A Global Study to Assess the Effects of MEDI4736 (Durvalumab) in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer (ATLANTIC)

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ClinicalTrials.gov Identifier: NCT02087423

Recruitment Status : Active, not recruiting

First Posted : March 14, 2014

Results First Posted : January 3, 2018

Last Update Posted : May 1, 2024

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Sponsor:

Information provided by (Responsible Party):

AstraZeneca

Study Type	Interventional
Study Design	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Non-Small Cell Lung Cancer
Intervention	Drug: MEDI4736
Enrollment	446

Participant Flow

Recruitment Details	First patient in: 25 Feb 2014; Last patient in: 28 Dec 2015. Primary Analysis data cut-off (DCO): 03 Jun 2016; Final Analysis DCO: 7 Nov 2017. Patients were treated with durvalumab (10 milligrams [mg] / kilogram [kg] every 2 weeks [Q2W] intravenously [iv]). 101 sites in 16 countries treated patients in this study.
Pre-assignment Details	Patients were enrolled in 3 cohorts. Cohort enrolment was dependent upon epidermal growth factor receptor (EGFR) / anaplastic lymphoma kinase (ALK) status and programmed cell death ligand-1 (PD-L1) expression level (percent of tumor cells [TC] with membrane staining).


Arm/Group Title	Cohort 1 (EGFR/ALK+)	Cohort 2	Cohort 3 (TC >= 90%)
Arm/Group Description	Consisted of patients who were EGFR...	Consisted of patients who were EGFR...	Consisted of patients who were EGFR...
Arm/Group Description	Consisted of patients who were EGFR/ALK positive and retrospectively or prospectively determined to be PD-L1 high (TC >=25%). In addition, the cohort included patients enrolled prior to Amendment 1 who were retrospectively determined to be PD-L1 low/neg (TC <25%) or PD-L1 status unknown.	Consisted of patients who were EGFR/ALK wild type/unknown and retrospectively or prospectively determined to be PD-L1 high (TC >=25%). In addition, the cohort included patients enrolled prior to Amendment 1 who were retrospectively determined to be PD-L1 low/neg (TC <25%) or PD-L1 status unknown.	Consisted of patients who were EGFR/ALK wild type/unknown and prospectively determined to be PD-L1 high (TC >=90%).
Period Title: Overall Study
Started	111 ^[1]	265 ^[1]	68 ^[1]
Completed 12 Months of Treatment	18	60	26
Completed	0	0	0
Not Completed	111	265	68
Reason Not Completed
Withdrawal by Subject	20	20	3
Death	68	207	40
Lost to Follow-up	0	2	0
Terminated from study at final DCO	23	36	25
[1] Treated

