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

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02000531
• Collaborator: (none)
• Enrollment: 45
• Locations: 11
• Arms: 2
• Duration (Months): 11
• Patients Per Site: 4.1
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

This trial is an extension to ENSURE, a study of erlotinib versus gemcitabine/cisplatin combination chemotherapy as the first-line treatment for patients with non-small-cell lung cancer (NSCLC) with mutations in the tyrosine kinase domain of EGFR.

This study is designed to examine the efficacy of erlotinib versus gemcitabine/cisplatin as a second-line treatment in NSCLC patients from the ENSURE trial (NCT01342965). Patients previously treated with gemcitabine/cisplatin will be given erlotinib daily until disease progression or unacceptable toxicity occurs. Patients previously treated with erlotinib will be given cisplatin on Day 1 and gemcitabine on Days 1 and 8 of 3-week chemotherapy cycles until disease progression, unacceptable toxicity or up to 4 cycles (whichever comes first).

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Non-Small-Cell Lung	Drug: Erlotinib; Drug: Chemotherapy	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Ensure Extension Study to Assess the PFS of First-Line Erlotinib (Tarceva®) and Erlotinib After the Time of Disease Progression in Chinese Population Enrolled in the Ensure Trial
• Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Erlotinib-Chemotherapy Erlotinib in first-line treatment, followed by chemotherapy in the second-line treatment	Drug: Erlotinib; 150 mg oral dose of erlotinib given once daily; Other Names: Tarceva ; Drug: Chemotherapy; Cisplatin (75 mg/m^2 intravenously [IV]) on Day 1 and gemcitabine (1250 mg/m^2 IV) on Days 1 and 8 of 3-week chemotherapy cycles until disease progression, unacceptable toxicity or up to 4 cycles (whichever comes first); Other Names: Gemcitabine/Cisplatin
Active Comparator: Chemotherapy-Erlotinib Chemotherapy in first-line treatment, followed by erlotinib in the second-line treatment	Drug: Erlotinib; 150 mg oral dose of erlotinib given once daily; Other Names: Tarceva ; Drug: Chemotherapy; Cisplatin (75 mg/m^2 intravenously [IV]) on Day 1 and gemcitabine (1250 mg/m^2 IV) on Days 1 and 8 of 3-week chemotherapy cycles until disease progression, unacceptable toxicity or up to 4 cycles (whichever comes first); Other Names: Gemcitabine/Cisplatin

Outcome Measures

Primary Outcome Measures

1. Progression Free Survival (PFS) Based on Well-documented and Verifiable Progression Events [within 3 years, 9 months (data cut-off December 2014)]

   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.

Secondary Outcome Measures

1. Participants With Adverse Events [start of second-line treatment to data cut-off in December 2014 (within 12 months)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Participant in ENSURE trial

• Disease progression during first-line treatment

Exclusion Criteria:

• N/A

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Beijing		China	101149
2		Changchun		China	130012
3		Chongqing		China	400038
4		ChongQing		China	400042
5		Fuzhou		China	350014
6		Guangzhou		China
7		Nanjing		China
8		Shanghai		China	200030
9		Shanghai		China	200433
10		Shantou		China	515041
11		Wuhan		China	430023

Sponsors and Collaborators

• Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT02000531
• Other Study ID Numbers: ML29028
• First Posted: Dec 4, 2013
• Last Update Posted: Jan 13, 2016
• Last Verified: Dec 1, 2015

• Keywords provided by Hoffmann-La Roche: Non-small-cell lung cancer (NSCLC)
• Additional relevant MeSH terms: Carcinoma, Non-Small-Cell Lung; Gemcitabine; Cisplatin; Erlotinib Hydrochloride

Study Results

Participant Flow

Arm/Group Title	Erlotinib-Chemotherapy	Chemotherapy-Erlotinib
Arm/Group Description	Erlotinib in first-line treatment, followed by chemotherapy in the second-line treatment	Chemotherapy in first-line treatment, followed by erlotinib in the second-line treatment
Period Title: Overall Study
STARTED	21	24
Safety Population	21	24
COMPLETED	17	16
NOT COMPLETED	4	8

Baseline Characteristics

Arm/Group Title	Erlotinib-Chemotherapy	Chemotherapy-Erlotinib	Total
Arm/Group Description	Erlotinib in first-line treatment, followed by chemotherapy in the second-line treatment	Chemotherapy in first-line treatment, followed by erlotinib in the second-line treatment	Total of all reporting groups
Overall Participants	21	24	45
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	17 81%	18 75%	35 77.8%
>=65 years	4 19%	6 25%	10 22.2%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57.8 (8.20)	57.0 (11.32)	57.3 (9.88)
Sex: Female, Male (Count of Participants)
Female	12 57.1%	10 41.7%	22 48.9%
Male	9 42.9%	14 58.3%	23 51.1%
Region of Enrollment (participants) [Number]
China	21 100%	24 100%	45 100%

