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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erlotinib-Chemotherapy | Experimental | Erlotinib in first-line treatment, followed by chemotherapy in the second-line treatment |
|
| Chemotherapy-Erlotinib | Active Comparator | Chemotherapy in first-line treatment, followed by erlotinib in the second-line treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erlotinib | Drug | 150 mg oral dose of erlotinib given once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) Based on Well-documented and Verifiable Progression Events | 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. | within 3 years, 9 months (data cut-off December 2014) |
| Measure | Description | Time Frame |
|---|---|---|
| Participants With Adverse Events | start of second-line treatment to data cut-off in December 2014 (within 12 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing | 101149 | China | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Erlotinib-Chemotherapy | Erlotinib in first-line treatment, followed by chemotherapy in the second-line treatment |
| FG001 | Chemotherapy-Erlotinib | Chemotherapy in first-line treatment, followed by erlotinib in the second-line treatment |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Erlotinib-Chemotherapy | Erlotinib in first-line treatment, followed by chemotherapy in the second-line treatment |
| BG001 | Chemotherapy-Erlotinib | Chemotherapy in first-line treatment, followed by erlotinib in the second-line treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression Free Survival (PFS) Based on Well-documented and Verifiable Progression Events | 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. | Intention to treat population, defined as all participants enrolled in this extension study | Posted | Median | 95% Confidence Interval | Months | within 3 years, 9 months (data cut-off December 2014) |
|
start of second-line treatment to data cut-off in December 2014 (within 12 months)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Erlotinib-Chemotherapy | Erlotinib in first-line treatment, followed by chemotherapy in the second-line treatment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sick sinus syndrome | Cardiac disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | HoffmannLa Roche | 1-800-821-8590 | genentech@druginfo.com |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D000069347 | Erlotinib Hydrochloride |
| D004358 | Drug Therapy |
| D000093542 | Gemcitabine |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Chemotherapy | Drug | 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) |
|
|
| Changchun |
| 130012 |
| China |
| Chongqing | 400038 | China |
| Chongqing | 400042 | China |
| Fuzhou | 350014 | China |
| Guangzhou | China |
| Nanjing | China |
| Shanghai | 200030 | China |
| Shanghai | 200433 | China |
| Shantou | 515041 | China |
| Wuhan | 430023 | China |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Chemotherapy in first-line treatment, followed by erlotinib in the second-line treatment
|
|
|
| Secondary | Participants With Adverse Events | Safety Population, defined as all participants enrolled in this extension study | Posted | Number | participants | start of second-line treatment to data cut-off in December 2014 (within 12 months) |
|
|
|
| 0 |
| 21 |
| 14 |
| 21 |
| EG001 | Chemotherapy-Erlotinib | Chemotherapy in first-line treatment, followed by erlotinib in the second-line treatment | 1 | 24 | 12 | 24 |
| Diarrhea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
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| Paronychia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
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.
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D013812 | Therapeutics |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| With any AEs Grade ≥ 3 |
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| With any drug related (possible/probable) AEs |
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| With any drug related (possible/probable) SAEs |
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| With any AEs leading to study drug withdrawal |
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| With any AEs leading to death |
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| With AEs of Special Interest |
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| With pregnancy |
|