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Trial Title:
A Study of SHR-A1811 in First-line Treatment of Patients With Advanced or Metastatic Non-small Cell Lung Cancer With HER2 Mutations
NCT ID:
NCT06430437
Condition:
Non-Small Cell Lung Cancer With HER2- Mutations
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Paclitaxel
Carboplatin
Pemetrexed
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SHR-A1811
Description:
Drug: SHR-A1811 administered intravenously every 3 weeks (Q3W)
Arm group label:
SHR-A1811
Intervention type:
Drug
Intervention name:
Camrelizumab、Pemetrexed/ Paclitaxel、Carboplatin/ Cisplatin
Description:
Drug: Camrelizumab 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)
Arm group label:
Standard of Care（Camrelizumab、Pemetrexed/ Paclitaxel、Carboplatin/ Cisplatin）
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
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Chest Hospital
Address:
City:
Shanghai
Zip:
200030
Country:
China
Investigator:
Last name:
Shun Lu
Email:
Principal Investigator
Start date:
August 2024
Completion date:
April 2027
Lead sponsor:
Agency:
Jiangsu HengRui Medicine Co., Ltd.
Agency class:
Industry
Source:
Jiangsu HengRui Medicine Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06430437
