Non-Small Cell Lung Cancer Clinical Trial
— IPASSOfficial title:
Open Label, Randomised, Parallel Group, Multicentre, Ph III Study To Assess Efficacy, Safety & Tolerability Of Gefitinib (IRESSA™) Versus Carboplatin/Paclitaxel DC As 1st-Line Treatment In Selected Patients With Stage IIIB / IV NSCLC In Asia
Verified date | October 2013 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | Hong Kong: Department of Health |
Study type | Interventional |
The purpose of this study is to compare gefitinib with carboplatin / paclitaxel doublet chemotherapy given as first line treatment in terms of progression free survival in selected NSCLC patients with the objective of demonstrating non-inferiority.
Status | Completed |
Enrollment | 1329 |
Est. completion date | June 2010 |
Est. primary completion date | April 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Locally advanced Stage IIIB not amenable to local therapy or Stage IV (metastatic) NSCLC with adenocarcinoma histology. - Never smokers or light ex-smokers.(ceased smoking at least 15 years before Day 1 of study treatment and 10 pack-years or fewer) Exclusion Criteria: - Had prior chemotherapy, biological (including targeted therapies such as EGFR and vascular epidermal growth factor (VEGF) inhibitors) or immunological therapy. - Pre-existing idiopathic pulmonary fibrosis evidence by CT scan at baseline. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Research Site | Beijing | |
China | Research Site | Chengdu | |
China | Research Site | Chongqing | Sichuan |
China | Research Site | Dalian | Liaoning |
China | Research Site | Fuzhou | Fujian |
China | Research Site | Guangzhou | Guangdong |
China | Research Site | Hangzhou | |
China | Research Site | Nanjing | Jiangsu |
China | Research Site | Shanghai | |
China | Research Site | Wuhan | Hubei |
Hong Kong | Research Site | Hong Kong | |
Indonesia | Research Site | Jakarta | |
Indonesia | Research Site | Malang | East Java |
Indonesia | Research Site | Semarang | Central Java |
Indonesia | Research Site | Solo | |
Indonesia | Research Site | Surabaya | |
Indonesia | Research Site | Yogyakarta | |
Japan | Research Site | Akashi | Hyogo |
Japan | Research Site | Bunkyo-ku | Tokyo |
Japan | Research Site | Fukuoka | |
Japan | Research Site | Izumisano | Osaka |
Japan | Research Site | Kanazawa | Ishikawa |
Japan | Research Site | Kashiwa | Chiba |
Japan | Research Site | Kobe | Hyogo |
Japan | Research Site | Koto-ku | Tokyo |
Japan | Research Site | Kumamoto | |
Japan | Research Site | Matsuyama | Ehime |
Japan | Research Site | Nagoya | Aichi |
Japan | Research Site | Okayama | |
Japan | Research Site | Okazaki | Aichi |
Japan | Research Site | Omura | Nagasaki |
Japan | Research Site | Osaka | |
Japan | Research Site | Osakasayama | Osaka |
Japan | Research Site | Sakai | Osaka |
Japan | Research Site | Sapporo | Hokkaido |
Japan | Research Site | Shinjuku | Tokyo |
Japan | Research Site | Sunto-gun | Shizuoka |
Japan | Research Site | Ube | Yamaguchi |
Japan | Research Site | Yokohama | Kanagawa |
Malaysia | Research Site | Kota Kinabalu | Sabah |
Malaysia | Research Site | Kuala Lumpur | |
Malaysia | Research Site | Nilai | |
Malaysia | Research Site | Penang | |
Malaysia | Research Site | Petaling Jaya | |
Philippines | Research Site | Cebu City | |
Philippines | Research Site | Manila | |
Philippines | Research Site | Quezon City | |
Singapore | Research Site | Singapore | |
Taiwan | Research Site | Changhua | |
Taiwan | Research Site | Kaohsiung | |
Taiwan | Research Site | Taipei | |
Taiwan | Research Site | Tao-Yuan | |
Thailand | Research Site | Bangkok | |
Thailand | Research Site | Chiang Mai | |
Thailand | Research Site | Khon Kaen | |
Thailand | Research Site | Songkla |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
China, Hong Kong, Indonesia, Japan, Malaysia, Philippines, Singapore, Taiwan, Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Median Progression Free Survival (PFS) in Months | PFS was defined as the interval from the date of randomization to the date of objective disease progression (as per RECIST) or the date of death (from any cause) in the absence of objective disease progression. The median PFS in months is presented here. | Tumour assessments as per RECIST were performed at baseline and then every 42 days ± 7 days from randomization until data cut off (14th April 2008). | No |
Secondary | Median Overall Survival (OS) in Months at OS Data Cut Off (14th June 2010) | Overall Survival was assessed via calculation of the time to death due to any cause. If a participant was known to have died, the time to death was defined as the time from the date of randomization to the date of death. Otherwise, a participant was censored at the last date they were known to be alive. Median Overall Survival in months is presented here. | Following the PFS DCO on 14th April 2008 information on survival status was collected every 8 weeks. | No |
Secondary | Objective Tumour Response Rate According to RECIST | Number of participants with an objective response. An objective response (OR) was defined as a patient having a best overall response of either complete response (CR) or partial response (PR) according to RECIST, confirmed at least 28 days following the date of the initial response. | Tumour assessments as per RECIST were performed at baseline and then every 42 days ± 7 days from randomization until data cut off (14th April 2008). | No |
