Trial Outcomes & Findings for An Observational Study of Tarceva (Erlotinib) in Participants With Locally Advanced or Metastatic Adenocarcinoma Non-Small Cell Lung Cancer (ELEMENT) (NCT NCT01836133)

NCT ID: NCT01836133

Last Updated: 2017-05-04

Results Overview

PFS was defined as the time from initial dose of erlotinib to progression or death from any cause.

Recruitment status

COMPLETED

Target enrollment

70 participants

Primary outcome timeframe

Approximately 3 years

Results posted on

2017-05-04

Participant Flow

Participant milestones

Participant milestones
Measure	Erlotinib 150 mg Participants received 150 mg erlotinib once daily, orally, as tablets, until disease progression or unacceptable toxicity, up to 3 years.
Overall Study STARTED	70
Overall Study COMPLETED	70
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An Observational Study of Tarceva (Erlotinib) in Participants With Locally Advanced or Metastatic Adenocarcinoma Non-Small Cell Lung Cancer (ELEMENT)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Erlotinib 150 mg n=70 Participants Participants received 150 mg erlotinib once daily, orally, as tablets, until disease progression or unacceptable toxicity, up to 3 years.
Age, Continuous	62 years STANDARD_DEVIATION 8 • n=99 Participants
Sex: Female, Male Female	33 Participants n=99 Participants
Sex: Female, Male Male	37 Participants n=99 Participants

PRIMARY outcome

Timeframe: Approximately 3 years

Population: The effectiveness analysis population included all enrolled participants in the study.

PFS was defined as the time from initial dose of erlotinib to progression or death from any cause.

Outcome measures

Outcome measures
Measure	Erlotinib 150 mg n=70 Participants Participants received 150 mg erlotinib once daily, orally, as tablets, until disease progression or unacceptable toxicity, up to 3 years.
Progression-Free Survival (PFS)	2.7 months Interval 2.4 to 3.0

SECONDARY outcome

Timeframe: Approximately 3 years

Population: The effectiveness analysis population included all enrolled participants in the study.

Overall response was defined, based on response evaluation criteria in solid tumours (RECIST) v 1.1, as complete response (CR) plus partial response (PR). CR: complete disappearance of all target lesions; PR: at least 30% decrease in the sum of the longest diameter of all target lesions taking as reference the baseline sum of all target lesions.

Outcome measures

Outcome measures
Measure	Erlotinib 150 mg n=70 Participants Participants received 150 mg erlotinib once daily, orally, as tablets, until disease progression or unacceptable toxicity, up to 3 years.
Percentage of Participants With Overall Response	8.57 Percentage of participants Interval 3.67 to 17.78

SECONDARY outcome

Timeframe: Baseline up to 3 years

Population: The safety analysis population included all enrolled participants who received a single dose of erlotinib.

An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. A SAE was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant, according to national cancer institute (NCI) common terminology criteria for adverse events (CTCAE) criteria version 4.0. An AESI was defined as interstitial pulmonary disease.

Outcome measures

Outcome measures
Measure	Erlotinib 150 mg n=70 Participants Participants received 150 mg erlotinib once daily, orally, as tablets, until disease progression or unacceptable toxicity, up to 3 years.
Proportions of Participants With Adverse Events (AEs), Serious AEs, and AEs of Special Interest (AESIs) AEs	0.56 Proportion of participants Interval 0.44 to 0.67
Proportions of Participants With Adverse Events (AEs), Serious AEs, and AEs of Special Interest (AESIs) SAEs	0.27 Proportion of participants Interval 0.18 to 0.39
Proportions of Participants With Adverse Events (AEs), Serious AEs, and AEs of Special Interest (AESIs) AESIs	0 Proportion of participants 95% Confidence Interval was not calculated because no AESIs were reported.

