NCT05950139 Peptide Vaccine To Prevent Acquired Resistance In Patients With Advanced ALK+ NSCLC
| NCT ID | NCT05950139 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
| Condition | NSCLC Stage IV |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2024-05-13 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 12 participants in total. It began in 2024-05-13 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to evaluate the safety of a cancer peptide vaccine to prevent or delay acquired resistance in advanced ALK+ lung cancer patients currently on ALK targeted therapy.
Eligibility 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
Contact & Investigator
Vincent Lam, MD
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT05950139 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying NSCLC Stage IV. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05950139 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05950139 currently recruiting?
Yes, NCT05950139 is actively recruiting participants. Contact the research team at ThoracicCancerTrials@jhmi.edu for enrollment information.
Where is the NCT05950139 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT05950139 clinical trial?
NCT05950139 is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The principal investigator is Vincent Lam, MD at Johns Hopkins University. The trial plans to enroll 12 participants.