Trial Outcomes & Findings for An Observational Study of Erlotinib (Tarceva) as Second-line Treatment in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer After Failure of Pemetrexed in First-line Therapy (NCT NCT01664533)

Last Updated: 2015-12-28

Results Overview

Progression-free survival was defined as the time from the first dose of erlotinib to disease progression or death from any cause, whichever occurred earlier. 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 of target lesions recorded since treatment started, or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.

Recruitment status

COMPLETED

Target enrollment

57 participants

Primary outcome timeframe

Baseline to the end of the study (up to 2 years)

Results posted on

2015-12-28

Participant Flow

Total of 59 patients were screened at 17 specialist oncology and pneumology centers in Belgium, 57 of which started Tarceva therapy as second-line treatment and constitute safety analysis (SA) population. Three patients violated the protocol, leaving 54 patients in the per-protocol (PP) population.

Participant milestones

Participant milestones
Measure	Erlotinib Selection of the dose of erlotinib most suitable for each participant was left to the discretion of the physician, guided by the recommendation in the Summary of Product Characteristics. The recommended daily oral dose of erlotinib is 150 mg.
Overall Study STARTED	57
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	57

Reasons for withdrawal

Reasons for withdrawal
Measure	Erlotinib Selection of the dose of erlotinib most suitable for each participant was left to the discretion of the physician, guided by the recommendation in the Summary of Product Characteristics. The recommended daily oral dose of erlotinib is 150 mg.
Overall Study Death	42
Overall Study Lost to Follow-up	3
Overall Study Study termination	9
Overall Study Protocol Violation	3

Baseline Characteristics

An Observational Study of Erlotinib (Tarceva) as Second-line Treatment in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer After Failure of Pemetrexed in First-line Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Erlotinib n=54 Participants Selection of the dose of erlotinib most suitable for each participant was left to the discretion of the physician, guided by the recommendation in the Summary of Product Characteristics. The recommended daily oral dose of erlotinib is 150 mg.
Age, Continuous	64.4 Years STANDARD_DEVIATION 8.9 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to the end of the study (up to 2 years)

Population: Per-protocol population: All enrolled participants who started erlotinib therapy and did not violate the study protocol.

Outcome measures

Outcome measures
Measure	Erlotinib n=54 Participants Selection of the dose of erlotinib most suitable for each participant was left to the discretion of the physician, guided by the recommendation in the Summary of Product Characteristics. The recommended daily oral dose of erlotinib is 150 mg.
Progression-free Survival	1.8 Months Interval 1.4 to 2.6

SECONDARY outcome

Timeframe: Baseline to the end of the study (up to 2 years)

Population: Per-protocol population: All enrolled participants who started erlotinib therapy and did not violate the study protocol. Only participants with an evaluable response were included in the analysis.

Reported are the 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). 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.

Outcome measures

Outcome measures
Measure	Erlotinib n=52 Participants Selection of the dose of erlotinib most suitable for each participant was left to the discretion of the physician, guided by the recommendation in the Summary of Product Characteristics. The recommended daily oral dose of erlotinib is 150 mg.
Best Overall Response Complete Response	0.0 Percentage of participants Interval 0.0 to 6.8
Best Overall Response Partial Response	0.0 Percentage of participants Interval 0.0 to 6.8
Best Overall Response Stable Disease	34.6 Percentage of participants Interval 21.9 to 49.0
Best Overall Response Progressive Disease	65.4 Percentage of participants Interval 50.9 to 78.0

SECONDARY outcome

Timeframe: Up to 2 years

Overall survival was defined as the time from Baseline until death from any cause.

Outcome measures

Outcome measures
Measure	Erlotinib n=54 Participants Selection of the dose of erlotinib most suitable for each participant was left to the discretion of the physician, guided by the recommendation in the Summary of Product Characteristics. The recommended daily oral dose of erlotinib is 150 mg.
Overall Survival	5.8 months Interval 3.3 to 8.6

SECONDARY outcome

Timeframe: Up to 2 years

Population: Safety analysis population: All participants who received at least 1 dose of erlotinib. Data was missing for 1 participant.

