Trial Outcomes & Findings for Progression Free Survival (PFS) Using Erlotinib for Non-Small-Cell Lung Cancer (NSCLC) in Chinese Population (NCT NCT02000531)

NCT ID: NCT02000531

Last Updated: 2016-01-13

Results Overview

Progression free survival is defined as the time of randomization in ENSURE study to progressive disease (PD) while on second-line treatment or death from any cause, whichever occurred first during the second-line treatment.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

45 participants

Primary outcome timeframe

within 3 years, 9 months (data cut-off December 2014)

Results posted on

2016-01-13

Participant Flow

Participant milestones

Participant milestones
Measure	Erlotinib-Chemotherapy Erlotinib in first-line treatment, followed by chemotherapy in the second-line treatment	Chemotherapy-Erlotinib Chemotherapy in first-line treatment, followed by erlotinib in the second-line treatment
Overall Study STARTED	21	24
Overall Study Safety Population	21	24
Overall Study COMPLETED	17	16
Overall Study NOT COMPLETED	4	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Erlotinib-Chemotherapy Erlotinib in first-line treatment, followed by chemotherapy in the second-line treatment	Chemotherapy-Erlotinib Chemotherapy in first-line treatment, followed by erlotinib in the second-line treatment
Overall Study Lost to Follow-up	1	0
Overall Study Discontinued due to data cut-off	3	8

Baseline Characteristics

Progression Free Survival (PFS) Using Erlotinib for Non-Small-Cell Lung Cancer (NSCLC) in Chinese Population

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Erlotinib-Chemotherapy n=21 Participants Erlotinib in first-line treatment, followed by chemotherapy in the second-line treatment	Chemotherapy-Erlotinib n=24 Participants Chemotherapy in first-line treatment, followed by erlotinib in the second-line treatment	Total n=45 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=99 Participants	18 Participants n=107 Participants	35 Participants n=206 Participants
Age, Categorical >=65 years	4 Participants n=99 Participants	6 Participants n=107 Participants	10 Participants n=206 Participants
Age, Continuous	57.8 years STANDARD_DEVIATION 8.20 • n=99 Participants	57.0 years STANDARD_DEVIATION 11.32 • n=107 Participants	57.3 years STANDARD_DEVIATION 9.88 • n=206 Participants
Sex: Female, Male Female	12 Participants n=99 Participants	10 Participants n=107 Participants	22 Participants n=206 Participants
Sex: Female, Male Male	9 Participants n=99 Participants	14 Participants n=107 Participants	23 Participants n=206 Participants
Region of Enrollment China	21 participants n=99 Participants	24 participants n=107 Participants	45 participants n=206 Participants

PRIMARY outcome

Timeframe: within 3 years, 9 months (data cut-off December 2014)

Population: Intention to treat population, defined as all participants enrolled in this extension study

Outcome measures

Outcome measures
Measure	Erlotinib-Chemotherapy n=21 Participants Erlotinib in first-line treatment, followed by chemotherapy in the second-line treatment	Chemotherapy-Erlotinib n=24 Participants Chemotherapy in first-line treatment, followed by erlotinib in the second-line treatment
Progression Free Survival (PFS) Based on Well-documented and Verifiable Progression Events	26.3 Months Interval 19.8 to 34.0	23.4 Months Interval 17.8 to 39.0

SECONDARY outcome

Timeframe: start of second-line treatment to data cut-off in December 2014 (within 12 months)

Population: Safety Population, defined as all participants enrolled in this extension study

Outcome measures

Outcome measures
Measure	Erlotinib-Chemotherapy n=21 Participants Erlotinib in first-line treatment, followed by chemotherapy in the second-line treatment	Chemotherapy-Erlotinib n=24 Participants Chemotherapy in first-line treatment, followed by erlotinib in the second-line treatment
Participants With Adverse Events With any AEs leading to death	0 participants	0 participants
Participants With Adverse Events With any adverse events (AEs)	14 participants	12 participants
Participants With Adverse Events With any serious AEs (SAEs)	0 participants	1 participants
Participants With Adverse Events With any AEs Grade ≥ 3	5 participants	2 participants
Participants With Adverse Events With any drug related (possible/probable) AEs	10 participants	9 participants
Participants With Adverse Events With any drug related (possible/probable) SAEs	0 participants	0 participants
Participants With Adverse Events With any AEs leading to study drug withdrawal	0 participants	0 participants
Participants With Adverse Events With AEs of Special Interest	0 participants	0 participants
Participants With Adverse Events With pregnancy	0 participants	0 participants

Adverse Events

Erlotinib-Chemotherapy

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Chemotherapy-Erlotinib

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Erlotinib-Chemotherapy n=21 participants at risk Erlotinib in first-line treatment, followed by chemotherapy in the second-line treatment	Chemotherapy-Erlotinib n=24 participants at risk Chemotherapy in first-line treatment, followed by erlotinib in the second-line treatment
Cardiac disorders Sick sinus syndrome	0.00% 0/21 • start of second-line treatment to data cut-off in December 2014 (within 12 months)	4.2% 1/24 • Number of events 1 • start of second-line treatment to data cut-off in December 2014 (within 12 months)

