AZD9291 Versus Placebo in Patients With Stage IB-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy. (ADAURA)

• ClinicalTrials.gov Identifier: NCT02511106
• Recruitment Status: Active, not recruiting
• First Posted: July 29, 2015
• Results First Posted: July 27, 2021
• Last Update Posted: July 27, 2023
• Sponsor: AstraZeneca
• Information provided by (Responsible Party): AstraZeneca

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Stage IB-IIIA Non-small Cell Lung Carcinoma
• Interventions: Drug: AZD9291 80 mg/40 mg; Drug: Placebo AZD9291 80 mg/40 mg; Drug: Open-label AZD9291 80 mg/40 mg
• Enrollment: 682

Participant Flow

Recruitment Details	A total of 682 Patients were randomized to treatment at 245 Centers in 25 Countries.
Pre-assignment Details	During the 28 day screening period, participants were enrolled based on the presence of at least 1 of the 2 most frequent Epidermal growth factor receptor (EGFR) mutations in their tumor. At the time of enrolment, all participant were required to have central confirmation of EGFR mutation status per eligibility criteria (Exon 19 deletion or L858R mutation).

Arm/Group Title	AZD9291	Placebo
Arm/Group Description	Taken once daily	Taken once daily
Period Title: Overall Study
Started	339	343
Received Treatment	337	343
Completed	8	20
Not Completed	331	323
Reason Not Completed
Lost to Follow-up	1	2
Withdrawal by Subject	19	14
Ongoing study at data cut-off	309	307
Without specified reason	1	0
Missing	1	0

Baseline Characteristics

Arm/Group Title		AZD9291	Placebo	Total
Arm/Group Description		Taken once daily	Taken once daily	Total of all reporting groups
Overall Number of Baseline Participants		339	343	682
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	339 participants	343 participants	682 participants
		62.5 (10.27)	61.6 (10.46)	62.1 (10.37)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	339 participants	343 participants	682 participants
	Female	230 67.8%	248 72.3%	478 70.1%
	Male	109 32.2%	95 27.7%	204 29.9%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants
Race	Number Analyzed	339 participants	343 participants	682 participants
	White	122 36.0%	122 35.6%	244 35.8%
	Black or African American	0 0.0%	0 0.0%	0 0.0%
	Asian	216 63.7%	218 63.6%	434 63.6%
	Native Hawaiian or other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Other	1 0.3%	2 0.6%	3 0.4%
	Unknown or Not Reported	0 0.0%	1 0.3%	1 0.1%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants
Ethnicity	Number Analyzed	339 participants	343 participants	682 participants
	Hispanic or Latino	12 3.5%	9 2.6%	21 3.1%
	Asian (other than Chinese or Japanese)	78 23.0%	67 19.5%	145 21.3%
	Chinese	95 28.0%	100 29.2%	195 28.6%
	Japanese	46 13.6%	51 14.9%	97 14.2%
	Other	108 31.9%	116 33.8%	224 32.8%
Region of Enrollment; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	339 participants	343 participants	682 participants
Australia		7 2.1%	9 2.6%	16 2.3%
Belgium		0 0.0%	1 0.3%	1 0.1%
Brazil		8 2.4%	6 1.7%	14 2.1%
Canada		1 0.3%	3 0.9%	4 0.6%
China		77 22.7%	82 23.9%	159 23.3%
Germany		8 2.4%	5 1.5%	13 1.9%
Spain		14 4.1%	16 4.7%	30 4.4%
France		4 1.2%	5 1.5%	9 1.3%
Hong Kong		4 1.2%	4 1.2%	8 1.2%
Hungary		1 0.3%	1 0.3%	2 0.3%
Israel		9 2.7%	3 0.9%	12 1.8%
Italy		15 4.4%	17 5.0%	32 4.7%
Japan		46 13.6%	53 15.5%	99 14.5%
Korea, Republic Of		27 8.0%	18 5.2%	45 6.6%
Poland		4 1.2%	9 2.6%	13 1.9%
Romania		2 0.6%	2 0.6%	4 0.6%
Russia		42 12.4%	39 11.4%	81 11.9%
Sweden		1 0.3%	1 0.3%	2 0.3%
Thailand		16 4.7%	17 5.0%	33 4.8%
Taiwan, Province Of China		24 7.1%	22 6.4%	46 6.7%
Turkey		3 0.9%	8 2.3%	11 1.6%
Ukraine		2 0.6%	1 0.3%	3 0.4%
United States		13 3.8%	8 2.3%	21 3.1%
Vietnam		11 3.2%	13 3.8%	24 3.5%

Outcome Measures

1. Primary Outcome

Title	Assess the Efficacy of AZD9291 Compared to Placebo as Measured by Disease Free Survival (DFS).
Description	Defined as the time from the date of randomization until the date of disease recurrence or death (by any cause in the absence of recurrence)
Time Frame	From date of randomization until date of disease recurrence or death (by any cause in the absence of recurrence), up to approximately 4 years.

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS) stage IIA-IIIA patients

Arm/Group Title	AZD9291 80mg Tablet	Placebo Tablet
Arm/Group Description:	Taken once daily	Taken once daily
Overall Number of Participants Analyzed	233	237
Median (95% Confidence Interval); Unit of Measure: Months
	NA [1]; (38.8 to NA)	19.6; (16.6 to 24.5)

[1]

Insufficient DFS events to estimate median and 95% confidence interval (Kaplan-Meier analysis)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	AZD9291 80mg Tablet, Placebo Tablet
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Log Rank
	Comments	Determined using a log rank test stratified by stage, race and mutation type.
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.17
	Confidence Interval	(2-Sided) 99.06%; 0.11 to 0.26
	Estimation Comments	A hazard ratio <1 favours AZD9291.

2. Primary Outcome

Title	Assess the Efficacy of AZD9291 Compared to Placebo as Measured by Disease Free Survival (DFS).
Description	Defined as the time from the date of randomization until the date of disease recurrence or death (by any cause in the absence of recurrence)
Time Frame	From date of randomization until date of disease recurrence or death (by any cause in the absence of recurrence), up to approximately 4 years.

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS) stage IB-IIIA patients

Arm/Group Title	AZD9291 80mg Tablet	Placebo Tablet
Arm/Group Description:	Taken once daily	Taken once daily
Overall Number of Participants Analyzed	339	343
Median (95% Confidence Interval); Unit of Measure: Months
	NA [1]; (NA to NA)	27.5; (22.0 to 35.0)

[1]

Insufficient DFS events to estimate median and 95% confidence interval (Kaplan-Meier analysis)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	AZD9291 80mg Tablet, Placebo Tablet
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Log Rank
	Comments	Determined using a log rank test stratified by stage, race and mutation type.
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.20
	Confidence Interval	(2-Sided) 99.12%; 0.14 to 0.30
	Estimation Comments	A hazard ratio <1 favours AZD9291.

3. Secondary Outcome

Title	Disease Free Survival (DFS) Rate at 2, 3 and 5 Years
Description	Defined as the percentage of patients alive and disease free at 2, 3 and 5 years, respectively, estimated from Kaplan Meier plots of the primary endpoint of DFS at the time of the primary analysis
Time Frame	From date of randomization until date of disease recurrence or death (by any cause in the absence of recurrence), up to approximately 4 years. Assessed at 2 years and 3 years.

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS) stage IIA-IIIA patients

Arm/Group Title	AZD9291 80mg Tablet	Placebo Tablet
Arm/Group Description:	Taken once daily	Taken once daily
Overall Number of Participants Analyzed	233	237
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
DFS rate at 2 years (%)	89.5; (84.0 to 93.2)	43.6; (36.5 to 50.6)
DFS rate at 3 years (%)	78.3; (64.5 to 87.3)	27.9; (18.9 to 37.6)

4. Secondary Outcome

Title	Disease Free Survival (DFS) Rate at 2, 3 and 5 Years
Description	Defined as the percentage of patients alive and disease free at 2, 3 and 5 years, respectively, estimated from Kaplan Meier plots of the primary endpoint of DFS at the time of the primary analysis
Time Frame	From date of randomization until date of disease recurrence or death (by any cause in the absence of recurrence), up to approximately 4 years. Assessed at 2 years and 3 years.

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS) stage IB-IIIA patients

Arm/Group Title	AZD9291 80mg Tablet	Placebo Tablet
Arm/Group Description:	Taken once daily	Taken once daily
Overall Number of Participants Analyzed	339	343
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
DFS rate at 2 years (%)	89.1; (84.5 to 92.4)	52.4; (46.4 to 58.1)
DFS rate at 3 years (%)	78.9; (68.7 to 86.1)	40.0; (32.1 to 47.8)

5. Secondary Outcome

Title	Overall Survival (OS)
Description	Defined as the time from the date of randomization until date of death due to any cause.
Time Frame	From date of randomization until date of death due to any cause, up to approximately 4 years.

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS) stage IIA-IIIA patients

Arm/Group Title	AZD9291 80mg Tablet	Placebo Tablet
Arm/Group Description:	Taken once daily	Taken once daily
Overall Number of Participants Analyzed	233	237
Median (95% Confidence Interval); Unit of Measure: Months
	NA [1]; (NA to NA)	NA [1]; (NA to NA)

[1]

Insufficient OS events to estimate median and 95% confidence interval (Kaplan Meier analysis)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	AZD9291 80mg Tablet, Placebo Tablet
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0244
	Comments	[Not Specified]
	Method	Log Rank
	Comments	Determined using a log rank test stratified by stage, race and mutation type.
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.4
	Confidence Interval	(2-Sided) 99.98%; 0.09 to 1.83
	Estimation Comments	A hazard ratio <1 favours AZD9291.

6. Secondary Outcome

Title	Overall Survival (OS)
Description	Defined as the time from the date of randomization until date of death due to any cause
Time Frame	From date of randomization until date of death due to any cause, up to approximately 4 years.

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS) stage IB-IIIA patients

Arm/Group Title	AZD9291 80mg Tablet	Placebo Tablet
Arm/Group Description:	Taken once daily	Taken once daily
Overall Number of Participants Analyzed	339	343
Median (95% Confidence Interval); Unit of Measure: Months
	NA [1]; (NA to NA)	48.2 [2]; (48.2 to NA)

[1]

Insufficient OS events to estimate median and 95% confidence interval (Kaplan Meier analysis)

[2]

Insufficient OS events to estimate upper 95% confidence interval (Kaplan Meier analysis)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	AZD9291 80mg Tablet, Placebo Tablet
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0553
	Comments	[Not Specified]
	Method	Log Rank
	Comments	Determined using a log rank test stratified by stage, race and mutation type.
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.48
	Confidence Interval	(2-Sided) 99.98%; 0.12 to 1.98
	Estimation Comments	A hazard ratio <1 favours AZD9291.

7. Secondary Outcome

Title	Overall Survival Rate at 2, 3 and 5 Years
Description	Defined as the percentage of patients alive at 2, 3 and 5 years, respectively, estimated from a Kaplan Meier plot of OS at the time of the primary analysis
Time Frame	From date of randomization until date of death due to any cause, up to approximately 4 years. Assessed at 2 years and 3 years.

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS) stage IIA-IIIA patients

Arm/Group Title	AZD9291 80mg Tablet	Placebo Tablet
Arm/Group Description:	Taken once daily	Taken once daily
Overall Number of Participants Analyzed	233	237
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
OS rate at 2 years (%)	100.0; (100.0 to 100.0)	92.6; (87.6 to 95.6)
OS rate at 3 years (%)	91.7; (82.4 to 96.2)	89.0; (82.1 to 93.3)

8. Secondary Outcome

Title	Overall Survival Rate at 2, 3 and 5 Years
Description	Defined as the percentage of patients alive at 2, 3 and 5 years, respectively, estimated from a Kaplan Meier plot of OS at the time of the primary analysis
Time Frame	From date of randomization until date of death due to any cause, up to approximately 4 years. Assessed at 2 years and 3 years.