Outcome measures

Outcome measures
Measure	Erlotinib n=56 Participants Selection of the dose of erlotinib most suitable for each participant was left to the discretion of the physician, guided by the recommendation in the Summary of Product Characteristics. The recommended daily oral dose of erlotinib is 150 mg.
Percentage of Participants Who Developed Rash	60.7 percentage of participants Interval 46.7 to 73.5

SECONDARY outcome

Timeframe: Up to 2 years

Population: Safety analysis population: All participants who received at least 1 dose of erlotinib. Data was missing for 1 participant.

Outcome measures

Outcome measures
Measure	Erlotinib n=56 Participants Selection of the dose of erlotinib most suitable for each participant was left to the discretion of the physician, guided by the recommendation in the Summary of Product Characteristics. The recommended daily oral dose of erlotinib is 150 mg.
Percentage of Participants Who Developed Diarrhea	42.8 percentage of participants Interval 29.7 to 56.8

Adverse Events

Erlotinib

Serious events: 17 serious events

Other events: 51 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Erlotinib n=57 participants at risk Selection of the dose of erlotinib most suitable for each participant was left to the discretion of the physician, guided by the recommendation in the Summary of Product Characteristics. The recommended daily oral dose of erlotinib is 150 mg.
Blood and lymphatic system disorders Anaemia	1.8% 1/57 • Number of events 1 • Time frame is up to 2 years Safety analysis population: All participants who received at least 1 dose of erlotinib.
Cardiac disorders Sinus tachycardia	1.8% 1/57 • Number of events 1 • Time frame is up to 2 years Safety analysis population: All participants who received at least 1 dose of erlotinib.
Gastrointestinal disorders Abdominal pain	1.8% 1/57 • Number of events 1 • Time frame is up to 2 years Safety analysis population: All participants who received at least 1 dose of erlotinib.
Gastrointestinal disorders Nausea	1.8% 1/57 • Number of events 1 • Time frame is up to 2 years Safety analysis population: All participants who received at least 1 dose of erlotinib.
Gastrointestinal disorders Vomiting	1.8% 1/57 • Number of events 1 • Time frame is up to 2 years Safety analysis population: All participants who received at least 1 dose of erlotinib.
General disorders General physical health deterioration	5.3% 3/57 • Number of events 3 • Time frame is up to 2 years Safety analysis population: All participants who received at least 1 dose of erlotinib.
General disorders Pyrexia	3.5% 2/57 • Number of events 2 • Time frame is up to 2 years Safety analysis population: All participants who received at least 1 dose of erlotinib.
Infections and infestations Infection	1.8% 1/57 • Number of events 1 • Time frame is up to 2 years Safety analysis population: All participants who received at least 1 dose of erlotinib.
Infections and infestations Pneumonia	3.5% 2/57 • Number of events 2 • Time frame is up to 2 years Safety analysis population: All participants who received at least 1 dose of erlotinib.
Investigations C-reactive protein increase	1.8% 1/57 • Number of events 1 • Time frame is up to 2 years Safety analysis population: All participants who received at least 1 dose of erlotinib.
Investigations Hepatic enzyme increased	1.8% 1/57 • Number of events 1 • Time frame is up to 2 years Safety analysis population: All participants who received at least 1 dose of erlotinib.
Investigations Procalcitonin increased	1.8% 1/57 • Number of events 1 • Time frame is up to 2 years Safety analysis population: All participants who received at least 1 dose of erlotinib.
Investigations Weight decreased	1.8% 1/57 • Number of events 1 • Time frame is up to 2 years Safety analysis population: All participants who received at least 1 dose of erlotinib.
Metabolism and nutrition disorders Decreased appetite	1.8% 1/57 • Number of events 1 • Time frame is up to 2 years Safety analysis population: All participants who received at least 1 dose of erlotinib.
Metabolism and nutrition disorders Dehydration	1.8% 1/57 • Number of events 1 • Time frame is up to 2 years Safety analysis population: All participants who received at least 1 dose of erlotinib.
Metabolism and nutrition disorders Hypokalaemia	1.8% 1/57 • Number of events 1 • Time frame is up to 2 years Safety analysis population: All participants who received at least 1 dose of erlotinib.
Metabolism and nutrition disorders Hyponatraemia	1.8% 1/57 • Number of events 1 • Time frame is up to 2 years Safety analysis population: All participants who received at least 1 dose of erlotinib.

