Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT05950139

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

Led by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Updated on 2025-09-23

12

Participants Needed

1

Research Sites

267 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

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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 treated with 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
Not Eligible

You will not qualify if you...

  • Known additional progressing malignancy or requiring active treatment within the past 3 years, except adequately treated non-melanoma skin cancer, in-situ disease, or other solid tumors treated with curative intent
  • Cytotoxic chemotherapy within 14 days before or during study vaccine treatment
  • Anti-neoplastic immunotherapy within 28 days before or during study vaccine treatment
  • Systemic immune suppression including chronic oral or systemic steroids (topical or inhalational steroids allowed) or other relevant immune suppression
  • Symptomatic central nervous system metastasis or asymptomatic CNS disease needing increased corticosteroids within 7 days before enrollment
  • Current spinal cord compression detected by imaging (symptomatic or asymptomatic); leptomeningeal disease without cord compression allowed

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Johns Hopkins University

Baltimore, Maryland, United States, 21287

Actively Recruiting

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Research Team

V

Vincent Lam, MD

CONTACT

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