Actively Recruiting
Led by AstraZeneca · Updated on 2026-04-13
304
Participants Needed
91
Research Sites
N/A
Total Duration
A
AstraZeneca
Lead Sponsor
D
Daiichi Sankyo
Collaborating Sponsor
Researchers are evaluating the safety and tolerability of trastuzumab deruxtecan (T-DXd) combined with immunotherapy agents, with or without chemotherapy, in patients who have HER2 over-expressing non-small cell lung cancer (NSCLC). This phase Ib study focuses on advanced or metastatic non-squamous NSCLC patients, aiming to understand optimal dosing and safety profiles. The study is sponsored by AstraZeneca and includes multiple study parts to explore different drug combinations and regimens. The trial includes several parts: Part 1 involved dose escalation of T-DXd with durvalumab plus cisplatin, carboplatin, or pemetrexed; Parts 3, 4, and 5 assess combinations of T-DXd with volrustomig or rilvegostomig, with or without carboplatin, in various dosing schedules. Patients receive the study drugs as intravenous infusions. Some parts involve randomization between arms with or without carboplatin, focusing on dose optimization in first-line treatment settings. Enrollment in some parts is closed, while others continue to explore safety and efficacy. Participants undergo regular assessments including tumor measurements by RECIST 1.1, organ and bone marrow function tests, and monitoring of adverse events for about 20 months. The study measures safety outcomes like frequency of adverse events and serious adverse events, and secondary outcomes such as response rate, duration of response, disease control, progression-free survival, overall survival, and pharmacokinetics of the drugs. Immunogenicity of the treatments is also evaluated. Participants must have measurable disease and meet performance status criteria, with follow-up to assess treatment effects and safety.
CONDITIONS
Phase Ib Study of the Safety of T-DXd and Immunotherapy Agents With and Without Chemotherapy in Advanced or Metastatic HER2+, Non-squamous NSCLC
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 20 months
Participants receive treatment with combinations of T-DXd and immunotherapy agents, with or without chemotherapy, administered as IV infusions. Treatment includes various drug combinations such as T-DXd with durvalumab and cisplatin or carboplatin, or T-DXd with volrustomig or rilvegostomig, with or without carboplatin, depending on the assigned arm.
Regular visits for treatment and monitoring (frequency determined by protocol)
Duration - Up to 20 months
Participants are monitored for safety, tolerability, and treatment response after completion of treatment. This includes assessments of adverse events, response rate, progression-free survival, overall survival, pharmacokinetics, and immunogenicity.
Scheduled visits for safety and efficacy assessments
Total: 91 locations
1
Research Site
Duarte, California, United States, 91010
Withdrawn
2
Research Site
Newport Beach, California, United States, 92663
Withdrawn
3
Research Site
Orange, California, United States, 92868
Actively Recruiting
4
Research Site
Santa Rosa, California, United States, 95403
Withdrawn
5
Research Site
Westwood, Kansas, United States, 66205
Withdrawn
6
Research Site
Baltimore, Maryland, United States, 21287
Actively Recruiting
7
Research Site
Detroit, Michigan, United States, 48201
Withdrawn
8
Research Site
Buffalo, New York, United States, 14263
Withdrawn
9
Research Site
New York, New York, United States, 10029
Withdrawn
10
Research Site
The Bronx, New York, United States, 10461
Withdrawn
11
Research Site
Houston, Texas, United States, 77030
Actively Recruiting
12
Research Site
Fairfax, Virginia, United States, 22031
Actively Recruiting
13
Research Site
Tacoma, Washington, United States, 98405
Withdrawn
14
Research Site
Adelaide, Australia, 5000
Terminated
15
Research Site
Heidelberg, Australia, 3084
Withdrawn
16
Research Site
Nedlands, Australia, 6009
Actively Recruiting
17
Research Site
Edegem, Belgium, 2650
Completed
18
Research Site
Barretos, Brazil, 14784-400
Actively Recruiting
19
Research Site
Porto Alegre, Brazil, 90035-903
Actively Recruiting
20
Research Site
São Paulo, Brazil, 05652-900
Actively Recruiting
21
Research Site
Winnipeg, Manitoba, Canada, R3E 0V9
Withdrawn
22
Research Site
London, Ontario, Canada, N6A 5W9
Withdrawn
23
Research Site
Montreal, Quebec, Canada, H3T 1E2
Actively Recruiting
24
Research Site
Changchun, China, 130000
Not Yet Recruiting
25
Research Site
Chengdu, China, 610041
Not Yet Recruiting
26
Research Site
Fuzhou, China, 350011
Not Yet Recruiting
27
Research Site
Shandong, China
Not Yet Recruiting
28
Research Site
Shanghai, China, 200433
Actively Recruiting
29
Research Site
Zhengzhou, China, 450000
Not Yet Recruiting
30
Research Site
Bordeaux, France, 33075
Withdrawn
31
Research Site
Dijon, France, 21079
Actively Recruiting
32
Research Site
Pierre-Bénite, France, 69495
Actively Recruiting
33
Research Site
Saint-Herblain, France, 44800
Actively Recruiting
34
Research Site
Villejuif, France, 94805
Actively Recruiting
35
Research Site
Kfar Saba, Israel, 4428164
Actively Recruiting
36
Research Site
Tel Litwinsky, Israel, 52620
Actively Recruiting
37
Research Site
Milan, Italy, 20133
Completed
38
Research Site
Milan, Italy, 20162
Actively Recruiting
39
Research Site
Monza, Italy, 20052
Actively Recruiting
40
Research Site
Naples, Italy, 80131
Actively Recruiting
41
Research Site
Padova, Italy, 35128
Withdrawn
42
Research Site
George Town, Malaysia, 10450
Actively Recruiting
43
Research Site
Kuala Lumpur, Malaysia, 59100
Actively Recruiting
44
Research Site
Kuala Selangor, Malaysia, 62250
Actively Recruiting
45
Research Site
Kuching, Malaysia, 93586
Actively Recruiting
46
Research Site
Amsterdam, Netherlands, 1066 CX
Completed
47
Research Site
Bacolod, Philippines, 6100
Actively Recruiting
48
Research Site
Cebu City, Philippines, 6000
Withdrawn
49
Research Site
City of Taguig, Philippines, 1634
Withdrawn
50
Research Site
Davao City, Philippines, PH-8000
Terminated
51
Research Site
Manila, Philippines, 1000
Terminated
52
Research Site
Manila, Philippines, 1015
Withdrawn
53
Research Site
Quezon City, Philippines, 1100
Actively Recruiting
54
Research Site
Quezon City, Philippines, 1112
Actively Recruiting
55
Research Site
San Juan City, Philippines, 1500
Terminated
56
Research Site
Gdansk, Poland, 80-214
Actively Recruiting
57
Research Site
Krakow, Poland, 30-727
Suspended
58
Research Site
Olsztyn, Poland, 10-357
Actively Recruiting
59
Research Site
Tomaszów Mazowiecki, Poland, 97-200
Terminated
60
Research Site
Warsaw, Poland, 02-781
Actively Recruiting
61
Research Site
Singapore, Singapore, 119228
Completed
62
Research Site
Singapore, Singapore, 168583
Completed
63
Research Site
Singapore, Singapore, 308433
Completed
64
Research Site
Cheongju-si, South Korea, 28644
Actively Recruiting
65
Research Site
Goyang-si, South Korea, 10408
Actively Recruiting
66
Research Site
Jinju, South Korea, 52727
Actively Recruiting
67
Research Site
Seoul, South Korea, 03722
Actively Recruiting
68
Research Site
Seoul, South Korea, 05505
Withdrawn
69
Research Site
Seoul, South Korea, 06351
Actively Recruiting
70
Research Site
Badalona, Spain, 08013
Withdrawn
71
Research Site
Madrid, Spain, 28041
Withdrawn
72
Research Site
Seville, Spain, 41013
Withdrawn
73
Research Site
Valencia, Spain, 46010
Withdrawn
74
Research Site
Kaohsiung City, Taiwan, 833
Actively Recruiting
75
Research Site
Taichung, Taiwan, 402
Actively Recruiting
76
Research Site
Taichung, Taiwan, 40705
Actively Recruiting
77
Research Site
Tainan, Taiwan, 70403
Actively Recruiting
78
Research Site
Taipei, Taiwan, 100
Actively Recruiting
79
Research Site
Taipei, Taiwan, 11217
Actively Recruiting
80
Research Site
Taipei, Taiwan, 235
Actively Recruiting
81
Research Site
Taoyuan, Taiwan, 333
Actively Recruiting
82
Research Site
Bangkok, Thailand, 10300
Actively Recruiting
83
Research Site
Bangkok, Thailand, 10330
Completed
84
Research Site
Hat Yai, Thailand, 90110
Completed
85
Research Site
Khon Kaen, Thailand, 40002
Completed
86
Research Site
Muang, Thailand, 22000
Not Yet Recruiting
87
Research Site
Muang, Thailand, 50200
Actively Recruiting
88
Research Site
Ankara, Turkey (Türkiye), 06800
Actively Recruiting
89
Research Site
Ankara, Turkey (Türkiye), 6200
Actively Recruiting
90
Research Site
Bornova-Izmir, Turkey (Türkiye), 35100
Active, Not Recruiting
91
Research Site
Istanbul, Turkey (Türkiye), 31755
Actively Recruiting
A
AstraZeneca Clinical Study Information Center
A
AstraZeneca Lung Cancer Study Locator Service
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
10
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David Planchard, Hye Ryun Kim, Thatthan Suksombooncharoen...
https://pubmed.ncbi.nlm.nih.gov/41448488