Baseline Characteristics

Arm/Group Title		Cohort 1 (EGFR/ALK+)	Cohort 2	Cohort 3 (TC >= 90%)	Total
Arm/Group Description		Consisted of patients who were EGFR...	Consisted of patients who were EGFR...	Consisted of patients who were EGFR...	Total of all reporting groups
Arm/Group Description		Consisted of patients who were EGFR/ALK positive and retrospectively or prospectively determined to be PD-L1 high (TC >=25%). In addition, the cohort included patients enrolled prior to Amendment 1 who were retrospectively determined to be PD-L1 low/neg (TC <25%) or PD-L1 status unknown.	Consisted of patients who were EGFR/ALK wild type/unknown and retrospectively or prospectively determined to be PD-L1 high (TC >=25%). In addition, the cohort included patients enrolled prior to Amendment 1 who were retrospectively determined to be PD-L1 low/neg (TC <25%) or PD-L1 status unknown.	Consisted of patients who were EGFR/ALK wild type/unknown and prospectively determined to be PD-L1 high (TC >=90%).	Total of all reporting groups
Overall Number of Baseline Participants		111	265	68	444
Baseline Analysis Population Description		...
Baseline Analysis Population Description		Baseline analysis was based on the safety analysis set, defined as all patients who received at least 1 dose of durvalumab and for whom any postdose data were available.
Age, Categorical ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	111 participants	265 participants	68 participants	444 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	66 59.5%	155 58.5%	44 64.7%	265 59.7%
	>=65 years	45 40.5%	110 41.5%	24 35.3%	179 40.3%
		[1] Measure Description: age groups of <=18, between 18 and 65, >=65,
Age, Continuous Median (Standard Deviation) Unit of measure: Years
	Number Analyzed	111 participants	265 participants	68 participants	444 participants
		61.0 (11.45)	62.0 (9.35)	61.0 (10.58)	62.0 (10.13)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	111 participants	265 participants	68 participants	444 participants
	Female	70 63.1%	103 38.9%	29 42.6%	202 45.5%
	Male	41 36.9%	162 61.1%	39 57.4%	242 54.5%
Race/Ethnicity, Customized Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	111 participants	265 participants	68 participants	444 participants
	White	44 39.6%	212 80.0%	42 61.8%	298 67.1%
	Black or African American	1 0.9%	2 0.8%	2 2.9%	5 1.1%
	Asian	66 59.5%	51 19.2%	24 35.3%	141 31.8%
Race/Ethnicity, Customized Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	111 participants	265 participants	68 participants	444 participants
	Hispanic or Latino	6 5.4%	19 7.2%	2 2.9%	27 6.1%
	Not Hispanic or Latino	105 94.6%	246 92.8%	66 97.1%	417 93.9%
Weight Median (Standard Deviation) Unit of measure: Kg
	Number Analyzed	111 participants	265 participants	68 participants	444 participants
		59 (14.15)	68 (14.52)	66 (15.79)	66 (14.93)
Weight group Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	111 participants	265 participants	68 participants	444 participants
	<70 kg	81 73.0%	146 55.1%	40 58.8%	267 60.1%
	Between 70 and 90 kg	27 24.3%	97 36.6%	21 30.9%	145 32.7%
	>90 kg	3 2.7%	22 8.3%	7 10.3%	32 7.2%
WHO performance status Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	111 participants	265 participants	68 participants	444 participants
	(0) Normal activity	45 40.5%	86 32.5%	19 27.9%	150 33.8%
	(1) Restricted activity	65 58.6%	178 67.2%	49 72.1%	292 65.8%
	(2) In bed <=50% of the time	1 0.9%	1 0.4%	0 0.0%	2 0.5%
	(3) In bed >50% of the time	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	(4) 100% bed ridden	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Primary tumor location ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	111 participants	265 participants	68 participants	444 participants
		111 100.0%	265 100.0%	68 100.0%	444 100.0%
		[1] Measure Description: Lung
Histology type Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	111 participants	265 participants	68 participants	444 participants
	Squamous	1 0.9%	55 20.8%	20 29.4%	76 17.1%
	Non-squamous	110 99.1%	210 79.2%	48 70.6%	368 82.9%
AJCC staging at initial diagnosis ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	111 participants	265 participants	68 participants	444 participants
	Stage IA	2 1.8%	3 1.1%	0 0.0%	5 1.1%
	Stage IB	0 0.0%	4 1.5%	0 0.0%	4 0.9%
	Stage II	0 0.0%	1 0.4%	0 0.0%	1 0.2%
	Stage IIA	1 0.9%	1 0.4%	1 1.5%	3 0.7%
	Stage IIB	0 0.0%	5 1.9%	0 0.0%	5 1.1%
	Stage III	0 0.0%	1 0.4%	0 0.0%	1 0.2%
	Stage IIIA	9 8.1%	13 4.9%	5 7.4%	27 6.1%
	Stage IIIB	8 7.2%	28 10.6%	9 13.2%	45 10.1%
	Stage IV	90 81.1%	208 78.5%	53 77.9%	351 79.1%
	Missing	1 0.9%	1 0.4%	0 0.0%	2 0.5%
		[1] Measure Description: Per tumor, node, metastasis (TNM) staging system as specified by American Joint Committee on Cancer (AJCC). The staging is determined by a number of different parameters and the higher the staging the worse the prognosis for survival.
Best response to previous therapy ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	111 participants	265 participants	68 participants	444 participants
	complete response	0 0.0%	1 0.4%	0 0.0%	1 0.2%
	partial response	31 27.9%	39 14.7%	18 26.5%	88 19.8%
	stable disease	34 30.6%	86 32.5%	18 26.5%	138 31.1%
	progression	38 34.2%	114 43.0%	26 38.2%	178 40.1%
	non-evaluable	2 1.8%	15 5.7%	2 2.9%	19 4.3%
	not applicable	6 5.4%	10 3.8%	4 5.9%	20 4.5%
		[1] Measure Description: based on the last therapy received prior to entering the study
Time from informed consent to first dose Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	111 participants	265 participants	68 participants	444 participants
	<=14 days	21 18.9%	68 25.7%	7 10.3%	96 21.6%
	Between 14 and 21 days	24 21.6%	73 27.5%	13 19.1%	110 24.8%
	between 21 and 42 days	65 58.6%	111 41.9%	45 66.2%	221 49.8%
	> 42 days	1 0.9%	13 4.9%	3 4.4%	17 3.8%
Overall disease classification ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	111 participants	265 participants	68 participants	444 participants
	Metastatic	102 91.9%	245 92.5%	61 89.7%	408 91.9%
	Locally advanced	9 8.1%	20 7.5%	7 10.3%	36 8.1%
		[1] Measure Description: either patient has any metastatic site of disease or has only locally advanced sites of disease
PD-L1 expression level ^[1] Measure Type: Number Unit of measure: Number of patients (per PD-L1 category)	Number Analyzed	111 participants	265 participants	68 participants	444 participants
Positive (>=25%)		77	149	68	294
Negative (<25%)		30	95	0	125
Positive (>=90%)		47	72	67	186
<90%		33	122	0	155
Unknown		3	21	0	24
Missing		1	0	0	1
Total per cohort		111	265	68	444
		[1] Measure Description: % of tumor cells with membrane staining for PD-L1
Smoking history ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	111 participants	265 participants	68 participants	444 participants
	Non-smoker	65 58.6%	39 14.7%	9 13.2%	113 25.5%
	Smoker	46 41.4%	225 84.9%	59 86.8%	330 74.3%
	Missing	0 0.0%	1 0.4%	0 0.0%	1 0.2%
		[1] Measure Description: Patients who checked options Cigarettes, Cigarillos, Cigars, Pipe Tobacco, or Tobacco for Smoking are considered smokers.
Number of regimens of previous anti-cancer therapy Median (Standard Deviation) Unit of measure: Number of regimens
	Number Analyzed	111 participants	265 participants	68 participants	444 participants
		3 (2.00)	3 (1.38)	2 (0.80)	3 (1.54)

Outcome Measures

1.Primary Outcome


Title	Objective Response Rate (ORR)
Description	Patients commenced treatment with durvalumab on Day 1 and continued on...
Description	Patients commenced treatment with durvalumab on Day 1 and continued on a Q2W schedule for a maximum of 12 months. Tumor assessments using computed tomography / magnetic resonance imaging were performed every 8 weeks. Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) measurements as given by the Independent Central Review (ICR) were used to derive the primary variable of ORR .
Time Frame	Responses recorded during initial 12 month treatment period (up to primary analysis DCO)

Outcome Measure Data

Analysis Population Description

The "Full analysis set [FAS] - evaluable for response per ICR" set, included all treated patients who had a baseline tumor assessment and had measurable disease at baseline according to the ICR.


