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NCT05950139 · ClinicalTrials.gov registry record · Phase 1
Peptide Vaccine To Prevent Acquired Resistance In Patients With Advanced ALK+ NSCLC
A Phase 1 study of NSCLC Stage IV and ALK Fusion Protein Expression, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT05950139: Recruiting Phase 1 study of NSCLC Stage IV and ALK Fusion Protein Expression, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT05950139 is a Phase 1 study of NSCLC Stage IV and ALK Fusion Protein Expression that is actively recruiting participants, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 12 participants, below the 121-participant average among 6 other NSCLC Stage IV trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05950139, a Phase 1 study of NSCLC Stage IV and ALK Fusion Protein Expression, is actively recruiting participants, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- BIOLOGICAL Peptide vaccine
Study Locations (1)
Maryland
- Johns Hopkins University - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2024-05-13 |
| Est. Completion | 2029-07 |
| Phase | Phase 1 |
What NCT05950139 shows while recruiting
NCT05950139 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 121-participant average among 6 other NSCLC Stage IV trials with a reported enrollment target (90% lower).
The record links to 2 conditions, with NSCLC Stage IV appearing as the primary indexed condition, and to 1 intervention - of which Peptide vaccine is the first listed.
NCT05950139 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT05950139 about?
NCT05950139 is a clinical study titled "Peptide Vaccine To Prevent Acquired Resistance In Patients With 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.
What is the current status of trial NCT05950139?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2024-05-13. Estimated completion is 2029-07.
What conditions does trial NCT05950139 study?
This clinical trial studies the following conditions: NSCLC Stage IV, ALK Fusion Protein Expression.
What interventions are being tested in trial NCT05950139?
The interventions under investigation include: Peptide vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT05950139?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05950139 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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