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

Sponsor
AstraZeneca (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02087423
Collaborator
(none)
446
Enrollment
139
Locations
1
Arm
112.1
Anticipated Duration (Months)
3.2
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A study to assess the Effects of MEDI4736 (Durvalumab) in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer in terms of efficacy, safety and tolerability

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

This study is designed to investigate the efficacy, safety, tolerability of a new drug, MEDI4736 (Durvalumab), in patients with Locally Advanced or Metastatic Non Small Cell Lung Cancer. MEDI4736 will be investigated in patients who have received at least two prior treatment regimens including one platinum-based chemotherapy

Study Design

Study Type:
Interventional
Actual Enrollment :
446 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II,Non-comparative,Open Label, Multi-centre, International Study of MEDI4736, in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB-IV) Who Have Received at Least 2 Prior Systemic Treatment Regimens Including 1 Platinum-based Chemotherapy Regimen
Actual Study Start Date :
Feb 25, 2014
Actual Primary Completion Date :
Jun 3, 2016
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: MEDI4736

see below

Drug: MEDI4736
MEDI4736 (durvalumab) by intravenous infusion every two weeks. Treatment from Day 1 for a maximum of 12 months or study drug withdrawal if this occurs earlier. Patients who achieve CR, PR or SD through the end of the initial 12-month treatment period can restart treatment with MEDI4736 (durvalumab) when they eventually do progress. This retreatment period can continue for as long as the investigator considers to patient to be receiving clinical benefit.

Outcome Measures

Primary Outcome Measures

  1. Objective Response Rate (ORR) [Responses recorded during initial 12 month treatment period (up to primary analysis DCO)]

    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 .

Secondary Outcome Measures

  1. Time to Response (TTR) [Responses recorded during initial 12 month treatment period (up to primary analysis DCO)]

    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.

  2. Duration of Response (DoR) [Time from response to progression, death, or last assessment (up to approximately 2 years 3 months for the primary analysis DCO)]

    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.

  3. Overall Survival (OS) [From date of first treatment until final DCO (up to approximately 3 years 8 months)]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 130 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Aged at least 18 years.

  • Documented evidence of NSCLC (stage IIIB/IV disease)

  • Disease progression or recurrence after both a platinum-based chemotherapy and at least 1 additional regimen for treatment of NSCLC

  • World Health Organisation (WHO) Performance Status of 0 or 1

  • Estimated life expectancy of more than 12 weeks

  • Patient's tumour sample must be PD-L1 positive (≥25%of tumour cells with membrane staining (Cohort 1 and 2) or PD-L1 positive with ≥90% of tumour cells with membrane staining (Cohort 3))

Exclusion Criteria:

  • Prior exposure to any anti-PD-1 or anti-PD-L1 antibody

  • Brain metastases or spinal cord compression or unless asymptomatic, treated and stable (not requiring steroids).

  • Active or prior autoimmune disease or history of immunodeficiency

  • Evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis B, C and HIV.

  • Evidence of uncontrolled illness such as symptomatic congestive heart failure, uncontrolled hypertension or unstable angina pectoris.

  • Any unresolved toxicity CTCAE >Grade 2 from previous anti-cancer therapy.

  • Any prior Grade ≥3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE >Grade 1

  • Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Research Site Goodyear Arizona United States
2 Research Site Santa Rosa California United States 95403
3 Research Site New Haven Connecticut United States 06511
4 Research Site Port Saint Lucie Florida United States 34952
5 Research Site Tampa Florida United States 33612
6 Research Site Lawrenceville Georgia United States 30046
7 Research Site Waterloo Iowa United States 50701
8 Research Site Topeka Kansas United States 66606
9 Research Site Bethesda Maryland United States 20817
10 Research Site Burlington Massachusetts United States 01803
11 Research Site Worcester Massachusetts United States 01608
12 Research Site Saint Louis Park Minnesota United States 55426
13 Research Site Bronx New York United States 10461
14 Research Site New York New York United States 10011
15 Research Site New York New York United States 10016
16 Research Site New York New York United States 10032
17 Research Site New York New York United States 10065
18 Research Site Huntersville North Carolina United States 28078
19 Research Site Bismarck North Dakota United States 58501
20 Research Site Fargo North Dakota United States 58102
21 Research Site Blue Ash Ohio United States 45242
22 Research Site Canton Ohio United States 44718
23 Research Site Middletown Ohio United States 45042
24 Research Site Chattanooga Tennessee United States 37404
25 Research Site Nashville Tennessee United States 37203
26 Research Site Fort Worth Texas United States 76104
27 Research Site Spokane Washington United States 99208
28 Research Site Wenatchee Washington United States 98801
29 Research Site Wien Austria 1145
30 Research Site Brussel Belgium 1000
31 Research Site Gent Belgium 9000
32 Research Site Gilly Belgium 6060
33 Research Site Kortrijk Belgium 8500
34 Research Site Leuven Belgium 3000
35 Research Site Liège Belgium 4000
36 Research Site Hamilton Ontario Canada L8V 5C2
37 Research Site London Ontario Canada N6A 4L6
38 Research Site Ottawa Ontario Canada K1H 8L6
39 Research Site Toronto Ontario Canada M4N 3M5
40 Research Site Toronto Ontario Canada M5G 2M9
41 Research Site Regina Saskatchewan Canada S4T 7T1
42 Research Site Brno Czechia 656 53
43 Research Site Praha 5 Czechia 150 06
44 Research Site Praha 8 Czechia 180 81
45 Research Site Praha Czechia 14059
46 Research Site Bordeaux Cedex France 33076
47 Research Site Brest Cedex France 29609
48 Research Site Creteil France 94010
49 Research Site Dijon France 21034
50 Research Site Le Mans Cedex 02 France 72015
51 Research Site Marseille France 13015
52 Research Site Pessac France 33600
53 Research Site Rennes Cedex 09 France 35033
54 Research Site Saint Herblain Cedex France 44805
55 Research Site Toulouse Cedex 9 France 31059
56 Research Site Berlin Germany 10967
57 Research Site Berlin Germany
58 Research Site Borstel Germany 23845
59 Research Site Dortmund Germany 44263
60 Research Site Frankfurt am Main Germany 60590
61 Research Site Freiburg Germany 79106
62 Research Site Großhansdorf Germany 22927
63 Research Site Hamburg Germany 20251
64 Research Site Heidelberg Germany 69126
65 Research Site Köln Germany 50924
