Trial Outcomes & Findings for Asia Pacific and Russia Diagnostic Study for EGFR Testing (NCT NCT01788163)
NCT ID: NCT01788163
Last Updated: 2017-05-17
Results Overview
The 95% Confidence intervals were calculated using Clopper Pearson method for each country.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
3500 participants
Primary outcome timeframe
At Screening
Results posted on
2017-05-17
Participant Flow
Males or females that had Stage IIIB or Stage IV adenocarcinoma of the lung and who were systemic treatment naive or patients with recurrent disease who have previously received adjuvant chemotherapy were enrolled 27 February 2013 and 25 July 2014. The study was carried out in Asiapac countries and Russia.
A total of 3500 patients were initially enrolled, of which 118 patients were enrolled but were excluded from the study upon failure to satisfy all eligibility criteria. These patients were not included in any analysis data sets.
Participant milestones
| Measure |
China
Subjects in China that meet Inclusion/Exclusion (I/E) and population criteria.
|
Taiwan
Subjects in Taiwan that meet I/E and population criteria
|
South Korea
Subjects in South Korea that meet I/E and population criteria
|
Australia
Subjects in Australia that meet I/E and population criteria
|
Thailand
Subjects in Thailand that meet I/E and population criteria
|
Singapore
Subjects in Singapore that meet I/E and population criteria
|
Malaysia
Subjects in Malaysia that meet I/E and population criteria
|
Indonesia
Subjects in Indonesia that meet I/E and population criteria
|
Russia
Subjects in Russia that meet I/E and population criteria
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1458
|
271
|
62
|
71
|
94
|
102
|
50
|
302
|
972
|
|
Overall Study
COMPLETED
|
1403
|
271
|
62
|
71
|
94
|
95
|
49
|
254
|
956
|
|
Overall Study
NOT COMPLETED
|
55
|
0
|
0
|
0
|
0
|
7
|
1
|
48
|
16
|
Reasons for withdrawal
| Measure |
China
Subjects in China that meet Inclusion/Exclusion (I/E) and population criteria.
|
Taiwan
Subjects in Taiwan that meet I/E and population criteria
|
South Korea
Subjects in South Korea that meet I/E and population criteria
|
Australia
Subjects in Australia that meet I/E and population criteria
|
Thailand
Subjects in Thailand that meet I/E and population criteria
|
Singapore
Subjects in Singapore that meet I/E and population criteria
|
Malaysia
Subjects in Malaysia that meet I/E and population criteria
|
Indonesia
Subjects in Indonesia that meet I/E and population criteria
|
Russia
Subjects in Russia that meet I/E and population criteria
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Other
|
53
|
0
|
0
|
0
|
0
|
7
|
1
|
48
|
15
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Asia Pacific and Russia Diagnostic Study for EGFR Testing
Baseline characteristics by cohort
| Measure |
China
n=1458 Participants
Subjects in China that meet I/E and population criteria.
|
Taiwan
n=271 Participants
Subjects in Taiwan that meet I/E and population criteria
|
South Korea
n=62 Participants
Subjects in South Korea that meet I/E and population criteria
|
Australia
n=71 Participants
Subjects in Australia that meet I/E and population criteria
|
Thailand
n=94 Participants
Subjects in Thailand that meet I/E and population criteria
|
Singapore
n=102 Participants
Subjects in Singapore that meet I/E and population criteria
|
Malaysia
n=50 Participants
Subjects in Malaysia that meet I/E and population criteria
|
Indonesia
n=302 Participants
Subjects in Indonesia that meet I/E and population criteria
|
Russia
n=972 Participants
Subjects in Russia that meet I/E and population criteria
|
Total
n=3382 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
Age (years)
|
59.8 Years
STANDARD_DEVIATION 10.57 • n=5 Participants
|
66.4 Years
STANDARD_DEVIATION 12.66 • n=7 Participants
|
65.9 Years
STANDARD_DEVIATION 11.91 • n=5 Participants
|
67.1 Years
STANDARD_DEVIATION 10.02 • n=4 Participants
|
61.2 Years
STANDARD_DEVIATION 12.3 • n=21 Participants
|
63.3 Years
STANDARD_DEVIATION 10.79 • n=10 Participants
|
58.7 Years
STANDARD_DEVIATION 10.5 • n=115 Participants
|
57.1 Years
STANDARD_DEVIATION 11.46 • n=6 Participants
|
59.8 Years
STANDARD_DEVIATION 8.9 • n=6 Participants
|
60.4 Years
STANDARD_DEVIATION 10.73 • n=64 Participants
|
|
Sex: Female, Male
Female
|
535 Participants
n=5 Participants
|
111 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
42 Participants
n=10 Participants
|
14 Participants
n=115 Participants
|
97 Participants
n=6 Participants
|
245 Participants
n=6 Participants
|
1142 Participants
n=64 Participants
|
|
Sex: Female, Male
Male
|
923 Participants
n=5 Participants
|
160 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
54 Participants
n=21 Participants
|
60 Participants
n=10 Participants
|
36 Participants
n=115 Participants
|
205 Participants
n=6 Participants
|
727 Participants
n=6 Participants
|
2240 Participants
n=64 Participants
|
PRIMARY outcome
Timeframe: At ScreeningPopulation: Tumour Evaluable Population
The 95% Confidence intervals were calculated using Clopper Pearson method for each country.
Outcome measures
| Measure |
China
n=1391 Participants
Subjects in China that meet I/E and population criteria.
|
Taiwan
n=271 Participants
Subjects in Taiwan that meet I/E and population criteria
|
South Korea
n=62 Participants
Subjects in South Korea that meet I/E and population criteria
|
Australia
n=58 Participants
Subjects in Australia that meet I/E and population criteria
|
Thailand
n=87 Participants
Subjects in Thailand that meet I/E and population criteria
|
Singapore
n=100 Participants
Subjects in Singapore that meet I/E and population criteria
|
Malaysia
n=49 Participants
Subjects in Malaysia that meet I/E and population criteria
|
Indonesia
n=273 Participants
Subjects in Indonesia that meet I/E and population criteria
|
Russia
n=924 Participants
Subjects in Russia that meet I/E and population criteria
|
Thailand-Non-adenocarcinoma
Subjects in Thailand that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Singapore-Adenocarcinoma
Subjects in Singapore that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Singapore-Non-adenocarcinoma
Subjects in Singapore that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Malaysia-Adenocarcinoma
Subjects in Malaysia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Malaysia-Non-adenocarcinoma
Subjects in Malaysia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Indonesia-Adenocarcinoma
Subjects in Indonesia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Indonesia-Non-adenocarcinoma
Subjects in Indonesia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Russia-Adenocarcinoma
Subjects in Russia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Russia-Non-adenocarcinoma
Subjects in Russia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Tumour Epidermal Growth Factor Receptor (EGFR) Mutation Status
Mutation Negative
|
59.2 Percentage of participants
Interval 56.6 to 61.8
|
52.0 Percentage of participants
Interval 45.9 to 58.1
|
77.4 Percentage of participants
Interval 65.0 to 87.1
|
70.7 Percentage of participants
Interval 57.3 to 81.9
|
71.3 Percentage of participants
Interval 60.6 to 80.5
|
45.0 Percentage of participants
Interval 35.0 to 55.3
|
65.3 Percentage of participants
Interval 50.4 to 78.3
|
57.5 Percentage of participants
Interval 51.4 to 63.4
|
88.1 Percentage of participants
Interval 85.8 to 90.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Overall Tumour Epidermal Growth Factor Receptor (EGFR) Mutation Status
Mutation Positive
|
40.8 Percentage of participants
Interval 38.2 to 43.4
|
48.0 Percentage of participants
Interval 41.9 to 54.1
|
22.6 Percentage of participants
Interval 12.9 to 35.0
|
29.3 Percentage of participants
Interval 18.1 to 42.7
|
28.7 Percentage of participants
Interval 19.5 to 39.4
|
55.0 Percentage of participants
Interval 44.7 to 65.0
|
34.7 Percentage of participants
Interval 21.7 to 49.6
|
42.5 Percentage of participants
Interval 36.6 to 48.6
|
11.9 Percentage of participants
Interval 9.9 to 14.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At ScreeningPopulation: Tumour Evaluable Population
Frequency distribution of subjects with a positive mutation status by the mutation subtype and country.