Adverse Events

Erlotinib 150 mg

Serious events: 19 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Erlotinib 150 mg n=70 participants at risk Participants received 150 mg erlotinib once daily, orally, as tablets, until disease progression or unacceptable toxicity, up to 3 years.
Gastrointestinal disorders Diarrhoea	4.3% 3/70 • Baseline up to 3 years All enrolled participants were included in the safety population.
Gastrointestinal disorders Gastrointestinal haemorrhage	1.4% 1/70 • Baseline up to 3 years All enrolled participants were included in the safety population.
General disorders General physical health deterioration	2.9% 2/70 • Baseline up to 3 years All enrolled participants were included in the safety population.
General disorders Pyrexia	1.4% 1/70 • Baseline up to 3 years All enrolled participants were included in the safety population.
General disorders Fatigue	1.4% 1/70 • Baseline up to 3 years All enrolled participants were included in the safety population.
General disorders Disease progression	2.9% 2/70 • Baseline up to 3 years All enrolled participants were included in the safety population.
General disorders Sudden death	1.4% 1/70 • Baseline up to 3 years All enrolled participants were included in the safety population.
Hepatobiliary disorders Hyperbilirubinemia	1.4% 1/70 • Baseline up to 3 years All enrolled participants were included in the safety population.
Hepatobiliary disorders Hepatotoxicity	2.9% 2/70 • Baseline up to 3 years All enrolled participants were included in the safety population.
Infections and infestations Pneumonia	1.4% 1/70 • Baseline up to 3 years All enrolled participants were included in the safety population.
Infections and infestations Infectious pleural effusion	1.4% 1/70 • Baseline up to 3 years All enrolled participants were included in the safety population.
Infections and infestations Conjuctivitis	1.4% 1/70 • Baseline up to 3 years All enrolled participants were included in the safety population.
Investigations Weight decreased	1.4% 1/70 • Baseline up to 3 years All enrolled participants were included in the safety population.
Investigations Alanine aminotransferase increased	1.4% 1/70 • Baseline up to 3 years All enrolled participants were included in the safety population.
Investigations Aspartate aminotransferase increased	1.4% 1/70 • Baseline up to 3 years All enrolled participants were included in the safety population.
Investigations Blood alkaline phosphatase increased	1.4% 1/70 • Baseline up to 3 years All enrolled participants were included in the safety population.
Investigations Gamma-glutamyltransferase increased	1.4% 1/70 • Baseline up to 3 years All enrolled participants were included in the safety population.
Renal and urinary disorders Azotaemia	1.4% 1/70 • Baseline up to 3 years All enrolled participants were included in the safety population.
Respiratory, thoracic and mediastinal disorders Dyspnea	1.4% 1/70 • Baseline up to 3 years All enrolled participants were included in the safety population.
Respiratory, thoracic and mediastinal disorders Cough	1.4% 1/70 • Baseline up to 3 years All enrolled participants were included in the safety population.
Respiratory, thoracic and mediastinal disorders Haemoptysis	1.4% 1/70 • Baseline up to 3 years All enrolled participants were included in the safety population.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.4% 1/70 • Baseline up to 3 years All enrolled participants were included in the safety population.
Skin and subcutaneous tissue disorders Rash	4.3% 3/70 • Baseline up to 3 years All enrolled participants were included in the safety population.
Skin and subcutaneous tissue disorders Dry skin	1.4% 1/70 • Baseline up to 3 years All enrolled participants were included in the safety population.
Vascular disorders Superior vena cava syndrome	1.4% 1/70 • Baseline up to 3 years All enrolled participants were included in the safety population.
Vascular disorders Deep vein thrombosis	1.4% 1/70 • Baseline up to 3 years All enrolled participants were included in the safety population.

Other adverse events

Other adverse events
Measure	Erlotinib 150 mg n=70 participants at risk Participants received 150 mg erlotinib once daily, orally, as tablets, until disease progression or unacceptable toxicity, up to 3 years.
Gastrointestinal disorders Diarrhoea	5.7% 4/70 • Number of events 4 • Baseline up to 3 years All enrolled participants were included in the safety population.
Infections and infestations Paronychia	8.6% 6/70 • Number of events 6 • Baseline up to 3 years All enrolled participants were included in the safety population.
Skin and subcutaneous tissue disorders Rash	24.3% 17/70 • Number of events 17 • Baseline up to 3 years All enrolled participants were included in the safety population.

Additional Information

Medical Communications

Hoffmann-La Roche

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