Actively Recruiting
Pilot Study of a Prophylactic Cancer Peptide Vaccine in Advanced ALK+ NSCLC
Led by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Updated on 2025-09-23
12
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
S
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead Sponsor
O
Oncovir, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a cancer peptide vaccine to prevent or delay acquired resistance in patients with advanced ALK-positive non-small cell lung cancer (NSCLC) who are currently receiving ALK targeted therapy. This pilot study focuses on assessing the safety of the vaccine in these patients with stage IV NSCLC or recurrent NSCLC not suitable for definitive multimodality therapy. The study is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins and includes patients with documented ALK rearrangement and stable disease on ALK inhibitors for at least 4 months. All participants will receive the peptide vaccine intervention during the study. The vaccine is a biological agent designed to target specific ALK acquired resistance alterations that the patients do not currently have. The study does not include a placebo or comparison group; instead, it monitors the treatment-related adverse events and vaccine-specific immune responses over up to two years. The trial spans phases 1 and 2 and involves ongoing treatment with approved ALK inhibitors such as crizotinib, ceritinib, alectinib, brigatinib, or lorlatinib. Participants will be closely monitored for safety and immune reactions related to the vaccine. Researchers will collect data on treatment-related side effects and immune responses for up to two years after vaccination. Eligibility evaluations include confirming ALK rearrangement by various testing methods and stable disease status. Patients with certain other malignancies, recent chemotherapy or immunotherapy, systemic immune suppression, or symptomatic central nervous system metastases are excluded. The study aims to provide important information on vaccine safety and immune effects in this patient population over the course of the trial.
CONDITIONS
Brief Title
Peptide Vaccine To Prevent Acquired Resistance In Patients With Advanced ALK+ NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed diagnosis of stage IV NSCLC or recurrent NSCLC not suitable for definitive multimodality therapy
- Documented ALK rearrangement detected by FISH, IHC, tissue NGS, or ctDNA NGS
- Currently receiving crizotinib, ceritinib, alectinib, brigatinib, or lorlatinib with stable disease for at least 4 months
- No known presence of specific ALK acquired resistance alterations targeted by the vaccine
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Male or female aged 18 years or older
You will not qualify if you...
- Known additional malignancy progressing or requiring treatment within past 3 years, except certain treated skin cancers and solid tumors
- Cytotoxic chemotherapy within 14 days prior to first vaccine dose or concurrent chemotherapy
- Anti-neoplastic immunotherapy within 28 days prior to first vaccine dose or concurrent immunotherapy
- Systemic immune suppression including chronic oral or systemic steroids (topical or inhalational steroids allowed)
- Symptomatic central nervous system metastasis or need for increasing corticosteroid doses within 7 days before enrollment
- Current spinal cord compression, symptomatic or asymptomatic (leptomeningeal disease without cord compression allowed)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 2 years
Participants receive a peptide vaccine as the active treatment to prevent acquired resistance in advanced ALK+ NSCLC.
Trial Site Locations
Total: 1 location
1
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Actively Recruiting
Research Team
V
Vincent Lam, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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