Other adverse events

Additional Information

Medical Communications

HoffmannLa Roche

Phone: 1-800-821-8590

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

Measure	Erlotinib-Chemotherapy n=21 participants at risk Erlotinib in first-line treatment, followed by chemotherapy in the second-line treatment	Chemotherapy-Erlotinib n=24 participants at risk Chemotherapy in first-line treatment, followed by erlotinib in the second-line treatment
Gastrointestinal disorders Nausea	28.6% 6/21 • Number of events 9 • start of second-line treatment to data cut-off in December 2014 (within 12 months)	0.00% 0/24 • start of second-line treatment to data cut-off in December 2014 (within 12 months)
Gastrointestinal disorders Diarrhea	4.8% 1/21 • Number of events 1 • start of second-line treatment to data cut-off in December 2014 (within 12 months)	16.7% 4/24 • Number of events 14 • start of second-line treatment to data cut-off in December 2014 (within 12 months)
Gastrointestinal disorders Vomiting	14.3% 3/21 • Number of events 6 • start of second-line treatment to data cut-off in December 2014 (within 12 months)	4.2% 1/24 • Number of events 1 • start of second-line treatment to data cut-off in December 2014 (within 12 months)
Skin and subcutaneous tissue disorders Rash	0.00% 0/21 • start of second-line treatment to data cut-off in December 2014 (within 12 months)	33.3% 8/24 • Number of events 8 • start of second-line treatment to data cut-off in December 2014 (within 12 months)
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/21 • start of second-line treatment to data cut-off in December 2014 (within 12 months)	12.5% 3/24 • Number of events 3 • start of second-line treatment to data cut-off in December 2014 (within 12 months)
Blood and lymphatic system disorders Leukopenia	19.0% 4/21 • Number of events 6 • start of second-line treatment to data cut-off in December 2014 (within 12 months)	0.00% 0/24 • start of second-line treatment to data cut-off in December 2014 (within 12 months)
Blood and lymphatic system disorders Anaemia	14.3% 3/21 • Number of events 3 • start of second-line treatment to data cut-off in December 2014 (within 12 months)	0.00% 0/24 • start of second-line treatment to data cut-off in December 2014 (within 12 months)
Blood and lymphatic system disorders Neutropenia	14.3% 3/21 • Number of events 6 • start of second-line treatment to data cut-off in December 2014 (within 12 months)	0.00% 0/24 • start of second-line treatment to data cut-off in December 2014 (within 12 months)
Blood and lymphatic system disorders Thrombocytopenia	14.3% 3/21 • Number of events 4 • start of second-line treatment to data cut-off in December 2014 (within 12 months)	0.00% 0/24 • start of second-line treatment to data cut-off in December 2014 (within 12 months)
Investigations Alanine aminotransferase increased	14.3% 3/21 • Number of events 4 • start of second-line treatment to data cut-off in December 2014 (within 12 months)	4.2% 1/24 • Number of events 1 • start of second-line treatment to data cut-off in December 2014 (within 12 months)
Investigations Platelet count decreased	9.5% 2/21 • Number of events 3 • start of second-line treatment to data cut-off in December 2014 (within 12 months)	4.2% 1/24 • Number of events 1 • start of second-line treatment to data cut-off in December 2014 (within 12 months)
Investigations White blood cell count decreased	14.3% 3/21 • Number of events 6 • start of second-line treatment to data cut-off in December 2014 (within 12 months)	0.00% 0/24 • start of second-line treatment to data cut-off in December 2014 (within 12 months)
Investigations Aspartate aminotransferase increased	9.5% 2/21 • Number of events 3 • start of second-line treatment to data cut-off in December 2014 (within 12 months)	0.00% 0/24 • start of second-line treatment to data cut-off in December 2014 (within 12 months)
Investigations Neutrophil count decreased	9.5% 2/21 • Number of events 5 • start of second-line treatment to data cut-off in December 2014 (within 12 months)	0.00% 0/24 • start of second-line treatment to data cut-off in December 2014 (within 12 months)
General disorders Chest discomfort	0.00% 0/21 • start of second-line treatment to data cut-off in December 2014 (within 12 months)	8.3% 2/24 • Number of events 2 • start of second-line treatment to data cut-off in December 2014 (within 12 months)
Musculoskeletal and connective tissue disorders Musculoskeletal pain	4.8% 1/21 • Number of events 1 • start of second-line treatment to data cut-off in December 2014 (within 12 months)	4.2% 1/24 • Number of events 1 • start of second-line treatment to data cut-off in December 2014 (within 12 months)
Nervous system disorders Dizziness	4.8% 1/21 • Number of events 2 • start of second-line treatment to data cut-off in December 2014 (within 12 months)	4.2% 1/24 • Number of events 1 • start of second-line treatment to data cut-off in December 2014 (within 12 months)
Infections and infestations Paronychia	0.00% 0/21 • start of second-line treatment to data cut-off in December 2014 (within 12 months)	8.3% 2/24 • Number of events 2 • start of second-line treatment to data cut-off in December 2014 (within 12 months)
Musculoskeletal and connective tissue disorders Back pain	4.8% 1/21 • Number of events 1 • start of second-line treatment to data cut-off in December 2014 (within 12 months)	0.00% 0/24 • start of second-line treatment to data cut-off in December 2014 (within 12 months)