Arm/Group Title	Cohort 1 (EGFR/ALK+) PD-L1+ (>=25%)	Cohort 1 (EGFR/ALK+) PD-L1+ (<25%)	Cohort 2 PD-L1+ (>=25%)	Cohort 2 PD-L1+ (<25%)	Cohort 3 (TC>=90%)
Arm/Group Description:	Consisted of patients who were EGFR...	Consisted of patients who were EGFR...	Consisted of patients who were EGFR...	Consisted of patients who were EGFR...	Consisted of patients who were EGFR...
Arm/Group Description:	Consisted of patients who were EGFR/ALK positive and retrospectively or prospectively determined to be PD-L1 high (TC >=25%). In addition, the cohort included patients enrolled prior to Amendment 1 who were retrospectively determined to be PD-L1 low/neg (TC <25%) or PD-L1 status unknown. patients with PD-L1 TC>=90% are included in this group.	Consisted of patients who were EGFR/ALK positive and retrospectively or prospectively determined to be PD-L1 high (TC >=25%). In addition, the cohort included patients enrolled prior to Amendment 1 who were retrospectively determined to be PD-L1 low/neg (TC <25%) or PD-L1 status unknown.	Consisted of patients who were EGFR/ALK wild type/unknown and retrospectively or prospectively determined to be PD-L1 high (TC >=25%). In addition, the cohort included patients enrolled prior to Amendment 1 who were retrospectively determined to be PD-L1 low/neg (TC <25%) or PD-L1 status unknown. Patients with PD-L1 TC>=90% are included within the PD-L1 high (TC>=25%) group.	Consisted of patients who were EGFR/ALK wild type/unknown and retrospectively or prospectively determined to be PD-L1 high (TC >=25%). In addition, the cohort included patients enrolled prior to Amendment 1 who were retrospectively determined to be PD-L1 low/neg (TC <25%) or PD-L1 status unknown.	Consisted of patients who were EGFR/ALK wild type/unknown and prospectively determined to be PD-L1 high (TC>=90%).
Overall Number of Participants Analyzed	74	28	146	93	68
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: % of patients evaluable for response
	12.2 (5.7 to 21.8)	3.6 (0.1 to 18.3)	16.4 (10.8 to 23.5)	7.5 (3.1 to 14.9)	30.9 (20.2 to 43.3)

2.Secondary Outcome


Title	Time to Response (TTR)
Description	TTR (per RECIST 1.1 as assessed by the ICR) is defined as the time fro...
Description	TTR (per RECIST 1.1 as assessed by the ICR) is defined as the time from the date of first dose until the date of first documented response (which is subsequently confirmed). TTR was only analyzed for Cohort 2.
Time Frame	Responses recorded during initial 12 month treatment period (up to primary analysis DCO)

Outcome Measure Data

Analysis Population Description

The "FAS - evaluable for response per ICR" set for Cohort 2, included all treated patients in Cohort 2 who had a baseline tumor assessment and had measurable disease at baseline according to the ICR.


Arm/Group Title	Cohort 1 (EGFR/ALK+) PD-L1+ (>=25%)	Cohort 1 (EGFR/ALK+) PD-L1+ (<25%)	Cohort 2 PD-L1+ (>=25%)	Cohort 2 PD-L1+ (<25%)	Cohort 3 (TC>=90%)
Arm/Group Description:	Consisted of patients who were EGFR...	Consisted of patients who were EGFR...	Consisted of patients who were EGFR...	Consisted of patients who were EGFR...	Consisted of patients who were EGFR...
Arm/Group Description:	Consisted of patients who were EGFR/ALK positive and retrospectively or prospectively determined to be PD-L1 high (TC >=25%). In addition, the cohort included patients enrolled prior to Amendment 1 who were retrospectively determined to be PD-L1 low/neg (TC <25%) or PD-L1 status unknown. patients with PD-L1 TC>=90% are included in this group.	Consisted of patients who were EGFR/ALK positive and retrospectively or prospectively determined to be PD-L1 high (TC >=25%). In addition, the cohort included patients enrolled prior to Amendment 1 who were retrospectively determined to be PD-L1 low/neg (TC <25%) or PD-L1 status unknown.	Consisted of patients who were EGFR/ALK wild type/unknown and retrospectively or prospectively determined to be PD-L1 high (TC >=25%). In addition, the cohort included patients enrolled prior to Amendment 1 who were retrospectively determined to be PD-L1 low/neg (TC <25%) or PD-L1 status unknown. Patients with PD-L1 TC>=90% are included within the PD-L1 high (TC>=25%) group.	Consisted of patients who were EGFR/ALK wild type/unknown and retrospectively or prospectively determined to be PD-L1 high (TC >=25%). In addition, the cohort included patients enrolled prior to Amendment 1 who were retrospectively determined to be PD-L1 low/neg (TC <25%) or PD-L1 status unknown.	Consisted of patients who were EGFR/ALK wild type/unknown and prospectively determined to be PD-L1 high (TC>=90%).
Overall Number of Participants Analyzed	0	0	24	7	0
Median (Full Range) Unit of Measure: Months
			1.9 (1.6 to 16.7)	2.1 (1.7 to 13.8)

3.Secondary Outcome


Title	Duration of Response (DoR)
Description	DoR (per RECIST 1.1 as assessed by the ICR) was defined as the time fr...
Description	DoR (per RECIST 1.1 as assessed by the ICR) was defined as the time from the date of first documented response (which was subsequently confirmed) until the first date of documented progression or death in the absence of disease progression (ie, date of PFS event or censoring - date of first response + 1). DoR was only analyzed for Cohort 2. Cohort 2: Median DoR was 12.3 months in the PD-L1 high (TC>=25%) group at DCO (Q3 was NR). Of the 7 evaluable patients, the median DoR was not reached in the PD-L1 low/neg group (TC <25%); therefore the DoR "number of participants analyzed" field has been entered as "0" and the DoR results field has been left blank.
Time Frame	Time from response to progression, death, or last assessment (up to approximately 2 years 3 months for the primary analysis DCO)

Outcome Measure Data

Analysis Population Description

The "FAS - evaluable for response per ICR" set for Cohort 2, included all treated patients in Cohort 2 who had a baseline tumor assessment and had measurable disease at baseline according to the ICR.


