Overview
This study is a multicenter, open-label, dose-finding/efficacy-expanding Phase IB/II clinical trial to evaluate SHR-A2102 in combination with adebelimab in combination with SHR-8068 in patients with locally advanced or metastatic non-small cell lung cancer. The study consists of two phases: Phase IB to explore the safety/tolerability of SHR-A2102 in combination with adebelimab in combination with SHR-8068 in patients with locally advanced or metastatic non-small cell lung cancer; Phase II: To explore the efficacy of SHR-A2102 in combination with adebelimab in combination with SHR-8068 in patients with locally advanced or metastatic non-small cell lung cancer.
Eligibility
Inclusion Criteria:
- Subjects are able to give voluntary informed consent, understand the study and are willing to follow and complete all the test procedures.
- Age 18~70 years old.
- Pathologically confirmed unresectable locally advanced/metastatic non-small cell lung cancer.
- At least one measurable lesion per RECIST v1.1 criteria.
- ECOG PS score: 0-1.
Exclusion Criteria:
- Active or symptomatic brain metastases.
- Previous diagnosis of any other malignancy.
- Clinically symptomatic moderate to severe ascites; Uncontrollable or moderate or above pleural effusion, pericardial effusion.
- Received anti-tumor therapy 4 weeks prior to initiation of study treatment.
- Uncontrolled tumor-related pain.
- Subjects with severe cardiovascular and cerebrovascular diseases.