Other adverse events

Other adverse events
Measure	Erlotinib n=57 participants at risk Selection of the dose of erlotinib most suitable for each participant was left to the discretion of the physician, guided by the recommendation in the Summary of Product Characteristics. The recommended daily oral dose of erlotinib is 150 mg.
Skin and subcutaneous tissue disorders Rash	61.4% 35/57 • Number of events 35 • Time frame is up to 2 years Safety analysis population: All participants who received at least 1 dose of erlotinib.
Gastrointestinal disorders Diarrhea	43.9% 25/57 • Number of events 25 • Time frame is up to 2 years Safety analysis population: All participants who received at least 1 dose of erlotinib.
Gastrointestinal disorders Nausea	8.8% 5/57 • Number of events 5 • Time frame is up to 2 years Safety analysis population: All participants who received at least 1 dose of erlotinib.
Gastrointestinal disorders Vomiting	7.0% 4/57 • Number of events 4 • Time frame is up to 2 years Safety analysis population: All participants who received at least 1 dose of erlotinib.
Metabolism and nutrition disorders Decreased appetite	22.8% 13/57 • Number of events 13 • Time frame is up to 2 years Safety analysis population: All participants who received at least 1 dose of erlotinib.
Investigations Weight decreased	14.0% 8/57 • Number of events 8 • Time frame is up to 2 years Safety analysis population: All participants who received at least 1 dose of erlotinib.
General disorders Asthenia	10.5% 6/57 • Number of events 6 • Time frame is up to 2 years Safety analysis population: All participants who received at least 1 dose of erlotinib.
General disorders Pyrexia	8.8% 5/57 • Number of events 5 • Time frame is up to 2 years Safety analysis population: All participants who received at least 1 dose of erlotinib.
General disorders Fatigue	7.0% 4/57 • Number of events 4 • Time frame is up to 2 years Safety analysis population: All participants who received at least 1 dose of erlotinib.
General disorders General physical health deterioration	7.0% 4/57 • Number of events 4 • Time frame is up to 2 years Safety analysis population: All participants who received at least 1 dose of erlotinib.
General disorders Chest pain	5.3% 3/57 • Number of events 3 • Time frame is up to 2 years Safety analysis population: All participants who received at least 1 dose of erlotinib.
Blood and lymphatic system disorders Anaemia	8.8% 5/57 • Number of events 5 • Time frame is up to 2 years Safety analysis population: All participants who received at least 1 dose of erlotinib.
Respiratory, thoracic and mediastinal disorders Cough	8.8% 5/57 • Number of events 5 • Time frame is up to 2 years Safety analysis population: All participants who received at least 1 dose of erlotinib.
Eye disorders Conjunctivities	5.3% 3/57 • Number of events 3 • Time frame is up to 2 years Safety analysis population: All participants who received at least 1 dose of erlotinib.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	5.3% 3/57 • Number of events 3 • Time frame is up to 2 years Safety analysis population: All participants who received at least 1 dose of erlotinib.
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.3% 3/57 • Number of events 3 • Time frame is up to 2 years Safety analysis population: All participants who received at least 1 dose of erlotinib.

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