Clinical trial NCT06430437: A Study of SHR-A1811 in First-line Treatment of Patients With Advanced or Metastatic Non-small Cell Lung Cancer With HER2 Mutations
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Non-Small Cell Lung Cancer With HER2- Mutations
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-05-28
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Progression-free survival (PFS) based on blinded independent central review (BICR)
timeFrame: Until progression, assessed up to approximately 2 years
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Until death, assessed up to approximately 3 years
measure: Progression Free Survival (PFS) by investigator assessment
timeFrame: Until progression, assessed up to approximately 2 years
measure: Incidence and severity of adverse events (AEs)/serious adverse events (SAEs)
timeFrame: until to 90 days after the last dose，assessed up to approximately 3 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
Study officials:
References: