A Study to Assess the Survival of Non-small Cell Lung Cancer Patients Treated With Tarceva After Failed Chemotherapy Treatment

NCT01990261 | Terminated Results

• 1 other identifier: ML28496
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the survival of non-small cell lung cancer (wild-type EGFR) participants treated with Tarceva after at least one failed chemotherapy treatment, and the impact of prior chemotherapy treatments.

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (4)

• Survival Rate at Month 6

  Month 6

• Survival Rate at Month 12

  Month 12

• Progression Free Survival (PFS) at Month 6

  PFS is defined as the time from inclusion in the study to the disease progression or death whichever occurs first. Disease progression was determined according to local treatment guidelines.

  From inclusion up to disease progression or death whichever occurs first (up to 6 months)

• Progression Free Survival (PFS) at Month 12

  PFS is defined as the time from inclusion in the study to the disease progression or death whichever occurs first. Disease progression was determined according to local treatment guidelines.

  From inclusion up to disease progression or death whichever occurs first (up to 12 months)

Secondary Outcomes (3)

• Overall Survival (OS)

  Up to 12 months

• Percentage of Participants With Adverse Events (AEs)

  Up to 12 months

• Overall Survival According to Prior Chemotherapy Treatment.

  Up to 12 months

Study Arms (1)

Erlotinib

Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.

Drug: Erlotinib

Interventions

Erlotinib DRUG

Erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.

Also known as: Tarceva

Erlotinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult participants diagnosed with locally advanced, metastatic or recurrent non-small cell lung carcinoma with wild-type EGFR.

You may qualify if:

• Adults \>/= 18 years
• Histologically documented locally advanced, metastatic, or recurrent non-small cell lung carcinoma with wild-type EGFR eligible for Tarceva treatment.
• At least one failed chemotherapy treatment.

You may not qualify if:

• \- Unknown EGFR mutation status

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Bucharest, 022338, Romania

Location

MeSH Terms

Interventions

Erlotinib Hydrochloride

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

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: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2013
• First Posted: November 21, 2013
• Study Start: May 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: September 16, 2016
• Results First Posted: July 28, 2016

Record last verified: 2016-06

Locations

RO (1)