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS) stage IB-IIIA patients

Arm/Group Title	AZD9291 80mg Tablet	Placebo Tablet
Arm/Group Description:	Taken once daily	Taken once daily
Overall Number of Participants Analyzed	339	343
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
OS rate at 2 years (%)	99.6; (96.9 to 99.9)	94.7; (91.4 to 96.8)
OS rate at 3 years (%)	93.9; (87.4 to 97.1)	91.8; (87.1 to 94.9)

9. Secondary Outcome

Title	Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Description	Change from baseline will be calculated for each domain and summary scale at each scheduled post-baseline assessment. The SF-36 includes eight domains: Physical Functioning (PF); Role Limitations-Physical (RP), Vitality (VT), General Health Perceptions (GH), Bodily Pain (BP), Social Function (SF), Role Limitations-Emotional (RE), and Mental Health (MH) and two summary scores: The Physical Component Summary (PCS) and Mental Component Summary (MCS). Final scores for each scale range from 0-100 with higher scores indicating better health.
Time Frame	Measured by SF-36 Questionnaire at baseline, 12 week, 24 week and then every 24 weeks until study complete, disease recurrence or other discontinuation criteria met, up to approximately 3 years.

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS)

Arm/Group Title		AZD9291 80mg Tablet	Placebo Tablet
Arm/Group Description:		Taken once daily	Taken once daily
Overall Number of Participants Analyzed		339	343
Mean (Standard Deviation); Unit of Measure: Unit on a scale
Week 12 - Bodily Pain	Number Analyzed	292 participants	300 participants
		1.026 (9.448)	1.442 (8.854)
Week 24 - Bodily Pain	Number Analyzed	274 participants	276 participants
		1.521 (9.171)	1.462 (9.279)
Week 48 - Bodily Pain	Number Analyzed	261 participants	219 participants
		2.032 (10.226)	2.438 (10.077)
Week 72 - Bodily Pain	Number Analyzed	212 participants	172 participants
		2.467 (9.929)	2.624 (9.639)
Week 96 - Bodily Pain	Number Analyzed	165 participants	125 participants
		2.124 (11.529)	3.378 (9.439)
Week 120 - Bodily Pain	Number Analyzed	105 participants	76 participants
		2.262 (9.644)	2.500 (11.118)
Week 144 - Bodily Pain	Number Analyzed	51 participants	42 participants
		1.930 (10.765)	2.516 (10.275)
Week 156 - Bodily Pain	Number Analyzed	30 participants	25 participants
		3.414 (12.001)	2.952 (9.930)
Week 12 - General Health Perceptions	Number Analyzed	294 participants	303 participants
		-0.597 (8.319)	0.343 (7.497)
Week 24 - General Health Perceptions	Number Analyzed	279 participants	277 participants
		-0.079 (8.910)	0.763 (8.122)
Week 48 - General Health Perceptions	Number Analyzed	264 participants	220 participants
		0.103 (8.029)	1.042 (8.416)
Week 72 - General Health Perceptions	Number Analyzed	215 participants	172 participants
		-0.143 (8.018)	2.337 (7.968)
Week 96 - General Health Perceptions	Number Analyzed	168 participants	125 participants
		-0.714 (8.734)	2.115 (8.034)
Week 120 - General Health Perceptions	Number Analyzed	108 participants	76 participants
		-1.383 (8.386)	0.738 (7.532)
Week 144 - General Health Perceptions	Number Analyzed	53 participants	42 participants
		-0.566 (8.438)	1.280 (8.184)
Week 156 - General Health Perceptions	Number Analyzed	31 participants	25 participants
		1.580 (7.522)	1.978 (9.222)
Week 12 - Mental Health	Number Analyzed	291 participants	302 participants
		0.928 (8.538)	1.892 (8.497)
Week 24 - Mental Health	Number Analyzed	276 participants	277 participants
		1.249 (8.780)	1.275 (9.660)
Week 48 - Mental Health	Number Analyzed	262 participants	219 participants
		2.456 (8.920)	2.234 (8.676)
Week 72 - Mental Health	Number Analyzed	213 participants	172 participants
		1.425 (9.313)	2.084 (8.861)
Week 96 - Mental Health	Number Analyzed	166 participants	124 participants
		1.329 (8.597)	1.847 (9.021)
Week 120 - Mental Health	Number Analyzed	106 participants	76 participants
		0.197 (8.988)	2.168 (9.764)
Week 144 - Mental Health	Number Analyzed	51 participants	42 participants
		-2.514 (10.132)	0.311 (10.095)
Week 156 - Mental Health	Number Analyzed	31 participants	25 participants
		-0.337 (10.823)	2.511 (11.034)
Week 12 - Physical functioning	Number Analyzed	294 participants	302 participants
		-0.314 (6.762)	0.898 (6.646)
Week 24 - Physical functioning	Number Analyzed	277 participants	275 participants
		0.494 (6.783)	0.923 (7.014)
Week 48 - Physical functioning	Number Analyzed	263 participants	220 participants
		0.940 (7.595)	1.914 (7.899)
Week 72 - Physical functioning	Number Analyzed	214 participants	172 participants
		1.048 (6.667)	2.114 (7.025)
Week 96 - Physical functioning	Number Analyzed	167 participants	125 participants
		0.562 (7.848)	2.082 (6.956)
Week 120 - Physical functioning	Number Analyzed	107 participants	76 participants
		0.811 (6.440)	2.643 (6.953)
Week 144 - Physical functioning	Number Analyzed	53 participants	42 participants
		2.068 (6.416)	2.005 (8.303)
Week 156 - Physical functioning	Number Analyzed	30 participants	24 participants
		1.610 (8.465)	1.435 (8.026)
Week 12 - Role Limitations - Emotional	Number Analyzed	292 participants	303 participants
		0.381 (10.413)	2.333 (11.168)
Week 24 - Role Limitations - Emotional	Number Analyzed	276 participants	276 participants
