Trial · NCT00322452

First Line IRESSA™ Versus Carboplatin/Paclitaxel in Asia

NCT00322452, Phase 3, Completed, AstraZeneca; results first posted 2010-05-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. First Line IRESSA™ Versus Carboplatin/Paclitaxel in Asia. Trials, record NCT00322452. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00322452

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: First Line IRESSA™ Versus Carboplatin/Paclitaxel in Asia
NCT number: NCT00322452
Status: Completed
Phases: Phase 3
Enrollment: 1,329 participants, actual
Lead sponsor: AstraZeneca
Conditions: Non-Small Cell Lung Cancer
Interventions: Gefitinib, Carboplatin, Paclitaxel
First posted: 2006-05-08
Last updated: 2013-11-07
Results first posted: 2010-05-17

Source ClinicalTrials.gov

Registered outcomes16

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Median Progression Free Survival (PFS) in Months	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).	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.
Secondary	Median Overall Survival (OS) in Months at OS Data Cut Off (14th June 2010)	Following the PFS DCO on 14th April 2008 information on survival status was collected every 8 weeks.	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.
Secondary	Objective Tumour Response Rate According to RECIST	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).	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.
Secondary	Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Neutropenia	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	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).
Secondary	Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Thrombocytopenia	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	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).
Secondary	Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Leukopenia	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	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).
Secondary	Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Anaemia	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	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).
Secondary	Neurotoxicity	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	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)
Secondary	Rashes/Acnes	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	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)
Secondary	Diarrhoea	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	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)

1 to 10 of 16Source ClinicalTrials.gov

See all 16 registered outcomes

Outcomes16

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Median Progression Free Survival (PFS) in Months	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).	Analysis was carried out on Intention-to-treat (ITT) population.	Months	MEDIAN
SECONDARY	Median Overall Survival (OS) in Months at OS Data Cut Off (14th June 2010)	Following the PFS DCO on 14th April 2008 information on survival status was collected every 8 weeks.	Analysis was carried out on Intention-to-treat (ITT) population.	Months	MEDIAN
SECONDARY	Objective Tumour Response Rate According to RECIST	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).	Analysis was carried out on Intention-to-treat (ITT) population.	Participants	NUMBER
SECONDARY	Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Neutropenia	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	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).	Participants	NUMBER
SECONDARY	Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Thrombocytopenia	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	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).	Participants	NUMBER
SECONDARY	Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Leukopenia	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	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).	Participants	NUMBER
SECONDARY	Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Anaemia	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	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).	Participants	NUMBER
SECONDARY	Neurotoxicity	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	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).	Participants	NUMBER
SECONDARY	Rashes/Acnes	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	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).	Participants	NUMBER
SECONDARY	Diarrhoea	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	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).	Participants	NUMBER

1 to 10 of 16Source ClinicalTrials.gov

See all 16 outcomes

Results by group32

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Median Progression Free Survival (PFS) in Months	Gefitinib	5.7	95% Confidence Interval 5.4 to 6.8	Months
Median Progression Free Survival (PFS) in Months	Carboplatin/Paclitaxel	5.8	95% Confidence Interval 5.6 to 6.4	Months
Median Overall Survival (OS) in Months at OS Data Cut Off (14th June 2010)	Gefitinib	18.8	95% Confidence Interval 17.3 to 20.4	Months
Median Overall Survival (OS) in Months at OS Data Cut Off (14th June 2010)	Carboplatin/Paclitaxel	17.4	95% Confidence Interval 16.2 to 18.7	Months
Objective Tumour Response Rate According to RECIST	Gefitinib	262		Participants
Objective Tumour Response Rate According to RECIST	Carboplatin/Paclitaxel	196		Participants
Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Neutropenia	Gefitinib	4		Participants
Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Neutropenia	Carboplatin/Paclitaxel	385		Participants
Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Thrombocytopenia	Gefitinib	5		Participants
Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Thrombocytopenia	Carboplatin/Paclitaxel	29		Participants

1 to 10 of 32Source ClinicalTrials.gov

See all 32 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Gefitinib	609
Overall Study	STARTED	Carboplatin/Paclitaxel	608
Overall Study	COMPLETED	Gefitinib	362
Overall Study	COMPLETED	Carboplatin/Paclitaxel	332
Overall Study	NOT COMPLETED	Gefitinib	247
Overall Study	NOT COMPLETED	Carboplatin/Paclitaxel	276

Source ClinicalTrials.gov

Adverse events322

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Acne	Skin and subcutaneous tissue disorders	Gefitinib	66	607
other	Acne	Skin and subcutaneous tissue disorders	Carboplatin/Paclitaxel	4	589
other	Alanine Aminotransferase Increased	Investigations	Gefitinib	61	607
other	Alanine Aminotransferase Increased	Investigations	Carboplatin/Paclitaxel	31	589
other	Alopecia	Skin and subcutaneous tissue disorders	Gefitinib	42	607
other	Alopecia	Skin and subcutaneous tissue disorders	Carboplatin/Paclitaxel	343	589
other	Anaemia	Blood and lymphatic system disorders	Gefitinib	36	607
other	Anaemia	Blood and lymphatic system disorders	Carboplatin/Paclitaxel	146	589
other	Anorexia	Metabolism and nutrition disorders	Gefitinib	92	607
other	Anorexia	Metabolism and nutrition disorders	Carboplatin/Paclitaxel	232	589

1 to 10 of 322Source ClinicalTrials.gov

See all 322 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Gefitinib
Total, all-cause mortality	Carboplatin/Paclitaxel
Total, other adverse events	Gefitinib	574
Total, other adverse events	Carboplatin/Paclitaxel	573
Total, serious adverse events	Gefitinib	110	607
Total, serious adverse events	Carboplatin/Paclitaxel	92	589

Source ClinicalTrials.gov

Papers6

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
19692680	DERIVED	PubMed
22897752	DERIVED	PubMed
23540718	DERIVED	PubMed
24361280	DERIVED	PubMed
28212993	DERIVED	PubMed
31920008	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons15

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Gefitinib vs Carboplatin/Paclitaxel: Objective Tumour Response Rate According to RECIST	Trial comparisons
Gefitinib vs Carboplatin/Paclitaxel: Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Thrombocytopenia	Trial comparisons
Gefitinib vs Carboplatin/Paclitaxel: Neurotoxicity	Trial comparisons
Gefitinib vs Carboplatin/Paclitaxel: Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Leukopenia	Trial comparisons
Gefitinib vs Carboplatin/Paclitaxel: Rashes/Acnes	Trial comparisons
Gefitinib vs Carboplatin/Paclitaxel: Vomiting	Trial comparisons
Gefitinib vs Carboplatin/Paclitaxel: Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Liver Transaminases	Trial comparisons
Gefitinib vs Carboplatin/Paclitaxel: Diarrhoea	Trial comparisons
Gefitinib vs Carboplatin/Paclitaxel: Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Neutropenia	Trial comparisons
Gefitinib vs Carboplatin/Paclitaxel: Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Anaemia	Trial comparisons

1 to 10 of 15

See all 15 trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00322452

GET https://conductscience.org/api/trials/v1/NCT00322452/results?page=2

API reference For AI assistants