A Study of SHR-A2102 in Combination With Adebrelimab and SHR-8068 in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SHR-A2102, Adebelimab (SHR-1316), SHR-8068.
- Who it may be relevant to
- Registry conditions: Non-Small Cell Lung Cancer. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Safety, Tolerability, and Efficacy of SHR-A2102 in Combination With Adebrelimab, With SHR-8068, in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer: A Phase IB/II Open-Label, Multicenter Clinical Study
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.
Interventions
- Drug SHR-A2102
SHR-A2102: injection, 80mg/ bottle, intravenous drip - Drug Adebelimab (SHR-1316)
Adebelimab (SHR-1316): injection, 600mg(12mL)/ bottle, intravenous drip - Drug SHR-8068
SHR-8068: injection, 50mg（10mL）/ bottle, intravenous drip
Primary outcome measures
- 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) [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 outcome measures (4)
- Disease Control Rate (DCR) [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) [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) [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) [Time frame: From time of first dose of objective disease progression until the date of death (up to 24 months)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai Chest Hospital — Shanghai
Identifiers
NCT: NCT06589778 · SHR-A2102-206