		0.858 (11.317)	1.678 (11.571)
Week 48 - Role Limitations - Emotional	Number Analyzed	262 participants	220 participants
		2.179 (11.131)	2.628 (10.952)
Week 72 - Role Limitations - Emotional	Number Analyzed	213 participants	172 participants
		1.357 (12.029)	2.429 (11.385)
Week 96 - Role Limitations - Emotional	Number Analyzed	165 participants	125 participants
		2.005 (11.859)	2.813 (11.664)
Week 120 - Role Limitations - Emotional	Number Analyzed	106 participants	76 participants
		2.266 (11.105)	2.611 (11.071)
Week 144 - Role Limitations - Emotional	Number Analyzed	51 participants	42 participants
		0.137 (11.796)	4.808 (11.508)
Week 156 - Role Limitations - Emotional	Number Analyzed	31 participants	25 participants
		2.134 (12.184)	2.785 (11.549)
Week 12 - Role Limitations - Physical	Number Analyzed	292 participants	303 participants
		1.056 (9.263)	2.915 (8.977)
Week 24 - Role Limitations - Physical	Number Analyzed	277 participants	276 participants
		1.727 (10.265)	4.063 (9.295)
Week 48 - Role Limitations - Physical	Number Analyzed	262 participants	220 participants
		3.437 (10.592)	5.332 (9.663)
Week 72 - Role Limitations - Physical	Number Analyzed	213 participants	172 participants
		3.511 (11.166)	5.457 (9.684)
Week 96 - Role Limitations - Physical	Number Analyzed	166 participants	125 participants
		3.125 (10.967)	5.569 (9.939)
Week 120 - Role Limitations - Physical	Number Analyzed	106 participants	76 participants
		4.661 (10.568)	5.644 (10.264)
Week 144 - Role Limitations - Physical	Number Analyzed	51 participants	42 participants
		3.082 (9.839)	5.721 (9.858)
Week 156 - Role Limitations - Physical	Number Analyzed	31 participants	25 participants
		5.288 (11.933)	5.839 (8.648)
Week 12 - Social Function	Number Analyzed	292 participants	301 participants
		1.391 (9.615)	3.164 (9.171)
Week 24 - Social Function	Number Analyzed	276 participants	276 participants
		2.634 (9.526)	3.433 (10.348)
Week 48 - Social Function	Number Analyzed	262 participants	220 participants
		3.731 (9.919)	4.170 (10.156)
Week 72 - Social Function	Number Analyzed	213 participants	172 participants
		3.036 (10.207)	4.693 (9.941)
Week 96 - Social Function	Number Analyzed	166 participants	125 participants
		3.806 (10.150)	4.772 (10.322)
Week 120 - Social Function	Number Analyzed	106 participants	76 participants
		2.459 (10.127)	3.430 (10.330)
Week 144 - Social Function	Number Analyzed	51 participants	42 participants
		0.492 (9.473)	1.790 (8.564)
Week 156 - Social Function	Number Analyzed	31 participants	25 participants
		1.617 (9.719)	3.208 (7.911)
Week 12 - Vitality	Number Analyzed	290 participants	302 participants
		0.570 (7.987)	2.344 (8.207)
Week 24 - Vitality	Number Analyzed	275 participants	277 participants
		0.630 (8.996)	2.463 (9.461)
Week 48 - Vitality	Number Analyzed	261 participants	219 participants
		2.231 (9.209)	3.029 (8.972)
Week 72 - Vitality	Number Analyzed	212 participants	172 participants
		0.981 (9.422)	3.903 (8.819)
Week 96 - Vitality	Number Analyzed	166 participants	124 participants
		1.199 (9.456)	4.000 (9.003)
Week 120 - Vitality	Number Analyzed	106 participants	76 participants
		0.084 (9.217)	2.579 (8.935)
Week 144 - Vitality	Number Analyzed	51 participants	42 participants
		-2.505 (9.568)	0.990 (9.522)
Week 156 - Vitality	Number Analyzed	31 participants	25 participants
		1.150 (9.783)	2.614 (8.546)
Week 12 - Mental Component Summary	Number Analyzed	291 participants	301 participants
		0.986 (8.068)	2.603 (8.965)
Week 24 - Mental Component Summary	Number Analyzed	274 participants	275 participants
		1.333 (8.919)	1.936 (10.152)
Week 48 - Mental Component Summary	Number Analyzed	261 participants	219 participants
		2.788 (9.301)	2.757 (9.141)
Week 72 - Mental Component Summary	Number Analyzed	212 participants	172 participants
		1.350 (9.874)	2.796 (9.061)
Week 96 - Mental Component Summary	Number Analyzed	165 participants	124 participants
		2.063 (9.193)	2.819 (9.934)
Week 120 - Mental Component Summary	Number Analyzed	105 participants	76 participants
		0.690 (9.629)	2.158 (9.354)
Week 144 - Mental Component Summary	Number Analyzed	51 participants	42 participants
		-2.692 (10.341)	1.522 (9.965)
Week 156 - Mental Component Summary	Number Analyzed	30 participants	25 participants
		-0.176 (9.287)	2.537 (11.397)
Week 12 - Physical Component Summary	Number Analyzed	291 participants	301 participants
		0.161 (6.341)	1.144 (6.078)
Week 24 - Physical Component Summary	Number Analyzed	274 participants	275 participants
		0.878 (7.009)	1.938 (6.643)
Week 48 - Physical Component Summary	Number Analyzed	261 participants	219 participants
		1.356 (6.800)	2.797 (7.497)
Week 72 - Physical Component Summary	Number Analyzed	212 participants	172 participants
		1.879 (6.942)	3.380 (7.021)
Week 96 - Physical Component Summary	Number Analyzed	165 participants	124 participants
		1.154 (7.889)	3.591 (6.601)
Week 120 - Physical Component Summary	Number Analyzed	105 participants	76 participants
		1.846 (6.492)	3.148 (7.371)
Week 144 - Physical Component Summary	Number Analyzed	51 participants	42 participants
		2.980 (6.856)	3.000 (7.775)
Week 156 - Physical Component Summary	Number Analyzed	30 participants	24 participants
		3.551 (7.481)	3.221 (8.046)