Arm/Group Title	Cohort 1 (EGFR/ALK+) PD-L1+ (>=25%)	Cohort 1 (EGFR/ALK+) PD-L1+ (<25%)	Cohort 2 PD-L1+ (>=25%)	Cohort 2 PD-L1+ (<25%)	Cohort 3 (TC>=90%)
Arm/Group Description:	Consisted of patients who were EGFR...	Consisted of patients who were EGFR...	Consisted of patients who were EGFR...	Consisted of patients who were EGFR...	Consisted of patients who were EGFR...
Arm/Group Description:	Consisted of patients who were EGFR/ALK positive and retrospectively or prospectively determined to be PD-L1 high (TC >=25%). In addition, the cohort included patients enrolled prior to Amendment 1 who were retrospectively determined to be PD-L1 low/neg (TC <25%) or PD-L1 status unknown. patients with PD-L1 TC>=90% are included in this group.	Consisted of patients who were EGFR/ALK positive and retrospectively or prospectively determined to be PD-L1 high (TC >=25%). In addition, the cohort included patients enrolled prior to Amendment 1 who were retrospectively determined to be PD-L1 low/neg (TC <25%) or PD-L1 status unknown.	Consisted of patients who were EGFR/ALK wild type/unknown and retrospectively or prospectively determined to be PD-L1 high (TC >=25%). In addition, the cohort included patients enrolled prior to Amendment 1 who were retrospectively determined to be PD-L1 low/neg (TC <25%) or PD-L1 status unknown. Patients with PD-L1 TC>=90% are included within the PD-L1 high (TC>=25%) group.	Consisted of patients who were EGFR/ALK wild type/unknown and retrospectively or prospectively determined to be PD-L1 high (TC >=25%). In addition, the cohort included patients enrolled prior to Amendment 1 who were retrospectively determined to be PD-L1 low/neg (TC <25%) or PD-L1 status unknown.	Consisted of patients who were EGFR/ALK wild type/unknown and prospectively determined to be PD-L1 high (TC>=90%).
Overall Number of Participants Analyzed	0	0	24	0	0
Median (Inter-Quartile Range) Unit of Measure: Months
			12.3 ^[1] (7.5 to NA)

[1]

75th percentile not reached (NR)

4.Secondary Outcome


Title	Overall Survival (OS)
Description	OS was defined as the time from the date of first dose until death due...
Description	OS was defined as the time from the date of first dose until death due to any cause (ie, date of death or censoring - date of first dose + 1). Results are reported as median OS, calculated using the Kaplan-Meier methodology.
Time Frame	From date of first treatment until final DCO (up to approximately 3 years 8 months)

Outcome Measure Data

Analysis Population Description

The FAS included all treated patients who had a baseline tumor assessment and had measurable disease at baseline according to the Investigator site assessment.


Arm/Group Title	Cohort 1 (EGFR/ALK+) PD-L1+ (>=25%)	Cohort 1 (EGFR/ALK+) PD-L1+ (<25%)	Cohort 2 PD-L1+ (>=25%)	Cohort 2 PD-L1+ (<25%)	Cohort 3 (TC>=90%)
Arm/Group Description:	Consisted of patients who were EGFR...	Consisted of patients who were EGFR...	Consisted of patients who were EGFR...	Consisted of patients who were EGFR...	Consisted of patients who were EGFR...
Arm/Group Description:	Consisted of patients who were EGFR/ALK positive and retrospectively or prospectively determined to be PD-L1 high (TC >=25%). In addition, the cohort included patients enrolled prior to Amendment 1 who were retrospectively determined to be PD-L1 low/neg (TC <25%) or PD-L1 status unknown. patients with PD-L1 TC>=90% are included in this group.	Consisted of patients who were EGFR/ALK positive and retrospectively or prospectively determined to be PD-L1 high (TC >=25%). In addition, the cohort included patients enrolled prior to Amendment 1 who were retrospectively determined to be PD-L1 low/neg (TC <25%) or PD-L1 status unknown.	Consisted of patients who were EGFR/ALK wild type/unknown and retrospectively or prospectively determined to be PD-L1 high (TC >=25%). In addition, the cohort included patients enrolled prior to Amendment 1 who were retrospectively determined to be PD-L1 low/neg (TC <25%) or PD-L1 status unknown. Patients with PD-L1 TC>=90% are included within the PD-L1 high (TC>=25%) group.	Consisted of patients who were EGFR/ALK wild type/unknown and retrospectively or prospectively determined to be PD-L1 high (TC >=25%). In addition, the cohort included patients enrolled prior to Amendment 1 who were retrospectively determined to be PD-L1 low/neg (TC <25%) or PD-L1 status unknown.	Consisted of patients who were EGFR/ALK wild type/unknown and prospectively determined to be PD-L1 high (TC>=90%).
Overall Number of Participants Analyzed	77	30	149	94	67
Median (95% Confidence Interval) Unit of Measure: Months
	13.3 (6.3 to 24.5)	9.9 (4.2 to 13.3)	10.9 (8.6 to 13.6)	9.3 (5.9 to 10.8)	13.2 ^[1] (5.9 to NA)

[1]

The upper limit of 95% confidence interval was not reached for patients in Cohort 3.

Adverse Events

Time Frame	Treatment-emergent adverse events (TEAEs) observed up until 90 days following discontinuation of durvalumab or until the initiation of the first subsequent anticancer therapy following discontinuation of durvalumab (whichever occurred first).
Adverse Event Reporting Description	All-Cause Mortality is reported for the overall study period, up to the final DCO. Serious and Other (non-serious) TEAE data is reported for the initial treatment phase (maximum of 12 months of treatment).

