To hear about similar clinical trials, please enter your email below
Trial Title:
A Study of SHR-A2102 in Combination With Adebrelimab and SHR-8068 in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
NCT ID:
NCT06589778
Condition:
Non-Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SHR-A2102
Description:
SHR-A2102: injection, 80mg/ bottle, intravenous drip
Arm group label:
SHR-A2102 in Combination with Adebrelimab and SHR-8068
Intervention type:
Drug
Intervention name:
Adebelimab (SHR-1316)
Description:
Adebelimab (SHR-1316): injection, 600mg(12mL)/ bottle, intravenous drip
Arm group label:
SHR-A2102 in Combination with Adebrelimab and SHR-8068
Intervention type:
Drug
Intervention name:
SHR-8068
Description:
SHR-8068: injection, 50mg（10mL）/ bottle, intravenous drip
Arm group label:
SHR-A2102 in Combination with Adebrelimab and SHR-8068
Summary:
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Chest Hospital
Address:
City:
Shanghai
Zip:
200030
Country:
China
Status:
Recruiting
Contact:
Last name:
Hua Zhong
Start date:
September 27, 2024
Completion date:
April 30, 2026
Lead sponsor:
Agency:
Shanghai Hengrui Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Shanghai Hengrui Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06589778