10. Secondary Outcome

Title	Plasma Concentrations of AZD9291
Description	The pharmacokinetics exposure parameters derived from plasma concentrations of AZD9291
Time Frame	Collected at pre-dose, 0.5-1.5hours and 2-4hours post-dose up to 96 weeks (approximately 24 months)

Outcome Measure Data

Analysis Population Description

Pharmacokinetic analysis set

Arm/Group Title		AZD9291 80mg Tablet
Arm/Group Description:		Taken once daily
Overall Number of Participants Analyzed		325
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: nM
Week 4 - Pre-dose	Number Analyzed	247 participants
		380.2563; (60.4465%)
Week 4 - 0.5-1.5 hours	Number Analyzed	246 participants
		383.9142; (74.3191%)
Week 4 - 2-4 hours	Number Analyzed	246 participants
		463.0098; (56.3562%)
Week 24- Pre-dose	Number Analyzed	213 participants
		288.8266; (181.8255%)
Week 24 - 0.5-1.5 hours	Number Analyzed	212 participants
		303.8269; (116.9411%)
Week 24 - 2-4 hours	Number Analyzed	211 participants
		358.831; (116.0567%)
Week 48- Pre-dose	Number Analyzed	198 participants
		301.7346; (125.4901%)
Week 48 - 0.5-1.5 hours	Number Analyzed	196 participants
		311.3503; (101.1574%)
Week 48 - 2-4 hours	Number Analyzed	195 participants
		375.6666; (69.9838%)
Week 96- Pre-dose	Number Analyzed	126 participants
		287.5375; (95.6634%)
Week 96 - 0.5-1.5 hours	Number Analyzed	127 participants
		273.3198; (126.003%)
Week 96 - 2-4 hours	Number Analyzed	127 participants
		341.5805; (79.0578%)

11. Secondary Outcome

Title	Plasma Concentrations of AZ5104 Metabolites
Description	The pharmacokinetics exposure parameters derived from plasma concentrations of AZ5104 metabolites
Time Frame	From date of dosing to week 96 (approximately 24 months)

Outcome Measure Data

Analysis Population Description

Pharmacokinetic analysis set

Arm/Group Title		AZ5104
Arm/Group Description:		AZD9291 metabolite
Overall Number of Participants Analyzed		325
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: nM
Week 4 - Pre-dose	Number Analyzed	247 participants
		44.4619; (66.2108%)
Week 4 - 0.5-1.5 hours	Number Analyzed	246 participants
		45.2280; (67.0500%)
Week 4 - 2-4 hours	Number Analyzed	246 participants
		49.6081; (65.5757%)
Week 24 - Pre-dose	Number Analyzed	213 participants
		38.7314; (111.0996%)
Week 24 - 0.5-1.5 hours	Number Analyzed	212 participants
		39.1687; (86.1118%)
Week 24 - 2-4 hours	Number Analyzed	211 participants
		41.3251; (99.2633%)
Week 48 - Pre-dose	Number Analyzed	198 participants
		41.1778; (53.8923%)
Week 48 - 0.5-1.5 hours	Number Analyzed	196 participants
		40.9276; (53.9916%)
Week 48 - 2-4 hours	Number Analyzed	195 participants
		42.9143; (68.8102%)
Week 96 - Pre-dose	Number Analyzed	126 participants
		38.0205; (81.4442%)
Week 96 - 0.5-1.5 hours	Number Analyzed	127 participants
		36.9723; (101.2317%)
Week 96 - 2-4 hours	Number Analyzed	127 participants
		39.8057; (78.0300%)

12. Secondary Outcome

Title	Plasma Concentrations of AZ7550 Metabolites
Description	The pharmacokinetics exposure parameters derived from plasma concentrations of AZ7550 metabolites
Time Frame	From date of dosing to week 96 (approximately 24 months)

Outcome Measure Data

Analysis Population Description

Pharmacokinetic analysis set

Arm/Group Title		AZ7550
Arm/Group Description:		AZD9291 metabolite
Overall Number of Participants Analyzed		325
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: nM
Week 4 - Pre-dose	Number Analyzed	225 participants
		44.3492; (56.5153%)
Week 4 - 0.5-1.5 hours	Number Analyzed	224 participants
		44.7386; (55.0410%)
Week 4 - 2-4 hours	Number Analyzed	223 participants
		48.0864; (61.8700%)
Week 24 - Pre-dose	Number Analyzed	171 participants
		40.7113; (75.3663%)
Week 24 - 0.5-1.5 hours	Number Analyzed	170 participants
		40.9375; (65.8656%)
Week 24 - 2-4 hours	Number Analyzed	169 participants
		44.1476; (60.2684%)
Week 48 - Pre-dose	Number Analyzed	104 participants
		41.3862; (52.2259%)
Week 48 - 0.5-1.5 hours	Number Analyzed	103 participants
		41.0467; (52.9773%)
Week 48 - 2-4 hours	Number Analyzed	102 participants
		40.4486; (99.6574%)
Week 96 - Pre-dose	Number Analyzed	30 participants
		28.1890; (180.0937%)
Week 96 - 0.5-1.5 hours	Number Analyzed	31 participants
		30.2419; (155.4156%)
Week 96 - 2-4 hours	Number Analyzed	31 participants
		33.9653; (79.2841%)

