Actively Recruiting
A Study of Novel Combinations in Non-Small Cell Lung Cancer (NSCLC)
Led by AstraZeneca · Updated on 2026-04-29
278
Participants Needed
64
Research Sites
191 weeks
Total Duration
On this page
Sponsors
A
AstraZeneca
Lead Sponsor
D
Daiichi Sankyo
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a Phase II, multi-center, open-label platform study evaluating novel combination treatment options in participants with locally advanced or metastatic NSCLC. The study will consist of several sub-studies, each evaluating the safety, tolerability, and preliminary antitumour activity of various treatment combinations. This study will be conducted in approximately 80 centers globally across 10 countries.
CONDITIONS
Official Title
A Study of Novel Combinations in Non-Small Cell Lung Cancer (NSCLC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must be 18 years of age or older at the time of consent
- WHO/ECOG performance status of 0 or 1
- At least one measurable lesion according to RECIST 1.1 at baseline
- Adequate bone marrow and organ function
- Life expectancy of at least 12 weeks
- Provision of acceptable tumor tissue sample
- For Sub-Studies 1 and 2: Histologically or cytologically confirmed advanced or metastatic NSCLC
- PD-L1 tumor cell expression of at least 1% (50% or more for Sub-Study 1; 1-49% for Sub-Study 2)
- No sensitizing EGFR mutations or ALK rearrangements; no other known actionable genomic alterations
- For Sub-Study 3: Histologically or cytologically confirmed advanced or metastatic non-squamous NSCLC
- Documented positive actionable genomic alteration and progression on prior targeted therapy
You will not qualify if you...
- Any severe or uncontrolled systemic disease making participation undesirable or jeopardizing protocol compliance
- Active or prior documented autoimmune or inflammatory disorders
- Persistent toxicities Grade 2 or higher caused by prior anticancer therapy, excluding hair loss
- Spinal cord compression or leptomeningeal carcinomatosis (for Sub-Studies 1 and 2); unstable spinal cord compression (for Sub-Study 3)
- Unstable brain metastases
- History of another primary malignancy
- Active infection including tuberculosis, HIV, hepatitis B, or hepatitis C
- Uncontrolled or significant cardiac disease
- Prior systemic chemotherapy, chemoradiation, or immunotherapy for advanced NSCLC (for Sub-Studies 1 and 2)
- Prior exposure to immune-mediated therapy
- History of uncontrolled hypertension, active bleeding, or bleeding disorders
- Any concurrent anti-cancer treatment
- Receipt of live, attenuated vaccine within 30 days prior to first study drug dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 64 locations
1
Research Site
Santa Monica, California, United States, 90404
Not Yet Recruiting
2
Research Site
Santa Rosa, California, United States, 95403
Not Yet Recruiting
3
Research Site
Atlanta, Georgia, United States, 30318
Actively Recruiting
4
Research Site
Baltimore, Maryland, United States, 21231
Not Yet Recruiting
5
Research Site
Houston, Texas, United States, 77090
Not Yet Recruiting
6
Research Site
Fairfax, Virginia, United States, 22031
Actively Recruiting
7
Research Site
Heidelberg, Australia, 3084
Not Yet Recruiting
8
Research Site
Nedlands, Australia, 6009
Not Yet Recruiting
9
Research Site
Woodville, Australia, 5011
Not Yet Recruiting
10
Research Site
Toronto, Ontario, Canada, M5G 2M9
Not Yet Recruiting
11
Research Site
Changsha, China, 410013
Actively Recruiting
12
Research Site
Chengdu, China, 610041
Actively Recruiting
13
Research Site
Deyang, China, 618000
Actively Recruiting
14
Research Site
Dongguan, China, 523059
Actively Recruiting
15
Research Site
Fuzhou, China, 350014
Not Yet Recruiting
16
Research Site
Guangzhou, China, 510080
Actively Recruiting
17
Research Site
Guangzhou, China, 510100
Actively Recruiting
18
Research Site
Hangzhou, China, 310014
Actively Recruiting
19
Research Site
Hefei, China, 230022
Actively Recruiting
20
Research Site
Linyi, China, 276001
Actively Recruiting
21
Research Site
Mianyang, China, 621000
Actively Recruiting
22
Research Site
Nanchang, China, 330000
Actively Recruiting
23
Research Site
Nanchang, China, 330006
Actively Recruiting
24
Research Site
Shantou, China
Actively Recruiting
25
Research Site
Shenyang, China, 110042
Actively Recruiting
26
Research Site
Wuhan, China, 430022
Actively Recruiting
27
Research Site
Zhengzhou, China, 450000
Actively Recruiting
28
Research Site
Zhengzhou, China, 450008
Actively Recruiting
29
Research Site
Zhuhai, China, 519000
Actively Recruiting
30
Research Site
Bunkyō City, Japan, 113-8677
Actively Recruiting
31
Research Site
Fukuyama-shi, Japan, 722-0001
Actively Recruiting
32
Research Site
Kobe, Japan, 650-0047
Actively Recruiting
33
Research Site
Kurume-shi, Japan, 830-0011
Actively Recruiting
34
Research Site
Kyoto, Japan, 602-8566
Actively Recruiting
35
Research Site
Kyoto, Japan, 606-8507
Actively Recruiting
36
Research Site
Osaka, Japan, 541-8567
Actively Recruiting
37
Research Site
Sakaishi, Japan, 591-8555
Actively Recruiting
38
Research Site
Shinjuku-ku, Japan, 162-8655
Actively Recruiting
39
Research Site
Wakayama, Japan, 641-8510
Actively Recruiting
40
Research Site
Yokohama, Japan, 236-0051
Actively Recruiting
41
Research Site
Singapore, Singapore, 119082
Actively Recruiting
42
Research Site
Singapore, Singapore, 168583
Actively Recruiting
43
Research Site
Cheongju-si, South Korea, 28644
Actively Recruiting
44
Research Site
Namdong-gu, South Korea, 21565
Actively Recruiting
45
Research Site
Seongnam-si, South Korea, 13496
Actively Recruiting
46
Research Site
Seoul, South Korea, 03080
Actively Recruiting
47
Research Site
Seoul, South Korea, 06351
Actively Recruiting
48
Research Site
Seoul, South Korea, 3722
Actively Recruiting
49
Research Site
Seoul, South Korea, 5505
Actively Recruiting
50
Research Site
Suwon, South Korea, 16247
Actively Recruiting
51
Research Site
Suwon, South Korea, 16499
Actively Recruiting
52
Research Site
Liuying, Taiwan, 736
Actively Recruiting
53
Research Site
Taichung, Taiwan, 402
Actively Recruiting
54
Research Site
Taichung, Taiwan, 40447
Actively Recruiting
55
Research Site
Tainan, Taiwan, 70403
Actively Recruiting
56
Research Site
Tainan, Taiwan, 710
Actively Recruiting
57
Research Site
Taipei, Taiwan, 100
Actively Recruiting
58
Research Site
Taipei, Taiwan, 110
Actively Recruiting
59
Research Site
Taipei, Taiwan, 11217
Actively Recruiting
60
Research Site
Taoyuan, Taiwan, 00333
Actively Recruiting
61
Research Site
Bangkok, Thailand, 10330
Not Yet Recruiting
62
Research Site
Bangkok, Thailand, 10400
Not Yet Recruiting
63
Research Site
Bangkok, Thailand, 10700
Not Yet Recruiting
64
Research Site
Banphaeo, Thailand, 74120
Not Yet Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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