Recruiting NCT06430437
A Study of SHR-A1811 in First-line Treatment of Patients With Advanced or Metastatic Non-small Cell Lung Cancer With HER2 Mutations
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-A1811, PD-1/PD-L1 inhibitors、Pemetrexed/ Paclitaxel、Carboplatin/ Cisplatin.
- Who it may be relevant to
- Registry conditions: Non-Small Cell Lung Cancer With HER2- Mutations. Basic parameters: 18 years — 75 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
A Randomized, Open-Label, Multicenter Phase III Study of SHR-A1811 for First-Line Treatment in Subjects With HER2-Mutated Advanced or Metastatic Non-Small Cell Lung Cancer
Overview
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
- Drug SHR-A1811
Drug: SHR-A1811 administered intravenously every 3 weeks (Q3W) - Drug PD-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)
Primary outcome measures
- Progression-free survival (PFS) based on blinded independent central review (BICR) [Time frame: Until progression, assessed up to approximately 2 years]
Secondary outcome measures (3)
- Overall Survival (OS) [Time frame: Until death, assessed up to approximately 3 years]
- Progression Free Survival (PFS) by investigator assessment [Time frame: Until progression, assessed up to approximately 2 years]
- Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) [Time frame: until to 90 days after the last dose，assessed up to approximately 3 years]
Eligibility criteria
Inclusion criteria
- Able and willing to provide a written informed consent
- 18-75 years old (inclusive of both ends)
- ECOG score of 0 or 1.
- Patients with histologically or cytologically confirmed advanced or metastatic NSCLC.
- Subjects with central laboratory- confirmed functional HER2 mutations
- No prior systemic antitumor therapy (including investigational agents) for advanced or metastatic NSCLC.
- Have at least one measurable lesion outside the central nervous system that meets the criteria defined by RECIST v1.1
- Protocol-defined adequate organ function including cardiac, renal, hepatic function
Exclusion criteria
- Mixed lung cancer with small cell components and sarcomatoid carcinoma confirmed by histology or cytology.
- Concurrently carrying other driver gene mutations, and targeted drugs for such driver gene mutations have been approved for market release.
- Subjects with untreated or active metastasis of central nervous system (CNS) tumors, or a history of meningeal metastasis or current meningeal metastasis.
- With poorly controlled tumor-related pain.
- previous or current with other malignancies.
- Subjects with a history of interstitial pneumonia/non-infectious pneumonia requiring hormone therapy, or current interstitial pneumonia/non-infectious pneumonia.
- Subjects with active or previous autoimmune diseases.
- Subjects with uncontrolled or severe cardiovascular diseases.
- Subjects with active hepatitis B or hepatitis C.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai Chest Hospital — Shanghai
Identifiers
NCT: NCT06430437 · SHR-A1811-310