Non Small Cell Lung Cancer
Conditions
Brief summary
This is a randomized, open-label, multicenter, phase 3 clinical study comparing the efficacy and safety of SHR-A1811 in combination with Adebrelimab versus platinum-based doublet chemotherapy in combination with Tislelizumab as first-line treatment in patients with HER2-overexpressing locally advanced or metastatic non-squamous non-small cell lung cancer.
Interventions
SHR-A1811 Injection.
Adebrelimab Injection.
Tislelizumab Injection.
Pemetrexed Disodium For Injection.
DRUGCarboplatin injection
Carboplatin Injection.
DRUGCisplatin injection
Cisplatin Injection.
Sponsors
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Eligible patients will be randomly assigned in a 1:1 ratio to one of the following two treatment arms: Experimental Arm: SHR-A1811 in combination with Adebrelimab; Active Comparator Arm: Platinum-based doublet chemotherapy in combination with Tislelizumab.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Able to provide informed consent, willing and able to comply with the scheduled visits, examinations, and other procedural requirements of the treatment. 2. Aged 18-75 years (inclusive) at the time of signing the informed consent form, with no restriction on sex. 3. ECOG score of 0 or 1. 4. Patients with histologically confirmed locally advanced or metastatic non-squamous NSCLC. 5. Participants with HER2 overexpression confirmed by a central laboratory. 6. Have not previously received systemic antitumor therapy for locally advanced or metastatic NSCLC.
Exclusion criteria
1. Participants with untreated or active metastasis of central nervous system (CNS) tumors, or a history of meningeal metastasis or current meningeal metastasis. 2. Previous or current with other malignancies. 3. Prior antitumor toxicity and/or complications have not recovered to NCI-CTCAE ≤ Grade 1. 4. Currently participating in another clinical study, or the interval between the start of study treatment and the end of the previous clinical study is less than specified period. 5. Participants with active or previous autoimmune diseases. 6. Participants with uncontrolled or severe cardiovascular diseases. 7. Participants with active hepatitis B or hepatitis C.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) based on blinded independent central review (BICR) | From randomization until disease progression or death from any cause, whichever occurs first, up to approximately 40 months. | PFS is defined, in accordance with RECIST v1.1, as the time from randomization to the date of the first documented disease progression or death from any cause, whichever occurs first, as assessed by BICR. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | From randomization until death from any cause, up to approximately 50 months. | OS is defined as the time from randomization to the date of death from any cause. |
| Progression-Free Survival (PFS) assessed by the Investigator | From randomization until disease progression or death from any cause, whichever occurs first, up to approximately 40 months. | PFS is defined, in accordance with RECIST v1.1, as the time from randomization to the date of the first documented disease progression or death from any cause, whichever occurs first, as assessed by the Investigator. |
| Objective Response Rate (ORR) assessed by the Investigator and BICR | From randomization until confirmed objective response, up to approximately 40 months. | ORR is defined as the proportion of participants who achieve a confirmed complete response (CR) or partial response (PR), in accordance with RECIST v1.1, as assessed by the Investigator and BICR. |
| Duration of Response (DoR) assessed by the Investigator and BICR | From the first documented objective response until disease progression or death from any cause, whichever occurs first, up to approximately 40 months. | DoR is defined, in accordance with RECIST v1.1, as the time from the date of the first documented CR or PR to the date of the first documented disease progression or death from any cause, whichever occurs first, as assessed by the Investigator and BICR. |
| Disease Control Rate (DCR) assessed by the Investigator and BICR | From randomization until confirmed disease control, up to approximately 40 months. | DCR is defined as the proportion of participants who achieve a complete response (CR), partial response (PR), or stable disease (SD), in accordance with RECIST v1.1, as assessed by the Investigator and BICR. |
| Incidence and Severity of Adverse Events (AEs), graded according to NCI-CTCAE v6.0 | From the first dose of study treatment through 30 days after the last dose, up to approximately 40 months. | This outcome is defined as the number and proportion of participants experiencing adverse events (AEs), serious adverse events (SAEs), and AEs leading to discontinuation of study treatment. AE severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 6.0. |
Countries
China
Contacts
CONTACTLiju Zong, M.M
Outcome results
None listed