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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

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.

First line IRESSA™ versus carboplatin/paclitaxel in Asia

Research Site

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

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.

Age Continuous

Gender, Male/Female

Race, Customized

Ethnicity, Customized

Smoking history

Study Specific Characteristic

WHO performance status

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.

Analysis was carried out on Intention-to-treat (ITT) population.

Median progression free survival (PFS) in months

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.

Median Overall Survival (OS) in Months at OS data cut off (14th June 2010)

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.

Objective tumour response rate according to RECIST

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).

Analysis was carried out on the Evaluable-for-safety (EFS) population. The EFS population is a subset of the ITT population which includes all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).

Common Toxicity Criteria (CTC) grade 3, 4, or 5 neutropenia

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).

Common Toxicity Criteria (CTC) grade 3, 4, or 5 thrombocytopenia

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).

Common Toxicity Criteria (CTC) grade 3, 4, or 5 leukopenia

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).

Common Toxicity Criteria (CTC) grade 3, 4, or 5 anaemia

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)

Neurotoxicity

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)

Rashes/acnes

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)

Diarrhoea

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)

Nausea

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)

Vomiting

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).

Common Toxicity Criteria (CTC) grade 3, 4, or 5 liver transaminases

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

Analysis was carried out on the Evaluable-for-QoL (EFQ) population.  The EFQ population is a subset of the ITT population containing patients with an evaluable baseline QoL assessment and at least 1 evaluable post-baseline QoL assessment.

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 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

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 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

Symptom improvement as measured by the Lung Cancer Subscale (LCS) of the FACT-L questionnaire

Overall Study

112 patients (out of 1329) failed screening and were not randomized, the majority of patients who failed screening did not comply with inclusion / exclusion criteria.  Other reasons were: patient withdrew informed consent; patient lost to follow up.  One patient was not randomized for 'other' (non-specified) reason.

Arms	Assigned Interventions
Experimental: 1 gefitinib	Drug: Gefitinib oral tablet Other Name: Iressa Other Name: ZD1839
Active Comparator: 2 Carboplatin/Paclitaxel	Drug: Carboplatin IV Drug: Paclitaxel IV

First line IRESSA™ versus carboplatin/paclitaxel in Asia - IPASS

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=413&filename=CSR-D791AC00007.pdf

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=413&filename=CSR-D791AC00007A.pdf

CSR-D791AC00007.pdf

Trial Results Summaries

Contacts

Contact

Contact Backup

Investigators

Principal Investigator