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Trial Title:
Prophylactic Peptide Vaccine in Advanced ALK+ NSCLC
NCT ID:
NCT05950139
Condition:
NSCLC Stage IV
ALK Fusion Protein Expression
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Peptide vaccine
Description:
Peptide vaccine
Arm group label:
Advanced ALK+ NSCLC
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Johns Hopkins University
Address:
City:
Baltimore
Zip:
21287
Country:
United States
Status:
Recruiting
Contact:
Last name:
Joanne Riemer, RN
Phone:
443-287-4114
Contact backup:
Last name:
Peggy Fitzpatrick, RN
Phone:
410-550-5848
Investigator:
Last name:
Vincent Lam, MD
Email:
Principal Investigator
Start date:
May 13, 2024
Completion date:
July 2029
Lead sponsor:
Agency:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Agency class:
Other
Source:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05950139