66 Research Site Budapest Hungary 1083
67 Research Site Budapest Hungary 1121
68 Research Site Győr Hungary 9024
69 Research Site Szolnok Hungary 5000
70 Research Site Tatabánya Hungary 2800
71 Research Site Törökbálint Hungary 2045
72 Research Site Candiolo Italy 10060
73 Research Site Catania Italy 95125
74 Research Site Milano Italy 20133
75 Research Site Monza Italy 20900
76 Research Site Orbassano Italy 10043
77 Research Site Perugia Italy 06132
78 Research Site Pisa Italy 56124
79 Research Site Roma Italy 00144
80 Research Site Rozzano Italy 20089
81 Research Site Akashi-shi Japan 673-8558
82 Research Site Bunkyo-ku Japan 113-8603
83 Research Site Chuo-ku Japan 104-0045
84 Research Site Habikino-shi Japan 583-8588
85 Research Site Hidaka-shi Japan 350-1298
86 Research Site Hirakata-shi Japan 573-1191
87 Research Site Kashiwa Japan 277-8577
88 Research Site Kitaadachi-gun Japan 362-0806
89 Research Site Kobe-shi Japan 650-0047
90 Research Site Koto-ku Japan 135-8550
91 Research Site Kurume-shi Japan 830-0011
92 Research Site Nagoya-shi Japan 460-0001
93 Research Site Natori-shi Japan 981-1293
94 Research Site Osaka-shi Japan 534-0021
95 Research Site Osaka-shi Japan 541-8567
96 Research Site Osakasayama Japan 589-8511
97 Research Site Sakai-shi Japan 591-8555
98 Research Site Sendai-shi Japan 980-0873
99 Research Site Shinjuku-ku Japan 160-0023
100 Research Site Sunto-gun Japan 411-8777
101 Research Site Ube-shi Japan 755-0241
102 Research Site Yokohama-shi Japan 236-0051
103 Research Site Yokohama-shi Japan 241-8515
104 Research Site Goyang-si Korea, Republic of 410-769
105 Research Site Hwasun-gun Korea, Republic of 58128
106 Research Site Seongnam-si Korea, Republic of 13620
107 Research Site Seoul Korea, Republic of 03080
108 Research Site Seoul Korea, Republic of 03722
109 Research Site Seoul Korea, Republic of 05505
110 Research Site Seoul Korea, Republic of 06351
111 Research Site Seoul Korea, Republic of 152-703
112 Research Site Cebu City Philippines 6000
113 Research Site Quezon City Philippines 0870
114 Research Site Quezon City Philippines 1100
115 Research Site Quezon City Philippines 1101
116 Research Site Gdańsk Poland 80-952
117 Research Site Warszawa Poland 02-781
118 Research Site Singapore Singapore 119228
119 Research Site Singapore Singapore 169610
120 Research Site Singapore Singapore 308440
121 Research Site Barcelona Spain 08908
122 Research Site Gerona Spain 17007
123 Research Site Madrid Spain 28007
124 Research Site Madrid Spain 28050
125 Research Site Málaga Spain 29010
126 Research Site Sevilla Spain 41009
127 Research Site Sevilla Spain 41013
128 Research Site Valencia Spain 46026
129 Research Site Taichung Taiwan 40447
130 Research Site Taichung Taiwan 40705
131 Research Site Tainan Taiwan 704
132 Research Site Taipei Taiwan 10002
133 Research Site Taipei Taiwan 112
134 Research Site Hat Yai Thailand 90110
135 Research Site Muang Thailand 50200
136 Research Site Edinburgh United Kingdom EH4 2XU
137 Research Site London United Kingdom EC1A 7BE
138 Research Site Manchester United Kingdom M20 4BX
139 Research Site Stoke-on-Trent United Kingdom ST4 6QG

