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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01990261
Other study ID # ML28496
Secondary ID
Status Terminated
Phase N/A
First received October 31, 2013
Last updated May 4, 2016
Start date May 2013
Est. completion date September 2014

Study information

Verified date May 2016
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority Romania: National Agency of Medicines and Medical Devices
Study type Observational

Clinical Trial Summary

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


Recruitment information / eligibility

Status Terminated
Enrollment 33
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- Unknown EGFR mutation status

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Romania, 

Outcome

Type Measure Description Time frame Safety issue
Primary Efficacy: Overall survival (OS) 12 months No
Primary Safety: Incidence of adverse events (AE) 12 months No
Secondary Efficacy: OS rate according to prior chemotherapy treatment 12 months No
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