Adverse Events

Time Frame	Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years.
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	AZD9291		Placebo
Arm/Group Description	Taken once daily		Taken once daily
All-Cause Mortality
	AZD9291		Placebo
	Affected / at Risk (%)		Affected / at Risk (%)
Total	9/339 (2.65%)		20/343 (5.83%)
Serious Adverse Events
	AZD9291		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	54/337 (16.02%)		42/343 (12.24%)
Cardiac disorders
Acute coronary syndrome † 1	1/337 (0.30%)	1	1/343 (0.29%)	1
Angina pectoris † 1	1/337 (0.30%)	1	0/343 (0.00%)	0
Atrial fibrillation † 1	0/337 (0.00%)	0	1/343 (0.29%)	1
Coronary artery disease † 1	1/337 (0.30%)	1	1/343 (0.29%)	1
Myocardial infarction † 1	1/337 (0.30%)	1	0/343 (0.00%)	0
Tachycardia paroxysmal † 1	1/337 (0.30%)	1	0/343 (0.00%)	0
Ear and labyrinth disorders
Otolithiasis † 1	1/337 (0.30%)	1	0/343 (0.00%)	0
Tympanic membrane perforation † 1	0/337 (0.00%)	0	1/343 (0.29%)	1
Vertigo † 1	0/337 (0.00%)	0	1/343 (0.29%)	1
Eye disorders
Cataract † 1	3/337 (0.89%)	4	0/343 (0.00%)	0
Glaucoma † 1	0/337 (0.00%)	0	1/343 (0.29%)	1
Gastrointestinal disorders
Colitis † 1	1/337 (0.30%)	1	0/343 (0.00%)	0
Diarrhoea † 1	2/337 (0.59%)	2	0/343 (0.00%)	0
Gastric polyps † 1	1/337 (0.30%)	1	0/343 (0.00%)	0
Inguinal hernia † 1	1/337 (0.30%)	1	0/343 (0.00%)	0
Intestinal polyp † 1	0/337 (0.00%)	0	1/343 (0.29%)	1
Large intestine perforation † 1	0/337 (0.00%)	0	1/343 (0.29%)	1
Large intestine polyp † 1	1/337 (0.30%)	1	0/343 (0.00%)	0
Nausea † 1	0/337 (0.00%)	0	1/343 (0.29%)	1
General disorders
Pyrexia † 1	1/337 (0.30%)	1	0/343 (0.00%)	0
Hepatobiliary disorders
Bile duct stone † 1	0/337 (0.00%)	0	1/343 (0.29%)	1
Cholangitis acute † 1	0/337 (0.00%)	0	1/343 (0.29%)	1
Cholecystitis † 1	0/337 (0.00%)	0	1/343 (0.29%)	1
Drug-induced liver injury † 1	1/337 (0.30%)	1	0/343 (0.00%)	0
Liver injury † 1	1/337 (0.30%)	1	0/343 (0.00%)	0
Immune system disorders
Contrast media allergy † 1	0/337 (0.00%)	0	1/343 (0.29%)	1
Infections and infestations
Appendicitis † 1	1/337 (0.30%)	1	1/343 (0.29%)	1
Biliary tract infection † 1	1/337 (0.30%)	1	0/343 (0.00%)	0
Endocarditis † 1	1/337 (0.30%)	1	0/343 (0.00%)	0
Gastroenteritis † 1	1/337 (0.30%)	1	0/343 (0.00%)	0
Herpes simplex † 1	1/337 (0.30%)	1	0/343 (0.00%)	0
Influenza † 1	1/337 (0.30%)	1	0/343 (0.00%)	0
Peritonitis † 1	0/337 (0.00%)	0	1/343 (0.29%)	1
Pharyngitis † 1	0/337 (0.00%)	0	1/343 (0.29%)	1
Pneumonia † 1	5/337 (1.48%)	5	4/343 (1.17%)	4
Respiratory tract infection † 1	0/337 (0.00%)	0	1/343 (0.29%)	1
Sepsis † 1	1/337 (0.30%)	1	0/343 (0.00%)	0
Subcutaneous abscess † 1	1/337 (0.30%)	1	0/343 (0.00%)	0
Upper respiratory tract infection † 1	1/337 (0.30%)	1	0/343 (0.00%)	0
Urinary tract infection † 1	1/337 (0.30%)	1	0/343 (0.00%)	0
Urinary tract infection bacterial † 1	1/337 (0.30%)	1	0/343 (0.00%)	0
Viral upper respiratory tract infection † 1	1/337 (0.30%)	1	0/343 (0.00%)	0
Injury, poisoning and procedural complications
Ankle fracture † 1	0/337 (0.00%)	0	1/343 (0.29%)	1
Comminuted fracture † 1	1/337 (0.30%)	1	1/343 (0.29%)	1
Craniocerebral injury † 1	0/337 (0.00%)	0	1/343 (0.29%)	1
Femur fracture † 1	2/337 (0.59%)	2	1/343 (0.29%)	1
Fibula fracture † 1	1/337 (0.30%)	1	0/343 (0.00%)	0
Fracture † 1	1/337 (0.30%)	1	0/343 (0.00%)	0
Ligament injury † 1	1/337 (0.30%)	1	0/343 (0.00%)	0
Tendon rupture † 1	1/337 (0.30%)	1	0/343 (0.00%)	0
Thoracic vertebral fracture † 1	0/337 (0.00%)	0	1/343 (0.29%)	1
Investigations
Alanine aminotransferase increased † 1	1/337 (0.30%)	1	0/343 (0.00%)	0
Aspartate aminotransferase increased † 1	1/337 (0.30%)	1	0/343 (0.00%)	0
White blood cell count increased † 1	0/337 (0.00%)	0	1/343 (0.29%)	1
Metabolism and nutrition disorders
Decreased appetite † 1	1/337 (0.30%)	1	1/343 (0.29%)	1
Dehydration † 1	1/337 (0.30%)	1	0/343 (0.00%)	0
Hyperuricaemia † 1	1/337 (0.30%)	1	1/343 (0.29%)	1
Hyponatraemia † 1	0/337 (0.00%)	0	1/343 (0.29%)	1
Musculoskeletal and connective tissue disorders
Bone hypertrophy † 1	1/337 (0.30%)	1	0/343 (0.00%)	0
Neck mass † 1	0/337 (0.00%)	0	1/343 (0.29%)	1
Osteoarthritis † 1	0/337 (0.00%)	0	1/343 (0.29%)	1
Pathological fracture † 1	0/337 (0.00%)	0	1/343 (0.29%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer stage 0, with cancer in situ † 1	1/337 (0.30%)	1	0/343 (0.00%)	0
Cancer pain † 1	0/337 (0.00%)	0	1/343 (0.29%)	1
Chronic lymphocytic leukaemia † 1	1/337 (0.30%)	1	0/343 (0.00%)	0
Invasive ductal breast carcinoma † 1	0/337 (0.00%)	0	1/343 (0.29%)	1
Lung adenocarcinoma † 1	0/337 (0.00%)	0	1/343 (0.29%)	1
Myeloproliferative neoplasm † 1	0/337 (0.00%)	0	1/343 (0.29%)	1
Neoplasm † 1	1/337 (0.30%)	1	0/343 (0.00%)	0
Prostate cancer † 1	1/337 (0.30%)	1	1/343 (0.29%)	1
Thyroid cancer † 1	0/337 (0.00%)	0	1/343 (0.29%)	1
