Peptide vaccine to prevent resistance in advanced lung cancer
Pilot Study of a Prophylactic Cancer Peptide Vaccine in Advanced ALK+ NSCLC
PHASE1; PHASE2 · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · NCT05950139
This study is testing a new vaccine to see if it can help people with advanced lung cancer who are on specific treatments avoid or delay their cancer from becoming resistant.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (other) |
| Drugs / interventions | crizotinib, ceritinib, alectinib, brigatinib, lorlatinib, chemotherapy, immunotherapy |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT05950139 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety of a peptide vaccine designed to prevent or delay acquired resistance in patients with advanced ALK+ non-small cell lung cancer (NSCLC) who are currently receiving ALK-targeted therapies. Participants must have a confirmed diagnosis of stage IV NSCLC and show stable disease after at least four months of treatment with specific ALK inhibitors. The study aims to assess the vaccine's effectiveness in enhancing treatment outcomes for these patients.
Who should consider this trial
Good fit: Ideal candidates include adults with stage IV NSCLC who have documented ALK rearrangement and are currently stable on ALK-targeted therapy.
Not a fit: Patients with known acquired resistance alterations to the targeted therapies or those with additional malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this vaccine could significantly improve treatment durability and outcomes for patients with advanced ALK+ lung cancer.
How similar studies have performed: While the approach of using peptide vaccines in cancer treatment is being explored, this specific application in advanced ALK+ NSCLC is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Histologically or cytologically confirmed diagnosis of stage IV NSCLC (or recurrent NSCLC not a candidate for definitive multimodality therapy) 2. Documented ALK rearrangement as detected by: (1) fluorescence in situ hybridization (FISH), (2) immuno-histochemistry (IHC), (3) tissue next-generation sequencing (NGS), or (4) circulating tumor DNA (ctDNA) NGS 3. Ongoing treatment with crizotinib, ceritinib, alectinib, brigatinib, or lorlatinib with at least stable disease ≥ 4 months 4. No known presence of the specific ALK acquired resistance alterations targeted by the study vaccine 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 6. Males or females at least 18 years old Exclusion Criteria: 1. Known additional malignancy that is progressing or has required active treatment within the past 3 years. Adequately resected non-melanoma skin cancer, curatively treated in-situ disease, and other solid tumors treated with potentially curative therapy are allowed. 2. Cytotoxic chemotherapy within 14 days of first dose of study vaccine or concurrent with study vaccine 3. Anti-neoplastic immunotherapy within 28 days of first dose of study vaccine or concurrent with study vaccine 4. Systemic immune suppression: 1. Use of chronic oral or systemic steroid medication (topical or inhalational steroids are permitted) 2. Other clinically relevant systemic immune suppression 5. Symptomatic central nervous system (CNS) metastasis. Asymptomatic CNS disease requiring increasing dose of corticosteroids within 7 days prior to study enrollment is also not permitted 6. Current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Patients with leptomeningeal disease and without cord compression are allowed
Where this trial is running
Baltimore, Maryland
- Johns Hopkins University — Baltimore, Maryland, United States (RECRUITING)
Study contacts
- Principal investigator: Vincent Lam, MD — Johns Hopkins University
- Study coordinator: Vincent Lam, MD
- Email: ThoracicCancerTrials@jhmi.edu
- Phone: 410-955-8964
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: NSCLC Stage IV, ALK Fusion Protein Expression