Peptide Vaccine To Prevent Acquired Resistance In Patients With Advanced ALK+ NSCLC

Recruiting now · Phase 1/Phase 2

Conditions studied: NSCLC Stage IV, ALK Fusion Protein Expression

In brief

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.

Key facts

Study ID

NCT05950139

Run by

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

People needed

12

Starts

2024-05-13

Expected to finish

2029-07-01

Last updated by the study team

2026-07-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Johns Hopkins University — Baltimore, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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