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Cancer Vaccine
Cancer Vaccine + Adjuvant for Lung Cancer
Phase 1 & 2
Recruiting
Led By David S Schrump, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participant must be >=18 years of age.
Participant must have an ECOG performance status of 0-2.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 12 weeks while on treatment, during follow up for every 3 months for 3 years then every 6 months for 2 years or disease progression, final dfs evaluation visit
Awards & highlights
Study Summary
This trial tests a new lung cancer treatment (vaccine + drug) to improve survival after surgery and reduce side effects. Eligibility: adults with NSCLC who had surgery.
Who is the study for?
Adults over 18 who've had surgery for non-small cell lung cancer (NSCLC) with no current signs of the disease. They must not be on active cancer treatment, agree to use contraception, and co-enroll in a related genetic study. Excluded are pregnant individuals, those with certain heart or lung conditions, uncontrolled illnesses, or an active COVID infection.Check my eligibility
What is being tested?
The trial is testing a new immunotherapy approach after NSCLC surgery: a vaccine made from H1299 lung cancer cells combined with N-803 drug. Participants will receive this combination through injections over six cycles and may continue N-803 afterwards, followed by up to five years of monitoring.See study design
What are the potential side effects?
Potential side effects include reactions at the injection site such as pain or swelling, flu-like symptoms due to immune activation from the vaccine and N-803 shots like fever or fatigue. There might also be risks associated with long-term stimulation of the immune system.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I am able to care for myself and perform daily activities.
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My cancer has low PD-L1 expression, under 1%.
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My lung cancer is stage IB-IIIA and currently shows no or minimal signs after treatment.
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My blood, liver, and kidney tests meet the required levels.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 12 weeks while on treatment, during follow up for every 3 months for 3 years then every 6 months for 2 years or disease progression, final dfs evaluation visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 12 weeks while on treatment, during follow up for every 3 months for 3 years then every 6 months for 2 years or disease progression, final dfs evaluation visit
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase I Component: To determine the safety of H1299 lung cancer cell lysate vaccines administered with Montanide (Registered Trademark) ISA-51 VG adjuvant and N-803
Phase II Component: To assess the frequency of immunologic responses to purified CT-X and autosomal CT antigens in NSCLC participants following vaccinations with H1299 cancer cell lysate and Montanide ISA-51 VG adjuvant in combination with N-803
Secondary outcome measures
To determine disease-free survival (DFS) in lung cancer participants receiving adjuvant H1299 lung cancer cell lysate vaccines administered with Montanide (Registered Trademark) ISA-51 VG and N-803
Trial Design
2Treatment groups
Experimental Treatment
Group I: 2/ Vaccine with Montanide Adjuvant and N-803Experimental Treatment4 Interventions
H1299 cell lysate vaccine administered with Montanide (Registered Trademark) ISA-51 VG adjuvant with N-803 (H1299 cell lysate at dose determined in Phase I)
Group II: 1/ Vaccine with Montanide AdjuvantExperimental Treatment4 Interventions
H1299 cell lysate vaccine administered with Montanide (Registered Trademark) ISA-51 VG adjuvant without or with N-803 (Phase I component to determine H1299 cell lysate dose)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
N-803
2021
Completed Phase 2
~30
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,665 Previous Clinical Trials
40,925,824 Total Patients Enrolled
David S Schrump, M.D.Principal InvestigatorNational Cancer Institute (NCI)
18 Previous Clinical Trials
2,194 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I am able to care for myself and perform daily activities.I currently have COVID-19.I joined this study within 3 months after finishing my last standard treatment.I do not have active hepatitis B or C, or if I had hepatitis C, my recent tests show no virus.My cancer has low PD-L1 expression, under 1%.I am on warfarin and cannot switch to or stop taking blood thinners for a day.I agree to use birth control as required.My lung function or oxygen levels were tested within the last 4 weeks.My lung cancer is stage IB-IIIA and currently shows no or minimal signs after treatment.I am currently receiving treatment for my cancer.You are not currently taking any other experimental drugs.I do not have uncontrolled high blood pressure or recent serious heart issues.My cancer was almost gone after treatment but got worse before starting a vaccine trial.My blood, liver, and kidney tests meet the required levels.You must have a negative HIV test from the NIH within the past 4 weeks.I am on long-term steroids in doses higher than what my body normally makes.
Research Study Groups:
This trial has the following groups:- Group 1: 1/ Vaccine with Montanide Adjuvant
- Group 2: 2/ Vaccine with Montanide Adjuvant and N-803
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the research currently recruiting individuals to participate?
"Clinicaltrials.gov clarifies that this clinical trial is no longer actively recruiting patients, as its initial posting date was December 13th 2022 and the last update occurred on December 7th 2022. Despite this, there are a plethora of other medical trials currently searching for participants at present time - 4288 to be exact."
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