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

Pilot Study of a Prophylactic Cancer Peptide Vaccine in Advanced ALK+ NSCLC

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.

Study Overview

• Status: Recruiting
• Conditions: NSCLC Stage IV; ALK Fusion Protein Expression
• Intervention / Treatment: Biological: Peptide vaccine

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Vincent Lam, MD; Phone Number: 410-955-8964; Email: ThoracicCancerTrials@jhmi.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • Johns Hopkins University
      • Principal Investigator: Vincent Lam, MD
      • Contact: Vincent Lam, MD; Phone Number: 410-955-8964; Email: ThoracicCancerTrials@jhmi.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Advanced ALK+ NSCLC; All patients will receive the intervention	Biological: Peptide vaccine; Peptide vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaccine-specific immune response	Vaccine-specific response will be evaluated by the fold change in interferon-producing mutant-ALK-specific CD8 and CD4 T cells in the peripheral blood.	Up to 2 years
Incidence of treatment-related adverse events	The safety of administering the ALK peptide vaccine will be assessed by the occurrence of the following adverse events: Grade 3 or above drug-related toxicities; Drug-related toxicity by grade; Vaccine site reactions after vaccine injections; Immune-related adverse events (AEs); Unacceptable toxicities; Treatment-emergent changes from normal to abnormal values in key laboratory parameters	Up to 2 years

Collaborators and Investigators

• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborators: Oncovir, Inc.
• Investigators: Principal Investigator: Vincent Lam, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2029

Study Registration Dates

• First Submitted: July 10, 2023
• First Submitted That Met QC Criteria: July 10, 2023
• First Posted (Actual): July 18, 2023

Study Record Updates

• Last Update Posted (Estimated): September 23, 2025
• Last Update Submitted That Met QC Criteria: September 18, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; Biological Products; Complex Mixtures; Vaccines; Vaccines, Acellular; Vaccines, Subunit; Protein Subunit Vaccines
• Other Study ID Numbers: J23120; IRB00398546 (Other Identifier: Johns Hopkins IRB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No