V941 for Carcinoma, Non-Small-Cell Lung

Phase-Based Estimates
1
Effectiveness
1
Safety
Prince of Wales Hospital ( Site 2002), Hong Kong, Hong Kong
Carcinoma, Non-Small-Cell Lung+3 More
V941 - Biological
Eligibility
18+
All Sexes
Eligible conditions
Carcinoma, Non-Small-Cell Lung

Study Summary

This study is evaluating whether a drug may help treat cancer.

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Eligible Conditions

  • Carcinoma, Non-Small-Cell Lung
  • Cancer of Pancreas
  • Colorectal Cancer
  • Cancer
  • Pancreatic Neoplasms
  • Colorectal Neoplasms
  • Neoplasms

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether V941 will improve 3 primary outcomes, 2 secondary outcomes, and 1 other outcome in patients with Carcinoma, Non-Small-Cell Lung. Measurement will happen over the course of Cycle 1 (Up to 21 days).

Day 21
Dose-Limiting Toxicities (DLTs)
Month 24
Mutant KRAS Specific T cells
Number of Participants Who Discontinued Study Treatment Due to an AE
Objective Response Rate (ORR)
T-cell receptor (TCR)
Month 25
Number of Participants Who Experienced an Adverse Event (AE)

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

2 Treatment Groups

No Control Group
V941 + Pembrolizumab

This trial requires 100 total participants across 2 different treatment groups

This trial involves 2 different treatments. V941 is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

V941 + PembrolizumabV941(mRNA-5671/V941) administered IM Q3W for 9 cycles and pembrolizumab 200 mg, intravenous (IV) for 35 3-week cycles
V941 Monotherapy
Biological
V941(mRNA-5671/V941) administered intramuscularly (IM) once every 3 weeks (Q3W) for 9 3-week cycles
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 25 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to approximately 25 months for reporting.

Closest Location

Northwest Medical Specialties, PLLC ( Site 1001) - Tacoma, WA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Carcinoma, Non-Small-Cell Lung or one of the other 3 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The female participant must not be pregnant, not breastfeeding, and not be of childbearing potential OR if of childbearing potential, agrees to follow study-approved contraceptive guidance during treatment period and for at least 120 days after the last dose of study intervention. show original
Subject has a histologically confirmed advanced or metastatic KRAS 4MUT+ (G12D, G12V, G13D or G12C) (4 prevalent KRAS mutant antigens in solid tumors) solid tumor, and has received, or been intolerant to, or ineligible for all treatment known to confer clinical benefit. show original
The individual has a histologically confirmed advanced or metastatic non-small cell lung cancer (NSCLC), non-mismatch repair deficient/microsatellite instability-high tumors colorectal cancers (non-MSI-H CRC), or pancreatic adenocarcinoma, and is confirmed to have the HLA types HLA-A11:01 and/or HLA C08:02 (and/or potentially other additional HLA types to be specified). show original
The patient has cancer that is measurable according to the RECIST 1.1 guidelines, as assessed by the local site investigator/radiology show original
Part 2 Only
The study is looking for people with a specific kind of lung cancer that has been tested for a specific gene mutation show original
The tumors of the participants must have been tested locally for MSI and have been found to be non-MSI-H. show original
All
The male participant must agree to use contraception during the treatment period and for at least 120 days after the last dose of study intervention show original
Cutaneous lesions can be helpful in diagnosing JIA, but measuring disease activity should be done using radiologic assessments. show original

Patient Q&A Section

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

How does v941 work?

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For lung cancers, v941 is equally effective compared to the benchmark treatment regimen of carboplatin plus paclitaxel. The mechanism of action of v941 may be related to increased apoptosis and reduction of angiogenesis.

Unverified Answer

How many people get carcinoma, non-small-cell lung a year in the United States?

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Each year, 100,300 people are diagnosed with carcinoma, non-small-cell lung, in the United States. About 7% of these patients die. Most people with carcinoma, non-small-cell lung can be treated with surgery. About 6% of the patients develop lung metastasis at the time of the first diagnosis. About 26% of the patients will die within two years.

