All > Non Small Cell Lung Cancer

1/ Vaccine with Montanide Adjuvant for Non-Small Cell Lung Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
National Institutes of Health Clinical Center, Bethesda, MDNon-Small Cell Lung Cancer+2 MoreMontanide (Registered Trademark) ISA-51 VG Adjuvant - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Non-Small Cell Lung Cancer
  • Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Patient reported outcomes
1
CD388 Injection
1
Cevostamab

Study Objectives

2 Primary · 1 Secondary · Reporting Duration: 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

Month 6
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
Week 2
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
Year 3
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 Safety

Safety Progress

1 of 3

Similar Trials

2
Patient reported outcomes
1
CD388 Injection
1
Cevostamab

Trial Design

2 Treatment Groups

1/ Vaccine with Montanide Adjuvant
1 of 2
2/ Vaccine with Montanide Adjuvant and N-803
1 of 2

Experimental Treatment

30 Total Participants · 2 Treatment Groups

Primary Treatment: 1/ Vaccine with Montanide Adjuvant · No Placebo Group · Phase 1 & 2

1/ Vaccine with Montanide AdjuvantExperimental Group · 4 Interventions: Montanide (Registered Trademark) ISA-51 VG Adjuvant, H1299 Cell Lysates, N-803, Ventana PD-L1 (SP263 or SP142) assay · Intervention Types: Biological, Biological, Drug, Device
2/ Vaccine with Montanide Adjuvant and N-803Experimental Group · 4 Interventions: Montanide (Registered Trademark) ISA-51 VG Adjuvant, H1299 Cell Lysates, N-803, Ventana PD-L1 (SP263 or SP142) assay · Intervention Types: Biological, Biological, Drug, Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
N-803
2021
Completed Phase 2
~50

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 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

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,154 Previous Clinical Trials
41,163,490 Total Patients Enrolled
David S Schrump, M.D.Principal InvestigatorNational Cancer Institute (NCI)
16 Previous Clinical Trials
2,171 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top