Non-Small Cell Lung Cancer
Conditions
Brief 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.
Interventions
Sponsors
Shanghai Hengrui Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determination of Recommended Phase II dose (RP2D) | From first dose of study treatment until the end of Cycle 1（up to 21 days） | — |
| Objective Response Rate (ORR) | 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) | The percentage of participants with a confirmed CR or PR according to RECIST v1.1 criteria. |
| Incidence and severity of AEs | 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
| Measure | Time frame | Description |
|---|---|---|
| Disease Control Rate (DCR) | 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) | The percentage of participants who have a best objective response of confirmed CR or PR or who have SD after start of treatment. |
| Overall Survival (OS) | From time of first dose of objective disease progression until the date of death (up to 24 months) | The time until death due to any cause. |
| Duration of Response (DoR) | From time of first dose of objective disease progression until the date of objective disease progression or death (up to 12 months)] | The time from the date of first response until date of disease progression or death in the absence of disease progression. |
| Progression free Survival (PFS) | 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 is defined as the time from the start of treatment until the date of objective disease progression or death. |
Countries
China
Contacts
Primary ContactXin Xu
Backup ContactYunfei Zhang
Outcome results
None listed