Arm/Group Title	Cohort 1 (EGFR/ALK+)		Cohort 2		Cohort 3 (TC >=90%)
Arm/Group Description	Consisted of patients who were EGFR...		Consisted of patients who were EGFR...		Consisted of patients who were EGFR...
Arm/Group Description	Consisted of patients who were EGFR/ALK positive and retrospectively or prospectively determined to be PD-L1 high (TC >=25%). In addition, the cohort included patients enrolled prior to Amendment 1 who were retrospectively determined to be PD-L1 low/neg (TC <25%) or PD-L1 status unknown.		Consisted of patients who were EGFR/ALK wild type/unknown and retrospectively or prospectively determined to be PD-L1 high (TC >=25%). In addition, the cohort included patients enrolled prior to Amendment 1 who were retrospectively determined to be PD-L1 low/neg (TC <25%) or PD-L1 status unknown.		Consisted of patients who were EGFR/ALK wild type/unknown and prospectively determined to be PD-L1 high (TC >=90%).
All-Cause Mortality
	Cohort 1 (EGFR/ALK+)		Cohort 2		Cohort 3 (TC >=90%)
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	70/111 (63.06%)		217/265 (81.89%)		41/68 (60.29%)
Serious Adverse Events Serious Adverse Events
	Cohort 1 (EGFR/ALK+)		Cohort 2		Cohort 3 (TC >=90%)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	18/111 (16.22%)		77/265 (29.06%)		24/68 (35.29%)
Blood and lymphatic system disorders
Anaemia ^† 1	0/111 (0.00%)	0	3/265 (1.13%)	7	2/68 (2.94%)	2
Haemolytic anaemia ^† 1	0/111 (0.00%)	0	1/265 (0.38%)	1	0/68 (0.00%)	0
Cardiac disorders
Acute coronary syndrome ^† 1	0/111 (0.00%)	0	1/265 (0.38%)	1	0/68 (0.00%)	0
Atrial fibrillation ^† 1	0/111 (0.00%)	0	2/265 (0.75%)	3	1/68 (1.47%)	1
Cardiac failure ^† 1	1/111 (0.90%)	1	0/265 (0.00%)	0	1/68 (1.47%)	1
Cardio-respiratory arrest ^† 1	0/111 (0.00%)	0	1/265 (0.38%)	1	0/68 (0.00%)	0
Pericardial effusion ^† 1	1/111 (0.90%)	1	0/265 (0.00%)	0	0/68 (0.00%)	0
Bradycardia ^† 1	0/111 (0.00%)	0	1/265 (0.38%)	1	0/68 (0.00%)	0
Endocrine disorders
Hypopituitarism ^† 1	0/111 (0.00%)	0	0/265 (0.00%)	0	1/68 (1.47%)	1
Adrenal insufficiency ^† 1	0/111 (0.00%)	0	2/265 (0.75%)	2	1/68 (1.47%)	1
Diabetes insipidus ^† 1	0/111 (0.00%)	0	0/265 (0.00%)	0	1/68 (1.47%)	1
Hypothyroidism ^† 1	0/111 (0.00%)	0	0/265 (0.00%)	0	1/68 (1.47%)	1
Gastrointestinal disorders
Dysphagia ^† 1	0/111 (0.00%)	0	1/265 (0.38%)	1	0/68 (0.00%)	0
Gastrointestinal haemorrhage ^† 1	0/111 (0.00%)	0	1/265 (0.38%)	1	0/68 (0.00%)	0
Gastrooesophageal reflux disease ^† 1	0/111 (0.00%)	0	0/265 (0.00%)	0	1/68 (1.47%)	1
Subileus ^† 1	0/111 (0.00%)	0	1/265 (0.38%)	1	0/68 (0.00%)	0
Abdominal pain ^† 1	0/111 (0.00%)	0	3/265 (1.13%)	3	1/68 (1.47%)	1
Constipation ^† 1	0/111 (0.00%)	0	1/265 (0.38%)	1	0/68 (0.00%)	0
Diarrhoea ^† 1	0/111 (0.00%)	0	2/265 (0.75%)	2	1/68 (1.47%)	1
Enterocolitis ^† 1	0/111 (0.00%)	0	0/265 (0.00%)	0	1/68 (1.47%)	1
Gastric haemorrhage ^† 1	0/111 (0.00%)	0	1/265 (0.38%)	1	0/68 (0.00%)	0
Gastritis ^† 1	0/111 (0.00%)	0	0/265 (0.00%)	0	1/68 (1.47%)	1
Gastrointestinal disorder ^† 1	0/111 (0.00%)	0	1/265 (0.38%)	1	0/68 (0.00%)	0
Nausea ^† 1	0/111 (0.00%)	0	1/265 (0.38%)	1	1/68 (1.47%)	1
Oesophageal rupture ^† 1	0/111 (0.00%)	0	1/265 (0.38%)	1	0/68 (0.00%)	0
Oesophagitis ^† 1	0/111 (0.00%)	0	0/265 (0.00%)	0	1/68 (1.47%)	1
Pancreatitis acute ^† 1	0/111 (0.00%)	0	1/265 (0.38%)	1	0/68 (0.00%)	0
Vomiting ^† 1	0/111 (0.00%)	0	1/265 (0.38%)	1	1/68 (1.47%)	1
General disorders
Pain ^† 1	0/111 (0.00%)	0	1/265 (0.38%)	3	1/68 (1.47%)	1
Sudden death ^† 1	0/111 (0.00%)	0	1/265 (0.38%)	1	0/68 (0.00%)	0
Asthenia ^† 1	0/111 (0.00%)	0	1/265 (0.38%)	1	0/68 (0.00%)	0
Fatigue ^† 1	0/111 (0.00%)	0	3/265 (1.13%)	3	1/68 (1.47%)	1
General physical health deterioration ^† 1	0/111 (0.00%)	0	2/265 (0.75%)	2	0/68 (0.00%)	0
Malaise ^† 1	0/111 (0.00%)	0	1/265 (0.38%)	1	0/68 (0.00%)	0
Non-cardiac chest pain ^† 1	0/111 (0.00%)	0	0/265 (0.00%)	0	1/68 (1.47%)	1
Pyrexia ^† 1	0/111 (0.00%)	0	1/265 (0.38%)	1	2/68 (2.94%)	2
Hepatobiliary disorders
Bile duct stone ^† 1	0/111 (0.00%)	0	1/265 (0.38%)	1	0/68 (0.00%)	0
Hepatic atrophy ^† 1	0/111 (0.00%)	0	0/265 (0.00%)	0	1/68 (1.47%)	1
Jaundice cholestatic ^† 1	0/111 (0.00%)	0	1/265 (0.38%)	1	0/68 (0.00%)	0
Cholangitis ^† 1	0/111 (0.00%)	0	1/265 (0.38%)	1	0/68 (0.00%)	0
Infections and infestations
Meningitis ^† 1	0/111 (0.00%)	0	0/265 (0.00%)	0	1/68 (1.47%)	1