Outcome measures
| Measure |
China
n=1391 Participants
Subjects in China that meet I/E and population criteria.
|
Taiwan
n=271 Participants
Subjects in Taiwan that meet I/E and population criteria
|
South Korea
n=62 Participants
Subjects in South Korea that meet I/E and population criteria
|
Australia
n=58 Participants
Subjects in Australia that meet I/E and population criteria
|
Thailand
n=87 Participants
Subjects in Thailand that meet I/E and population criteria
|
Singapore
n=100 Participants
Subjects in Singapore that meet I/E and population criteria
|
Malaysia
n=49 Participants
Subjects in Malaysia that meet I/E and population criteria
|
Indonesia
n=273 Participants
Subjects in Indonesia that meet I/E and population criteria
|
Russia
n=924 Participants
Subjects in Russia that meet I/E and population criteria
|
Thailand-Non-adenocarcinoma
Subjects in Thailand that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Singapore-Adenocarcinoma
Subjects in Singapore that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Singapore-Non-adenocarcinoma
Subjects in Singapore that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Malaysia-Adenocarcinoma
Subjects in Malaysia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Malaysia-Non-adenocarcinoma
Subjects in Malaysia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Indonesia-Adenocarcinoma
Subjects in Indonesia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Indonesia-Non-adenocarcinoma
Subjects in Indonesia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Russia-Adenocarcinoma
Subjects in Russia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Russia-Non-adenocarcinoma
Subjects in Russia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tumour EGFR Mutation by Subtype
G719x mutation only
|
8 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Tumour EGFR Mutation by Subtype
Exon 19 deletion only
|
283 Participants
|
61 Participants
|
5 Participants
|
12 Participants
|
13 Participants
|
27 Participants
|
7 Participants
|
43 Participants
|
63 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Tumour EGFR Mutation by Subtype
Exon 19 Other only
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Tumour EGFR Mutation by Subtype
T790M only
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Tumour EGFR Mutation by Subtype
L858R mutation only
|
239 Participants
|
57 Participants
|
7 Participants
|
4 Participants
|
7 Participants
|
17 Participants
|
8 Participants
|
70 Participants
|
26 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Tumour EGFR Mutation by Subtype
Other
|
6 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Tumour EGFR Mutation by Subtype
Exon 19 deletion +T790M
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Tumour EGFR Mutation by Subtype
Exon 19 deletion + other
|
6 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Tumour EGFR Mutation by Subtype
T790M + other
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Tumour EGFR Mutation by Subtype
Exon 20 insertions only
|
11 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Tumour EGFR Mutation by Subtype
S768I mutation only
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Tumour EGFR Mutation by Subtype
L858R mutation + other
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Tumour EGFR Mutation by Subtype
L861Q mutation only
|
6 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Tumour EGFR Mutation by Subtype
Exon 21 Other only
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At ScreeningPopulation: Tumour Evaluable Population
Only subjects who had a recorded Histological Type of Adenocarcinoma or Non-adenocarcinoma are included. Confidence intervals were calculated using Clopper Pearson method for each country.
Outcome measures
| Measure |
China
n=1026 Participants
Subjects in China that meet I/E and population criteria.
|
Taiwan
n=361 Participants
Subjects in Taiwan that meet I/E and population criteria
|
South Korea
n=208 Participants
Subjects in South Korea that meet I/E and population criteria
|
Australia
n=61 Participants
Subjects in Australia that meet I/E and population criteria
|
Thailand
n=46 Participants
Subjects in Thailand that meet I/E and population criteria
|
Singapore
n=15 Participants
Subjects in Singapore that meet I/E and population criteria
|
Malaysia
n=49 Participants
Subjects in Malaysia that meet I/E and population criteria
|
Indonesia
n=7 Participants
Subjects in Indonesia that meet I/E and population criteria
|
Russia
n=73 Participants
Subjects in Russia that meet I/E and population criteria
|
Thailand-Non-adenocarcinoma
n=13 Participants
Subjects in Thailand that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Singapore-Adenocarcinoma
n=95 Participants
Subjects in Singapore that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Singapore-Non-adenocarcinoma
n=3 Participants
Subjects in Singapore that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Malaysia-Adenocarcinoma
n=40 Participants
Subjects in Malaysia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Malaysia-Non-adenocarcinoma
n=6 Participants
Subjects in Malaysia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Indonesia-Adenocarcinoma
n=212 Participants
Subjects in Indonesia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Indonesia-Non-adenocarcinoma
n=59 Participants
Subjects in Indonesia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Russia-Adenocarcinoma
n=500 Participants
Subjects in Russia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Russia-Non-adenocarcinoma
n=402 Participants
Subjects in Russia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tumour EGFR Mutation Status by Histology
Mutation Negative
|
48.7 Percentage of participants
Interval 45.6 to 51.8
|
88.9 Percentage of participants
Interval 85.2 to 92.0
|
42.8 Percentage of participants
Interval 36.0 to 49.8
|
83.6 Percentage of participants
Interval 71.9 to 91.8
|
69.6 Percentage of participants
Interval 54.2 to 82.3
|
100.0 Percentage of participants
Interval 78.2 to 100.0
|
67.3 Percentage of participants
Interval 52.5 to 80.1
|
85.7 Percentage of participants
Interval 42.1 to 99.6
|
69.9 Percentage of participants
Interval 58.0 to 80.1
|
84.6 Percentage of participants
Interval 54.6 to 98.1
|
43.2 Percentage of participants
Interval 33.0 to 53.7
|
66.7 Percentage of participants
Interval 9.4 to 99.2
|
62.5 Percentage of participants
Interval 45.8 to 77.3
|
83.3 Percentage of participants
Interval 35.9 to 99.6
|
54.7 Percentage of participants
Interval 47.8 to 61.5
|
67.8 Percentage of participants
Interval 54.4 to 79.4
|
82.0 Percentage of participants
Interval 78.3 to 85.3
|
96.3 Percentage of participants
Interval 93.9 to 97.9
|
|
Tumour EGFR Mutation Status by Histology
Mutation Positive
|
51.3 Percentage of participants
Interval 48.2 to 54.4
|
11.1 Percentage of participants
Interval 8.0 to 14.8
|
57.2 Percentage of participants
Interval 50.2 to 64.0
|
16.4 Percentage of participants
Interval 8.2 to 28.1
|
30.4 Percentage of participants
Interval 17.7 to 45.8
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
32.7 Percentage of participants
Interval 19.9 to 47.5
|
14.3 Percentage of participants
Interval 0.4 to 57.9
|
30.1 Percentage of participants
Interval 19.9 to 42.0
|
15.4 Percentage of participants
Interval 1.9 to 45.4
|
56.8 Percentage of participants
Interval 46.3 to 67.0
|
33.3 Percentage of participants
Interval 0.8 to 90.6
|
37.5 Percentage of participants
Interval 22.7 to 54.2
|
16.7 Percentage of participants
Interval 0.4 to 64.1
|
45.3 Percentage of participants
Interval 38.5 to 52.2
|
32.2 Percentage of participants
Interval 20.6 to 45.6
|
18.0 Percentage of participants
Interval 14.7 to 21.7
|
3.7 Percentage of participants
Interval 2.1 to 6.1
|
PRIMARY outcome
Timeframe: At ScreeningPopulation: Plasma Evaluable Population
Plasma samples were only performed in China, Taiwan, South Korea and Russia. The Confidence intervals were calculated using Clopper Pearson method for each country.
Outcome measures
| Measure |
China
n=1421 Participants
Subjects in China that meet I/E and population criteria.
|
Taiwan
n=271 Participants
Subjects in Taiwan that meet I/E and population criteria
|
South Korea
n=61 Participants
Subjects in South Korea that meet I/E and population criteria
|
Australia
n=941 Participants
Subjects in Australia that meet I/E and population criteria
|
Thailand
Subjects in Thailand that meet I/E and population criteria
|
Singapore
Subjects in Singapore that meet I/E and population criteria
|
Malaysia
Subjects in Malaysia that meet I/E and population criteria
|
Indonesia
Subjects in Indonesia that meet I/E and population criteria
|
Russia
Subjects in Russia that meet I/E and population criteria
|
Thailand-Non-adenocarcinoma
Subjects in Thailand that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Singapore-Adenocarcinoma
Subjects in Singapore that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Singapore-Non-adenocarcinoma
Subjects in Singapore that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Malaysia-Adenocarcinoma
Subjects in Malaysia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Malaysia-Non-adenocarcinoma
Subjects in Malaysia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Indonesia-Adenocarcinoma
Subjects in Indonesia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Indonesia-Non-adenocarcinoma
Subjects in Indonesia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Russia-Adenocarcinoma
Subjects in Russia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Russia-Non-adenocarcinoma
Subjects in Russia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Plasma EGFR Mutation Status
Mutation Negative
|
79.3 Percentage of participants
Interval 77.1 to 81.4
|
73.1 Percentage of participants
Interval 67.4 to 78.3
|
86.9 Percentage of participants
Interval 75.8 to 94.2
|
90.8 Percentage of participants
Interval 88.7 to 92.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Overall Plasma EGFR Mutation Status
Mutation Positive
|
20.7 Percentage of participants
Interval 18.6 to 22.9
|
26.9 Percentage of participants
Interval 21.7 to 32.6
|
13.1 Percentage of participants
Interval 5.8 to 24.2
|
9.2 Percentage of participants
Interval 7.5 to 11.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At ScreeningPopulation: Plasma Evaluable Population
Plasma samples were only performed in China, Taiwan, South Korea and Russia. Frequency distribution of subjects with a positive mutation status by the mutation subtype and country.
