Actively Recruiting
A Study of ZL-1310 in Subjects With Small Cell Lung Cancer
Led by Zai Lab (Shanghai) Co., Ltd. · Updated on 2026-04-03
339
Participants Needed
38
Research Sites
183 weeks
Total Duration
On this page
Sponsors
Z
Zai Lab (Shanghai) Co., Ltd.
Lead Sponsor
Z
Zai Lab (US) LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
An open-label, multicenter study of ZL-1310 as a single agent and in combination with Atezolizumab (with and without Carboplatin) to evaluate the safety, efficacy, and pharmacokinetics in subjects with small cell lung cancer
CONDITIONS
Official Title
A Study of ZL-1310 in Subjects With Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Metastatic or extensive-stage small cell lung cancer (de novo, not transformed)
- For Part 1A and 1B: disease progression during or after platinum-based chemotherapy
- For Part 1C and Part 4: no prior systemic treatment for small cell lung cancer
- For Part 1B backfill and Part 3 first-line setting: no prior systemic treatment for small cell lung cancer
- For Part 1B backfill and Part 3 first-line maintenance: received at least 4 cycles of 1L induction therapy with carboplatin or cisplatin, etoposide, and anti-PD-L1 inhibitor with ongoing CR, PR, or SD per RECIST v1.1
- For Part 2-1: received no more than 2 prior therapies and progressed after platinum-based chemotherapy and anti-DLL3 T-cell engager
- Adult men and women 18 years or older
- ECOG performance status of 0 or 1
- At least one measurable target lesion by RECIST v1.1 on CT, PET/CT, or MRI
- Willing to undergo tumor biopsy or provide archived tumor tissue
- Life expectancy of 3 months or more
You will not qualify if you...
- Another progressing malignancy needing active treatment within last 2 years (exceptions apply)
- Symptomatic or untreated brain metastasis requiring treatment (except stable brain metastases meeting criteria for Parts 2, 3, and 4)
- Leptomeningeal disease
- Systemic anti-cancer treatment or investigational product within 3 weeks before first study dose
- Non-palliative radiotherapy within 2 weeks before first study dose or history of radiation pneumonitis
- Major surgery within 4 weeks before first study dose
- Hypersensitivity to study treatment ingredients
- Inadequate organ function within 10 days before first study dose
- Immunodeficiency or chronic systemic steroid/immunosuppressive therapy within 14 days or 5 half-lives before first dose
- Live or live-attenuated vaccine within 30 days before study therapy
- Impaired cardiac function or significant cardiac disease within 3 months before first dose
- Lung-specific serious illnesses and autoimmune, connective tissue, or inflammatory disorders including pneumonitis
- Pregnant or nursing women
- Use of strong CYP3A or CYP2D6 inhibitors within 14 days or 5 half-lives before first dose
- Prior treatment with CD137 agonists or immune checkpoint therapies for Parts 1C and 4
- Prior systemic immunostimulatory agents within 4 weeks or 5 half-lives before study treatment for Parts 1B and 1C
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 38 locations
1
Zai Lab Site 2005
Duarte, California, United States, 91010
Actively Recruiting
2
Zai Lab Site 2030
New Haven, Connecticut, United States, 06519
Actively Recruiting
3
Zai Lab Site 2026
Sarasota, Florida, United States, 34232
Actively Recruiting
4
Zai Lab Site 2013
Detroit, Michigan, United States, 48201
Actively Recruiting
5
Zai Lab Site 2001
Hackensack, New Jersey, United States, 07601
Actively Recruiting
6
Zai Lab Site 2002
Buffalo, New York, United States, 14263
Actively Recruiting
7
Zai Lab Site 2018
Durham, North Carolina, United States, 27710
Actively Recruiting
8
Zai Lab Site 2024
Cleveland, Ohio, United States, 44106
Actively Recruiting
9
Zai Lab Site 2029
Pittsburgh, Pennsylvania, United States, 15232
Not Yet Recruiting
10
Zai Lab Site 2012
Charleston, South Carolina, United States, 29425
Actively Recruiting
11
Zai Lab Site 2006
Fairfax, Virginia, United States, 22031
Actively Recruiting
12
Zai Lab Site 1004
Hefei, Anhui, China, 230022
Actively Recruiting
13
Zai Lab Site 1005
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
14
Zai Lab Site 1012
Xiamen, Fujian, China, 361000
Not Yet Recruiting
15
Zai Lab Site 1001
Guangzhou, Guangdong, China, 510030
Actively Recruiting
16
Zai Lab Site 1009
Harbin, Heilongjiang, China, 150000
Not Yet Recruiting
17
Zai Lab Site 1006
Zhengzhou, Henan, China, 450008
Actively Recruiting
18
Zai Lab 1002
Wuhan, Hubei, China, 430022
Actively Recruiting
19
Zai Lab Site 1014
Changsha, Hunan, China, 410013
Not Yet Recruiting
20
Zai Lab Site 1016
Nanjing, Jiangsu, China, 210008
Actively Recruiting
21
Zai Lab Site 1003
Nanchang, Jiangxi, China, 330006
Actively Recruiting
22
Zai Lab Site 1008
Ch’ang-ch’un, Jilin, China, 130012
Actively Recruiting
23
Zai Lab Site 1017
Shenyang, Liaoning, China, 110041
Not Yet Recruiting
24
Zai Lab Site 1015
Xi'an, Shaanxi, China, 710061
Not Yet Recruiting
25
Zai Lab Site 1011
Jinan, Shandong, China, 250000
Actively Recruiting
26
Zai Lab Site 1010
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
27
Zai Lab Site 1013
Chengdu, Sichaun, China, 610041
Actively Recruiting
28
Zai Lab Site 8002
Barcelona, Barcelona, Spain, 8035
Actively Recruiting
29
Zai Lab Site 8003
Madrid, Madrid, Spain, 28034
Actively Recruiting
30
Zai Lab Site 8006
Madrid, Madrid, Spain, 28041
Actively Recruiting
31
Zai Lab Site 8005
Seville, Sevilla, Spain, 41009
Actively Recruiting
32
Zai Lab Site 8004
Valencia, Valencia, Spain, 46010
Actively Recruiting
33
Zai Lab Site 8001
Valencia, Valencia, Spain, 46026
Actively Recruiting
34
Zai Lab Site 8007
Barcelona, Spain, 08023
Not Yet Recruiting
35
Zai Lab Site 8009
Madrid, Spain, 28050
Not Yet Recruiting
36
Zai Lab Site 8008
Málaga, Spain, 29010
Not Yet Recruiting
37
Zai Lab Site 8010
Pozuelo de Alarcón, Spain, 28223
Not Yet Recruiting
38
Zai Lab Site 8011
Seville, Spain, 41013
Not Yet Recruiting
Research Team
E
Erin Nurre
CONTACT
M
Mona Qureshi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
13
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