Sponsors and Collaborators

  • AstraZeneca

Investigators

  • Study Director: Phillip Dennis, MD, PhD, AstraZeneca

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT02087423
Other Study ID Numbers:
  • D4191C00003
First Posted:
Mar 14, 2014
Last Update Posted:
Jul 18, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by AstraZeneca
Locally advanced, metastatic, Non-Small Cell Lung Cancer, MEDI4736, Durvalumab, PD-L1
Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Durvalumab

Study Results

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 Detail 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/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 111 265 68
Completed 12 Months of Treatment 18 60 26
COMPLETED 0 0 0
NOT COMPLETED 111 265 68

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/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 Participants 111 265 68 444
Age (Count of Participants)
<=18 years
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%
Age (years) [Median (Standard Deviation) ]
Median (Standard Deviation) [years]
61.0
(11.45)
62.0
(9.35)
61.0
(10.58)
62.0
(10.13)
Sex: Female, Male (Count of 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 (Count of Participants)
White
44
39.6%
212
80%
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 (Count of 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 (kg) [Median (Standard Deviation) ]
Median (Standard Deviation) [kg]
59
(14.15)
68
(14.52)
66
(15.79)
66
(14.93)
Weight group (Count of Participants)
<70 kg
81
73%
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 (Count of 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%
2
0.5%
(3) In bed >50% of the time
0
0%
0
0%
0
0%
0
0%
(4) 100% bed ridden
0
0%
0
0%
0
0%
0
0%
Primary tumor location (Count of Participants)
Count of Participants [Participants]
111
100%
265
100%
68
100%
444
100%
Histology type (Count of 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 (Count of Participants)
Stage IA
2
1.8%
3
1.1%
0
0%
5
1.1%
Stage IB
0
0%
4
1.5%
0
0%
4
0.9%
Stage II
0
0%
1
0.4%
0
0%
1
0.2%
Stage IIA
1
0.9%
1
0.4%
1
1.5%
3
0.7%
Stage IIB
0
0%
5
1.9%
0
0%
5
1.1%
Stage III
0
0%
1
0.4%
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%
2
0.5%
Best response to previous therapy (Count of Participants)
complete response
0
0%
1
0.4%
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%
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%
Time from informed consent to first dose (Count of 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 (Count of 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%
PD-L1 expression level (Number of patients (per PD-L1 category)) [Number]
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
Smoking history (Count of 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%
1
0.4%
0
0%
1
0.2%
Number of regimens of previous anti-cancer therapy (Number of regimens) [Median (Standard Deviation) ]
Median (Standard Deviation) [Number of regimens]
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 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/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%).
Measure Participants 74 28 146 93 68
Number (95% Confidence Interval) [% of patients evaluable for response]
12.2
3.6
16.4
7.5
30.9
2. Secondary Outcome
Title Time to Response (TTR)
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/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%).
Measure Participants 0 0 24 7 0
Median (Full Range) [Months]
1.9
2.1
3. Secondary Outcome
Title Duration of Response (DoR)
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/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%).
Measure Participants 0 0 24 0 0
Median (Inter-Quartile Range) [Months]
12.3
4. Secondary Outcome
Title Overall Survival (OS)
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/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%).
Measure Participants 77 30 149 94 67
Median (95% Confidence Interval) [Months]
13.3
9.9
10.9
9.3
13.2

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/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 (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 70/111 (63.1%) 217/265 (81.9%) 41/68 (60.3%)
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 (16.2%) 77/265 (29.1%) 24/68 (35.3%)
Blood and lymphatic system disorders
Anaemia 0/111 (0%) 0 3/265 (1.1%) 7 2/68 (2.9%) 2
Haemolytic anaemia 0/111 (0%) 0 1/265 (0.4%) 1 0/68 (0%) 0
Cardiac disorders
Acute coronary syndrome 0/111 (0%) 0 1/265 (0.4%) 1 0/68 (0%) 0
Atrial fibrillation 0/111 (0%) 0 2/265 (0.8%) 3 1/68 (1.5%) 1
Cardiac failure 1/111 (0.9%) 1 0/265 (0%) 0 1/68 (1.5%) 1
Cardio-respiratory arrest 0/111 (0%) 0 1/265 (0.4%) 1 0/68 (0%) 0
Pericardial effusion 1/111 (0.9%) 1 0/265 (0%) 0 0/68 (0%) 0
Bradycardia 0/111 (0%) 0 1/265 (0.4%) 1 0/68 (0%) 0
Endocrine disorders
Hypopituitarism 0/111 (0%) 0 0/265 (0%) 0 1/68 (1.5%) 1
Adrenal insufficiency 0/111 (0%) 0 2/265 (0.8%) 2 1/68 (1.5%) 1
Diabetes insipidus 0/111 (0%) 0 0/265 (0%) 0 1/68 (1.5%) 1
Hypothyroidism 0/111 (0%) 0 0/265 (0%) 0 1/68 (1.5%) 1
Gastrointestinal disorders
Dysphagia 0/111 (0%) 0 1/265 (0.4%) 1 0/68 (0%) 0
Gastrointestinal haemorrhage 0/111 (0%) 0 1/265 (0.4%) 1 0/68 (0%) 0
Gastrooesophageal reflux disease 0/111 (0%) 0 0/265 (0%) 0 1/68 (1.5%) 1
Subileus 0/111 (0%) 0 1/265 (0.4%) 1 0/68 (0%) 0
Abdominal pain 0/111 (0%) 0 3/265 (1.1%) 3 1/68 (1.5%) 1
Constipation 0/111 (0%) 0 1/265 (0.4%) 1 0/68 (0%) 0
Diarrhoea 0/111 (0%) 0 2/265 (0.8%) 2 1/68 (1.5%) 1
Enterocolitis 0/111 (0%) 0 0/265 (0%) 0 1/68 (1.5%) 1
Gastric haemorrhage 0/111 (0%) 0 1/265 (0.4%) 1 0/68 (0%) 0
Gastritis 0/111 (0%) 0 0/265 (0%) 0 1/68 (1.5%) 1
Gastrointestinal disorder 0/111 (0%) 0 1/265 (0.4%) 1 0/68 (0%) 0
Nausea 0/111 (0%) 0 1/265 (0.4%) 1 1/68 (1.5%) 1
Oesophageal rupture 0/111 (0%) 0 1/265 (0.4%) 1 0/68 (0%) 0
Oesophagitis 0/111 (0%) 0 0/265 (0%) 0 1/68 (1.5%) 1
Pancreatitis acute 0/111 (0%) 0 1/265 (0.4%) 1 0/68 (0%) 0
Vomiting 0/111 (0%) 0 1/265 (0.4%) 1 1/68 (1.5%) 1
General disorders
Pain 0/111 (0%) 0 1/265 (0.4%) 3 1/68 (1.5%) 1
Sudden death 0/111 (0%) 0 1/265 (0.4%) 1 0/68 (0%) 0
Asthenia 0/111 (0%) 0 1/265 (0.4%) 1 0/68 (0%) 0
Fatigue 0/111 (0%) 0 3/265 (1.1%) 3 1/68 (1.5%) 1
General physical health deterioration 0/111 (0%) 0 2/265 (0.8%) 2 0/68 (0%) 0
Malaise 0/111 (0%) 0 1/265 (0.4%) 1 0/68 (0%) 0
Non-cardiac chest pain 0/111 (0%) 0 0/265 (0%) 0 1/68 (1.5%) 1
Pyrexia 0/111 (0%) 0 1/265 (0.4%) 1 2/68 (2.9%) 2
Hepatobiliary disorders
Bile duct stone 0/111 (0%) 0 1/265 (0.4%) 1 0/68 (0%) 0
Hepatic atrophy 0/111 (0%) 0 0/265 (0%) 0 1/68 (1.5%) 1
Jaundice cholestatic 0/111 (0%) 0 1/265 (0.4%) 1 0/68 (0%) 0
Cholangitis 0/111 (0%) 0 1/265 (0.4%) 1 0/68 (0%) 0
Infections and infestations
Meningitis 0/111 (0%) 0 0/265 (0%) 0 1/68 (1.5%) 1
Ophthalmic herpes zoster 0/111 (0%) 0 1/265 (0.4%) 1 0/68 (0%) 0
Pneumonia 0/111 (0%) 0 8/265 (3%) 9 1/68 (1.5%) 1
Sepsis 0/111 (0%) 0 3/265 (1.1%) 3 0/68 (0%) 0
Septic shock 0/111 (0%) 0 1/265 (0.4%) 1 0/68 (0%) 0
Urinary tract infection 1/111 (0.9%) 1 1/265 (0.4%) 1 0/68 (0%) 0
Bronchitis 1/111 (0.9%) 1 1/265 (0.4%) 1 0/68 (0%) 0
Bronchitis bacterial 0/111 (0%) 0 1/265 (0.4%) 1 0/68 (0%) 0
Campylobacter gastroenteritis 0/111 (0%) 0 1/265 (0.4%) 1 0/68 (0%) 0
Cellulitis 0/111 (0%) 0 1/265 (0.4%) 1 0/68 (0%) 0
Central nervous system infection 1/111 (0.9%) 1 0/265 (0%) 0 0/68 (0%) 0
Device related infection 0/111 (0%) 0 1/265 (0.4%) 1 0/68 (0%) 0
Diverticulitis 0/111 (0%) 0 1/265 (0.4%) 1 0/68 (0%) 0
Infection 0/111 (0%) 0 1/265 (0.4%) 1 0/68 (0%) 0
Infectious pleural effusion 0/111 (0%) 0 2/265 (0.8%) 2 0/68 (0%) 0
Lower respiratory tract infection 1/111 (0.9%) 1 1/265 (0.4%) 1 0/68 (0%) 0
Lung abscess 0/111 (0%) 0 1/265 (0.4%) 2 0/68 (0%) 0
Lung infection 0/111 (0%) 0 1/265 (0.4%) 1 0/68 (0%) 0
Pneumococcal sepsis 0/111 (0%) 0 1/265 (0.4%) 1 0/68 (0%) 0
Pulmonary sepsis 0/111 (0%) 0 1/265 (0.4%) 1 0/68 (0%) 0
Respiratory tract infection 0/111 (0%) 0 2/265 (0.8%) 4 0/68 (0%) 0
Staphylococcal infection 0/111 (0%) 0 1/265 (0.4%) 1 0/68 (0%) 0
Streptococcal abscess 0/111 (0%) 0 1/265 (0.4%) 1 0/68 (0%) 0
Injury, poisoning and procedural complications
Hip fracture 0/111 (0%) 0 0/265 (0%) 0 1/68 (1.5%) 1
Infusion related reaction 1/111 (0.9%) 1 1/265 (0.4%) 1 1/68 (1.5%) 1
Investigations
Alanine aminotransferase increased 0/111 (0%) 0 1/265 (0.4%) 1 0/68 (0%) 0
Hepatic enzyme increased 0/111 (0%) 0 1/265 (0.4%) 1 1/68 (1.5%) 1
Transaminases increased 0/111 (0%) 0 1/265 (0.4%) 1 1/68 (1.5%) 1
Urine output decreased 1/111 (0.9%) 1 0/265 (0%) 0 0/68 (0%) 0
Weight decreased 0/111 (0%) 0 1/265 (0.4%) 1 0/68 (0%) 0
Metabolism and nutrition disorders
Decreased appetite 1/111 (0.9%) 1 1/265 (0.4%) 1 0/68 (0%) 0
Dehydration 0/111 (0%) 0 1/265 (0.4%) 1 1/68 (1.5%) 1
Hyperglycaemia 0/111 (0%) 0 0/265 (0%) 0 1/68 (1.5%) 1
Musculoskeletal and connective tissue disorders
Back pain 0/111 (0%) 0 1/265 (0.4%) 1 0/68 (0%) 0
Musculoskeletal pain 0/111 (0%) 0 1/265 (0.4%) 1 0/68 (0%) 0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma 0/111 (0%) 0 1/265 (0.4%) 1 0/68 (0%) 0
Colon cancer 0/111 (0%) 0 1/265 (0.4%) 1 0/68 (0%) 0
Metastases to central nervous system 2/111 (1.8%) 2 0/265 (0%) 0 0/68 (0%) 0
