Actively Recruiting
An Open-label, Multicenter Study of ZL-1310 to Evaluate the Safety, Efficacy, and Pharmacokinetics in Participants With Small Cell Lung Cancer
Led by Zai Lab (Shanghai) Co., Ltd. · Updated on 2026-04-03
339
Participants Needed
38
Research Sites
8 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
Researchers are evaluating ZL-1310 alone and in combination with Atezolizumab, with or without Carboplatin, in participants with extensive small cell lung cancer (SCLC). This open-label phase 1 study aims to assess the safety, efficacy, and how the body processes ZL-1310 in these patients. The study is designed in multiple parts to explore different dosing and combination strategies for this condition. Participants receive ZL-1310 either as a single agent, combined with Atezolizumab, or combined with both Atezolizumab and Carboplatin. Some parts include an induction phase with the triplet combination followed by maintenance therapy with ZL-1310 and Atezolizumab. Dose levels are escalated and expanded based on safety and tolerability findings. Extensions and optimizations are planned depending on emerging data. During the study, participants undergo regular assessments including tumor imaging by RECIST v1.1 criteria, safety monitoring for dose-limiting toxicities and adverse events, and pharmacokinetic sampling to measure drug levels. Researchers also evaluate treatment responses such as objective response rate and disease control rate. The study lasts up to 24 months of follow-up, with ongoing observation of safety and efficacy outcomes throughout this period.
CONDITIONS
Brief 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 Parts 1A and 1B: disease progression after platinum-based chemotherapy
- For Parts 1C and 4: no prior systemic treatment for SCLC
- For Part 1B backfill and Part 3: first-line or first-line maintenance setting with specific prior treatments
- For Part 2-1: no more than 2 prior therapies in extensive-stage setting and prior progression
- Adults aged 18 years or older
- ECOG performance status of 0 or 1
- At least one measurable target lesion by RECIST v1.1
- Willing to provide tumor biopsy or archived tumor tissue
- Life expectancy of at least 3 months
You will not qualify if you...
- Another progressing malignancy requiring treatment within last 2 years, except certain skin or cervical cancers
- Symptomatic or untreated brain metastases requiring treatment, except stable cases in certain parts
- Leptomeningeal disease
- Anti-cancer treatment or investigational product within 3 weeks prior to study
- Non-palliative radiotherapy within 2 weeks prior or history of radiation pneumonitis
- Major surgery within 4 weeks prior
- Hypersensitivity to study treatment ingredients
- Inadequate organ function within 10 days prior
- Immunodeficiency or recent immunosuppressive therapy
- Live or live-attenuated vaccine within 30 days prior
- Significant cardiac disease within last 3 months
- Lung illnesses or autoimmune disorders including pneumonitis
- Pregnant or nursing women
- Recent use of strong CYP3A or CYP2D6 inhibitors
- Prior treatment with specific immune therapies for certain parts
- Recent systemic immunostimulatory agents prior to study start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants receive ZL-1310 as a single agent, in combination with Atezolizumab, or with Atezolizumab and Carboplatin according to their assigned cohort. Treatment involves multiple dosing cycles to evaluate safety, efficacy, and pharmacokinetics.
Multiple visits during treatment cycles as scheduled by the study team
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
M
Mona Qureshi
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
13
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here