Trial Outcomes & Findings for A Non-interventional Trial of Erlotinib (Tarceva) Metastatic Non-small Cell Lung Cancer (NCT NCT02595450)

Last Updated: 2016-01-25

Results Overview

Time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. Progression was defined as at least 20 percent (%) increase in the sum of diameters of target lesions, or unequivocal progression of existing non-target lesions. Kaplan-Meier estimates were used for calculating PFS.

Recruitment status

COMPLETED

Target enrollment

299 participants

Primary outcome timeframe

Up to 6 years

Results posted on

2016-01-25

Participant Flow

It was physician's decision to prescribe erlotinib in participants and to document their treatment cycles.

Participant milestones

Participant milestones
Measure	Erlotinib Participants with locally advanced or metastatic non-small cell lung cancer were treated with erlotinib according to the product label. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported retrospective data, which already existed in the participants' medical files.
Overall Study STARTED	299
Overall Study Treated	291
Overall Study COMPLETED	218
Overall Study NOT COMPLETED	81

Reasons for withdrawal

Reasons for withdrawal
Measure	Erlotinib Participants with locally advanced or metastatic non-small cell lung cancer were treated with erlotinib according to the product label. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported retrospective data, which already existed in the participants' medical files.
Overall Study Unspecified (only completed 1 cycle)	73
Overall Study Enrolled, but not treated	8

Baseline Characteristics

A Non-interventional Trial of Erlotinib (Tarceva) Metastatic Non-small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Erlotinib n=291 Participants Participants with locally advanced or metastatic non-small cell lung cancer were treated with erlotinib according to the product label. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported retrospective data, which already existed in the participants' medical files.
Age, Continuous	66.0 years STANDARD_DEVIATION 10.7 • n=93 Participants
Sex: Female, Male Female	119 Participants n=93 Participants
Sex: Female, Male Male	172 Participants n=93 Participants

PRIMARY outcome

Timeframe: Up to 6 years

Population: Analysis population included participants who received at least 2 documented treatment cycles.

Outcome measures

Outcome measures
Measure	Erlotinib n=218 Participants Participants with locally advanced or metastatic non-small cell lung cancer were treated with erlotinib according to the product label. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported retrospective data, which already existed in the participants' medical files.
Progression-free Survival (PFS) Time	4.87 months Interval 4.07 to 5.9

PRIMARY outcome

Timeframe: Up to 6 years

Population: Analysis population included participants who received at least 2 documented treatment cycles. Missing data was not reported.

Percentage of participants with best overall response of complete remission (CR), partial remission (PR), stable disease (SD), or progressive disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) were reported. Per RECIST Version 1.1: CR was defined as complete disappearance of all target lesions and non-target disease. All nodes, both target and non-target, must decrease to normal (short axis less than \[\<\] 10 millimeter \[mm\]). No new lesions. PR was defined as greater than or equal to (\>=) 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. PD was defined as at least 20% increase in the sum of diameters of target lesions, or unequivocal progression of existing non-target lesions. SD was defined as not qualifying for CR, PR, PD.

Outcome measures

Outcome measures
Measure	Erlotinib n=218 Participants Participants with locally advanced or metastatic non-small cell lung cancer were treated with erlotinib according to the product label. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported retrospective data, which already existed in the participants' medical files.
Percentage of Participants With Best Overall Response CR	0.92 percentage of participants
Percentage of Participants With Best Overall Response PR	15.14 percentage of participants
Percentage of Participants With Best Overall Response SD	63.76 percentage of participants
Percentage of Participants With Best Overall Response PD	12.39 percentage of participants

SECONDARY outcome

Timeframe: Up to 6 years

Population: As per the study design, no follow up data was collected and documentation ended with end of erlotinib therapy. Due to less events, median OS was not reached.

Time from the start of study treatment to date of death due to any cause. Kaplan-Meier estimates were used for calculating OS.

Outcome measures

Outcome measures
Measure	Erlotinib n=218 Participants Participants with locally advanced or metastatic non-small cell lung cancer were treated with erlotinib according to the product label. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported retrospective data, which already existed in the participants' medical files.
Overall Survival (OS) Time	NA months Data was not evaluable because as per the study design, no follow up data was collected and documentation ended with end of erlotinib therapy. Due to less events, median OS was not reached.

Adverse Events

Erlotinib

Serious events: 14 serious events

Other events: 134 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Erlotinib n=291 participants at risk Participants with locally advanced or metastatic non-small cell lung cancer were treated with erlotinib according to the product label. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported retrospective data, which already existed in the participants' medical files.
Gastrointestinal disorders Diarrhoea	3.8% 11/291 • Up to 6 years Analysis population included participants who received at least 1 documented treatment cycle.
Gastrointestinal disorders Nausea	1.0% 3/291 • Up to 6 years Analysis population included participants who received at least 1 documented treatment cycle.
Gastrointestinal disorders Aphthous ulcer	0.34% 1/291 • Up to 6 years Analysis population included participants who received at least 1 documented treatment cycle.
Skin and subcutaneous tissue disorders Rash	3.8% 11/291 • Up to 6 years Analysis population included participants who received at least 1 documented treatment cycle.
Skin and subcutaneous tissue disorders Diffuse alopecia	0.34% 1/291 • Up to 6 years Analysis population included participants who received at least 1 documented treatment cycle.
Skin and subcutaneous tissue disorders Pruritus	0.34% 1/291 • Up to 6 years Analysis population included participants who received at least 1 documented treatment cycle.
General disorders Fatigue	0.69% 2/291 • Up to 6 years Analysis population included participants who received at least 1 documented treatment cycle.
General disorders Feeling cold	0.34% 1/291 • Up to 6 years Analysis population included participants who received at least 1 documented treatment cycle.
General disorders Hyperhidrosis	0.34% 1/291 • Up to 6 years Analysis population included participants who received at least 1 documented treatment cycle.
Nervous system disorders Hypogeusia	0.69% 2/291 • Up to 6 years Analysis population included participants who received at least 1 documented treatment cycle.
Respiratory, thoracic and mediastinal disorders Pneumonia	0.69% 2/291 • Up to 6 years Analysis population included participants who received at least 1 documented treatment cycle.
Metabolism and nutrition disorders Decreased appetite	0.34% 1/291 • Up to 6 years Analysis population included participants who received at least 1 documented treatment cycle.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.34% 1/291 • Up to 6 years Analysis population included participants who received at least 1 documented treatment cycle.

Other adverse events

Other adverse events
Measure	Erlotinib n=291 participants at risk Participants with locally advanced or metastatic non-small cell lung cancer were treated with erlotinib according to the product label. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported retrospective data, which already existed in the participants' medical files.
Skin and subcutaneous tissue disorders Rash	42.3% 123/291 • Up to 6 years Analysis population included participants who received at least 1 documented treatment cycle.
Gastrointestinal disorders Diarrhoea	14.1% 41/291 • Up to 6 years Analysis population included participants who received at least 1 documented treatment cycle.

Additional Information

Medical Communications

Hoffmann-LaRoche

Phone: 800-821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER