Non-Small Cell Lung Cancer With HER2- Mutations
Conditions
Brief summary
The study is being conducted to evaluate the efficacy, and safety of SHR-A1811 versus Standard of Care as first-line treatment of advanced or metastatic Non-Small Cell Lung Cancer with HER2- Mutations
Interventions
DRUGSHR-A1811
Drug: SHR-A1811 administered intravenously every 3 weeks (Q3W)
DRUGPD-1/PD-L1 inhibitors、Pemetrexed/ Paclitaxel、Carboplatin/ Cisplatin
Drug: PD-1/PD-L1 inhibitors administered intravenously every 3 weeks (Q3W) Drug: Pemetrexed Based on the investigator's choice was administered intravenously every 3 weeks (Q3W) Drug: Paclitaxel Based on the investigator's choice was administered intravenously every 3 weeks (Q3W) Drug: Carboplatin Based on the investigator's choice was administered intravenously every 3 weeks (Q3W) Drug: Cisplatin Based on the investigator's choice was administered intravenously every 3 weeks (Q3W)
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Able and willing to provide a written informed consent 2. 18-75 years old (inclusive of both ends) 3. ECOG score of 0 or 1. 4. Patients with histologically or cytologically confirmed advanced or metastatic NSCLC. 5. Subjects with central laboratory- confirmed functional HER2 mutations 6. No prior systemic antitumor therapy (including investigational agents) for advanced or metastatic NSCLC. 7. Have at least one measurable lesion outside the central nervous system that meets the criteria defined by RECIST v1.1 8. Protocol-defined adequate organ function including cardiac, renal, hepatic function
Exclusion criteria
1. Mixed lung cancer with small cell components and sarcomatoid carcinoma confirmed by histology or cytology. 2. Concurrently carrying other driver gene mutations, and targeted drugs for such driver gene mutations have been approved for market release. 3. Subjects with untreated or active metastasis of central nervous system (CNS) tumors, or a history of meningeal metastasis or current meningeal metastasis. 4. With poorly controlled tumor-related pain. 5. previous or current with other malignancies. 6. Subjects with a history of interstitial pneumonia/non-infectious pneumonia requiring hormone therapy, or current interstitial pneumonia/non-infectious pneumonia. 7. Subjects with active or previous autoimmune diseases. 8. Subjects with uncontrolled or severe cardiovascular diseases. 9. Subjects 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) | Until progression, assessed up to approximately 2 years | Defined as time from randomization until progression per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Until death, assessed up to approximately 3 years | Defined as time from randomization until the date of death due to any cause |
| Progression Free Survival (PFS) by investigator assessment | Until progression, assessed up to approximately 2 years | Defined as time from randomization until progression per RECIST 1.1 as assessed by the investigator |
| Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) | until to 90 days after the last dose，assessed up to approximately 3 years | Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 |
Countries
China
Contacts
CONTACTYou Li
Outcome results
None listed