Study on Preventive Peptide Vaccine for Advanced ALK+ Lung Cancer
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials ID:NCT05950139
This clinical trial is testing a new cancer vaccine designed to prevent or delay resistance to treatment in patients with advanced ALK+ lung cancer who are currently receiving targeted therapy.
Patient Parameters
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Program Overview
The aim of this study is to test the safety of a new peptide vaccine for patients with advanced ALK+ lung cancer. The vaccine is intended to help prevent or delay the cancer from becoming resistant to current treatments. Participants in the study are those who are already receiving ALK-targeted therapies and have shown stable disease for at least four months.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with stage IV non-small cell lung cancer (NSCLC) or recurrent NSCLC that cannot be treated with standard therapies.
- Have a confirmed ALK gene rearrangement, identified through specific medical tests.
- Currently being treated with ALK-targeted drugs like crizotinib, ceritinib, alectinib, brigatinib, or lorlatinib, and have stable disease for at least four months.
- Do not have specific ALK resistance mutations that the vaccine targets.
- Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Are 18 years or older.
Exclusion Criteria
- Have another cancer that is progressing or has needed treatment in the past three years, except for certain skin cancers or other tumors treated successfully.
- Have received chemotherapy within 14 days before starting the vaccine or at the same time as the vaccine.
- Have received immunotherapy within 28 days before starting the vaccine or at the same time as the vaccine.
- Are on systemic immune suppression, including chronic oral or systemic steroids (except topical or inhaled steroids).
- Have symptomatic brain metastases or need increasing doses of steroids for brain issues within seven days before joining the study.
- Have current spinal cord compression, whether or not it causes symptoms, unless it is not causing any issues.
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