An Observational Study of Tarceva (Erlotinib) in Elderly Patients With Advanced Non-Small Cell Lung Cancer

NCT01535729 | Completed Results

• 1 other identifier: ML23023
• Study Type: observational
• Target: 465
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective observational study will evaluate the efficacy and safety of Tarceva (erlotinib) in elderly patients with advanced non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen. Data of patients treated with Tarceva in routine clinical practice will be collected for 1 year.

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Were Alive 1 Year After Start of Treatment

  Overall survival was defined as the time from the date of first medication to the date of death from any cause. If death was not observed during the study, survival time was censored at the last day of observation (latest at the end of study after one year). Overall percentage of participants who were alive 1 year after study treatment and those based on the factor of age (65-69, 70-74, 75-79, ≥ 80 years) were reported.

  Year 1

Secondary Outcomes (23)

• Median Overall Survival: Age

  From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40)

• Percentage of Participants With Fatigue

  Months 3, 6, 9, 12

• Percentage of Participants With Rash

  Months 3, 6, 9, 12

• Percentage of Participants With Diarrhea

  Months 3, 6, 9, 12

• Percentage of Participants With Rash Based on Severity During the Course of Time

  Months 3, 6, 9, 12

Study Arms (1)

Cohort

Eligibility Criteria

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

Study Population

Elderly patients with advanced non-small cell lung cancer after first-line platinum-based chemotherapy

You may qualify if:

• Adult patients, \> 65 years of age
• Locally advanced or metastatic non-small cell lung cancer (Stage IIIb or IV)
• Failure of at least one prior standard platinum-based chemotherapy

You may not qualify if:

• Age \< 65 years

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Nuremberg, 90419, Germany

Location

Related Publications (1)

• Brueckl WM, Achenbach HJ, Ficker JH, Schuette W. Erlotinib treatment after platinum-based therapy in elderly patients with non-small-cell lung cancer in routine clinical practice - results from the ElderTac study. BMC Cancer. 2018 Mar 27;18(1):333. doi: 10.1186/s12885-018-4208-x.

  PMID: 29587656 DERIVED

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: February 15, 2012
• First Posted: February 20, 2012
• Study Start: May 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: October 29, 2015
• Results First Posted: October 29, 2015

Record last verified: 2015-10

Locations

DE (1)