Treatment of advanced lung cancer with HER2 mutations using SHR-A1811

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

This study is testing a new treatment called SHR-A1811 to see if it works better than standard care for adults with advanced lung cancer that has specific HER2 mutations.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (industry)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06430437 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of SHR-A1811 compared to standard care for patients with advanced or metastatic non-small cell lung cancer (NSCLC) that has HER2 mutations. It is a Phase 3 interventional trial that includes patients aged 18-75 who have not received prior systemic therapy for their condition. Participants will receive either SHR-A1811 or standard treatments such as Camrelizumab, Pemetrexed/Paclitaxel, or Carboplatin/Cisplatin, with the aim of determining which approach provides better outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with confirmed advanced or metastatic NSCLC and functional HER2 mutations who have not undergone prior systemic therapy.

Not a fit: Patients with mixed lung cancer types, other concurrent driver gene mutations, or untreated CNS metastases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new effective option for patients with advanced lung cancer harboring HER2 mutations.

How similar studies have performed: While there have been studies targeting HER2 mutations in lung cancer, the specific use of SHR-A1811 in this context is a novel approach.

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai Chest Hospital — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Study coordinator: You Li

Conditions: Non-Small Cell Lung Cancer With HER2- Mutations