Transitional cell carcinoma † 1	0/337 (0.00%)	0	1/343 (0.29%)	1
Nervous system disorders
Cerebral ischaemia † 1	1/337 (0.30%)	6	0/343 (0.00%)	0
Dizziness † 1	1/337 (0.30%)	1	0/343 (0.00%)	0
Headache † 1	0/337 (0.00%)	0	1/343 (0.29%)	1
Hypoaesthesia † 1	0/337 (0.00%)	0	1/343 (0.29%)	1
Ischaemic stroke † 1	0/337 (0.00%)	0	1/343 (0.29%)	1
Loss of consciousness † 1	1/337 (0.30%)	1	0/343 (0.00%)	0
Vocal cord paralysis † 1	1/337 (0.30%)	1	0/343 (0.00%)	0
Renal and urinary disorders
Acute kidney injury † 1	2/337 (0.59%)	2	0/343 (0.00%)	0
Renal colic † 1	1/337 (0.30%)	1	0/343 (0.00%)	0
Renal failure † 1	0/337 (0.00%)	0	1/343 (0.29%)	1
Ureterolithiasis † 1	2/337 (0.59%)	2	0/343 (0.00%)	0
Reproductive system and breast disorders
Metrorrhagia † 1	1/337 (0.30%)	1	0/343 (0.00%)	0
Uterine polyp † 1	0/337 (0.00%)	0	1/343 (0.29%)	1
Respiratory, thoracic and mediastinal disorders
Asthma † 1	1/337 (0.30%)	1	0/343 (0.00%)	0
Cough † 1	0/337 (0.00%)	0	1/343 (0.29%)	1
Haemoptysis † 1	1/337 (0.30%)	1	1/343 (0.29%)	2
Interstitial lung disease † 1	1/337 (0.30%)	1	0/343 (0.00%)	0
Laryngeal inflammation † 1	1/337 (0.30%)	1	0/343 (0.00%)	0
Pleurisy † 1	1/337 (0.30%)	1	0/343 (0.00%)	0
Pneumothorax † 1	1/337 (0.30%)	1	1/343 (0.29%)	1
Pulmonary embolism † 1	0/337 (0.00%)	0	1/343 (0.29%)	1
Pulmonary oedema † 1	1/337 (0.30%)	1	0/343 (0.00%)	0
Skin and subcutaneous tissue disorders
Skin reaction † 1	1/337 (0.30%)	1	0/343 (0.00%)	0
Vascular disorders
Aneurysm † 1	0/337 (0.00%)	0	1/343 (0.29%)	1
Deep vein thrombosis † 1	1/337 (0.30%)	1	0/343 (0.00%)	0
Embolism † 1	1/337 (0.30%)	1	0/343 (0.00%)	0
Hypertension † 1	1/337 (0.30%)	1	0/343 (0.00%)	0
Peripheral arterial occlusive disease † 1	1/337 (0.30%)	1	0/343 (0.00%)	0
Venous thrombosis limb † 1	1/337 (0.30%)	1	0/343 (0.00%)	0
1 Term from vocabulary, MedDRA 22.1; † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	AZD9291		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	309/337 (91.69%)		236/343 (68.80%)
Blood and lymphatic system disorders
Anaemia † 1	24/337 (7.12%)	29	6/343 (1.75%)	6
Leukopenia † 1	18/337 (5.34%)	34	5/343 (1.46%)	5
Neutropenia † 1	20/337 (5.93%)	28	1/343 (0.29%)	1
Thrombocytopenia † 1	25/337 (7.42%)	42	0/343 (0.00%)	0
Eye disorders
Dry eye † 1	19/337 (5.64%)	19	12/343 (3.50%)	18
Gastrointestinal disorders
Abdominal pain † 1	20/337 (5.93%)	25	5/343 (1.46%)	6
Constipation † 1	16/337 (4.75%)	22	18/343 (5.25%)	21
Diarrhoea † 1	154/337 (45.70%)	286	68/343 (19.83%)	107
Mouth ulceration † 1	39/337 (11.57%)	75	8/343 (2.33%)	11
Nausea † 1	29/337 (8.61%)	32	19/343 (5.54%)	20
Stomatitis † 1	59/337 (17.51%)	100	14/343 (4.08%)	16
Vomiting † 1	28/337 (8.31%)	41	15/343 (4.37%)	19
General disorders
Fatigue † 1	31/337 (9.20%)	40	16/343 (4.66%)	18
Infections and infestations
Influenza † 1	20/337 (5.93%)	27	15/343 (4.37%)	16
Nasopharyngitis † 1	47/337 (13.95%)	98	35/343 (10.20%)	70
Paronychia † 1	85/337 (25.22%)	131	5/343 (1.46%)	6
Upper respiratory tract infection † 1	45/337 (13.35%)	72	35/343 (10.20%)	49
Urinary tract infection † 1	19/337 (5.64%)	24	15/343 (4.37%)	19
Investigations
Alanine aminotransferase increased † 1	20/337 (5.93%)	27	24/343 (7.00%)	32
Aspartate aminotransferase increased † 1	21/337 (6.23%)	29	22/343 (6.41%)	25
Blood creatinine increased † 1	29/337 (8.61%)	37	5/343 (1.46%)	7
Electrocardiogram qt prolonged † 1	22/337 (6.53%)	32	4/343 (1.17%)	4
Neutrophil count decreased † 1	23/337 (6.82%)	41	3/343 (0.87%)	4
Platelet count decreased † 1	21/337 (6.23%)	34	2/343 (0.58%)	2
Weight decreased † 1	28/337 (8.31%)	30	7/343 (2.04%)	8
White blood cell count decreased † 1	23/337 (6.82%)	48	1/343 (0.29%)	1
Metabolism and nutrition disorders
Decreased appetite † 1	43/337 (12.76%)	47	12/343 (3.50%)	12
Musculoskeletal and connective tissue disorders
Arthralgia † 1	14/337 (4.15%)	15	23/343 (6.71%)	24
Back pain † 1	20/337 (5.93%)	21	21/343 (6.12%)	32
Muscle spasms † 1	20/337 (5.93%)	21	2/343 (0.58%)	2
Nervous system disorders
Dizziness † 1	25/337 (7.42%)	31	24/343 (7.00%)	26
Headache † 1	20/337 (5.93%)	22	30/343 (8.75%)	45
Respiratory, thoracic and mediastinal disorders
Cough † 1	62/337 (18.40%)	76	56/343 (16.33%)	68
Epistaxis † 1	19/337 (5.64%)	23	3/343 (0.87%)	3
Skin and subcutaneous tissue disorders
Alopecia † 1	19/337 (5.64%)	20	7/343 (2.04%)	7
Dermatitis acneiform † 1	37/337 (10.98%)	45	16/343 (4.66%)	20
Dry skin † 1	79/337 (23.44%)	88	22/343 (6.41%)	25
Nail disorder † 1	20/337 (5.93%)	20	3/343 (0.87%)	3
Pruritus † 1	65/337 (19.29%)	78	30/343 (8.75%)	42
Rash † 1	27/337 (8.01%)	36	9/343 (2.62%)	10
Rash maculo-papular † 1	21/337 (6.23%)	27	14/343 (4.08%)	19
Skin fissures † 1	19/337 (5.64%)	26	0/343 (0.00%)	0
1 Term from vocabulary, MedDRA 22.1; † Indicates events were collected by systematic assessment

