NCT07170995 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 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Suzhou Suncadia Biopharmaceuticals Co., Ltd. |
| Condition | Advanced or Metastatic Non-small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 460 participants |
| Start Date | 2025-10-22 |
| Primary Completion | 2030-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 460 participants in total. It began in 2025-10-22 with a primary completion date of 2030-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is a randomized, open-label, controlled, multicenter Phase III clinical trial to evaluate the efficacy and safety of SHR-8068 combined with adebrelimab and platinum-based chemotherapy versus tislelizumab combined with platinum-based chemotherapy as first-line treatment for advanced or metastatic non-small cell lung cancer.
Eligibility Criteria
Inclusion Criteria: 1. Voluntary participation and written informed consent. 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: 1. Have untreated central nervous system metastasis; or have meningeal metastasis or spinal cord compression; 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07170995 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Advanced or Metastatic Non-small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07170995 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 460 participants.
Is NCT07170995 currently recruiting?
Yes, NCT07170995 is actively recruiting participants. Contact the research team at weixia.li@hengrui.com for enrollment information.
Where is the NCT07170995 trial being conducted?
This trial is being conducted at Jinan, China.
Who is sponsoring the NCT07170995 clinical trial?
NCT07170995 is sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd.. The trial plans to enroll 460 participants.
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