Peptide Vaccine To Prevent Acquired Resistance In Patients With Advanced ALK+ NSCLC
Pilot Study of a Prophylactic Cancer Peptide Vaccine in Advanced ALK+ NSCLC
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests the safety of a cancer peptide vaccine in adults with advanced ALK-positive non-small cell lung cancer. It aims to prevent or delay cancer changes that make ALK-targeted drugs stop working. It is for people already taking these drugs.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Age 18 or older.
- Tests confirm non-small cell lung cancer that is stage IV (has spread) or has returned and cannot be treated with a combination of treatments meant to cure it.
- Tests show a change in the ALK gene.
- Taking crizotinib, ceritinib, alectinib, brigatinib, or lorlatinib, with cancer staying stable or improving for at least 4 months.
- No known ALK changes that cause drug resistance and are targeted by the study vaccine.
- Able to do all usual activities, or limited only in hard physical activities.
Who can't join
- Another cancer that is growing or needed active treatment in the past 3 years. Some cancers treated with surgery or treatment meant to cure them are allowed.
- Cell-killing chemotherapy within 14 days before the first vaccine dose or during vaccine treatment.
- Cancer immunotherapy (treatment that uses the immune system) within 28 days before the first vaccine dose or during vaccine treatment.
- Long-term steroid pills or other steroids that affect the whole body, or other major immune suppression. Skin creams and inhaled steroids are allowed.
- Cancer spread to the brain or spinal cord that causes symptoms. Without symptoms, it is still not allowed if steroid doses had to increase within 7 days before joining.
- Current pressure on the spinal cord, with or without symptoms. Cancer in the tissue around the brain and spinal cord is allowed if there is no pressure on the cord.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 sites (1)
MD
- Johns Hopkins University · Baltimore, MD 21287Vincent Lam, MD · Study contact · 410-955-8964 · ThoracicCancerTrials@jhmi.eduVincent Lam, MD · Principal investigatorMore trials in Baltimore