Ophthalmic herpes zoster ^† 1	0/111 (0.00%)	0	1/265 (0.38%)	1	0/68 (0.00%)	0
Pneumonia ^† 1	0/111 (0.00%)	0	8/265 (3.02%)	9	1/68 (1.47%)	1
Sepsis ^† 1	0/111 (0.00%)	0	3/265 (1.13%)	3	0/68 (0.00%)	0
Septic shock ^† 1	0/111 (0.00%)	0	1/265 (0.38%)	1	0/68 (0.00%)	0
Urinary tract infection ^† 1	1/111 (0.90%)	1	1/265 (0.38%)	1	0/68 (0.00%)	0
Bronchitis ^† 1	1/111 (0.90%)	1	1/265 (0.38%)	1	0/68 (0.00%)	0
Bronchitis bacterial ^† 1	0/111 (0.00%)	0	1/265 (0.38%)	1	0/68 (0.00%)	0
Campylobacter gastroenteritis ^† 1	0/111 (0.00%)	0	1/265 (0.38%)	1	0/68 (0.00%)	0
Cellulitis ^† 1	0/111 (0.00%)	0	1/265 (0.38%)	1	0/68 (0.00%)	0
Central nervous system infection ^† 1	1/111 (0.90%)	1	0/265 (0.00%)	0	0/68 (0.00%)	0
Device related infection ^† 1	0/111 (0.00%)	0	1/265 (0.38%)	1	0/68 (0.00%)	0
Diverticulitis ^† 1	0/111 (0.00%)	0	1/265 (0.38%)	1	0/68 (0.00%)	0
Infection ^† 1	0/111 (0.00%)	0	1/265 (0.38%)	1	0/68 (0.00%)	0
Infectious pleural effusion ^† 1	0/111 (0.00%)	0	2/265 (0.75%)	2	0/68 (0.00%)	0
Lower respiratory tract infection ^† 1	1/111 (0.90%)	1	1/265 (0.38%)	1	0/68 (0.00%)	0
Lung abscess ^† 1	0/111 (0.00%)	0	1/265 (0.38%)	2	0/68 (0.00%)	0
Lung infection ^† 1	0/111 (0.00%)	0	1/265 (0.38%)	1	0/68 (0.00%)	0
Pneumococcal sepsis ^† 1	0/111 (0.00%)	0	1/265 (0.38%)	1	0/68 (0.00%)	0
Pulmonary sepsis ^† 1	0/111 (0.00%)	0	1/265 (0.38%)	1	0/68 (0.00%)	0
Respiratory tract infection ^† 1	0/111 (0.00%)	0	2/265 (0.75%)	4	0/68 (0.00%)	0
Staphylococcal infection ^† 1	0/111 (0.00%)	0	1/265 (0.38%)	1	0/68 (0.00%)	0
Streptococcal abscess ^† 1	0/111 (0.00%)	0	1/265 (0.38%)	1	0/68 (0.00%)	0
Injury, poisoning and procedural complications
Hip fracture ^† 1	0/111 (0.00%)	0	0/265 (0.00%)	0	1/68 (1.47%)	1
Infusion related reaction ^† 1	1/111 (0.90%)	1	1/265 (0.38%)	1	1/68 (1.47%)	1
Investigations
Alanine aminotransferase increased ^† 1	0/111 (0.00%)	0	1/265 (0.38%)	1	0/68 (0.00%)	0
Hepatic enzyme increased ^† 1	0/111 (0.00%)	0	1/265 (0.38%)	1	1/68 (1.47%)	1
Transaminases increased ^† 1	0/111 (0.00%)	0	1/265 (0.38%)	1	1/68 (1.47%)	1
Urine output decreased ^† 1	1/111 (0.90%)	1	0/265 (0.00%)	0	0/68 (0.00%)	0
Weight decreased ^† 1	0/111 (0.00%)	0	1/265 (0.38%)	1	0/68 (0.00%)	0
Metabolism and nutrition disorders
Decreased appetite ^† 1	1/111 (0.90%)	1	1/265 (0.38%)	1	0/68 (0.00%)	0
Dehydration ^† 1	0/111 (0.00%)	0	1/265 (0.38%)	1	1/68 (1.47%)	1
Hyperglycaemia ^† 1	0/111 (0.00%)	0	0/265 (0.00%)	0	1/68 (1.47%)	1
Musculoskeletal and connective tissue disorders
Back pain ^† 1	0/111 (0.00%)	0	1/265 (0.38%)	1	0/68 (0.00%)	0
Musculoskeletal pain ^† 1	0/111 (0.00%)	0	1/265 (0.38%)	1	0/68 (0.00%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma ^† 1	0/111 (0.00%)	0	1/265 (0.38%)	1	0/68 (0.00%)	0
Colon cancer ^† 1	0/111 (0.00%)	0	1/265 (0.38%)	1	0/68 (0.00%)	0
Metastases to central nervous system ^† 1	2/111 (1.80%)	2	0/265 (0.00%)	0	0/68 (0.00%)	0
Tumour haemorrhage ^† 1	1/111 (0.90%)	1	0/265 (0.00%)	0	0/68 (0.00%)	0
Nervous system disorders
Intracranial pressure increased ^† 1	0/111 (0.00%)	0	1/265 (0.38%)	1	0/68 (0.00%)	0
Seizure ^† 1	0/111 (0.00%)	0	1/265 (0.38%)	1	0/68 (0.00%)	0
Somnolence ^† 1	0/111 (0.00%)	0	1/265 (0.38%)	1	0/68 (0.00%)	0
Cerebral ischaemia ^† 1	0/111 (0.00%)	0	1/265 (0.38%)	1	0/68 (0.00%)	0
Headache ^† 1	0/111 (0.00%)	0	1/265 (0.38%)	1	1/68 (1.47%)	1
Memory impairment ^† 1	0/111 (0.00%)	0	1/265 (0.38%)	1	0/68 (0.00%)	0
Spinal cord compression ^† 1	1/111 (0.90%)	1	1/265 (0.38%)	1	0/68 (0.00%)	0
Psychiatric disorders
Mental status changes ^† 1	0/111 (0.00%)	0	0/265 (0.00%)	0	1/68 (1.47%)	1
Renal and urinary disorders
Ureteric obstruction ^† 1	0/111 (0.00%)	0	1/265 (0.38%)	1	0/68 (0.00%)	0
Hydronephrosis ^† 1	1/111 (0.90%)	1	0/265 (0.00%)	0	0/68 (0.00%)	0
Nephritis ^† 1	0/111 (0.00%)	0	1/265 (0.38%)	1	0/68 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism ^† 1	1/111 (0.90%)	1	2/265 (0.75%)	2	2/68 (2.94%)	2
Chronic obstructive pulmonary disease ^† 1	0/111 (0.00%)	0	1/265 (0.38%)	1	0/68 (0.00%)	0
Dyspnoea ^† 1	3/111 (2.70%)	3	7/265 (2.64%)	7	0/68 (0.00%)	0
Haemoptysis ^† 1	1/111 (0.90%)	2	1/265 (0.38%)	1	1/68 (1.47%)	1
Interstitial lung disease ^† 1	0/111 (0.00%)	0	0/265 (0.00%)	0	1/68 (1.47%)	2
Organising pneumonia ^† 1	0/111 (0.00%)	0	1/265 (0.38%)	1	0/68 (0.00%)	0
Pleural effusion ^† 1	1/111 (0.90%)	1	5/265 (1.89%)	5	1/68 (1.47%)	1
