Recruiting NCT05950139
Peptide Vaccine To Prevent Acquired Resistance In Patients With Advanced ALK+ NSCLC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Peptide vaccine.
- Who it may be relevant to
- Registry conditions: NSCLC Stage IV, ALK Fusion Protein Expression. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Pilot Study of a Prophylactic Cancer Peptide Vaccine in Advanced ALK+ NSCLC
Overview
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.
Interventions
- Biological Peptide vaccine
Peptide vaccine
Primary outcome measures
- Incidence of treatment-related adverse events [Time frame: Up to 2 years]
- Vaccine-specific immune response [Time frame: Up to 2 years]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
- Current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Patients with leptomeningeal disease and without cord compression are allowed
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Johns Hopkins University — Baltimore
Identifiers
NCT: NCT05950139 · J23120 · IRB00398546