An Observational Study of Tarceva (Erlotinib) in Routine Daily Clinical Practice as Second Line Treatment in Patients With Non-small Cell Lung Cancer

A Non-interventional Study to Follow and Evaluate Patients With Advanced NSCLC Who Are Treated in Second Line Setting With Tarceva (Erlotinib) in a Real Life Clinical Setting

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01161173

Acronym

TEAM

Enrollment

347

Registered

2010-07-13

Start date

2008-04-30

Completion date

2012-08-31

Last updated

2016-03-28

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

Conditions

Nonsquamous Nonsmall Cell Neoplasm of Lung

Brief summary

This observational study will evaluate the safety and efficacy of Tarceva (erlotinib) in routine clinical practice as second-line treatment in patients with recurrent or metastatic non-small dell lung cancer (NSCLC). Data will be collected from patients who have received 1 course of standard systemic chemotherapy, experienced disease progression, and who are receiveingTarceva in a second-line setting. Patients will also be followed through third-line treatment if there is disease progression on Tarceva therapy.

Interventions

DRUGErlotinib

Erlotinib was provided in the retail versions of the product.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Adult patients ≥ 18 years of age. * Written informed consent. * Recurrent or metastatic, Stage III or IV non-small cell lung cancer (NSCLC). * Measurable disease (Response Evaluation Criteria In Solid Tumors). * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. * Prior course of standard systemic chemotherapy.

Exclusion criteria

\- Contra-indications to treatment with Tarceva.

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)	Baseline to the end of the study (up to 4 years, 4 months)	The best overall response to treatment was determined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. A CR was defined as the disappearance of all target lesions (TL) or the disappearance of all non-TLs. A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD. SD was defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since treatment started for TLs and the persistence of 1 or more non-TL(s). PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. For the best overall responses of CR and PR, a response was confirmed if a subsequent RECIST evaluation also showed a CR or PR.

Secondary

Measure	Time frame	Description
Time to Disease Progression	Baseline to the end of the study (up to 4 years, 4 months)	The time to disease progression was defined as the time from Baseline until disease progression as determined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.
Progression-free Survival	Baseline to the end of the study (up to 4 years, 4 months)	Progression-free survival was defined as the time from Baseline until disease progression or death from any cause. Progressive disease was determined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.
Overall Survival	Baseline to the end of the study (up to 4 years, 4 months)	Overall survival was defined as the time from Baseline until or death from any cause
Change From Baseline in the Lung Cancer Symptom Scale (LCSS) Scores	Baseline to the end of the study (up to 4 years, 4 months)	Study participants and treating physicians completed the LCSS, a measure of Quality of Life (QoL), at Baseline and throughout the study. The patient LCSS measures 6 major symptoms, the Symptom Burden Index (SBI), associated with lung malignancies (3 thoracic \[cough, dyspnea, haemoptysis\] and 3 general symptoms \[loss of appetite, fatigue, pain\]) and 3 additional scores (overall symptomatic distress, interference with daily activities, global QoL), each on a 100 mm visual analogue scale (0=no impairment, 100=maximum impairment). The physician LCSS evaluates the 6 lung malignancy associated symptoms, the SBI, on an ordinal scale (100=none, 75=mild, 50=moderate, 25=marked, 0=severe). The average of the patient and physician SBI scores (6 symptoms) and the average of the patient total score (9 symptoms) ranged from 0 to 100, with a higher patient and a lower physician score indicating more impairment. A negative patient and a positive physician change score indicates improvement.
Percentage of Participants Who Developed Rash	Baseline to the end of the study (up to 4 years, 4 months)	At each study visit, the presence of skin rash was graded using the Common Toxicity Criteria (CTC), with grade 0 = no rash, grade 1 = mild, grade 2 = moderate, grade 3 = severe, and grade 4 = life threatening or disabling rash. Reported is the percentage of participants who developed a grade ≥ 1 rash.

Countries

Belgium, Luxembourg

Participant flow

Participants by arm

Arm	Count
Cohort Participants in the observational cohort received second-line therapy with Tarceva. At the time of discontinuation of Tarceva, a third-line chemotherapy or best supportive care were initiated as appropriate.	334
Total	334

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Death	194
Overall Study	End of Study	2
Overall Study	Lost to Follow-up	7
Overall Study	Progressive Disease	82
Overall Study	Protocol Violation	13
Overall Study	Reasons Not Specified	23
Overall Study	Unacceptable Toxicity	21
Overall Study	Withdrawal of Consent	5

Baseline characteristics

Characteristic	Cohort
Age, Continuous	65 years
Sex: Female, Male Female	95 Participants
Sex: Female, Male Male	239 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	0 / 347
serious Total, serious adverse events	210 / 347

Outcome results

Primary

Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)

The best overall response to treatment was determined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. A CR was defined as the disappearance of all target lesions (TL) or the disappearance of all non-TLs. A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD. SD was defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since treatment started for TLs and the persistence of 1 or more non-TL(s). PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. For the best overall responses of CR and PR, a response was confirmed if a subsequent RECIST evaluation also showed a CR or PR.