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What causes carcinoma, non-small-cell lung?

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The carcinoma, non-small-cell lung is caused by abnormal DNA, protein, and metabolism of an affected patient. Many factors influence carcinoma, non-small-cell lung occurrence including family history, environmental exposures.

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What are the signs of carcinoma, non-small-cell lung?

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The present study has shown the importance of looking for lymph node metastases and signs of invasion in carcinoma, non-small-cell lung. The lymph node ratio is useful in the evaluation of the extent of disease. It can be useful in making decisions on further treatment in combination with other investigations.

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What are common treatments for carcinoma, non-small-cell lung?

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Treatment of carcinoma, non-small-cell lung is dependent upon the stage of the disease: early, localized stages (stages IA and IB with only one lymph node metastasis) are treated with surgery, and later stages (stages II, III, IV; two or three metastatic lymph nodes) are treated with chemotherapy, radiation therapy, and surgery. The five-year survival for carcinoma, non-small-cell lung is 5% for stage IA, 30% for stage IB, 59% for stage II, and 69% for stage III and IV. Treatment with chemotherapy and/or radiation and for early cancer treatment often results in complete remission of the cancer.

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What is carcinoma, non-small-cell lung?

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Results from a recent clinical trial indicate the following factors to be important in assessing prognosis, treatment decisions, and survival for lung carcinoma patients who present at diagnosis: (1) age, sex, stage, and performance status; (2) presence or absence of distant metastases; (3) whether surgery, chemotherapy, or combined modality therapy is offered; (4) number of involved sites; (5) radiographic evidence of local/regional recurrence; and (6) systemic disease burden, as expressed by number of involved sites, serum CA 19-9 level, and elevated CEA. The prognostic significance of number of involved sites is most marked at all stages except stage IA.

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Can carcinoma, non-small-cell lung be cured?

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In a small number of patients a good prognosis can be achieved by a well-established multi-component system with the goal to prevent occurrence of recurrent or metastatic disease and therefore prolong survival.

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What is v941?

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In the light of these findings, the FDA could well be re-examining its regulatory policies on gene-silencing agents. The FDA's apparent reluctance to label and market gene-silencing technologies may be due to concern over the risk of 'off-label' gene silencing usage, which in the worst-case scenario could lead to a 'genetic time bomb' (or 'epigenetic time bomb') in the form of an intersex'mutant-phenotype' (i.e., 'human-genome-crossing') individual, with consequent lifelong health risk to members of his/her family or other intersex members, if they happen to live to old age.

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Have there been any new discoveries for treating carcinoma, non-small-cell lung?

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The use of monoclonal antibodies in cancer research has led to the development of new therapies for various cancer types, and this trend may soon reach lung cancer. The monoclonal antibodies targeting CD20 and CD30 may be the best choice in the second-line therapy for patients with non-small cell lung carcinoma.

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What is the primary cause of carcinoma, non-small-cell lung?

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This information may provide clinicians and patients with a more thorough understanding of the disease process and treatment options, as well as aid in guiding patient-family discussions of end of life care.

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What are the chances of developing carcinoma, non-small-cell lung?

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[The percentage of patients who develop carcinoma, non-small-cell lung, from the general population] was (1.15 x 0.83) = 1.38. Taking the data at 1 year, this gives an expected probability of carcinoma, non-small-cell lung, of 4.9%. [This calculation helps to determine if there is a need to perform preventive screening for this disease] (P<0.05). Power makes it easy to find trials tailored to the needs of your condition, treatment, or location.

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Have there been other clinical trials involving v941?

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The most well-known patient with v941 was a child with retinoblastoma, and clinical trials may not be appropriate treatment for all patients with v941-positive cancers. We recommend that patients with v941-positive cancer do not participate in cancer clinical trials without a more appropriate trial involving v941. A small number of clinical trials on v941 are still ongoing, however more studies investigating the effectiveness and safety of v941 in patients with carcinoma may be the future direction for clinical trials with v941.

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Get access to this novel treatment for Carcinoma, Non-Small-Cell Lung by sharing your contact details with the study coordinator.