TVB-2640 for Carcinoma, Non-Small-Cell Lung

Phase-Based Estimates
1
Effectiveness
2
Safety
University of Cincinnati, Cincinnati, OH
Carcinoma, Non-Small-Cell Lung+2 More
TVB-2640 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Carcinoma, Non-Small-Cell Lung

Study Summary

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

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Eligible Conditions

  • Carcinoma, Non-Small-Cell Lung
  • Lung Cancer
  • Lung Neoplasms
  • KRAS Gene Mutation

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether TVB-2640 will improve 2 primary outcomes and 4 secondary outcomes in patients with Carcinoma, Non-Small-Cell Lung. Measurement will happen over the course of Pretreatment and four weeks of treatment..

Pretreatment and four weeks of treatment.
Establish the predictive value of 11C-acetate PET
Mean change in fasting plasma lipidomics
Mean change in sebaceous secretion of fatty acids
Safety profile of TVB-2640
Year 1
Disease control rate of TVB-2640
Response rate of TVB-2640

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Control
TVB-2640

This trial requires 12 total participants across 2 different treatment groups

This trial involves 2 different treatments. TVB-2640 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

TVB-2640
Drug
Patients will be administered TVB-2640 100mg/m2 orally once a day for 8 weeks.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TVB-2640
2019
Completed Phase 2
~360

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: every 8 weeks through study completion, an average of 1 year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly every 8 weeks through study completion, an average of 1 year for reporting.

Closest Location

University of Cincinnati - Cincinnati, OH

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 2 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:
Metastatic or advanced stage, histologically or cytologically confirmed NSCLC and molecular identification of oncogenic KRAS mutation.
KRAS mutant NSCLC must be refractory, relapsed, and/or intolerant (including contraindications to) of combination platinum-doublet chemotherapy and immune checkpoint inhibitor therapy
Age ≥ 18 years.
You have no symptoms or signs of cancer. show original
Predicted life expectancy of >3 months.
absolute neutrophil count ≥ 1,500/mcL
This study is evaluating whether a new type of blood test can help predict which patients with non-small cell lung cancer will respond to treatment with a specific type of cancer drug. show original
Subjects must have EGFR mutation or ALK gene rearrangement status known prior to study entry show original
You have evidence of disease progression on most recent line of therapy. show original
You have measurable disease by RECIST v1.1 (Eisenhauer, 2009). 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.

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

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Carcinoma, non-small-cell lung is a highly aggressive cancer, and its overall prognosis is poor. Due to these factors, it is necessary to assess the current status of treatment for patients with carcinoma, non-small-cell lung with regard to PFS. This is a crucial point for developing an effective treatment strategy. In this paper, standard therapeutic options for carcinoma, non-small-cell lung and strategies to improve treatment for patients with carcinoma, non-small-cell lung was reviewed, and the treatment options for carcinoma, non-small-cell lung were organized according to PFS.

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

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Carcinoma, non-small-cell lung make up 5.8% of Americans. Carcinoma, non-small-cell lung comprise 1.9% of all malignancies reported to the Centers for Disease Control and Prevention in the United States in 2000. The most common cancer in 2000 was small cell carcinoma, malignant neuroblastoma of the lung, (14.7% of all reported malignancies); the second most common was squamous cell carcinoma, non-small cell lung (11.5% of all reported malignancies) and adenoid cystic carcinoma of the salivary gland, (8.2% of all reported malignancies).

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What is carcinoma, non-small-cell lung?

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Carcinoma, non-small-cell lung, first appeared in the third millennium, about 4000 years later than what was previously hypothesized. A combination of radiometric and genetic evidence strongly supports a relationship between this tumour and smoking.

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

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It is very difficult to predict whether a carcinoma, NSCLC can be cured, or not. However, it is possible to cure it if it is detected early and treated.

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

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Patients with cancer of the lung with a palpable mass and persistent or worsening symptoms of cough should undergo CT scan. Imaging is particularly helpful in detecting unsuspected metastases or unsuspected pneumonic disease.

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What causes carcinoma, non-small-cell lung?

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The cause of carcinoma is still unknown; however, it almost certainly is multifactorial. Tobacco smoking appears to play a causative role, as does occupational asbestos exposure.

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What is tvb-2640?

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TVB-2640 is a novel synthetic compound. Its chemical structure and mode of action are similar to cyclophosphamide. Despite the structural similarity, this compound causes very different anticancer activity.

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Is tvb-2640 typically used in combination with any other treatments?

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A combination treatment with a low-dose combination of TVB-2640 with a second-line treatment was effective and safe in this study. In view of the limited number of patients and their inclusion criteria, the results need to be confirmed in a larger study.

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Has tvb-2640 proven to be more effective than a placebo?

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To date, this medication has not been proven to be more effective than a placebo. Moreover, for patients who already received a bronchodilator, the side-effects of this medication were more problematic than their adverse drug reactions in general.

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Does tvb-2640 improve quality of life for those with carcinoma, non-small-cell lung?

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In people with carcinoma, non-small-cell lung, in whom the cancer is growing and invading surrounding tissues, the TV-2640 combination improved both quality of life and survival by slowing the tumor growth rate and reducing symptoms of cough and dyspnea.

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What are the latest developments in tvb-2640 for therapeutic use?

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TVB2640 was efficacious and safe as a single agent and combination therapy in early-phase clinical trials. Further studies, preferably randomized phase III trials, are warranted to assess its utility in the treatment-resistant setting. Clin Cancer Res; 1-10. ©2016 AACR.

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How serious can carcinoma, non-small-cell lung be?

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The overall five-year survival for stage III-IV NSCLC is about 35%; however, survival is significantly higher for stage III-IV NSCLC patients with adenocarcinoma (57%). The significant survival difference is probably due to adenocarcinoma patients' being younger, healthier, and having better staging (stage I-II patients having lower survival). The data suggest that adenocarcinoma patients should have aggressive and intensive treatment, including surgery, chemotherapy, and/or targeted therapy.

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