Tumour haemorrhage 1/111 (0.9%) 1 0/265 (0%) 0 0/68 (0%) 0
Nervous system disorders
Intracranial pressure increased 0/111 (0%) 0 1/265 (0.4%) 1 0/68 (0%) 0
Seizure 0/111 (0%) 0 1/265 (0.4%) 1 0/68 (0%) 0
Somnolence 0/111 (0%) 0 1/265 (0.4%) 1 0/68 (0%) 0
Cerebral ischaemia 0/111 (0%) 0 1/265 (0.4%) 1 0/68 (0%) 0
Headache 0/111 (0%) 0 1/265 (0.4%) 1 1/68 (1.5%) 1
Memory impairment 0/111 (0%) 0 1/265 (0.4%) 1 0/68 (0%) 0
Spinal cord compression 1/111 (0.9%) 1 1/265 (0.4%) 1 0/68 (0%) 0
Psychiatric disorders
Mental status changes 0/111 (0%) 0 0/265 (0%) 0 1/68 (1.5%) 1
Renal and urinary disorders
Ureteric obstruction 0/111 (0%) 0 1/265 (0.4%) 1 0/68 (0%) 0
Hydronephrosis 1/111 (0.9%) 1 0/265 (0%) 0 0/68 (0%) 0
Nephritis 0/111 (0%) 0 1/265 (0.4%) 1 0/68 (0%) 0
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism 1/111 (0.9%) 1 2/265 (0.8%) 2 2/68 (2.9%) 2
Chronic obstructive pulmonary disease 0/111 (0%) 0 1/265 (0.4%) 1 0/68 (0%) 0
Dyspnoea 3/111 (2.7%) 3 7/265 (2.6%) 7 0/68 (0%) 0
Haemoptysis 1/111 (0.9%) 2 1/265 (0.4%) 1 1/68 (1.5%) 1
Interstitial lung disease 0/111 (0%) 0 0/265 (0%) 0 1/68 (1.5%) 2
Organising pneumonia 0/111 (0%) 0 1/265 (0.4%) 1 0/68 (0%) 0
Pleural effusion 1/111 (0.9%) 1 5/265 (1.9%) 5 1/68 (1.5%) 1
Pneumonitis 1/111 (0.9%) 1 4/265 (1.5%) 4 0/68 (0%) 0
Pulmonary haemorrhage 1/111 (0.9%) 1 0/265 (0%) 0 0/68 (0%) 0
Respiratory failure 0/111 (0%) 0 2/265 (0.8%) 2 0/68 (0%) 0
Vascular disorders
Vena cava thrombosis 1/111 (0.9%) 1 0/265 (0%) 0 0/68 (0%) 0
Hypertensive crisis 0/111 (0%) 0 0/265 (0%) 0 1/68 (1.5%) 1
Hypovolaemic shock 0/111 (0%) 0 1/265 (0.4%) 1 0/68 (0%) 0
Superior vena cava syndrome 0/111 (0%) 0 1/265 (0.4%) 1 0/68 (0%) 0
Other (Not Including 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 96/111 (86.5%) 233/265 (87.9%) 60/68 (88.2%)
Blood and lymphatic system disorders
Anaemia 3/111 (2.7%) 3 43/265 (16.2%) 52 8/68 (11.8%) 8
Endocrine disorders
Hyperthyroidism 11/111 (9.9%) 12 17/265 (6.4%) 18 7/68 (10.3%) 8
Hypothyroidism 11/111 (9.9%) 14 19/265 (7.2%) 24 8/68 (11.8%) 9
Gastrointestinal disorders
Abdominal pain 5/111 (4.5%) 6 10/265 (3.8%) 10 4/68 (5.9%) 6
Abdominal pain upper 7/111 (6.3%) 8 12/265 (4.5%) 12 1/68 (1.5%) 1
Constipation 14/111 (12.6%) 15 37/265 (14%) 45 16/68 (23.5%) 19
Diarrhoea 11/111 (9.9%) 14 39/265 (14.7%) 53 9/68 (13.2%) 10
Nausea 14/111 (12.6%) 16 46/265 (17.4%) 57 12/68 (17.6%) 15
Vomiting 13/111 (11.7%) 15 27/265 (10.2%) 36 10/68 (14.7%) 13
General disorders
Asthenia 14/111 (12.6%) 15 53/265 (20%) 76 4/68 (5.9%) 4
Fatigue 15/111 (13.5%) 16 69/265 (26%) 80 20/68 (29.4%) 31
