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New treatment option for NSCLC Stage IV
Official title Peptide Vaccine To Prevent Acquired Resistance In Patients With Advanced ALK+ NSCLC
ClinicalTrials.gov ID: NCT05950139
What this study is testing
What is Peptide vaccine?
Peptide vaccine is an investigational medicine, being studied as a potential treatment for nsclc stage iv.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- 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
You likely can't join if
- Known additional malignancy that is progressing or has required active treatment within the past 3 years. Adequately resected non-melanoma skin...
- 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
See the full eligibility criteria
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.