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Cancer Vaccine

Advanced ALK+ NSCLC for Non-Small Cell Lung Cancer

Phase 1 & 2

Recruiting

Led By Vincent Lam, MD

Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Histologically or cytologically confirmed diagnosis of stage IV NSCLC (or recurrent NSCLC not a candidate for definitive multimodality therapy)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial aims to test if a cancer vaccine can help advanced ALK+ lung cancer patients who are already on a specific treatment by preventing or delaying the cancer from becoming resistant to the treatment.

Who is the study for?

This trial is for adults over 18 with advanced ALK+ lung cancer who are responding to current ALK targeted therapy and have a good performance status. They must not have specific resistance alterations the vaccine targets, and their diagnosis should be confirmed by certain tests.Check my eligibility

What is being tested?

The study is testing a peptide vaccine's safety in preventing or delaying drug resistance in patients with advanced ALK+ lung cancer who are already on an ALK inhibitor treatment.See study design

What are the potential side effects?

While the trial aims to assess safety, potential side effects of the peptide vaccine may include typical immune responses like redness or pain at injection site, fever, fatigue, and allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has an ALK rearrangement confirmed by a specific test.

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My lung cancer is at stage IV or has come back and cannot be treated with surgery or radiation.

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I've been on ALK inhibitors for 4+ months with stable disease.

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I am fully active or can carry out light work.

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My cancer does not have the specific ALK changes the study vaccine targets.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of treatment-related adverse events

Vaccine-specific immune response

Trial Design

1Treatment groups

Experimental Treatment

Group I: Advanced ALK+ NSCLCExperimental Treatment1 Intervention

All patients will receive the intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Peptide vaccine

2008

Completed Phase 1

~30

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor

560 Previous Clinical Trials

33,037 Total Patients Enrolled

Vincent Lam, MDPrincipal InvestigatorJohns Hopkins University

2 Previous Clinical Trials

53 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the current clinical trial open for patient enrollment at this time?

"Indeed, details on clinicaltrials.gov highlight that this study is actively seeking participants. The trial was initially registered on August 1st, 2024, and had its latest update on April 18th, 2024. Enrollment aims to include a total of twelve patients from one designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Prophylactic Peptide Vaccine in Advanced ALK+ NSCLC

2024. "Prophylactic Peptide Vaccine in Advanced ALK+ NSCLC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05950139.