Outcome measures
| Measure |
China
n=1421 Participants
Subjects in China that meet I/E and population criteria.
|
Taiwan
n=271 Participants
Subjects in Taiwan that meet I/E and population criteria
|
South Korea
n=61 Participants
Subjects in South Korea that meet I/E and population criteria
|
Australia
n=941 Participants
Subjects in Australia that meet I/E and population criteria
|
Thailand
Subjects in Thailand that meet I/E and population criteria
|
Singapore
Subjects in Singapore that meet I/E and population criteria
|
Malaysia
Subjects in Malaysia that meet I/E and population criteria
|
Indonesia
Subjects in Indonesia that meet I/E and population criteria
|
Russia
Subjects in Russia that meet I/E and population criteria
|
Thailand-Non-adenocarcinoma
Subjects in Thailand that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Singapore-Adenocarcinoma
Subjects in Singapore that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Singapore-Non-adenocarcinoma
Subjects in Singapore that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Malaysia-Adenocarcinoma
Subjects in Malaysia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Malaysia-Non-adenocarcinoma
Subjects in Malaysia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Indonesia-Adenocarcinoma
Subjects in Indonesia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Indonesia-Non-adenocarcinoma
Subjects in Indonesia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Russia-Adenocarcinoma
Subjects in Russia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Russia-Non-adenocarcinoma
Subjects in Russia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Plasma EGFR Mutation by Subtype
G719X mutation only
|
5 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Plasma EGFR Mutation by Subtype
L858R mutation only
|
122 Participants
|
30 Participants
|
6 Participants
|
25 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Plasma EGFR Mutation by Subtype
S768I mutation only
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Plasma EGFR Mutation by Subtype
L861Q mutation only
|
4 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Plasma EGFR Mutation by Subtype
Other
|
3 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Plasma EGFR Mutation by Subtype
Exon 19 deletion only
|
152 Participants
|
35 Participants
|
1 Participants
|
61 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Plasma EGFR Mutation by Subtype
Exon 19 deletion + other
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Plasma EGFR Mutation by Subtype
T790M + other
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Plasma EGFR Mutation by Subtype
Exon 20 insertions only
|
4 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Plasma EGFR Mutation by Subtype
L858R mutation + Other
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At ScreeningPopulation: Plasma Evaluable Population
Only subjects who had a recorded Histological Type of Adenocarcinoma or Non-adenocarcinoma are included. Confidence intervals were calculated using Clopper Pearson method for each country
Outcome measures
| Measure |
China
n=1047 Participants
Subjects in China that meet I/E and population criteria.
|
Taiwan
n=369 Participants
Subjects in Taiwan that meet I/E and population criteria
|
South Korea
n=208 Participants
Subjects in South Korea that meet I/E and population criteria
|
Australia
n=61 Participants
Subjects in Australia that meet I/E and population criteria
|
Thailand
n=46 Participants
Subjects in Thailand that meet I/E and population criteria
|
Singapore
n=15 Participants
Subjects in Singapore that meet I/E and population criteria
|
Malaysia
n=513 Participants
Subjects in Malaysia that meet I/E and population criteria
|
Indonesia
n=409 Participants
Subjects in Indonesia that meet I/E and population criteria
|
Russia
Subjects in Russia that meet I/E and population criteria
|
Thailand-Non-adenocarcinoma
Subjects in Thailand that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Singapore-Adenocarcinoma
Subjects in Singapore that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Singapore-Non-adenocarcinoma
Subjects in Singapore that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Malaysia-Adenocarcinoma
Subjects in Malaysia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Malaysia-Non-adenocarcinoma
Subjects in Malaysia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Indonesia-Adenocarcinoma
Subjects in Indonesia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Indonesia-Non-adenocarcinoma
Subjects in Indonesia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Russia-Adenocarcinoma
Subjects in Russia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Russia-Non-adenocarcinoma
Subjects in Russia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Plasma EGFR Mutation Status by Histology
Mutation Negative
|
74.4 Percentage of participants
Interval 71.6 to 77.0
|
93.2 Percentage of participants
Interval 90.2 to 95.6
|
68.3 Percentage of participants
Interval 61.5 to 74.5
|
90.2 Percentage of participants
Interval 79.8 to 96.3
|
82.6 Percentage of participants
Interval 68.6 to 92.2
|
100.0 Percentage of participants
Interval 78.2 to 100.0
|
89.3 Percentage of participants
Interval 86.3 to 91.8
|
92.9 Percentage of participants
Interval 90.0 to 95.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Plasma EGFR Mutation Status by Histology
Mutation Positive
|
25.6 Percentage of participants
Interval 23.0 to 28.4
|
6.8 Percentage of participants
Interval 4.4 to 9.8
|
31.7 Percentage of participants
Interval 25.5 to 38.5
|
9.8 Percentage of participants
Interval 3.7 to 20.2
|
17.4 Percentage of participants
Interval 7.8 to 31.4
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
10.7 Percentage of participants
Interval 8.2 to 13.7
|
7.1 Percentage of participants
Interval 4.8 to 10.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At ScreeningPopulation: Tumour and Plasma Evaluable Population
Plasma samples were only performed in China, Taiwan, South Korea and Russia.
Outcome measures
| Measure |
China
n=1355 Participants
Subjects in China that meet I/E and population criteria.
|
Taiwan
n=271 Participants
Subjects in Taiwan that meet I/E and population criteria
|
South Korea
n=61 Participants
Subjects in South Korea that meet I/E and population criteria
|
Australia
n=894 Participants
Subjects in Australia that meet I/E and population criteria
|
Thailand
Subjects in Thailand that meet I/E and population criteria
|
Singapore
Subjects in Singapore that meet I/E and population criteria
|
Malaysia
Subjects in Malaysia that meet I/E and population criteria
|
Indonesia
Subjects in Indonesia that meet I/E and population criteria
|
Russia
Subjects in Russia that meet I/E and population criteria
|
Thailand-Non-adenocarcinoma
Subjects in Thailand that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Singapore-Adenocarcinoma
Subjects in Singapore that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Singapore-Non-adenocarcinoma
Subjects in Singapore that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Malaysia-Adenocarcinoma
Subjects in Malaysia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Malaysia-Non-adenocarcinoma
Subjects in Malaysia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Indonesia-Adenocarcinoma
Subjects in Indonesia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Indonesia-Non-adenocarcinoma
Subjects in Indonesia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Russia-Adenocarcinoma
Subjects in Russia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Russia-Non-adenocarcinoma
Subjects in Russia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Concordance Rate of Comparison of Mutation Status Between Tumour and Plasma Samples
|
77.6 Percentage
Interval 75.2 to 79.8
|
76.8 Percentage
Interval 71.3 to 81.6
|
83.6 Percentage
Interval 71.9 to 91.8
|
85.8 Percentage
Interval 83.3 to 88.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At ScreeningPopulation: Tumour and Plasma Evaluable Population
Plasma samples were only performed in China, Taiwan, South Korea, and Russia. Participants only include those who had sensitivity and specificity tests performed.
Outcome measures
| Measure |
China
n=548 Participants
Subjects in China that meet I/E and population criteria.
|
Taiwan
n=807 Participants
Subjects in Taiwan that meet I/E and population criteria
|
South Korea
n=130 Participants
Subjects in South Korea that meet I/E and population criteria
|
Australia
n=141 Participants
Subjects in Australia that meet I/E and population criteria
|
Thailand
n=14 Participants
Subjects in Thailand that meet I/E and population criteria
|
Singapore
n=47 Participants
Subjects in Singapore that meet I/E and population criteria
|
Malaysia
n=109 Participants
Subjects in Malaysia that meet I/E and population criteria
|
Indonesia
n=785 Participants
Subjects in Indonesia that meet I/E and population criteria
|
Russia
Subjects in Russia that meet I/E and population criteria
|
Thailand-Non-adenocarcinoma
Subjects in Thailand that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Singapore-Adenocarcinoma
Subjects in Singapore that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Singapore-Non-adenocarcinoma
Subjects in Singapore that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Malaysia-Adenocarcinoma
Subjects in Malaysia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Malaysia-Non-adenocarcinoma
Subjects in Malaysia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Indonesia-Adenocarcinoma
Subjects in Indonesia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Indonesia-Non-adenocarcinoma
Subjects in Indonesia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Russia-Adenocarcinoma
Subjects in Russia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Russia-Non-adenocarcinoma
Subjects in Russia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Sensitivity and Specificity of Comparison of Mutation Status Between Tumour and Plasma Samples
|
48.7 Percentage
|
97.1 Percentage
|
53.8 Percentage
|
97.9 Percentage
|
42.9 Percentage
|
95.7 Percentage
|
30.3 Percentage
|
93.5 Percentage
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At ScreeningPopulation: Tumour and Plasma Evaluable Population
Plasma samples were only performed in China, Taiwan, South Korea, and Russia. Participants include only those who had Positive and Negative Predictive tests performed.