Non-cardiac chest pain 3/111 (2.7%) 4 10/265 (3.8%) 15 4/68 (5.9%) 5
Oedema peripheral 7/111 (6.3%) 8 25/265 (9.4%) 25 9/68 (13.2%) 13
Pain 1/111 (0.9%) 1 8/265 (3%) 8 4/68 (5.9%) 4
Pyrexia 12/111 (10.8%) 14 53/265 (20%) 81 12/68 (17.6%) 16
Infections and infestations
Pneumonia 2/111 (1.8%) 2 4/265 (1.5%) 4 4/68 (5.9%) 5
Upper respiratory tract infection 6/111 (5.4%) 9 8/265 (3%) 8 6/68 (8.8%) 6
Urinary tract infection 4/111 (3.6%) 4 15/265 (5.7%) 19 3/68 (4.4%) 4
Viral upper respiratory tract infection 5/111 (4.5%) 6 12/265 (4.5%) 13 11/68 (16.2%) 18
Investigations
Alanine aminotransferase increased 5/111 (4.5%) 5 11/265 (4.2%) 13 5/68 (7.4%) 5
Aspartate aminotransferase increased 3/111 (2.7%) 3 12/265 (4.5%) 14 5/68 (7.4%) 5
Blood alkaline phosphatase increased 2/111 (1.8%) 2 14/265 (5.3%) 14 2/68 (2.9%) 2
Gamma-glutamyltransferase increased 4/111 (3.6%) 4 15/265 (5.7%) 15 0/68 (0%) 0
Weight decreased 3/111 (2.7%) 3 22/265 (8.3%) 22 13/68 (19.1%) 13
Metabolism and nutrition disorders
Decreased appetite 15/111 (13.5%) 15 71/265 (26.8%) 77 12/68 (17.6%) 12
Hyponatraemia 2/111 (1.8%) 2 14/265 (5.3%) 20 4/68 (5.9%) 5
Musculoskeletal and connective tissue disorders
Arthralgia 7/111 (6.3%) 7 21/265 (7.9%) 25 5/68 (7.4%) 6
Back pain 11/111 (9.9%) 11 23/265 (8.7%) 24 8/68 (11.8%) 10
Musculoskeletal pain 4/111 (3.6%) 4 16/265 (6%) 21 3/68 (4.4%) 4
Neck pain 3/111 (2.7%) 3 8/265 (3%) 8 7/68 (10.3%) 7
Pain in extremity 5/111 (4.5%) 5 18/265 (6.8%) 21 2/68 (2.9%) 2
Nervous system disorders
Dizziness 6/111 (5.4%) 6 12/265 (4.5%) 18 4/68 (5.9%) 6
Headache 13/111 (11.7%) 15 26/265 (9.8%) 32 6/68 (8.8%) 6
Psychiatric disorders
Anxiety 2/111 (1.8%) 2 16/265 (6%) 16 2/68 (2.9%) 2
Insomnia 10/111 (9%) 12 16/265 (6%) 19 5/68 (7.4%) 5
Respiratory, thoracic and mediastinal disorders
Cough 26/111 (23.4%) 32 56/265 (21.1%) 67 13/68 (19.1%) 16
Dysphonia 0/111 (0%) 0 14/265 (5.3%) 15 1/68 (1.5%) 1
Dyspnoea 13/111 (11.7%) 14 43/265 (16.2%) 46 7/68 (10.3%) 10
Haemoptysis 3/111 (2.7%) 3 14/265 (5.3%) 20 4/68 (5.9%) 6
Productive cough 4/111 (3.6%) 4 20/265 (7.5%) 23 4/68 (5.9%) 4
Skin and subcutaneous tissue disorders
Pruritus 9/111 (8.1%) 11 27/265 (10.2%) 39 13/68 (19.1%) 14
Rash 7/111 (6.3%) 9 19/265 (7.2%) 20 8/68 (11.8%) 8

Limitations/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

Name/Title Phillip Dennis, MD, PhD
Organization AstraZeneca
Phone +1 301 398-5549
Email ClinicalTrialTransparency@astrazeneca.com
Responsible Party:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT02087423
Other Study ID Numbers:
  • D4191C00003
First Posted:
Mar 14, 2014
Last Update Posted:
Jul 18, 2022
Last Verified:
Jun 1, 2022