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This is a double blind, multicentre, randomized, placebo-controlled study. The eligible patients will be randomized to receive gefitinib or placebo at 1:1 ratio. This study will recruit 296 male or female, histologically or cytologically diagnosed locally advanced or metastatic NSCLC patients with a World Health Organization (WHO) Performance Status (PS) 0-2. Patients must have completed 4 cycles of platinum based first line doublet chemotherapy without experiencing disease progression or unacceptable toxicity. The chemotherapy shall be given every 3 weeks, which includes cisplatin or carboplatin, combined with any one of the following: gemcitabine, paclitaxel, docetaxel, vinorelbine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| gefitinib | Experimental | Gefitinib (Iressa® 250 mg) 1 tablet daily |
|
| placebo | Placebo Comparator | placebo 1 tablet daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gefitinib | Drug | Dose form: 250 mg/tablet; Route: oral; Frequency: 1 tablet per day; Duration: until to objective PD |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | PFS will be calculated from the tumour measurements collected at each tumour assessment per the RECIST criteria and/or the date of patient death. Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline. | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first.The primary analysis of PFS will be performed when at least 265 events have occurred, which is expected to occur approximately. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | The OS will be assessed from the time of randomisation to death from any cause. For patients not known to have died(which may include those who have been lost to follow up or who have withdrawn from the study for whatever reason), OS will be censored for the analysis at the last date at which the patients were known to be alive. | The OS will be assessed from the time of randomization to death from any cause.For patients not known to have died or who have withdrawn from the study for whatever reason,OS will be censored at the last date at which patients were known to be alive. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Beijing | Beijing Municipality | China | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25546556 | Derived | Zhao H, Fan Y, Ma S, Song X, Han B, Cheng Y, Huang C, Yang S, Liu X, Liu Y, Lu S, Wang J, Zhang S, Zhou C, Wang M, Zhang L; INFORM investigators. Final overall survival results from a phase III, randomized, placebo-controlled, parallel-group study of gefitinib versus placebo as maintenance therapy in patients with locally advanced or metastatic non-small-cell lung cancer (INFORM; C-TONG 0804). J Thorac Oncol. 2015 Apr;10(4):655-64. doi: 10.1097/JTO.0000000000000445. | |
| 22512843 |
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A total of 298 patients were screened for the study and 296 subsequently randomized
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| ID | Title | Description |
|---|---|---|
| FG000 | Gefitinib | Gefitinib (Iressa® 250 mg) 1 tablet daily |
| FG001 | Placebo | placebo 1 tablet daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | To match Gefitinib |
|
| Objective Tumour Response (ORR) | The objective tumour response will be calculated as the number of patients with CR or PR per RECIST Criteria. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | TTumour assessment using RECIST will be performed at baseline then every 42 days (6 weeks) ± 7 days (1 week) from randomisation until objective progression or death from any cause. |
| Disease Control Rate (DCR) | DCR will be calculated as the number of patients with CR, PR or sustained SD≥6 weeks per RECIST Criteria. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase | Tumour assessment using RECIST will be performed at baseline then every 42 days (6 weeks) ± 7 days (1 week) from randomisation until objective progression or death from any cause. |
| Symptom Improvement | Symptom improvement will be assessed from the 7-question Lung Cancer Subscale domain score derived from the FACT-L questionnaire. It is defined as an increase of two or more points on the LCS from randomization, maintained for 21 or more days. It will be calculated as the number of patients analysed with improvement. | at randomization, every 6 weeks until disease progression, and at discontinuation. |
| Adverse Event | Appropriate description of AEs and laboratory data/vital signs will be produced. Number of patients who had at least one adverse events will be calculated. | AEs and SAEs must be collected from the time that the main study informed consent is obtained to 28 days after discontinuation of study drug. Any ongoing AE or SAE at discontinuation of study treatment and during 28 day follow-up period must be monitored |
| Fuzhou |
| Fujian |
| China |
| Research Site | Guangzhou | Guangdong | China |
| Research Site | Nanning | Guangxi | China |
| Research Site | Zhengzhou | Henan | China |
| Research Site | Wuhan | Hubei | China |
| Research Site | Nanjing | Jiangsu | China |
| Research Site | Changchun | Jilin | China |
| Research Site | Shengyang | Liaoning | China |
| Research Site | Shanghai | Shanghai Municipality | China |
| Research Site | Xi’an | Shanxi | China |
| Research Site | Chengdu | Sichuan | China |
| Research Site | Tianjin | Tianjin Municipality | China |
| Research Site | Hangzhou | Zhejiang | China |
| Derived |
| Zhang L, Ma S, Song X, Han B, Cheng Y, Huang C, Yang S, Liu X, Liu Y, Lu S, Wang J, Zhang S, Zhou C, Zhang X, Hayashi N, Wang M; INFORM investigators. Gefitinib versus placebo as maintenance therapy in patients with locally advanced or metastatic non-small-cell lung cancer (INFORM; C-TONG 0804): a multicentre, double-blind randomised phase 3 trial. Lancet Oncol. 2012 May;13(5):466-75. doi: 10.1016/S1470-2045(12)70117-1. Epub 2012 Apr 17. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Gefitinib | Gefitinib (Iressa® 250 mg) 1 tablet daily |
