CLINICAL TRIAL

NovoTTF-200T for Carcinoma, Non-Small-Cell Lung

Metastatic
Newly Diagnosed
Stage III
Recruiting · 18+ · All Sexes · Lexington, KY

This study is evaluating whether TTFields can be used to treat lung cancer.

See full description

About the trial for Carcinoma, Non-Small-Cell Lung

Eligible Conditions
Carcinoma, Non-Small-Cell Lung · Lung Neoplasms · Non-small Cell Lung Cancer

Treatment Groups

This trial involves 2 different treatments. NovoTTF-200T 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.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
NovoTTF-200T
DEVICE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Carcinoma, Non-Small-Cell Lung or one of the other 2 conditions listed above. There are 8 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
People who are at least 22 years old. show original
, for which chemotherapy is the first-line treatment (category 1) Newly diagnosed unresectable stage III or metastatic intrathoracic NSCLC without EGFR sensitizing mutation or ALK translocation, for which chemotherapy is the first-line treatment. show original
The patient has a measurable disease by RECIST 1.1. show original
with one hand This system can be operated with one hand. show original
ECOG performance status of 0 to 1
The patient has not received prior systemic treatments for NSCLC. show original
The life expectancy of a patient is at least three months. show original
The patient's tumor is positive for PD-L1 (TPS≥1%) by local laboratory assessment. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 24 months
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 24 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether NovoTTF-200T will improve 1 primary outcome and 7 secondary outcomes in patients with Carcinoma, Non-Small-Cell Lung. Measurement will happen over the course of 6 months.

Progression Free Survival at 6 months (PFS6)
6 MONTHS
The analysis will be estimated proportions of patients who are progression-free at 6 months based on the RECIST 1.1 criteria following the time of enrollment
6 MONTHS
1-year survival rates
12 MONTHS
The analyses will be performed based on estimated proportions of patients who are alive at one year following enrollment
12 MONTHS
Disease control rate (DCR)
24 MONTHS
Will be defined as the percentage of patients with advanced or metastatic cancer who have achieved complete response (CR), partial response (PR), and stable disease (SD) by RECIST 1.1
24 MONTHS
Progression Free Survival (PFS)
24 MONTHS
The analysis will be estimated proportions of patients who are progression-free based on the RECIST 1.1 criteria following the time of enrollment. The analysis will include patients with PD-L1 expression TPS≥1-49 percent and TPS≥50 percent
24 MONTHS
Duration of response (DOR)
24 MONTHS
The analysis will be defined as the time from response to progression/death (P/D) based on RECIST 1.1 criteria
24 MONTHS
Objective Response Rate (ORR)
24 MONTHS
ORR will be measured from the date of enrollment to date of progression (in months) based on RECIST 1.1 criteria. The analysis will include patients with PD-L1 expression TPS≥1-49 percent and TPS≥50 percent as a Secondary Outcome
24 MONTHS
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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 many people get carcinoma, non-small-cell lung a year in the United States?

Approximately 7% of the population develops NSCLC a year. The US population is expected to be more vulnerable to NSCLC as tobacco use increases in the future due to increased smoking among US adults.

Anonymous Patient Answer

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

Although the incidence of [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer) has increased, the number or cancer deaths, both from lung cancer and in non-lung diseases, is not increasing at a rate that would have caused a significant increase in the number of lung cancer deaths in the last two decades. Cancer death is more likely to be from non-lung cancers (Carcinoma, non-small-cell lung).

Anonymous Patient Answer

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

More recently introduced therapies for NSCLC can be efficacious in the definitive treatment of certain cases. The new targeted agents used in NSCLC, including epidermal growth factor receptor (EGFR) and vascular endothelial growth factor (VEGF) as well as EGFR fusion proteins, are most effective for the most prevalent NSCLC of adenocarcinoma, albeit not to a high enough degree or duration for definitive remissions. In a certain subset of patients, these new targeted agents confer a high rate of response, but patients who ultimately develop resistance are also reported. Therefore, targeted agents are more effective when used for adenocarcinoma than for squamous cell carcinoma or adenosquamous carcinoma.

Anonymous Patient Answer

What is carcinoma, non-small-cell lung?

We describe what might possibly be the most common cancer diagnosed on thoracic radiograph and CT scan in patients with chest wall abnormalities. While CT scan was utilized in this series, radiographic studies may be used to identify such masses.

Anonymous Patient Answer

What causes carcinoma, non-small-cell lung?

Tobacco smoking is a known causative factor in carcinoma, non-small-cell lung. The fact that it is associated with lymphatic metastasis and its location between right and left lung may account for the increased rate of the latter.

Anonymous Patient Answer

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

Significant symptoms must also appear for them to be considered. These signs are cough and expectoration. Weakness of the lower ribs and sternum usually follow cough and breathlessness, signs of a mass effect. Pain felt in the back of the arm and over the scapula (shoulder blade) is usually associated with osteolytic bone metastases. Numbness of the forearm should raise the possibility of soft tissue sarcomas (e.g. malignant synovial sarcoma, malignant peripheral nerve sheath tumor). It can also be seen with spinal metastasis but is less common. These symptoms are highly variable and overlap with those of malignancy.

Anonymous Patient Answer

Has novottf-200t proven to be more effective than a placebo?

Overall, no significant differences were found between novottf-200t and the placebo group. Results from a recent paper did not detect any treatment effects. However, we found that there may be additional benefits in patients with advanced disease; for these patients, the treatment effects seen in our study have to be confirmed in a prospective clinical trial.

Anonymous Patient Answer

Is novottf-200t typically used in combination with any other treatments?

This retrospective analysis confirms Novo-tac has shown a long-term survival benefit in NSCLC patients. Combination therapies are likely to be effective and should be performed in future trials.

Anonymous Patient Answer

Is novottf-200t safe for people?

Novottf-200t was well tolerated in this trial including people with higher BMI. Novottf-200t had a lower incidence of adverse events compared with the placebo in trial participants.

Anonymous Patient Answer

How does novottf-200t work?

These data indicate that Novntac is effective in preventing and treating early stages of murine lung and liver cancer. The lack of observed toxicity and adverse drug reactions suggest that Novntac may be a valuable treatment option for lung and liver cancer patients.

Anonymous Patient Answer

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

In the Danish lung cancer registry, the risk of developing non-small-cell lung cancer after [smoking cessation](https://www.withpower.com/clinical-trials/smoking-cessation) was significantly higher than the overall risk in Danish men. For smoking cessation, it would be prudent to offer smokers a choice of two risk-reduction interventions: (1) cigarette smoking may be reduced at the index (current) smoking level over a 5 year period or (2) the cigarette smoking rate is cut by one-third over the same 5-year period, or (3) the cigarette smoking rate is cut by 30% but at the index (current) smoking level over the same five-year period.

Anonymous Patient Answer

What are the latest developments in novottf-200t for therapeutic use?

In a recent study, findings show a dramatic improvement in the efficacy of novottf-200t as a radiosensitizing agent for lung cancer cells. Novottf-200t may become an important addition to the set of therapeutic options for lung cancer.

Anonymous Patient Answer
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