Outcome measures
| Measure |
China
n=290 Participants
Subjects in China that meet I/E and population criteria.
|
Taiwan
n=1065 Participants
Subjects in Taiwan that meet I/E and population criteria
|
South Korea
n=73 Participants
Subjects in South Korea that meet I/E and population criteria
|
Australia
n=198 Participants
Subjects in Australia that meet I/E and population criteria
|
Thailand
n=8 Participants
Subjects in Thailand that meet I/E and population criteria
|
Singapore
n=53 Participants
Subjects in Singapore that meet I/E and population criteria
|
Malaysia
n=84 Participants
Subjects in Malaysia that meet I/E and population criteria
|
Indonesia
n=810 Participants
Subjects in Indonesia that meet I/E and population criteria
|
Russia
Subjects in Russia that meet I/E and population criteria
|
Thailand-Non-adenocarcinoma
Subjects in Thailand that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Singapore-Adenocarcinoma
Subjects in Singapore that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Singapore-Non-adenocarcinoma
Subjects in Singapore that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Malaysia-Adenocarcinoma
Subjects in Malaysia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Malaysia-Non-adenocarcinoma
Subjects in Malaysia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Indonesia-Adenocarcinoma
Subjects in Indonesia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Indonesia-Non-adenocarcinoma
Subjects in Indonesia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Russia-Adenocarcinoma
Subjects in Russia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Russia-Non-adenocarcinoma
Subjects in Russia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Predictive Values of Comparison of Mutation Status Between Tumour and Plasma Samples
|
92.1 Percentage
|
73.6 Percentage
|
95.9 Percentage
|
69.7 Percentage
|
75.0 Percentage
|
84.9 Percentage
|
39.3 Percentage
|
90.6 Percentage
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At ScreeningPopulation: Enrolled Population
Frequencies of tumour EGFR mutation testing practices parameters.
Outcome measures
| Measure |
China
n=1458 Participants
Subjects in China that meet I/E and population criteria.
|
Taiwan
n=271 Participants
Subjects in Taiwan that meet I/E and population criteria
|
South Korea
n=62 Participants
Subjects in South Korea that meet I/E and population criteria
|
Australia
n=71 Participants
Subjects in Australia that meet I/E and population criteria
|
Thailand
n=94 Participants
Subjects in Thailand that meet I/E and population criteria
|
Singapore
n=102 Participants
Subjects in Singapore that meet I/E and population criteria
|
Malaysia
n=50 Participants
Subjects in Malaysia that meet I/E and population criteria
|
Indonesia
n=302 Participants
Subjects in Indonesia that meet I/E and population criteria
|
Russia
n=972 Participants
Subjects in Russia that meet I/E and population criteria
|
Thailand-Non-adenocarcinoma
Subjects in Thailand that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Singapore-Adenocarcinoma
Subjects in Singapore that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Singapore-Non-adenocarcinoma
Subjects in Singapore that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Malaysia-Adenocarcinoma
Subjects in Malaysia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Malaysia-Non-adenocarcinoma
Subjects in Malaysia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Indonesia-Adenocarcinoma
Subjects in Indonesia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Indonesia-Non-adenocarcinoma
Subjects in Indonesia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Russia-Adenocarcinoma
Subjects in Russia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Russia-Non-adenocarcinoma
Subjects in Russia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tumour EGFR Mutation Testing
Tumour Sample
|
1394 Participants
|
271 Participants
|
62 Participants
|
60 Participants
|
92 Participants
|
101 Participants
|
49 Participants
|
273 Participants
|
936 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Tumour EGFR Mutation Testing
Mutation Test Not Performed
|
64 Participants
|
0 Participants
|
0 Participants
|
11 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
29 Participants
|
36 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At ScreeningPopulation: Enrolled Population
Testing Success rate is the percentage of subjects with a non-missing test result. Mutation Detection Rate is the percentage of subjects with successful test that detects a mutation.
Outcome measures
| Measure |
China
n=1458 Participants
Subjects in China that meet I/E and population criteria.
|
Taiwan
n=271 Participants
Subjects in Taiwan that meet I/E and population criteria
|
South Korea
n=62 Participants
Subjects in South Korea that meet I/E and population criteria
|
Australia
n=71 Participants
Subjects in Australia that meet I/E and population criteria
|
Thailand
n=94 Participants
Subjects in Thailand that meet I/E and population criteria
|
Singapore
n=102 Participants
Subjects in Singapore that meet I/E and population criteria
|
Malaysia
n=50 Participants
Subjects in Malaysia that meet I/E and population criteria
|
Indonesia
n=302 Participants
Subjects in Indonesia that meet I/E and population criteria
|
Russia
n=972 Participants
Subjects in Russia that meet I/E and population criteria
|
Thailand-Non-adenocarcinoma
Subjects in Thailand that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Singapore-Adenocarcinoma
Subjects in Singapore that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Singapore-Non-adenocarcinoma
Subjects in Singapore that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Malaysia-Adenocarcinoma
Subjects in Malaysia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Malaysia-Non-adenocarcinoma
Subjects in Malaysia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Indonesia-Adenocarcinoma
Subjects in Indonesia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Indonesia-Non-adenocarcinoma
Subjects in Indonesia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Russia-Adenocarcinoma
Subjects in Russia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Russia-Non-adenocarcinoma
Subjects in Russia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tumour EGFR Mutation Testing Rates
Testing Success Rate
|
99.8 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
96.7 Percentage of Participants
|
94.6 Percentage of Participants
|
99.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
98.7 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Tumour EGFR Mutation Testing Rates
Mutation Detection Rate
|
40.7 Percentage of Participants
|
48.0 Percentage of Participants
|
24.2 Percentage of Participants
|
28.3 Percentage of Participants
|
27.2 Percentage of Participants
|
54.5 Percentage of Participants
|
34.7 Percentage of Participants
|
42.5 Percentage of Participants
|
12.7 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At ScreeningPopulation: Enrolled Population
Tumour EGFR mutation testing turnaround time is the number of days from the test request to getting the test result.
Outcome measures
| Measure |
China
n=1458 Participants
Subjects in China that meet I/E and population criteria.
|
Taiwan
n=271 Participants
Subjects in Taiwan that meet I/E and population criteria
|
South Korea
n=62 Participants
Subjects in South Korea that meet I/E and population criteria
|
Australia
n=71 Participants
Subjects in Australia that meet I/E and population criteria
|
Thailand
n=94 Participants
Subjects in Thailand that meet I/E and population criteria
|
Singapore
n=102 Participants
Subjects in Singapore that meet I/E and population criteria
|
Malaysia
n=50 Participants
Subjects in Malaysia that meet I/E and population criteria
|
Indonesia
n=302 Participants
Subjects in Indonesia that meet I/E and population criteria
|
Russia
n=972 Participants
Subjects in Russia that meet I/E and population criteria
|
Thailand-Non-adenocarcinoma
Subjects in Thailand that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Singapore-Adenocarcinoma
Subjects in Singapore that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Singapore-Non-adenocarcinoma
Subjects in Singapore that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Malaysia-Adenocarcinoma
Subjects in Malaysia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Malaysia-Non-adenocarcinoma
Subjects in Malaysia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Indonesia-Adenocarcinoma
Subjects in Indonesia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Indonesia-Non-adenocarcinoma
Subjects in Indonesia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Russia-Adenocarcinoma
Subjects in Russia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Russia-Non-adenocarcinoma
Subjects in Russia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tumour EGFR Mutation Testing Turnaround Time
|
6.2 Time (Days)
Standard Deviation 5.34
|
7.4 Time (Days)
Standard Deviation 12.29
|
11.7 Time (Days)
Standard Deviation 12.70
|
12.9 Time (Days)
Standard Deviation 8.19
|
70.8 Time (Days)
Standard Deviation 43.85
|
8.4 Time (Days)
Standard Deviation 4.90
|
8.6 Time (Days)
Standard Deviation 3.55
|
6.5 Time (Days)
Standard Deviation 2.33
|
14.3 Time (Days)
Standard Deviation 26.84
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At ScreeningPopulation: Enrolled Population
Plasma samples were only performed in China, Taiwan, South Korea and Russia. Frequencies of plasma EGFR mutation testing practices parameters.
