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

Phase 2RecruitingNCT06589778

Shanghai Hengrui Pharmaceutical Co., Ltd.124 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

124

Conditions

Non-Small Cell Lung Cancer

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Determination of Recommended Phase II dose (RP2D)

Time frame: From first dose of study treatment until the end of Cycle 1（up to 21 days）

Objective Response Rate (ORR)

The percentage of participants with a confirmed CR or PR according to RECIST v1.1 criteria.

Time frame: From time of first dose of SHR-A2102 or Adebrelimab or SHR-8068 until the date of objective disease progression or death (up to 12 months)

Incidence and severity of AEs

Time frame: The observation period ended at the end of the 21-day period after the first dose of SHR-A2102 or Adebrelimab or SHR-8068 (up to 21 days)

Secondary Outcomes

Disease Control Rate (DCR)

The percentage of participants who have a best objective response of confirmed CR or PR or who have SD after start of treatment.

Time frame: From time of first dose of SHR-A2102 or Adebrelimab or SHR-8068 until the date of objective disease progression or death (up to 12 months)

Duration of Response (DoR)

The time from the date of first response until date of disease progression or death in the absence of disease progression.

Time frame: From time of first dose of objective disease progression until the date of objective disease progression or death (up to 12 months)]

Progression free Survival (PFS)

Progression-free survival is defined as the time from the start of treatment until the date of objective disease progression or death.

Time frame: From time of first dose of objective disease progression until the date of objective disease progression or death (up to 12 months)

Overall Survival (OS)

The time until death due to any cause.

Time frame: From time of first dose of objective disease progression until the date of death (up to 24 months)