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

The Survival of Non-Small Cell Lung Carcinoma EGFR Non-mutated (Wild Type) Patients Treated With Erlotinib (TARceva) After the Failure of at Least One Chemotherapy Regimen

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01990261

Acronym

STAR

Enrollment

Registered

2013-11-21

Start date

2013-05-31

Completion date

2014-09-30

Last updated

2016-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Squamous Non-Small Cell Lung Cancer

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.

Interventions

DRUGErlotinib

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Survival Rate at Month 6	Month 6	—
Survival Rate at Month 12	Month 12	—
Progression Free Survival (PFS) at Month 6	From inclusion up to disease progression or death whichever occurs first (up to 6 months)	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.
Progression Free Survival (PFS) at Month 12	From inclusion up to disease progression or death whichever occurs first (up to 12 months)	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.

Secondary

Measure	Time frame	Description
Percentage of Participants With Adverse Events (AEs)	Up to 12 months	An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Overall Survival According to Prior Chemotherapy Treatment.	Up to 12 months	Prior chemotherapy treatment is presented as reported by the investigators.
Overall Survival (OS)	Up to 12 months	OS is defined as time from first administration of study drug until death from any cause.

Countries

Romania

Participant flow

Recruitment details

A total of 33 participants were enrolled in 13 centers in Romania.

Participants by arm

Arm	Count
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.	33
Total	33

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Death Before Treatment Start	2
Overall Study	Death due to Disease Progression (PD)	10
Overall Study	Death From other Causes	1
Overall Study	Disease Progression (PD)	8
Overall Study	Dossier not Approved	1
Overall Study	Lost to Follow-up	2
Overall Study	PD Before Treatment Start	1

Baseline characteristics

Characteristic	Erlotinib
Age, Customized 60 years and older	23 participants
Age, Customized From 18 to 60 years	10 participants
Sex: Female, Male Female	14 Participants
Sex: Female, Male Male	19 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	3 / 33
serious Total, serious adverse events	7 / 33

Outcome results

Primary

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.

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