NCT01161173

Brief Summary

This observational study will evaluate the safety and efficacy of Tarceva (erlotinib) in routine clinical practice as second-line treatment in patients with recurrent or metastatic non-small dell lung cancer (NSCLC). Data will be collected from patients who have received 1 course of standard systemic chemotherapy, experienced disease progression, and who are receiveingTarceva in a second-line setting. Patients will also be followed through third-line treatment if there is disease progression on Tarceva therapy.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
347

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2008

Longer than P75 for all trials

Geographic Reach
2 countries

36 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

April 1, 2008

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 13, 2010

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

March 28, 2016

Completed
Last Updated

March 28, 2016

Status Verified

February 1, 2016

Enrollment Period

4.3 years

First QC Date

July 12, 2010

Results QC Date

August 5, 2015

Last Update Submit

February 25, 2016

Conditions

Nonsquamous Nonsmall Cell Neoplasm of Lung

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)

    The best overall response to treatment was determined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. A CR was defined as the disappearance of all target lesions (TL) or the disappearance of all non-TLs. A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD. SD was defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since treatment started for TLs and the persistence of 1 or more non-TL(s). PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. For the best overall responses of CR and PR, a response was "confirmed" if a subsequent RECIST evaluation also showed a CR or PR.

    Baseline to the end of the study (up to 4 years, 4 months)

Secondary Outcomes (5)

  • Time to Disease Progression

    Baseline to the end of the study (up to 4 years, 4 months)

  • Progression-free Survival

    Baseline to the end of the study (up to 4 years, 4 months)

  • Overall Survival

    Baseline to the end of the study (up to 4 years, 4 months)

  • Change From Baseline in the Lung Cancer Symptom Scale (LCSS) Scores

    Baseline to the end of the study (up to 4 years, 4 months)

  • Percentage of Participants Who Developed Rash

    Baseline to the end of the study (up to 4 years, 4 months)

Study Arms (1)

Erlotinib

Participants received erlotinib (Tarceva) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics. The recommended daily dose of erlotinib is 150 mg orally once daily.

Drug: Erlotinib

Interventions

ErlotinibDRUG

Erlotinib was provided in the retail versions of the product.

Also known as: Tarceva
Erlotinib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Non-small cell lung cancer patients with progressive disease after first-line chemotherapy.

You may qualify if:

  • Adult patients ≥ 18 years of age.
  • Written informed consent.
  • Recurrent or metastatic, Stage III or IV non-small cell lung cancer (NSCLC).
  • Measurable disease (Response Evaluation Criteria In Solid Tumors).
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  • Prior course of standard systemic chemotherapy.

You may not qualify if:

  • \- Contra-indications to treatment with Tarceva.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (36)

Unknown Facility

Aalst, 9300, Belgium

Location

Unknown Facility

Antwerp, 2020, Belgium

Location

Unknown Facility

Arlon, 6700, Belgium

Location

Unknown Facility

Bonheiden, 2820, Belgium

Location

Unknown Facility

Bouge, 5004, Belgium

Location

Unknown Facility

Boussu, 7360, Belgium

Location

Unknown Facility

Brussels, 1020, Belgium

Location

Unknown Facility

Brussels, 1050, Belgium

Location

Unknown Facility

Brussels, 1180, Belgium

Location

Unknown Facility

Brussels, 1200, Belgium

Location

Unknown Facility

Charleroi, 6000, Belgium

Location

Unknown Facility

Chimay, 6460, Belgium

Location

Unknown Facility

Duffel, 2570, Belgium

Location

Unknown Facility

Edegem, 2650, Belgium

Location

Unknown Facility

Frameries, 7080, Belgium

Location

Unknown Facility

Genk, 3600, Belgium

Location

Unknown Facility

Gilly, 6060, Belgium

Location

Unknown Facility

Hasselt, 3500, Belgium

Location

Unknown Facility

Leuven, 3000, Belgium

Location

Unknown Facility

Liège, 4000, Belgium

Location

Unknown Facility

Marche-en-Famenne, 5411, Belgium

Location

Unknown Facility

Mons, 7000, Belgium

Location

Unknown Facility

Namur, 5000, Belgium

Location

Unknown Facility

Ostend, 8400, Belgium

Location

Unknown Facility

Ottignies, 1340, Belgium

Location

Unknown Facility

Roeselare, 8800, Belgium

Location

Unknown Facility

Seraing, 4100, Belgium

Location

Unknown Facility

Sint-Niklaas, 9100, Belgium

Location

Unknown Facility

Tournai, 7500, Belgium

Location

Unknown Facility

Turnhout, 2300, Belgium

Location

Unknown Facility

Verviers, 4800, Belgium

Location

Unknown Facility

Vilvoorde, 1800, Belgium

Location

Unknown Facility

Wilrijk, 2610, Belgium

Location

Unknown Facility

Differdange, 4602, Luxembourg

Location

Unknown Facility

Esch-alzette, Luxembourg

Location

Unknown Facility

Luxembourg, 1210, Luxembourg

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
Hoffman-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
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2010

First Posted

July 13, 2010

Study Start

April 1, 2008

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

March 28, 2016

Results First Posted

March 28, 2016

Record last verified: 2016-02

Locations

LU(3)BE(33)