Outcome Measures

1. Primary Outcome

Title	Progression Free Survival (PFS) Based on Well-documented and Verifiable Progression Events
Description	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.
Time Frame	within 3 years, 9 months (data cut-off December 2014)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Erlotinib-Chemotherapy	Chemotherapy-Erlotinib
Arm/Group Description	Erlotinib in first-line treatment, followed by chemotherapy in the second-line treatment	Chemotherapy in first-line treatment, followed by erlotinib in the second-line treatment
Measure Participants	21	24
Median (95% Confidence Interval) [Months]	26.3	23.4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Erlotinib-Chemotherapy, Chemotherapy-Erlotinib
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.26
	Confidence Interval	(2-Sided) 95%; 0.61 to 2.62
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Participants With Adverse Events
Time Frame	start of second-line treatment to data cut-off in December 2014 (within 12 months)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Erlotinib-Chemotherapy	Chemotherapy-Erlotinib
Arm/Group Description	Erlotinib in first-line treatment, followed by chemotherapy in the second-line treatment	Chemotherapy in first-line treatment, followed by erlotinib in the second-line treatment
Measure Participants	21	24
With any adverse events (AEs)	14 66.7%	12 50%
With any serious AEs (SAEs)	0 0%	1 4.2%
With any AEs Grade ≥ 3	5 23.8%	2 8.3%
With any drug related (possible/probable) AEs	10 47.6%	9 37.5%
With any drug related (possible/probable) SAEs	0 0%	0 0%
With any AEs leading to study drug withdrawal	0 0%	0 0%
With any AEs leading to death	0 0%	0 0%
With AEs of Special Interest	0 0%	0 0%
With pregnancy	0 0%	0 0%

Adverse Events

Time Frame	start of second-line treatment to data cut-off in December 2014 (within 12 months)
Arm/Group Title	Erlotinib-Chemotherapy		Chemotherapy-Erlotinib
Arm/Group Description	Erlotinib in first-line treatment, followed by chemotherapy in the second-line treatment		Chemotherapy in first-line treatment, followed by erlotinib in the second-line treatment
All Cause Mortality
	Erlotinib-Chemotherapy		Chemotherapy-Erlotinib
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Erlotinib-Chemotherapy		Chemotherapy-Erlotinib
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		1/24 (4.2%)
Cardiac disorders
Sick sinus syndrome	0/21 (0%)	0	1/24 (4.2%)	1
Other (Not Including Serious) Adverse Events
	Erlotinib-Chemotherapy		Chemotherapy-Erlotinib
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	14/21 (66.7%)		12/24 (50%)
Blood and lymphatic system disorders
Leukopenia	4/21 (19%)	6	0/24 (0%)	0
Anaemia	3/21 (14.3%)	3	0/24 (0%)	0
Neutropenia	3/21 (14.3%)	6	0/24 (0%)	0
Thrombocytopenia	3/21 (14.3%)	4	0/24 (0%)	0
Gastrointestinal disorders
Nausea	6/21 (28.6%)	9	0/24 (0%)	0
Diarrhea	1/21 (4.8%)	1	4/24 (16.7%)	14
Vomiting	3/21 (14.3%)	6	1/24 (4.2%)	1
General disorders
Chest discomfort	0/21 (0%)	0	2/24 (8.3%)	2
Infections and infestations
Paronychia	0/21 (0%)	0	2/24 (8.3%)	2
Investigations
Alanine aminotransferase increased	3/21 (14.3%)	4	1/24 (4.2%)	1
Platelet count decreased	2/21 (9.5%)	3	1/24 (4.2%)	1
White blood cell count decreased	3/21 (14.3%)	6	0/24 (0%)	0
Aspartate aminotransferase increased	2/21 (9.5%)	3	0/24 (0%)	0
Neutrophil count decreased	2/21 (9.5%)	5	0/24 (0%)	0
Musculoskeletal and connective tissue disorders
Musculoskeletal pain	1/21 (4.8%)	1	1/24 (4.2%)	1
Back pain	1/21 (4.8%)	1	0/24 (0%)	0
Nervous system disorders
Dizziness	1/21 (4.8%)	2	1/24 (4.2%)	1
Skin and subcutaneous tissue disorders
Rash	0/21 (0%)	0	8/24 (33.3%)	8
Dry skin	0/21 (0%)	0	3/24 (12.5%)	3

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.