Outcome measures
| Measure |
China
n=1458 Participants
Subjects in China that meet I/E and population criteria.
|
Taiwan
n=271 Participants
Subjects in Taiwan that meet I/E and population criteria
|
South Korea
n=62 Participants
Subjects in South Korea that meet I/E and population criteria
|
Australia
n=972 Participants
Subjects in Australia that meet I/E and population criteria
|
Thailand
Subjects in Thailand that meet I/E and population criteria
|
Singapore
Subjects in Singapore that meet I/E and population criteria
|
Malaysia
Subjects in Malaysia that meet I/E and population criteria
|
Indonesia
Subjects in Indonesia that meet I/E and population criteria
|
Russia
Subjects in Russia that meet I/E and population criteria
|
Thailand-Non-adenocarcinoma
Subjects in Thailand that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Singapore-Adenocarcinoma
Subjects in Singapore that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Singapore-Non-adenocarcinoma
Subjects in Singapore that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Malaysia-Adenocarcinoma
Subjects in Malaysia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Malaysia-Non-adenocarcinoma
Subjects in Malaysia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Indonesia-Adenocarcinoma
Subjects in Indonesia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Indonesia-Non-adenocarcinoma
Subjects in Indonesia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Russia-Adenocarcinoma
Subjects in Russia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Russia-Non-adenocarcinoma
Subjects in Russia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Plasma EGFR Mutation Testing
Plasma Sample
|
1421 Participants
|
271 Participants
|
62 Participants
|
950 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Plasma EGFR Mutation Testing
Mutation Test Not performed
|
37 Participants
|
0 Participants
|
0 Participants
|
22 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At ScreeningPopulation: Enrolled Population
Testing Success rate is the percentage of subjects with a non-missing test result. Mutation Detection Rate is the percentage of subjects with successful test that detects a mutation. Plasma samples were only performed in China, Taiwan, South Korea and Russia.
Outcome measures
| Measure |
China
n=1458 Participants
Subjects in China that meet I/E and population criteria.
|
Taiwan
n=271 Participants
Subjects in Taiwan that meet I/E and population criteria
|
South Korea
n=62 Participants
Subjects in South Korea that meet I/E and population criteria
|
Australia
n=972 Participants
Subjects in Australia that meet I/E and population criteria
|
Thailand
Subjects in Thailand that meet I/E and population criteria
|
Singapore
Subjects in Singapore that meet I/E and population criteria
|
Malaysia
Subjects in Malaysia that meet I/E and population criteria
|
Indonesia
Subjects in Indonesia that meet I/E and population criteria
|
Russia
Subjects in Russia that meet I/E and population criteria
|
Thailand-Non-adenocarcinoma
Subjects in Thailand that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Singapore-Adenocarcinoma
Subjects in Singapore that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Singapore-Non-adenocarcinoma
Subjects in Singapore that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Malaysia-Adenocarcinoma
Subjects in Malaysia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Malaysia-Non-adenocarcinoma
Subjects in Malaysia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Indonesia-Adenocarcinoma
Subjects in Indonesia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Indonesia-Non-adenocarcinoma
Subjects in Indonesia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Russia-Adenocarcinoma
Subjects in Russia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Russia-Non-adenocarcinoma
Subjects in Russia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Plasma EGFR Mutation Testing Rates
Mutation Detection Rate
|
20.7 Percentage of Participants
|
26.9 Percentage of Participants
|
12.9 Percentage of Participants
|
9.2 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Plasma EGFR Mutation Testing Rates
Testing Success Rate
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
98.4 Percentage of Participants
|
99.1 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At ScreeningPopulation: Enrolled Population
Plasma samples were only performed in China, Taiwan, South Korea and Russia. Plasma EGFR mutation testing turnaround time is the number of days from the test request to getting the test result.
Outcome measures
| Measure |
China
n=1458 Participants
Subjects in China that meet I/E and population criteria.
|
Taiwan
n=271 Participants
Subjects in Taiwan that meet I/E and population criteria
|
South Korea
n=62 Participants
Subjects in South Korea that meet I/E and population criteria
|
Australia
n=972 Participants
Subjects in Australia that meet I/E and population criteria
|
Thailand
Subjects in Thailand that meet I/E and population criteria
|
Singapore
Subjects in Singapore that meet I/E and population criteria
|
Malaysia
Subjects in Malaysia that meet I/E and population criteria
|
Indonesia
Subjects in Indonesia that meet I/E and population criteria
|
Russia
Subjects in Russia that meet I/E and population criteria
|
Thailand-Non-adenocarcinoma
Subjects in Thailand that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Singapore-Adenocarcinoma
Subjects in Singapore that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Singapore-Non-adenocarcinoma
Subjects in Singapore that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Malaysia-Adenocarcinoma
Subjects in Malaysia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Malaysia-Non-adenocarcinoma
Subjects in Malaysia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Indonesia-Adenocarcinoma
Subjects in Indonesia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Indonesia-Non-adenocarcinoma
Subjects in Indonesia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Russia-Adenocarcinoma
Subjects in Russia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Russia-Non-adenocarcinoma
Subjects in Russia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Plasma EGFR Mutation Testing Turnaround Time
|
39.8 Time (Days)
Standard Deviation 44.24
|
26.7 Time (Days)
Standard Deviation 12.62
|
18.1 Time (Days)
Standard Deviation 13.72
|
90.1 Time (Days)
Standard Deviation 105.69
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At ScreeningPopulation: Tumour Evaluable Population
Correlation of demographic and disease characteristics are summarized by EGFR mutation status with results from a multivariate logistic regression using stepwise forward selection with a 10% significance level for model entry.
Outcome measures
| Measure |
China
n=1051 Participants
Subjects in China that meet I/E and population criteria.
|
Taiwan
n=2164 Participants
Subjects in Taiwan that meet I/E and population criteria
|
South Korea
Subjects in South Korea that meet I/E and population criteria
|
Australia
Subjects in Australia that meet I/E and population criteria
|
Thailand
Subjects in Thailand that meet I/E and population criteria
|
Singapore
Subjects in Singapore that meet I/E and population criteria
|
Malaysia
Subjects in Malaysia that meet I/E and population criteria
|
Indonesia
Subjects in Indonesia that meet I/E and population criteria
|
Russia
Subjects in Russia that meet I/E and population criteria
|
Thailand-Non-adenocarcinoma
Subjects in Thailand that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Singapore-Adenocarcinoma
Subjects in Singapore that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Singapore-Non-adenocarcinoma
Subjects in Singapore that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Malaysia-Adenocarcinoma
Subjects in Malaysia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Malaysia-Non-adenocarcinoma
Subjects in Malaysia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Indonesia-Adenocarcinoma
Subjects in Indonesia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Indonesia-Non-adenocarcinoma
Subjects in Indonesia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Russia-Adenocarcinoma
Subjects in Russia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Russia-Non-adenocarcinoma
Subjects in Russia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Demographics and Disease Characteristics by Tumour EGFR Mutation Status
Number of Organs with Metastasis = 4
|
53 Participants
|
61 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Demographics and Disease Characteristics by Tumour EGFR Mutation Status
Number of Organs with Metastasis = 5
|
16 Participants
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Demographics and Disease Characteristics by Tumour EGFR Mutation Status
Number of Organs with Metastasis = 7
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Demographics and Disease Characteristics by Tumour EGFR Mutation Status
Smoking Status: Never-Smoker
|
705 Participants
|
647 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Demographics and Disease Characteristics by Tumour EGFR Mutation Status
Smoking Status: Ever-Smoker
|
346 Participants
|
1517 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Demographics and Disease Characteristics by Tumour EGFR Mutation Status
Gender: Male
|
480 Participants
|
1647 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Demographics and Disease Characteristics by Tumour EGFR Mutation Status
Gender: Female
|
571 Participants
|
517 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Demographics and Disease Characteristics by Tumour EGFR Mutation Status
Region: Asia Pacific
|
941 Participants
|
1350 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Demographics and Disease Characteristics by Tumour EGFR Mutation Status
Region: Russia
|
110 Participants
|
814 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Demographics and Disease Characteristics by Tumour EGFR Mutation Status
Age: <=65
|
695 Participants
|
1447 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Demographics and Disease Characteristics by Tumour EGFR Mutation Status
>65
|
356 Participants
|
717 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Demographics and Disease Characteristics by Tumour EGFR Mutation Status
World Health Organization Performance Status: 0-1
|
866 Participants
|
1808 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Demographics and Disease Characteristics by Tumour EGFR Mutation Status
World Health Organization Performance Status: 2
|
128 Participants
|
276 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Demographics and Disease Characteristics by Tumour EGFR Mutation Status
Current Disease Status: IIIA
|
42 Participants
|
266 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Demographics and Disease Characteristics by Tumour EGFR Mutation Status
Current Disease Status: IIIB
|
86 Participants
|
371 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Demographics and Disease Characteristics by Tumour EGFR Mutation Status
Current Disease Status: IV
|
923 Participants
|
1527 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Demographics and Disease Characteristics by Tumour EGFR Mutation Status
Number of Organs with Metastasis = 1
|
458 Participants
|
901 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Demographics and Disease Characteristics by Tumour EGFR Mutation Status
Number of Organs with Metastasis = 2
|
266 Participants
|
408 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Demographics and Disease Characteristics by Tumour EGFR Mutation Status
Number of Organs with Metastasis = 3
|
127 Participants
|
149 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Demographics and Disease Characteristics by Tumour EGFR Mutation Status
Number of Organs with Metastasis = 6
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Demographics and Disease Characteristics by Tumour EGFR Mutation Status
Histology: Adenocarcinoma
|
952 Participants
|
1297 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Demographics and Disease Characteristics by Tumour EGFR Mutation Status
Histology: Non-adenocarcinoma
|
89 Participants
|
838 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At ScreeningPopulation: Tumour Evaluable Population
Number of months since the first diagnosis of NSCLC from informed consent date.