Pneumonitis ^† 1	1/111 (0.90%)	1	4/265 (1.51%)	4	0/68 (0.00%)	0
Pulmonary haemorrhage ^† 1	1/111 (0.90%)	1	0/265 (0.00%)	0	0/68 (0.00%)	0
Respiratory failure ^† 1	0/111 (0.00%)	0	2/265 (0.75%)	2	0/68 (0.00%)	0
Vascular disorders
Vena cava thrombosis ^† 1	1/111 (0.90%)	1	0/265 (0.00%)	0	0/68 (0.00%)	0
Hypertensive crisis ^† 1	0/111 (0.00%)	0	0/265 (0.00%)	0	1/68 (1.47%)	1
Hypovolaemic shock ^† 1	0/111 (0.00%)	0	1/265 (0.38%)	1	0/68 (0.00%)	0
Superior vena cava syndrome ^† 1	0/111 (0.00%)	0	1/265 (0.38%)	1	0/68 (0.00%)	0
1 Term from vocabulary, MedDRA 20.0 † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Cohort 1 (EGFR/ALK+)		Cohort 2		Cohort 3 (TC >=90%)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	96/111 (86.49%)		233/265 (87.92%)		60/68 (88.24%)
Blood and lymphatic system disorders
Anaemia ^† 1	3/111 (2.70%)	3	43/265 (16.23%)	52	8/68 (11.76%)	8
Endocrine disorders
Hyperthyroidism ^† 1	11/111 (9.91%)	12	17/265 (6.42%)	18	7/68 (10.29%)	8
Hypothyroidism ^† 1	11/111 (9.91%)	14	19/265 (7.17%)	24	8/68 (11.76%)	9
Gastrointestinal disorders
Abdominal pain ^† 1	5/111 (4.50%)	6	10/265 (3.77%)	10	4/68 (5.88%)	6
Abdominal pain upper ^† 1	7/111 (6.31%)	8	12/265 (4.53%)	12	1/68 (1.47%)	1
Constipation ^† 1	14/111 (12.61%)	15	37/265 (13.96%)	45	16/68 (23.53%)	19
Diarrhoea ^† 1	11/111 (9.91%)	14	39/265 (14.72%)	53	9/68 (13.24%)	10
Nausea ^† 1	14/111 (12.61%)	16	46/265 (17.36%)	57	12/68 (17.65%)	15
Vomiting ^† 1	13/111 (11.71%)	15	27/265 (10.19%)	36	10/68 (14.71%)	13
General disorders
Asthenia ^† 1	14/111 (12.61%)	15	53/265 (20.00%)	76	4/68 (5.88%)	4
Fatigue ^† 1	15/111 (13.51%)	16	69/265 (26.04%)	80	20/68 (29.41%)	31
Non-cardiac chest pain ^† 1	3/111 (2.70%)	4	10/265 (3.77%)	15	4/68 (5.88%)	5
Oedema peripheral ^† 1	7/111 (6.31%)	8	25/265 (9.43%)	25	9/68 (13.24%)	13
Pain ^† 1	1/111 (0.90%)	1	8/265 (3.02%)	8	4/68 (5.88%)	4
Pyrexia ^† 1	12/111 (10.81%)	14	53/265 (20.00%)	81	12/68 (17.65%)	16
Infections and infestations
Pneumonia ^† 1	2/111 (1.80%)	2	4/265 (1.51%)	4	4/68 (5.88%)	5
Upper respiratory tract infection ^† 1	6/111 (5.41%)	9	8/265 (3.02%)	8	6/68 (8.82%)	6
Urinary tract infection ^† 1	4/111 (3.60%)	4	15/265 (5.66%)	19	3/68 (4.41%)	4
Viral upper respiratory tract infection ^† 1	5/111 (4.50%)	6	12/265 (4.53%)	13	11/68 (16.18%)	18
Investigations
Alanine aminotransferase increased ^† 1	5/111 (4.50%)	5	11/265 (4.15%)	13	5/68 (7.35%)	5
Aspartate aminotransferase increased ^† 1	3/111 (2.70%)	3	12/265 (4.53%)	14	5/68 (7.35%)	5
Blood alkaline phosphatase increased ^† 1	2/111 (1.80%)	2	14/265 (5.28%)	14	2/68 (2.94%)	2
Gamma-glutamyltransferase increased ^† 1	4/111 (3.60%)	4	15/265 (5.66%)	15	0/68 (0.00%)	0
Weight decreased ^† 1	3/111 (2.70%)	3	22/265 (8.30%)	22	13/68 (19.12%)	13
Metabolism and nutrition disorders
Decreased appetite ^† 1	15/111 (13.51%)	15	71/265 (26.79%)	77	12/68 (17.65%)	12
Hyponatraemia ^† 1	2/111 (1.80%)	2	14/265 (5.28%)	20	4/68 (5.88%)	5
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	7/111 (6.31%)	7	21/265 (7.92%)	25	5/68 (7.35%)	6
Back pain ^† 1	11/111 (9.91%)	11	23/265 (8.68%)	24	8/68 (11.76%)	10
Musculoskeletal pain ^† 1	4/111 (3.60%)	4	16/265 (6.04%)	21	3/68 (4.41%)	4
Neck pain ^† 1	3/111 (2.70%)	3	8/265 (3.02%)	8	7/68 (10.29%)	7
Pain in extremity ^† 1	5/111 (4.50%)	5	18/265 (6.79%)	21	2/68 (2.94%)	2
Nervous system disorders
Dizziness ^† 1	6/111 (5.41%)	6	12/265 (4.53%)	18	4/68 (5.88%)	6
Headache ^† 1	13/111 (11.71%)	15	26/265 (9.81%)	32	6/68 (8.82%)	6
Psychiatric disorders
Anxiety ^† 1	2/111 (1.80%)	2	16/265 (6.04%)	16	2/68 (2.94%)	2
Insomnia ^† 1	10/111 (9.01%)	12	16/265 (6.04%)	19	5/68 (7.35%)	5
Respiratory, thoracic and mediastinal disorders
Cough ^† 1	26/111 (23.42%)	32	56/265 (21.13%)	67	13/68 (19.12%)	16
Dysphonia ^† 1	0/111 (0.00%)	0	14/265 (5.28%)	15	1/68 (1.47%)	1
Dyspnoea ^† 1	13/111 (11.71%)	14	43/265 (16.23%)	46	7/68 (10.29%)	10
Haemoptysis ^† 1	3/111 (2.70%)	3	14/265 (5.28%)	20	4/68 (5.88%)	6
Productive cough ^† 1	4/111 (3.60%)	4	20/265 (7.55%)	23	4/68 (5.88%)	4
Skin and subcutaneous tissue disorders
Pruritus ^† 1	9/111 (8.11%)	11	27/265 (10.19%)	39	13/68 (19.12%)	14
Rash ^† 1	7/111 (6.31%)	9	19/265 (7.17%)	20	8/68 (11.76%)	8
1 Term from vocabulary, MedDRA 20.0 † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT 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

