Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Males or females that had never smoked or were light ex-smokers, who had Stage IIIB or Stage IV adenocarcinoma of the lung and had not received any previous chemotherapy excluding non-platinum based adjuvant chemotherapy were randomised between 30 March 2006 and 9 October 2007. The study was carried out in Asian countries (including Japan & China).

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups

	Description
Gefitinib	Gefitinib 250mg daily
Carboplatin/Paclitaxel	Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks

Participant Flow:   Overall Study

	Gefitinib	Carboplatin/Paclitaxel
STARTED	609 [1]	608 [1]
COMPLETED	362 [2]	332 [3]
NOT COMPLETED	247	276
Eligibility criteria not fulfilled	0	1
Lost to Follow-up	5	2
Withdrawal by Subject	19	46
Death	223	227

Reporting Groups

	Description
Gefitinib	Gefitinib 250mg daily
Carboplatin/Paclitaxel	Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks

Baseline Measures

	Gefitinib	Carboplatin/Paclitaxel	Total
Number of Participants   [units: participants]	609	608	1217
Age   [units: Years] Median ( Full Range )	57     ( 24 to 84 )	57     ( 25 to 84 )	57     ( 24 to 84 )
Gender   [units: Participants]
Female	484	481	965
Male	125	127	252
Race/Ethnicity, Customized   [units: Participants]
Caucasian	3	1	4
Oriental	603	606	1209
Other	3	1	4
Race/Ethnicity, Customized   [units: Participants]
Asian (other than Chinese or Japanese)	179	184	363
Chinese	314	304	618
Japanese	114	119	233
Other	2	1	3
Smoking history   [units: Participants]
Never Smoker	571	569	1140
Light ex-smoker	37	38	75
Ex-smoker (non-light)	1	1	2
WHO performance status   [units: Participants]
0 (normal activity)	157	161	318
1 (restricted activity)	391	382	773
2 (in bed =< 50% of the time)	61	65	126

1.  Primary:

Median Progression Free Survival (PFS) in Months   [ Time Frame: 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). ]

2.  Secondary:

Median Overall Survival (OS) in Months at OS Data Cut Off (14th June 2010)   [ Time Frame: Following the PFS DCO on 14th April 2008 information on survival status was collected every 8 weeks. ]

3.  Secondary:

Objective Tumour Response Rate According to RECIST   [ Time Frame: 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). ]

4.  Secondary:

Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Neutropenia   [ Time Frame: 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 ]

5.  Secondary:

Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Thrombocytopenia   [ Time Frame: 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 ]

6.  Secondary:

Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Leukopenia   [ Time Frame: 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 ]

7.  Secondary:

Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Anaemia   [ Time Frame: 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 ]

8.  Secondary:

Neurotoxicity   [ Time Frame: 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 ]

9.  Secondary:

Rashes/Acnes   [ Time Frame: 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 ]

10.  Secondary:

Diarrhoea   [ Time Frame: 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 ]

11.  Secondary:

Nausea   [ Time Frame: 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 ]

12.  Secondary:

Vomiting   [ Time Frame: 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 ]

13.  Secondary:

Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Liver Transaminases   [ Time Frame: 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 ]

14.  Secondary:

Quality of Life (QoL) as Measured by the Total Score of the Functional Assessment of Cancer Therapy - Lung Cancer (FACT-L) Questionnaire   [ Time Frame: 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. ]

15.  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   [ Time Frame: 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. ]

16.  Secondary:

Symptom Improvement as Measured by the Lung Cancer Subscale (LCS) of the FACT-L Questionnaire   [ Time Frame: 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. ]