Phase
Condition
Small Cell Lung Cancer
Treatment
Carboplatin
ZL-1310
Atezolizumab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Signed informed consent
Subjects must have histologically or cytologically confirmed metastatic orextensive-stage small cell lung cancer with documented disease progression during orfollowing a platinum-based chemotherapy regimen. No more than 3 prior regimens inthe metastatic or extensive stage are allowed.
Adult men and women ≥18 years of age. Eastern Cooperative Oncology Group (ECOG)performance status of 0 or 1.
Subjects must have at least one measurable target lesion as defined by RECIST v1.1on CT, PET/CT, or MRI.
Subjects must be willing to undergo a tumor biopsy or must provide archived tumortissue sample at screening per protocol guidelines.
Life Expectancy >3 months.
Exclusion
Exclusion Criteria:
Subjects with another known malignancy that is progressing or requires activetreatment within the last 2 years. Exceptions: basal cell carcinoma of the skin orlocalized squamous cell carcinoma of the skin with previously administered curativetreatment, in situ cervical cancer, or other cancers that do not require systemicanti-cancer therapies and will not impact life expectancy.
Symptomatic or untreated brain metastasis requiring concurrent treatment. For Part 2, the following subjects can be enrolled if they have a stable neurologic statusfor at least 2 weeks prior to the first dose of ZL-1310:
Subjects with untreated and asymptomatic brain metastases.
Subjects with treated brain metastases that are no longer symptomatic (i.e.without neurologic signs or symptoms), who require no treatment with steriodsor anticonvulsants and have recovered from the actue toxic effects ofradiotherapy.
Subjects with leptomeningeal metastasis.
Treatment with any systemic anti-cancer treatment or other investigational products/device within 3 weeks before first dose of study treatment.
Non-palliative radiotherapy within 2 weeks prior to first dose of study treatment orhave had a history of radiation pneumonitis.
Major surgery within 4 weeks of the first dose of study treatment.
Hypersensitivity to any ingredient of the study treatment.
Out of range lab value (as defined in protocol) within 10 days prior to the firstdose of study treatment,
Subjects with a diagnosis of immunodeficiency or receiving chronic systemic steroidtherapy or any other form of immunosuppressive therapy within 14 days or 5half-lives before the first dose of study treatment, whichever is longer.
Subjects have received a live or live-attenuated vaccine within 30 days of plannedstart of study therapy.
Impaired cardiac function or clinically significant cardiac disease within the last 3 months before administration of the first dose of the study treatment
Lung-specific intercurrent clinically significant illnesses and any autoimmune,connective tissue, or inflammatory disorders, including not limited to pneumonitis.
Pregnant or nursing (lactating) women.
Subjects who have been on concomitant strong CYP3A or CYP2D6 inhibitors within 14days or 5 half-lives before the first study treatment, whichever is longer.
For Part 1C only (ZL-1310 in combination with Atezolizumab and Carboplatin),subjects who received prior treatment with CD137agonists or immune checkpointblockade therapies, anti-PD-1, and anti-PD-L1 therapeutic antibodies.
For Part 1B (Z-1310 in combination with Atezolizumab) and Part 1C (ZL-1310 incombination with Atezolizumab and Carboplatin), subjects who received systemicimmunostimulatory agents (including but not limited to, IFNs and IL2) within 4 weeksor 5 drug-elimination half-lives prior to the initiation of study treatment.
Study Design
Study Description
Connect with a study center
Zai Lab Site 1004
Hefei, Anhui 230022
ChinaActive - Recruiting
Zai Lab Site 1005
Beijing, Beijing 100142
ChinaActive - Recruiting
Zai Lab Site 1005
Bejing, Bejing 100142
ChinaSite Not Available
Zai Lab Site 1012
Xiamen, Fujian 361000
ChinaSite Not Available
Zai Lab Site 1001
Guangzhou, Guangdong 510030
ChinaActive - Recruiting
Zai Lab Site 1009
Harbin, Heilongjiang 150000
ChinaSite Not Available
Zai Lab Site 1006
Zhengzhou, Henan 450008
ChinaActive - Recruiting
Zai Lab 1002
Wuhan, Hubei 430022
ChinaActive - Recruiting
Zai Lab Site 1014
Changsha, Hunan 410013
ChinaSite Not Available
Zai Lab Site 1016
Nanjing, Jiangsu 210008
ChinaActive - Recruiting
Zai Lab Site 1003
Nanchang, Jiangxi 330006
ChinaActive - Recruiting
Zai Lab Site 1008
Ch'ang-ch'un, Jilin 130012
ChinaActive - Recruiting
Zai Lab Site 1017
Shenyang, Liaoning 110041
ChinaSite Not Available
Zai Lab Site 1015
Xi'an, Shaanxi 710061
ChinaSite Not Available
Zai Lab Site 1011
Jinan, Shandong 250000
ChinaActive - Recruiting
Zai Lab Site 1010
Shanghai, Shanghai 200032
ChinaActive - Recruiting
Zai Lab Site 1013
Chengdu, Sichaun 610041
ChinaActive - Recruiting
Zai Lab Site 8002
Barcelona, 8035
SpainActive - Recruiting
Zai Lab Site 8003
Madrid, 28034
SpainActive - Recruiting
Zai Lab Site 8006
Madrid, 28041
SpainActive - Recruiting
Zai Lab Site 8005
Sevilla, 41009
SpainActive - Recruiting
Zai Lab Site 8001
Valencia, 46026
SpainActive - Recruiting
Zai Lab Site 8004
Valencia, 46010
SpainActive - Recruiting
Zai Lab Site 2005
Duarte, California 91010
United StatesActive - Recruiting
Zai Lab Site 2030
New Haven, Connecticut 06519
United StatesActive - Recruiting
Zai Lab Site 2026
Sarasota, Florida 34232
United StatesActive - Recruiting
Zai Lab Site 2013
Detroit, Michigan 48201
United StatesActive - Recruiting
Zai Lab Site 2001
Hackensack, New Jersey 07601
United StatesActive - Recruiting
Zai Lab Site 2002
Buffalo, New York 14263
United StatesActive - Recruiting
Zai Lab Site 2018
Durham, North Carolina 27710
United StatesActive - Recruiting
Zai Lab Site 2024
Cleveland, Ohio 44106
United StatesActive - Recruiting
Zai Lab Site 2029
Pittsburgh, Pennsylvania 15232
United StatesSite Not Available
Zai Lab Site 2012
Charleston, South Carolina 29425
United StatesActive - Recruiting
Zai Lab Site 2006
Fairfax, Virginia 22031
United StatesActive - Recruiting
Zai Lab Site 2008
Falls Church, Virginia 22042
United StatesSite Not Available
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