Outcome measures
| Measure |
China
n=1051 Participants
Subjects in China that meet I/E and population criteria.
|
Taiwan
n=2164 Participants
Subjects in Taiwan that meet I/E and population criteria
|
South Korea
Subjects in South Korea that meet I/E and population criteria
|
Australia
Subjects in Australia that meet I/E and population criteria
|
Thailand
Subjects in Thailand that meet I/E and population criteria
|
Singapore
Subjects in Singapore that meet I/E and population criteria
|
Malaysia
Subjects in Malaysia that meet I/E and population criteria
|
Indonesia
Subjects in Indonesia that meet I/E and population criteria
|
Russia
Subjects in Russia that meet I/E and population criteria
|
Thailand-Non-adenocarcinoma
Subjects in Thailand that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Singapore-Adenocarcinoma
Subjects in Singapore that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Singapore-Non-adenocarcinoma
Subjects in Singapore that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Malaysia-Adenocarcinoma
Subjects in Malaysia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Malaysia-Non-adenocarcinoma
Subjects in Malaysia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Indonesia-Adenocarcinoma
Subjects in Indonesia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Indonesia-Non-adenocarcinoma
Subjects in Indonesia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Russia-Adenocarcinoma
Subjects in Russia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Russia-Non-adenocarcinoma
Subjects in Russia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time Since First Non-small-cell Lung Carcinoma (NSCLC) Diagnosis by Tumor EGFR Mutation
|
2.6 Months
Standard Deviation 8.93
|
2.6 Months
Standard Deviation 9.79
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At ScreeningPopulation: Tumour Evaluable Population
Summary of number of organs with metastasis. Only participants with at least 1 organ with metastasis are included.
Outcome measures
| Measure |
China
n=925 Participants
Subjects in China that meet I/E and population criteria.
|
Taiwan
n=1537 Participants
Subjects in Taiwan that meet I/E and population criteria
|
South Korea
Subjects in South Korea that meet I/E and population criteria
|
Australia
Subjects in Australia that meet I/E and population criteria
|
Thailand
Subjects in Thailand that meet I/E and population criteria
|
Singapore
Subjects in Singapore that meet I/E and population criteria
|
Malaysia
Subjects in Malaysia that meet I/E and population criteria
|
Indonesia
Subjects in Indonesia that meet I/E and population criteria
|
Russia
Subjects in Russia that meet I/E and population criteria
|
Thailand-Non-adenocarcinoma
Subjects in Thailand that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Singapore-Adenocarcinoma
Subjects in Singapore that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Singapore-Non-adenocarcinoma
Subjects in Singapore that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Malaysia-Adenocarcinoma
Subjects in Malaysia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Malaysia-Non-adenocarcinoma
Subjects in Malaysia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Indonesia-Adenocarcinoma
Subjects in Indonesia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Indonesia-Non-adenocarcinoma
Subjects in Indonesia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Russia-Adenocarcinoma
Subjects in Russia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Russia-Non-adenocarcinoma
Subjects in Russia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Organs With Metastasis by Tumour EGFR Mutation Status
|
1.8 Number
Standard Deviation 1.05
|
1.6 Number
Standard Deviation 0.91
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At ScreeningPopulation: Plasma Evaluable Population
Correlation of demographic and disease characteristics are summarized by EGFR mutation status with results from a multivariate logistic regression using stepwise forward selection with a 10% significance level for model entry.
Outcome measures
| Measure |
China
n=462 Participants
Subjects in China that meet I/E and population criteria.
|
Taiwan
n=2232 Participants
Subjects in Taiwan that meet I/E and population criteria
|
South Korea
Subjects in South Korea that meet I/E and population criteria
|
Australia
Subjects in Australia that meet I/E and population criteria
|
Thailand
Subjects in Thailand that meet I/E and population criteria
|
Singapore
Subjects in Singapore that meet I/E and population criteria
|
Malaysia
Subjects in Malaysia that meet I/E and population criteria
|
Indonesia
Subjects in Indonesia that meet I/E and population criteria
|
Russia
Subjects in Russia that meet I/E and population criteria
|
Thailand-Non-adenocarcinoma
Subjects in Thailand that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Singapore-Adenocarcinoma
Subjects in Singapore that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Singapore-Non-adenocarcinoma
Subjects in Singapore that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Malaysia-Adenocarcinoma
Subjects in Malaysia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Malaysia-Non-adenocarcinoma
Subjects in Malaysia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Indonesia-Adenocarcinoma
Subjects in Indonesia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Indonesia-Non-adenocarcinoma
Subjects in Indonesia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Russia-Adenocarcinoma
Subjects in Russia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Russia-Non-adenocarcinoma
Subjects in Russia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Demographics and Disease Characteristics by Plasma EGFR Mutation Status
Histology: Adenocarcinoma
|
397 Participants
|
1417 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Demographics and Disease Characteristics by Plasma EGFR Mutation Status
WHO Performance Status: 0-1
|
400 Participants
|
1956 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Demographics and Disease Characteristics by Plasma EGFR Mutation Status
WHO Performance Status: 2
|
43 Participants
|
237 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Demographics and Disease Characteristics by Plasma EGFR Mutation Status
Current Disease Status: IIIA
|
23 Participants
|
257 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Demographics and Disease Characteristics by Plasma EGFR Mutation Status
Current Disease Status: IIIB
|
32 Participants
|
378 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Demographics and Disease Characteristics by Plasma EGFR Mutation Status
Current Disease Status: IV
|
407 Participants
|
1597 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Demographics and Disease Characteristics by Plasma EGFR Mutation Status
Number of Organs with Metastasis = 2
|
120 Participants
|
420 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Demographics and Disease Characteristics by Plasma EGFR Mutation Status
Histology: Non-adenocarcinoma
|
60 Participants
|
794 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Demographics and Disease Characteristics by Plasma EGFR Mutation Status
Smoking Status: Never-Smoker
|
298 Participants
|
835 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Demographics and Disease Characteristics by Plasma EGFR Mutation Status
Smoking Status: Ever-Smoker
|
164 Participants
|
1397 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Demographics and Disease Characteristics by Plasma EGFR Mutation Status
Gender: Male
|
228 Participants
|
1575 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Demographics and Disease Characteristics by Plasma EGFR Mutation Status
Gender: Female
|
234 Participants
|
657 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Demographics and Disease Characteristics by Plasma EGFR Mutation Status
Region: Asia Pacific
|
375 Participants
|
1378 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Demographics and Disease Characteristics by Plasma EGFR Mutation Status
Region: Russia
|
87 Participants
|
854 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Demographics and Disease Characteristics by Plasma EGFR Mutation Status
Age: <=65
|
337 Participants
|
1454 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Demographics and Disease Characteristics by Plasma EGFR Mutation Status
Age: >65
|
125 Participants
|
778 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Demographics and Disease Characteristics by Plasma EGFR Mutation Status
Number of Organs with Metastasis = 1
|
167 Participants
|
956 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Demographics and Disease Characteristics by Plasma EGFR Mutation Status
Number of Organs with Metastasis = 3
|
67 Participants
|
155 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Demographics and Disease Characteristics by Plasma EGFR Mutation Status
Number of Organs with Metastasis = 4
|
37 Participants
|
57 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Demographics and Disease Characteristics by Plasma EGFR Mutation Status
Number of Organs with Metastasis = 5
|
12 Participants
|
17 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Demographics and Disease Characteristics by Plasma EGFR Mutation Status
Number of Organs with Metastasis = 6
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Demographics and Disease Characteristics by Plasma EGFR Mutation Status
Number of Organs with Metastasis = 7
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At ScreeningPopulation: Plasma Evaluable Population
Number of months since the first diagnosis of NSCLC from informed consent date.
