (maximum up to 27 months)

  • Probability of Being Progression Free 12 Months After Baseline

    According to RECIST v1.1, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.

    12 months

Secondary Outcomes (7)

  • Percentage of Participants Who Died

    Every 8 weeks during treatment, after discontinuation participants were followed for up to 1 year after enrollment of the last participant (maximum up to 27 months)

  • Overall Survival (OS)

    Every 8 weeks during treatment, after discontinuation participants were followed for up to 1 year after enrollment of the last participant (maximum up to 27 months)

  • Percentage of Participants With a Response by Best Overall Response

    Baseline up to disease progression or end of study (up to 12 Months)

  • Percentage of Participants With Objective Response

    Baseline up to disease progression or end of study (up to 12 Months)

  • Percentage of Participants Achieving CR, PR, or SD as Best Overall Response

    Baseline up to disease progression or end of study (up to 12 Months)

  • +2 more secondary outcomes

Study Arms (1)

Single Arm

EXPERIMENTAL
Drug: erlotinib

Interventions

erlotinibDRUG

150 mg orally once a day for 12 months

Also known as: Tarceva
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 non-small cell lung cancer
  • Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Life expectancy over \>/=12 weeks
  • Adequate hematological, liver, or kidney function

You may not qualify if:

  • Previous therapy against epidermal growth factor receptor for metastatic disease
  • Treatment with investigational drug during the 3 weeks before enrollment
  • History of neoplasm
  • Patients with symptomatic cerebral metastases
  • Unstable systemic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica A

Napoli, Campania, 80131, Italy

Location

Ospedale Bellaria; U.O. Oncologia Medica

Bologna, Emilia-Romagna, 40133, Italy

Location

A.O. Universitaria Policlinico Di Modena; Ematologia

Modena, Emilia-Romagna, 41100, Italy

Location

Istituto Regina Elena; Oncologia Medica A

Rome, Lazio, 00168, Italy

Location

Istituto Europeo Di Oncologia

Milan, Lombardy, 20141, Italy

Location

Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia

Rozzano, Lombardy, 20089, Italy

Location

Az Ospedaliera Nuovo Garibaldi Quartiere Nesima; Oncologia Medica

Catania, Sicily, 95122, Italy

Location

Policlinico P. Giaccone; Istituto Di Oncologia, Clinica Medica 1

Palermo, Sicily, 90127, Italy

Location

A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii

Pisa, Tuscany, 56124, Italy

Location

Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica

Perugia, Umbria, 06156, Italy

Location

MeSH Terms

Interventions

Erlotinib Hydrochloride

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

Study Record Dates

First Submitted

June 21, 2011

First Posted

June 23, 2011

Study Start

March 31, 2011

Primary Completion

June 30, 2013

Study Completion

January 31, 2017

Last Updated

January 23, 2018

Results First Posted

October 29, 2015

Record last verified: 2017-12

Locations

IT(10)