A Clinical Study of BT02 in Treating Patients With Advanced Lung Cancer

Launched by BIOTROY THERAPEUTICS · Aug 5, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called BT02 for people with advanced lung cancer, including two main types: non-small cell lung cancer and small cell lung cancer. The main goal is to see if the treatment is safe and well-tolerated, and to get an early idea of whether it might help slow down or shrink the cancer. People between 18 and 75 years old who have advanced lung cancer that has not responded to previous treatments may be eligible to join. Participants need to have a certain level of health and physical function, at least one measurable tumor outside the brain, and agree to use effective birth control during the study if applicable.

If accepted into the trial, patients will receive the BT02 drug through an infusion into a vein every two weeks. They can continue this treatment for up to two years as long as their cancer does not get worse and side effects remain manageable. It’s important to note that people with certain genetic mutations, active infections, severe heart or lung problems, or recent immunotherapy may not be eligible. This study is currently not yet recruiting participants, but it aims to offer a new option for those with advanced lung cancer who have limited treatment choices.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with pathologically confirmed locally advanced/unresectable or metastatic or recurrent non-small cell lung cancer (NSCLC, according to AJCC TNM staging) and advanced/unresectable limited-stage or extensive-stage small cell lung cancer (SCLC, according to VALG combined with AJCC TNM staging)，who have failed in the prior systemic therapy .
• • 2. Adequate organ and hematologic function.
• • 3. At least 1 extracranial measurable lesion.
• • 4. An ECOG activity status score of 0-1.
• • 5. A life expectancy of ≥ 3 months.
• • 6. Eligible participants of childbearing potential (both males and females) must agree to using effective contraception throughout the study period.
• • 7. Good compliance and willingness to follow up.
• Exclusion Criteria:
• • 1. Patients with sensitive mutations or gene fusions related to lung cancer.
• • 2. Prior to the first dose , received systemic antitumor therapy, scheduled major surgical procedure within 4 weeks, received systemic immunostimulants within 5 half-lives and systemic corticosteroids or other immunosuppressive medications within 14 days.
• • 3. A history of active autoimmune disease within the past 2 years.
• • 4. A history of clinically significant cardiovascular disease, severe cardiac rhythm /conduction abnormalities or LVEF \<50% . A history of severe pulmonary disease that may lead to severe episodes of dyspnea.
• • 5. A severe acute or chronic infection when enrollment.
• • 6. Remaining the toxic reaction in previous anti-tumor therapy that has not recovered to ≤ Grade 1 .
• • 7. Unresolved \> Grade 1 irAE or the history of a grade ≥ 3 irAE in previous immunotherapy, or known hypersensitivity to the formulation of the investigational product.
• • 8. Clinically active CNS metastases or meningeal metastases.
• • 9. A history of other type of malignancies.
• • 10. Received a live attenuated vaccine within 28 days prior to the administration of the investigational product.
• • 11. Poor compliance.
• • 12. A history of alcohol or drugs abuse.
• • 13. Current pregnancy or breastfeeding.
• • 14. Other severe physical or mental illnesses or abnormal laboratory test results that the investigator deems unsuitable for participation in this study considering safety and compliance.