Tumor biopsy for Carcinoma, Non-Small-Cell Lung

Phase-Based Estimates
1
Effectiveness
2
Safety
GSK Investigational Site, Nashville, TN
Carcinoma, Non-Small-Cell Lung+2 More
Tumor biopsy - Procedure
Eligibility
18+
All Sexes
Eligible conditions
Carcinoma, Non-Small-Cell Lung

Study Summary

This study is evaluating whether a molecular analysis of tumor tissue and blood samples may help predict how well a patient will respond to a specific treatment.

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Eligible Conditions

  • Carcinoma, Non-Small-Cell Lung
  • Cancer
  • Neoplasms
  • Non-Small Cell Lung Carcinoma (NSCLC)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Tumor biopsy will improve 3 primary outcomes in patients with Carcinoma, Non-Small-Cell Lung. Measurement will happen over the course of Up to 2 years.

Up to 2 years
Number of participants with positive Inducible T-cell Co-Stimulator (ICOS) status
Number of participants with positive New York esophageal squamous cell carcinoma 1 (NY-ESO-1)/Cancer testis antigen 2 (LAGE-1a) status
Number of participants with positive Programmed death protein 1 Ligand (PD-L1) status

Trial Safety

Safety Estimate

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

Compared to trials

Side Effects for

Gemcitabine & Genistein
Absolute neutrophil count (ANC)
26%
White blood cells (WBC)
26%
Pain
16%
Platelets
16%
Dyspnea
16%
Fatigue
11%
Elevated Aspartate Aminotransferase (AST)
5%
Hot flashes
5%
Hemoglobin (Hgb)
5%
Elevated Alkaline Phosphate
5%
Elevated Alanine Aminotransferase (ALT)
5%
Vomiting
5%
Rash
5%
This histogram enumerates side effects from a completed 2009 Phase 2 trial (NCT00244933) in the Gemcitabine & Genistein ARM group. Side effects include: Absolute neutrophil count (ANC) with 26%, White blood cells (WBC) with 26%, Pain with 16%, Platelets with 16%, Dyspnea with 16%.

Trial Design

2 Treatment Groups

Control
Participants undergoing tumor biopsy

This trial requires 400 total participants across 2 different treatment groups

This trial involves 2 different treatments. Tumor Biopsy 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.

Participants undergoing tumor biopsy
Procedure
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tumor biopsy
2014
Completed Phase 2
~100

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 2 years for reporting.

Closest Location

GSK Investigational Site - Nashville, TN

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
People who can provide a tumor specimen that has been fixed in formalin and embedded in paraffin less than two years ago can participate in this study show original
Female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: -Is not a woman of childbearing potential (WOCBP) -Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of less than [<]1 percent [%] per year), preferably with low user dependency; -A WOCBP must have a negative highly sensitive pregnancy test (urine or serum) as required by local regulations) within 24 hours before tumor biopsy; and if a urine test cannot be confirmed as negative (for example, an ambiguous result), a serum pregnancy test is required show original
The Participant is a potential candidate for a clinical study of a precision therapeutic medicine from GlaxoSmithKline (GSK) that is being conducted at or near the recruitment site for the Molecular Disease Clinical Institute (MDCI). show original
The participant is willing to travel to a site that is recruiting for the intended GSK treatment protocol (or an alternative treatment protocol), if it is feasible, and if, in the investigator's opinion, the participant would benefit from enrolment into the intended GSK treatment protocol at an alternative clinical site. show original
People who have a confirmed advanced/metastatic diagnosis of solid malignancy in one of the following disease-areas: Non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), Breast, ovarian, and colorectal cancer (CRC) are participants. show original
It is necessary for both men and women participating in clinical studies to follow the local regulations regarding contraception methods. show original
The study found that participants with a life expectancy of greater than six months had a better quality of life. show original
The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to determine if a woman is at risk for an early undetected pregnancy. show original
People who can understand the information in the form and agree to comply with the listed requirements and restrictions. show original
People who can donate blood. 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 is carcinoma, non-small-cell lung?

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Most NSCLC patients are asymptomatic at diagnosis as approximately 30% have detectable lung cancer at the time of diagnosis; thus, careful follow-up is necessary, as delays in diagnosis can lead to late relapse. Furthermore, a small proportion of patients do not experience symptoms at presentation, but later on as they develop the disease.

Unverified Answer

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

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The most common treatments for carcinoma, non-small-cell lung are radical surgery and chemotherapy, either alone or in combination with other treatments. Other treatments may include radiotherapy, targeted therapies, and biologics. These treatments vary depending on the extent of the disease and overall staging.

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What causes carcinoma, non-small-cell lung?

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Exposure to radon-222, a product of thorium (the decay product of polonium). Radon may enter the body through the skin and nasal passages. However, no statistical evidence for this link between radon and lung cancer has been found, except in the highest of exposures.

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

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CTCL can be cured only if the disease-free time is long. The long-term improvement of the P0 patients is better with a second TBI chemotherapy.

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

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Around 2.3 million people are diagnosed with NSCLC a year in the US. Overall, the number of people diagnosed with lung cancer exceeded that of colon carcinoma a year earlier than colon carcinoma did.

Unverified Answer

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

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Symptoms of carcinoma, non-small-cell lung, can help in the detection, diagnosis and management of these patients. Most patients present with cough, weakness, shortness of breath and a mass which cannot be felt and palpated in the chest. A history of smoking aids in the diagnosis of carcinoma, non-small-cell lung.

Unverified Answer

What are the common side effects of tumor biopsy?

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Even though the common side effects of FDG PET are more well-known than their common side effects from PET/CT, we have found that some of the side effects of FDG PET include serious side effects. Although FDG PET/CT is still an important medical resource, we have shown that it needs to be complemented by accurate clinical judgment to avoid severe side effects. The key point is early treatment when serious side effects occur. Some of the adverse events are inevitable and we have also found that these adverse effects can be easily avoided, but we all want to keep our health and quality of life.

Unverified Answer

Who should consider clinical trials for carcinoma, non-small-cell lung?

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Clinical trials are not generally cost-effective for patients with non-small-cell lung carcinoma. Patients treated with a clinical trial of gemcitabine have fewer new symptoms than patients receiving an alternative treatment (gemcitabine monotherapy).

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Is tumor biopsy safe for people?

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The safety profile of tumor biopsy performed for oncologic reasons as a single investigation is quite similar to that of an isolated examination of an unknown mass. The potential of tumor sampling, including the presence of suspicious, indeterminate, or suspicious cells, should, therefore, not be considered additional indications for the use of tumor sampling for diagnostic purposes.

Unverified Answer

Have there been other clinical trials involving tumor biopsy?

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In a recent study, findings suggested that tumor biopsy has a very high success rate in the early stage of clinical trials, with high patient satisfaction. In a recent study, findings will be more reliable in prospective clinical trials.

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How quickly does carcinoma, non-small-cell lung spread?

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A patient with adenocarcinoma of the lung has a median survival time of 8.4 months. However, a patient with Stage IV adenocarcinoma of the lung or any stage of malignancy (cancer) has a median survival time of 11 months. In a recent study, findings demonstrate that while adenocarcinoma of the lung metastasizes with great dispatch, the other malignancies do not spread as quickly.

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Has tumor biopsy proven to be more effective than a placebo?

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biopsy was proven to be statistically superior to a placebo in diagnosing lung carcinoma. To minimize costs and harm to the patient, a patient who undergoes a pneumo-thoracic biopsy should be placed under a full anesthesia. Patients undergoing a needle biopsy should expect to be under anesthesia for 2 to 5 days to evaluate for tumor growth, while patients undergoing a pneumo-thoracic biopsy may return to their usual lifestyle.

Unverified Answer
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