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Name/Title:	Phillip Dennis, MD, PhD
Organization:	AstraZeneca
Phone:	+1 301 398-5549
EMail:	ClinicalTrialTransparency@astrazeneca.com

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

Gavrilov S, Zhudenkov K, Helmlinger G, Dunyak J, Peskov K, Aksenov S. Longitudinal Tumor Size and Neutrophil-to-Lymphocyte Ratio Are Prognostic Biomarkers for Overall Survival in Patients With Advanced Non-Small Cell Lung Cancer Treated With Durvalumab. CPT Pharmacometrics Syst Pharmacol. 2021 Jan;10(1):67-74. doi: 10.1002/psp4.12578. Epub 2020 Dec 21.

Zhang Q, Luo J, Wu S, Si H, Gao C, Xu W, Abdullah SE, Higgs BW, Dennis PA, van der Heijden MS, Segal NH, Chaft JE, Hembrough T, Barrett JC, Hellmann MD. Prognostic and Predictive Impact of Circulating Tumor DNA in Patients with Advanced Cancers Treated with Immune Checkpoint Blockade. Cancer Discov. 2020 Dec;10(12):1842-1853. doi: 10.1158/2159-8290.CD-20-0047. Epub 2020 Aug 14.

Garassino MC, Cho BC, Kim JH, Mazieres J, Vansteenkiste J, Lena H, Jaime JC, Gray JE, Powderly J, Chouaid C, Bidoli P, Wheatley-Price P, Park K, Soo RA, Poole L, Wadsworth C, Dennis PA, Rizvi NA. Final overall survival and safety update for durvalumab in third- or later-line advanced NSCLC: The phase II ATLANTIC study. Lung Cancer. 2020 Sep;147:137-142. doi: 10.1016/j.lungcan.2020.06.032. Epub 2020 Jun 30.

Ouwens MJNM, Mukhopadhyay P, Zhang Y, Huang M, Latimer N, Briggs A. Estimating Lifetime Benefits Associated with Immuno-Oncology Therapies: Challenges and Approaches for Overall Survival Extrapolations. Pharmacoeconomics. 2019 Sep;37(9):1129-1138. doi: 10.1007/s40273-019-00806-4.

Garassino MC, Cho BC, Kim JH, Mazieres J, Vansteenkiste J, Lena H, Corral Jaime J, Gray JE, Powderly J, Chouaid C, Bidoli P, Wheatley-Price P, Park K, Soo RA, Huang Y, Wadsworth C, Dennis PA, Rizvi NA; ATLANTIC Investigators. Durvalumab as third-line or later treatment for advanced non-small-cell lung cancer (ATLANTIC): an open-label, single-arm, phase 2 study. Lancet Oncol. 2018 Apr;19(4):521-536. doi: 10.1016/S1470-2045(18)30144-X. Epub 2018 Mar 12.

Layout table for additonal information

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT02087423
Other Study ID Numbers:	D4191C00003 2013-005427-16 ( EudraCT Number )
First Submitted:	March 4, 2014
First Posted:	March 14, 2014
Results First Submitted:	June 3, 2017
Results First Posted:	January 3, 2018
Last Update Posted:	May 1, 2024

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