Outcome measures
| Measure |
China
n=462 Participants
Subjects in China that meet I/E and population criteria.
|
Taiwan
n=2232 Participants
Subjects in Taiwan that meet I/E and population criteria
|
South Korea
Subjects in South Korea that meet I/E and population criteria
|
Australia
Subjects in Australia that meet I/E and population criteria
|
Thailand
Subjects in Thailand that meet I/E and population criteria
|
Singapore
Subjects in Singapore that meet I/E and population criteria
|
Malaysia
Subjects in Malaysia that meet I/E and population criteria
|
Indonesia
Subjects in Indonesia that meet I/E and population criteria
|
Russia
Subjects in Russia that meet I/E and population criteria
|
Thailand-Non-adenocarcinoma
Subjects in Thailand that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Singapore-Adenocarcinoma
Subjects in Singapore that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Singapore-Non-adenocarcinoma
Subjects in Singapore that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Malaysia-Adenocarcinoma
Subjects in Malaysia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Malaysia-Non-adenocarcinoma
Subjects in Malaysia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Indonesia-Adenocarcinoma
Subjects in Indonesia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Indonesia-Non-adenocarcinoma
Subjects in Indonesia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Russia-Adenocarcinoma
Subjects in Russia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Russia-Non-adenocarcinoma
Subjects in Russia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time Since First NSCLC Diagnosis by Plasma EGFR Mutation
|
2.2 Months
Standard Deviation 7.99
|
3.0 Months
Standard Deviation 11.09
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At ScreeningPopulation: Plasma Evaluable Population
Summary of number of organs with metastasis. Only participants with at least 1 organ with metastasis are included.
Outcome measures
| Measure |
China
n=408 Participants
Subjects in China that meet I/E and population criteria.
|
Taiwan
n=1607 Participants
Subjects in Taiwan that meet I/E and population criteria
|
South Korea
Subjects in South Korea that meet I/E and population criteria
|
Australia
Subjects in Australia that meet I/E and population criteria
|
Thailand
Subjects in Thailand that meet I/E and population criteria
|
Singapore
Subjects in Singapore that meet I/E and population criteria
|
Malaysia
Subjects in Malaysia that meet I/E and population criteria
|
Indonesia
Subjects in Indonesia that meet I/E and population criteria
|
Russia
Subjects in Russia that meet I/E and population criteria
|
Thailand-Non-adenocarcinoma
Subjects in Thailand that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Singapore-Adenocarcinoma
Subjects in Singapore that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Singapore-Non-adenocarcinoma
Subjects in Singapore that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Malaysia-Adenocarcinoma
Subjects in Malaysia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Malaysia-Non-adenocarcinoma
Subjects in Malaysia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Indonesia-Adenocarcinoma
Subjects in Indonesia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Indonesia-Non-adenocarcinoma
Subjects in Indonesia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Russia-Adenocarcinoma
Subjects in Russia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Russia-Non-adenocarcinoma
Subjects in Russia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Organs With Metastasis by Plasma EGFR Mutation Status
|
2.1 Number
Standard Deviation 1.21
|
1.6 Number
Standard Deviation 0.89
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At ScreeningPopulation: Tumour Evaluable Population
Outcome measures
| Measure |
China
n=1391 Participants
Subjects in China that meet I/E and population criteria.
|
Taiwan
n=271 Participants
Subjects in Taiwan that meet I/E and population criteria
|
South Korea
n=62 Participants
Subjects in South Korea that meet I/E and population criteria
|
Australia
n=58 Participants
Subjects in Australia that meet I/E and population criteria
|
Thailand
n=87 Participants
Subjects in Thailand that meet I/E and population criteria
|
Singapore
n=100 Participants
Subjects in Singapore that meet I/E and population criteria
|
Malaysia
n=49 Participants
Subjects in Malaysia that meet I/E and population criteria
|
Indonesia
n=273 Participants
Subjects in Indonesia that meet I/E and population criteria
|
Russia
n=924 Participants
Subjects in Russia that meet I/E and population criteria
|
Thailand-Non-adenocarcinoma
Subjects in Thailand that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Singapore-Adenocarcinoma
Subjects in Singapore that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Singapore-Non-adenocarcinoma
Subjects in Singapore that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Malaysia-Adenocarcinoma
Subjects in Malaysia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Malaysia-Non-adenocarcinoma
Subjects in Malaysia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Indonesia-Adenocarcinoma
Subjects in Indonesia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Indonesia-Non-adenocarcinoma
Subjects in Indonesia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Russia-Adenocarcinoma
Subjects in Russia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Russia-Non-adenocarcinoma
Subjects in Russia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
First Line Treatment Choice by Asia Pacific Country
Other: Yes
|
33 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
First Line Treatment Choice by Asia Pacific Country
Other: No
|
1358 Participants
|
271 Participants
|
62 Participants
|
56 Participants
|
87 Participants
|
100 Participants
|
49 Participants
|
273 Participants
|
916 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
First Line Treatment Choice by Asia Pacific Country
Systemic Anticancer Treatment: Yes
|
1151 Participants
|
218 Participants
|
44 Participants
|
45 Participants
|
65 Participants
|
87 Participants
|
29 Participants
|
174 Participants
|
641 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
First Line Treatment Choice by Asia Pacific Country
Cisplatin
|
424 Participants
|
11 Participants
|
15 Participants
|
3 Participants
|
7 Participants
|
9 Participants
|
12 Participants
|
0 Participants
|
301 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
First Line Treatment Choice by Asia Pacific Country
Crizotinib
|
7 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
First Line Treatment Choice by Asia Pacific Country
Docetaxel
|
77 Participants
|
18 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
19 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
First Line Treatment Choice by Asia Pacific Country
Etoposide
|
12 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
11 Participants
|
244 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
First Line Treatment Choice by Asia Pacific Country
Gemcitabine
|
284 Participants
|
14 Participants
|
5 Participants
|
25 Participants
|
9 Participants
|
5 Participants
|
22 Participants
|
1 Participants
|
46 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
First Line Treatment Choice by Asia Pacific Country
Icotinib
|
55 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
First Line Treatment Choice by Asia Pacific Country
Paclitaxel
|
133 Participants
|
12 Participants
|
9 Participants
|
4 Participants
|
46 Participants
|
4 Participants
|
0 Participants
|
18 Participants
|
166 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
First Line Treatment Choice by Asia Pacific Country
Vincristine
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
First Line Treatment Choice by Asia Pacific Country
Vinorelbine
|
41 Participants
|
22 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
First Line Treatment Choice by Asia Pacific Country
Investigational agent
|
17 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
First Line Treatment Choice by Asia Pacific Country
Other Chemotherapy
|
142 Participants
|
5 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
44 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
First Line Treatment Choice by Asia Pacific Country
Surgery: Yes
|
8 Participants
|
6 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
First Line Treatment Choice by Asia Pacific Country
Radiotherapy: Yes
|
62 Participants
|
26 Participants
|
14 Participants
|
14 Participants
|
3 Participants
|
11 Participants
|
17 Participants
|
7 Participants
|
72 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
First Line Treatment Choice by Asia Pacific Country
Radiotherapy: No
|
1329 Participants
|
245 Participants
|
48 Participants
|
44 Participants
|
84 Participants
|
89 Participants
|
32 Participants
|
266 Participants
|
852 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
First Line Treatment Choice by Asia Pacific Country
Systemic Anticancer Treatment: No
|
240 Participants
|
53 Participants
|
18 Participants
|
13 Participants
|
22 Participants
|
13 Participants
|
20 Participants
|
99 Participants
|
283 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
First Line Treatment Choice by Asia Pacific Country
Afatinib
|
0 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
10 Participants
|
0 Participants
|
0 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
First Line Treatment Choice by Asia Pacific Country
Bevacizumab
|
5 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
First Line Treatment Choice by Asia Pacific Country
Carboplatin
|
273 Participants
|
2 Participants
|
10 Participants
|
26 Participants
|
52 Participants
|
23 Participants
|
10 Participants
|
100 Participants
|
235 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
First Line Treatment Choice by Asia Pacific Country
Cetuximab
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
First Line Treatment Choice by Asia Pacific Country
Erlotinib
|
21 Participants
|
46 Participants
|
2 Participants
|
5 Participants
|
0 Participants
|
16 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
First Line Treatment Choice by Asia Pacific Country
Gefitinib
|
137 Participants
|
65 Participants
|
6 Participants
|
3 Participants
|
1 Participants
|
21 Participants
|
4 Participants
|
73 Participants
|
33 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
First Line Treatment Choice by Asia Pacific Country
Pemetrexed
|
332 Participants
|
25 Participants
|
9 Participants
|
0 Participants
|
0 Participants
|
25 Participants
|
1 Participants
|
0 Participants
|
28 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
First Line Treatment Choice by Asia Pacific Country
Surgery: No
|
1383 Participants
|
265 Participants
|
61 Participants
|
58 Participants
|
87 Participants
|
99 Participants
|
48 Participants
|
273 Participants
|
912 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At ScreeningPopulation: Tumour Evaluable Population
Outcome measures
| Measure |
China
n=567 Participants
Subjects in China that meet I/E and population criteria.
