NCT05950139RecruitingPhase 1/2
Peptide Vaccine To Prevent Acquired Resistance In Patients With Advanced ALK+ NSCLC
Pilot Study of a Prophylactic Cancer Peptide Vaccine in Advanced ALK+ NSCLC
Source: ClinicalTrials.gov · Last updated 28 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- First submitted
- 10 Jul 2023
- Start date
- 13 May 2024
- Primary completion date
- Jul 2027
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Diseases
- Lung cancer
- NCT number
- NCT05950139
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 12
- From 13 May 2024 to the primary completion date, Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Cytotoxic chemotherapy within 14 days of first dose of study vaccine or concurrent with study vaccine
- Anti-neoplastic immunotherapy within 28 days of first dose of study vaccine or concurrent with study vaccine
- Systemic immune suppression:
- Use of chronic oral or systemic steroid medication (topical or inhalational steroids are permitted)
- Other clinically relevant systemic immune suppression
- 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
Other illness
- Current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Patients with leptomeningeal disease and without cord compression are allowed
Who the study is looking for
- Histologically or cytologically confirmed diagnosis of stage IV NSCLC (or recurrent NSCLC not a candidate for definitive multimodality therapy)
- 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
- Ongoing treatment with crizotinib, ceritinib, alectinib, brigatinib, or lorlatinib with at least stable disease ≥ 4 months
- No known presence of the specific ALK acquired resistance alterations targeted by the study vaccine
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Males or females at least 18 years old
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins University Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.