Phase III Study of SHR-8068 Combined With Adebrelimab and Chemotherapy Versus Tislelizumab Combined With Chemotherapy in the Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer
NCT ID: NCT07170995
Last Updated: 2025-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
460 participants
INTERVENTIONAL
2025-10-22
2030-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SHR-8068，adebelizumab and platinum-based chemotherapy
SHR-8068，adebelizumab and platinum-based chemotherapy
SHR-8068，adebelizumab and platinum-based chemotherapy
tislelizumab, and platinum-based chemotherapy
tislelizumab, and platinum-based chemotherapy
tislelizumab, and platinum-based chemotherapy
Interventions
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SHR-8068，adebelizumab and platinum-based chemotherapy
SHR-8068，adebelizumab and platinum-based chemotherapy
tislelizumab, and platinum-based chemotherapy
tislelizumab, and platinum-based chemotherapy
Eligibility Criteria
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Inclusion Criteria
2. 18-75 years old, no gender limitation.
3. Newly diagnosed histologically or cytologically confirmed, locally advanced or metastatic non-small cell lung cancer (NSCLC) that is treatment naive and not amenable to curative therapy including surgical resection or chemoradiation.
4. Confirmed tumor PD-L1 status prior to randomization.
5. Eastern Cooperative Oncology Group (ECOG) score: 0-1
6. With a life expectancy ≥ 3 months.
7. At least one measurable lesion according to RECIST v1.1.
Exclusion Criteria
2. Uncontrolled clinically symptomatic pleural effusion, pericardial effusion, or ascites;
3. Previous or co-existing malignancies；
4. Have Active or prior documented autoimmune or inflammatory disorders;
5. Active hepatitis B or hepatitis C, or with a history of immunodeficiency;
6. Have an active or past medical history of interstitial lung disease (ILD)/pneumonitis, including drug-induced or radiation ILD/pneumonitis.
18 Years
75 Years
ALL
No
Sponsors
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Suzhou Suncadia Biopharmaceuticals Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Affiliated Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China
Countries
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Central Contacts
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Other Identifiers
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SHR-8068-302
Identifier Type: -
Identifier Source: org_study_id
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