| BG001 | Placebo | placebo 1 tablet daily |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Participants |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Smoking status | Number | 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) | PFS will be calculated from the tumour measurements collected at each tumour assessment per the RECIST criteria and/or the date of patient death. Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline. | Posted | Jun 2011 | Median | 95% Confidence Interval | month | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first.The primary analysis of PFS will be performed when at least 265 events have occurred, which is expected to occur approximately. |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | The OS will be assessed from the time of randomisation to death from any cause. For patients not known to have died(which may include those who have been lost to follow up or who have withdrawn from the study for whatever reason), OS will be censored for the analysis at the last date at which the patients were known to be alive. | Posted | Jun 2011 | Median | 95% Confidence Interval | month | The OS will be assessed from the time of randomization to death from any cause.For patients not known to have died or who have withdrawn from the study for whatever reason,OS will be censored at the last date at which patients were known to be alive. |
|
| |||||||||||||||||||||||||||||
| Secondary | Objective Tumour Response (ORR) | The objective tumour response will be calculated as the number of patients with CR or PR per RECIST Criteria. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | Posted | Jun 2011 | Number | Participants | TTumour assessment using RECIST will be performed at baseline then every 42 days (6 weeks) ± 7 days (1 week) from randomisation until objective progression or death from any cause. |
|
| ||||||||||||||||||||||||||||||
| Secondary | Disease Control Rate (DCR) | DCR will be calculated as the number of patients with CR, PR or sustained SD≥6 weeks per RECIST Criteria. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase | Not Posted | Number | Participants | Tumour assessment using RECIST will be performed at baseline then every 42 days (6 weeks) ± 7 days (1 week) from randomisation until objective progression or death from any cause. | |||||||||||||||||||||||||||||||||
| Secondary | Symptom Improvement | Symptom improvement will be assessed from the 7-question Lung Cancer Subscale domain score derived from the FACT-L questionnaire. It is defined as an increase of two or more points on the LCS from randomization, maintained for 21 or more days. It will be calculated as the number of patients analysed with improvement. | Posted | Jul 2011 | Number | Participants | at randomization, every 6 weeks until disease progression, and at discontinuation. |
|
| ||||||||||||||||||||||||||||||
| Secondary | Adverse Event | Appropriate description of AEs and laboratory data/vital signs will be produced. Number of patients who had at least one adverse events will be calculated. | Posted | Jun 2011 | Number | Participants | AEs and SAEs must be collected from the time that the main study informed consent is obtained to 28 days after discontinuation of study drug. Any ongoing AE or SAE at discontinuation of study treatment and during 28 day follow-up period must be monitored |
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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 | Gefitinib | Gefitinib (Iressa® 250 mg) 1 tablet daily | 10 | 147 | 118 | |||
| EG001 | Placebo | placebo 1 tablet daily | 5 | 148 | 79 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Interstitial Lung Disease | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Lung Infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Sudden Death | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Accidental Death | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Paraplegia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Completed Suicide | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Subcutaneous Nodule | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Arterial Thrombosis Limb | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Circulatory Collapse | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| rash | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| pruritus | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| dry skin | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| aspartate aminotransferase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| transaminases increased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| serious hepatic dysfunction | Investigations | MedDRA 12.0 | Systematic Assessment |
|
PI agrees to collaborate in good faith with AZ regard to contents and formation of any publication and to pay due consideration to the comments, views and opinions offered by AZ. AZ shall have a period of 30 days from receipt of the proposed final manuscript to review and may require submission be delayed in order for AZ to file patent application
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | 52564555 | 86 21 | aztrial_results_posting@astrazeneca.com |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000077156 | Gefitinib |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Title | Measurements |
|---|---|
|
| 65-74 years |
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| >=75 years |
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| Male |
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| ex-smoker |
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| current smoker |
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