Limitations and Caveats

Primary analysis was performed two years early as per IDMC recommendation. The study is currently ongoing with no change to study treatment or schedule of assessment until final OS analysis can be reported. Insufficient data was available to calculate DFS and OS rates at five years at this time, it will be reported at the time of final analyses.

The AZ7550 metabolite samples were not analysed after March 2019, hence the ratio of metabolite to AZD9291 was not available for calculation.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

 

Results Point of Contact

• Name/Title: Global Clinical Leader
• Organization: AstraZeneca AB
• Phone: +447920183730
• EMail: ClinicalTrialTransparency@astrazeneca.com

Publications of Results:

Herbst RS, Wu YL, Tsuboi M. Osimertinib in EGFR-Mutated Lung Cancer. Reply. N Engl J Med. 2021 Feb 18;384(7):675-676. doi: 10.1056/NEJMc2033951. No abstract available.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Majem M, Goldman JW, John T, Grohe C, Laktionov K, Kim SW, Kato T, Vu HV, Lu S, Li S, Lee KY, Akewanlop C, Yu CJ, de Marinis F, Bonanno L, Domine M, Shepherd FA, Atagi S, Zeng L, Kulkarni D, Medic N, Tsuboi M, Herbst RS, Wu YL. Health-Related Quality of Life Outcomes in Patients with Resected Epidermal Growth Factor Receptor-Mutated Non-Small Cell Lung Cancer Who Received Adjuvant Osimertinib in the Phase III ADAURA Trial. Clin Cancer Res. 2022 Jun 1;28(11):2286-2296. doi: 10.1158/1078-0432.CCR-21-3530.

Wu YL, John T, Grohe C, Majem M, Goldman JW, Kim SW, Kato T, Laktionov K, Vu HV, Wang Z, Lu S, Lee KY, Akewanlop C, Yu CJ, de Marinis F, Bonanno L, Domine M, Shepherd FA, Zeng L, Atasoy A, Herbst RS, Tsuboi M. Postoperative Chemotherapy Use and Outcomes From ADAURA: Osimertinib as Adjuvant Therapy for Resected EGFR-Mutated NSCLC. J Thorac Oncol. 2022 Mar;17(3):423-433. doi: 10.1016/j.jtho.2021.10.014. Epub 2021 Nov 2.

Wu YL, Tsuboi M, John T, Grohe C, Majem M, Goldman JW, Laktionov K, Kim SW, Kato T, Vu HV, Lu S, Lee KY, Akewanlop C, Yu CJ, de Marinis F, Bonanno L, Domine M, Shepherd FA, Zeng L, Hodge R, Atasoy A, Rukazenkov Y, Herbst RS. A plain language summary of results from the ADAURA study: osimertinib after surgery for patients who have early-stage EGFR-mutated non-small cell lung cancer. Future Oncol. 2021 Dec 1;17(35):4827-4835. doi: 10.2217/fon-2021-0752. Epub 2021 Nov 1.

Wu YL, Tsuboi M, He J, John T, Grohe C, Majem M, Goldman JW, Laktionov K, Kim SW, Kato T, Vu HV, Lu S, Lee KY, Akewanlop C, Yu CJ, de Marinis F, Bonanno L, Domine M, Shepherd FA, Zeng L, Hodge R, Atasoy A, Rukazenkov Y, Herbst RS; ADAURA Investigators. Osimertinib in Resected EGFR-Mutated Non-Small-Cell Lung Cancer. N Engl J Med. 2020 Oct 29;383(18):1711-1723. doi: 10.1056/NEJMoa2027071. Epub 2020 Sep 19.

Wu YL, Herbst RS, Mann H, Rukazenkov Y, Marotti M, Tsuboi M. ADAURA: Phase III, Double-blind, Randomized Study of Osimertinib Versus Placebo in EGFR Mutation-positive Early-stage NSCLC After Complete Surgical Resection. Clin Lung Cancer. 2018 Jul;19(4):e533-e536. doi: 10.1016/j.cllc.2018.04.004. Epub 2018 May 1.

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT02511106
• Other Study ID Numbers: D5164C00001; 2015-000662-65 ( EudraCT Number )
• First Submitted: July 28, 2015
• First Posted: July 29, 2015
• Results First Submitted: January 15, 2021
• Results First Posted: July 27, 2021
• Last Update Posted: July 27, 2023