|
Taiwan
n=824 Participants
Subjects in Taiwan that meet I/E and population criteria
|
South Korea
n=130 Participants
Subjects in South Korea that meet I/E and population criteria
|
Australia
n=141 Participants
Subjects in Australia that meet I/E and population criteria
|
Thailand
n=14 Participants
Subjects in Thailand that meet I/E and population criteria
|
Singapore
n=48 Participants
Subjects in Singapore that meet I/E and population criteria
|
Malaysia
n=17 Participants
Subjects in Malaysia that meet I/E and population criteria
|
Indonesia
n=41 Participants
Subjects in Indonesia that meet I/E and population criteria
|
Russia
n=25 Participants
Subjects in Russia that meet I/E and population criteria
|
Thailand-Non-adenocarcinoma
n=62 Participants
Subjects in Thailand that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Singapore-Adenocarcinoma
n=55 Participants
Subjects in Singapore that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Singapore-Non-adenocarcinoma
n=45 Participants
Subjects in Singapore that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Malaysia-Adenocarcinoma
n=17 Participants
Subjects in Malaysia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Malaysia-Non-adenocarcinoma
n=32 Participants
Subjects in Malaysia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Indonesia-Adenocarcinoma
n=116 Participants
Subjects in Indonesia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Indonesia-Non-adenocarcinoma
n=157 Participants
Subjects in Indonesia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
Russia-Adenocarcinoma
n=110 Participants
Subjects in Russia that meet I/E and population criteria with a histological type of Adenocarcinoma.
|
Russia-Non-adenocarcinoma
n=814 Participants
Subjects in Russia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
First Line Treatment Choice by Asia Pacific Country by Tumour EGFR Mutation Status
Systemic Anticancer Treatment? Yes
|
499 Participants
|
652 Participants
|
122 Participants
|
96 Participants
|
12 Participants
|
32 Participants
|
13 Participants
|
32 Participants
|
19 Participants
|
46 Participants
|
54 Participants
|
33 Participants
|
10 Participants
|
19 Participants
|
80 Participants
|
94 Participants
|
86 Participants
|
555 Participants
|
|
First Line Treatment Choice by Asia Pacific Country by Tumour EGFR Mutation Status
Systemic Anticancer Treatment? No
|
68 Participants
|
172 Participants
|
8 Participants
|
45 Participants
|
2 Participants
|
16 Participants
|
4 Participants
|
9 Participants
|
6 Participants
|
16 Participants
|
1 Participants
|
12 Participants
|
7 Participants
|
13 Participants
|
36 Participants
|
63 Participants
|
24 Participants
|
259 Participants
|
|
First Line Treatment Choice by Asia Pacific Country by Tumour EGFR Mutation Status
Afatinib
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
10 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
13 Participants
|
0 Participants
|
|
First Line Treatment Choice by Asia Pacific Country by Tumour EGFR Mutation Status
Bevacizumab
|
1 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
First Line Treatment Choice by Asia Pacific Country by Tumour EGFR Mutation Status
Carboplatin
|
96 Participants
|
177 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
9 Participants
|
1 Participants
|
25 Participants
|
16 Participants
|
36 Participants
|
5 Participants
|
18 Participants
|
3 Participants
|
7 Participants
|
8 Participants
|
94 Participants
|
28 Participants
|
207 Participants
|
|
First Line Treatment Choice by Asia Pacific Country by Tumour EGFR Mutation Status
Docetaxel
|
19 Participants
|
58 Participants
|
3 Participants
|
15 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
16 Participants
|
|
First Line Treatment Choice by Asia Pacific Country by Tumour EGFR Mutation Status
Etoposide
|
1 Participants
|
11 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
8 Participants
|
18 Participants
|
226 Participants
|
|
First Line Treatment Choice by Asia Pacific Country by Tumour EGFR Mutation Status
Gefitinib
|
127 Participants
|
10 Participants
|
65 Participants
|
0 Participants
|
6 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
21 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
73 Participants
|
0 Participants
|
24 Participants
|
9 Participants
|
|
First Line Treatment Choice by Asia Pacific Country by Tumour EGFR Mutation Status
Gemcitabine
|
61 Participants
|
223 Participants
|
1 Participants
|
13 Participants
|
0 Participants
|
5 Participants
|
1 Participants
|
24 Participants
|
3 Participants
|
6 Participants
|
1 Participants
|
4 Participants
|
6 Participants
|
16 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
44 Participants
|
|
First Line Treatment Choice by Asia Pacific Country by Tumour EGFR Mutation Status
Icotinib
|
50 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
First Line Treatment Choice by Asia Pacific Country by Tumour EGFR Mutation Status
Vincristine
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
First Line Treatment Choice by Asia Pacific Country by Tumour EGFR Mutation Status
Vinorelbine
|
14 Participants
|
27 Participants
|
3 Participants
|
19 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
|
First Line Treatment Choice by Asia Pacific Country by Tumour EGFR Mutation Status
Investigational Agent
|
15 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
First Line Treatment Choice by Asia Pacific Country by Tumour EGFR Mutation Status
Cetuximab
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
First Line Treatment Choice by Asia Pacific Country by Tumour EGFR Mutation Status
Surgery: Yes
|
2 Participants
|
6 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
10 Participants
|
|
First Line Treatment Choice by Asia Pacific Country by Tumour EGFR Mutation Status
Surgery: No
|
565 Participants
|
818 Participants
|
125 Participants
|
140 Participants
|
14 Participants
|
47 Participants
|
17 Participants
|
41 Participants
|
25 Participants
|
62 Participants
|
55 Participants
|
44 Participants
|
17 Participants
|
31 Participants
|
116 Participants
|
157 Participants
|
108 Participants
|
804 Participants
|
|
First Line Treatment Choice by Asia Pacific Country by Tumour EGFR Mutation Status
Radiotherapy: No
|
546 Participants
|
783 Participants
|
128 Participants
|
117 Participants
|
11 Participants
|
37 Participants
|
14 Participants
|
30 Participants
|
23 Participants
|
61 Participants
|
49 Participants
|
40 Participants
|
11 Participants
|
21 Participants
|
114 Participants
|
152 Participants
|
103 Participants
|
749 Participants
|
|
First Line Treatment Choice by Asia Pacific Country by Tumour EGFR Mutation Status
Other: Yes
|
14 Participants
|
19 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
7 Participants
|
|
First Line Treatment Choice by Asia Pacific Country by Tumour EGFR Mutation Status
Cisplatin
|
123 Participants
|
301 Participants
|
2 Participants
|
9 Participants
|
0 Participants
|
15 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
5 Participants
|
1 Participants
|
8 Participants
|
3 Participants
|
9 Participants
|
0 Participants
|
0 Participants
|
15 Participants
|
286 Participants
|
|
First Line Treatment Choice by Asia Pacific Country by Tumour EGFR Mutation Status
Crizotinib
|
0 Participants
|
7 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
First Line Treatment Choice by Asia Pacific Country by Tumour EGFR Mutation Status
Erlotinib
|
17 Participants
|
4 Participants
|
43 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
16 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
|
First Line Treatment Choice by Asia Pacific Country by Tumour EGFR Mutation Status
Paclitaxel
|
37 Participants
|
96 Participants
|
2 Participants
|
10 Participants
|
0 Participants
|
9 Participants
|
0 Participants
|
4 Participants
|
13 Participants
|
33 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
14 Participants
|
18 Participants
|
148 Participants
|
|
First Line Treatment Choice by Asia Pacific Country by Tumour EGFR Mutation Status
Pemetrexed
|
139 Participants
|
193 Participants
|
0 Participants
|
25 Participants
|
1 Participants
|
8 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
22 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
27 Participants
|
|
First Line Treatment Choice by Asia Pacific Country by Tumour EGFR Mutation Status
Other Chemotherapy
|
52 Participants
|
90 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
41 Participants
|
|
First Line Treatment Choice by Asia Pacific Country by Tumour EGFR Mutation Status
Radiotherapy: Yes
|
21 Participants
|
41 Participants
|
2 Participants
|
24 Participants
|
3 Participants
|
11 Participants
|
3 Participants
|
11 Participants
|
2 Participants
|
1 Participants
|
6 Participants
|
5 Participants
|
6 Participants
|
11 Participants
|
2 Participants
|
5 Participants
|
7 Participants
|
65 Participants
|
|
First Line Treatment Choice by Asia Pacific Country by Tumour EGFR Mutation Status
Other: No
|
553 Participants
|
805 Participants
|
130 Participants
|
141 Participants
|
14 Participants
|
48 Participants
|
15 Participants
|
41 Participants
|
25 Participants
|
62 Participants
|
55 Participants
|
45 Participants
|
17 Participants
|
32 Participants
|
16 Participants
|
157 Participants
|
109 Participants
|
807 Participants
|
Adverse Events
China
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Taiwan
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
South Korea
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Australia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Thailand
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Singapore
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Malaysia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Indonesia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Russia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60