A Study of SHR-A2102 in Combination With Adebrelimab and SHR-8068 in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Hengrui Medicine

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: SHR-8068; Drug: SHR-A2102; Drug: Adebelimab (SHR-1316)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06589778

SHR-A2102-206

Details and patient eligibility

About

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.

Enrollment: 124 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subjects are able to give voluntary informed consent, understand the study and are willing to follow and complete all the test procedures.
2. Age 18~70 years old.
3. Pathologically confirmed unresectable locally advanced/metastatic non-small cell lung cancer.
4. At least one measurable lesion per RECIST v1.1 criteria.
5. ECOG PS score: 0-1.

Exclusion criteria

1. Active or symptomatic brain metastases.
2. Previous diagnosis of any other malignancy.
3. Clinically symptomatic moderate to severe ascites; Uncontrollable or moderate or above pleural effusion, pericardial effusion.
4. Received anti-tumor therapy 4 weeks prior to initiation of study treatment.
5. Uncontrolled tumor-related pain.
6. Subjects with severe cardiovascular and cerebrovascular diseases.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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124 participants in 1 patient group

SHR-A2102 in Combination with Adebrelimab and SHR-8068

Experimental group

Treatment:

Drug: Adebelimab (SHR-1316)

Drug: SHR-A2102

Drug: SHR-8068