Secondary | Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Neutropenia | Number of patients with a neutropenia event, identified from the lab data as a worsening in absolute neutrophil count from baseline to a CTC grade 3 or above which Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel). | Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel | Yes |
Secondary | Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Thrombocytopenia | Number of patients with a thromboctyopenia event, identified from the lab data as a worsening in platelet count from baseline to a CTC grade 3 or above. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel). | Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel | Yes |
Secondary | Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Leukopenia | Number of patients with a leukopenia event, identified from the lab data as a worsening in white blood cell count from baseline to a CTC grade 3 or above. Based on the evaluable for-safety-population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel). | Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel | Yes |
Secondary | Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Anaemia | Number of patients with an anaemia event, identified from the lab data as a worsening in haemoglobin from baseline to a CTC grade 3 or above. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel). | Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel | Yes |
Secondary | Neurotoxicity | Number of patients with a neurotoxicity event. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel) | Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel | Yes |
Secondary | Rashes/Acnes | Number of patients with a rashes/acnes event. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel) | Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel | Yes |
Secondary | Diarrhoea | Number of patients with a diarrhoea event. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel) | Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel | Yes |
Secondary | Nausea | Number of patients with a nausea event. Based on the evaluable for-safety-population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel) | Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel | Yes |
Secondary | Vomiting | Number of patients with a vomiting event. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel) | Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel | Yes |
Secondary | Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Liver Transaminases | Number of patients with an elevated liver transaminase event, identified from the lab data as a worsening in ALT or AST from baseline to a CTC grade 3 or above. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel). | Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel | Yes |
Secondary | Quality of Life (QoL) as Measured by the Total Score of the Functional Assessment of Cancer Therapy - Lung Cancer (FACT-L) Questionnaire | Number of patients improving: a patient was described as improved if they had 2 visits (at least 21 days apart) where there was an increase in FACT-L score (from baseline) of 6 or more, and there were no intervening visits showing a decrease from baseline of 6 or more. Includes all patients with QoL data at baseline & at least 1 post-baseline visit | FACT-L data were collected at baseline, week 1, every 3 weeks (from baseline) until day 127, then every 42 days until the patient was confirmed as having objectively progressed (via RECIST), and at treatment discontinuation. | No |
Secondary | Quality of Life (QoL) as Measured by the Trial Outcome Index (TOI) of the Functional Assessment of Cancer Therapy - Lung Cancer (FACT-L) Questionnaire | Number of patients improving: a patient was described as improved if they had 2 visits (at least 21 days apart) where there was an increase in TOI score (from baseline) of 6 or more, and there were no intervening visits showing a decrease from baseline of 6 or more. Includes all patients with QoL data at baseline & at least 1 post-baseline visit | FACT-L data were collected at baseline, week 1, every 3 weeks (from baseline) until day 127, then every 42 days until the patient was confirmed as having objectively progressed (via RECIST), and at treatment discontinuation. | No |
Secondary | Symptom Improvement as Measured by the Lung Cancer Subscale (LCS) of the FACT-L Questionnaire | Number of patients improving: a patient was described as improved if they had 2 visits (at least 21 days apart) where there was an increase in LCS score (from baseline) of 2 or more, and there were no intervening visits showing a decrease from baseline of 2 or more. Includes all patients with QoL data at baseline & at least 1 post-baseline visit | FACT-L data were collected at baseline, week 1, every 3 weeks (from baseline) until day 127, then every 42 days until the patient was confirmed as having objectively progressed (via RECIST), and at treatment discontinuation. | No |
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