A Study of SHR-A1811 in Subjects With Advanced Non-small Cell Lung Cancer

Launched by JIANGSU HENGRUI MEDICINE CO., LTD. · Mar 25, 2021

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called SHR-A1811 for patients with advanced non-small cell lung cancer (NSCLC) that has certain characteristics known as HER2 expression, amplification, or mutation. The study aims to understand how safe the treatment is, how well it works, and how the body processes it. This trial is currently active but not recruiting new participants at this time.

To be eligible for this trial, patients should be between the ages of 18 and 100, have advanced NSCLC with the specific HER2 characteristics, and have already received platinum-based chemotherapy but either saw their cancer progress or could not tolerate the treatment. Participants will need to sign a consent form and must have at least one measurable cancer lesion. Throughout the trial, participants can expect close monitoring of their health and the effects of the treatment. It's important to note that individuals with certain medical issues, like active infections or unresolved side effects from past cancer treatments, may not be able to participate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Able and willing to provide a written informed consent
• • 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• • 3. advanced non-small cell lung cancer with HER2 expression , amplification, or mutation
• • 4. has previously received platinum-based chemotherapy for advanced or metastatic NSCLC, has developed disease progression during or after treatment, or is unable to tolerate platinum-based chemotherapy.
• • 5. There is at least one measurable lesion according to RECIST V1.1 criteria
• Exclusion Criteria:
• • 1. Has unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0 grade ≤ 1.
• • 2. Has received HER2 antibody drug conjugates,
• • 3. Central nervous system metastasis or meningeal metastasis with clinical symptoms
• • 4. Has active infection requiring systemic treatment.