A Study Examining Long Response in Lung Cancer Patients Treated With Tarceva (Erlotinib)

Observational Trial on Long Responses in Patients With Advanced Non-Small Cell Lung Cancer Treated in Second-Line With Erlotinib

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02133508

Enrollment

172

Registered

2014-05-08

Start date

2014-04-30

Completion date

2016-06-10

Last updated

2017-10-24

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

Conditions

Non-Small Cell Lung Cancer

Brief summary

This multicenter, retrospective and prospective observational, cohort study will examine the effect of second-line Tarceva treatment on long response in non-small cell lung cancer (NSCLC) participants with wild type or unknown EGFR status. Participants will be observed from the start of treatment for 8 months or until death. The extension of the retrospective versus prospective observation will depend on the lag between the date of the participant enrollment and the date of beginning of erlotinib therapy.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Participants with stage IIIb or IV NSCLC * Participants aged \>/= 18 years * Second-line treatment with Tarceva started before study inclusion and SD response, or CR/PR according to RECIST v1.1, lasting for at least 4 weeks

Exclusion criteria

* Known presence of epidermal growth factor receptor (EGFR) mutation * Participation in a clinical trial with Tarceva during the study observation period

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants With Stable Disease (SD) or Objective Response (Complete and Partial Response [CR + PR] According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1	Up to 8 months	SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. Objective response was defined as having a CR or PR. CR was defined as disappearance of all target and non-target lesions and no new lesions, and all pathological lymph nodes must have decreased to \<10 millimeters (mm) in short axis. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. PD was defined as at least a 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and an absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.
Duration of SD or Objective Response According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1	Up to 8 months	The duration of SD or objective response (CR+PR) was defined as the time from first occurrence of SD or objective response to the time of PD, or death for any cause. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Objective response was defined as having a CR or PR. CR was defined as disappearance of all target and non-target lesions and no new lesions, and all pathological lymph nodes must have decreased to \<10 mm in short axis. PR was defined as at least 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. PD was defined as at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and an absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.

Secondary

Measure	Time frame	Description
Progression-free Survival (PFS) According to RECIST v1.1	Up to 8 months	PFS was defined as the time from the beginning of therapy with erlotinib to the first occurrence of disease progression, as determined by the investigator using RECIST v1.1 criteria, or death from any cause. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.
Overall Survival	Up to 8 months	Overall survival was defined as the time from the beginning of therapy with erlotinib to death from any cause.
Percentage of Participants With Adverse Events (AEs)	Up to 8 months	An AE is an unfavorable and unintended sign, symptom, or disease temporally associated with a clinical study, regardless of causality.

Countries

Italy

Participant flow

Recruitment details

A total of 172 participants were enrolled; 16 participants had protocol violations; 156 participants were eligible.

Participants by arm

Arm	Count
NSCLC Participants Participants with advanced non-small cell lung cancer (NSCLC), treated in second-line with erlotinib, presenting wild-type, not tested or unknown Epidermal Growth Factor Receptor (EGFR) status, and with stable disease at the first revaluation after start of erlotinib therapy.	156
Total	156

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Death	12
Overall Study	Decision of Investigator or Sponsor	1
Overall Study	Lost to Follow-up	2

Baseline characteristics

Characteristic	NSCLC Participants
Age, Continuous	68.4 years STANDARD_DEVIATION 8.9
Sex: Female, Male Female	60 Participants
Sex: Female, Male Male	96 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	74 / 156
serious Total, serious adverse events	20 / 156

Outcome results

Primary

Duration of SD or Objective Response According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

The duration of SD or objective response (CR+PR) was defined as the time from first occurrence of SD or objective response to the time of PD, or death for any cause. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Objective response was defined as having a CR or PR. CR was defined as disappearance of all target and non-target lesions and no new lesions, and all pathological lymph nodes must have decreased to \<10 mm in short axis. PR was defined as at least 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. PD was defined as at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and an absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.

Time frame: Up to 8 months