First Line IRESSA™ Versus Carboplatin/Paclitaxel in Asia

Non-Small Cell Lung Cancer Clinical Trial

— IPASS  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00322452
• Other study ID #: D791AC00007
• Secondary ID: Iressa Pan Asian
• Status: Completed
• Phase: Phase 3
• First received: May 5, 2006
• Last updated: October 14, 2013
• Start date: March 2006
• Est. completion date: June 2010

Study information

• Verified date: October 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Department of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-Small Cell Lung Cancer

Intervention

Drug:
• Gefitinib
oral tablet
• Carboplatin
IV
• Paclitaxel
IV

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

China,  Hong Kong,  Indonesia,  Japan,  Malaysia,  Philippines,  Singapore,  Taiwan,  Thailand, 

Outcome

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