A Prospective Clinical Trial of Tumor Immunomodulation Using Tumor-Treating Fields (TTFields) in Patients With Early-Stage Resectable Lung Adenocarcinoma

New trial tests TTFields to boost immune response in early lung cancer

NCT: NCT05764954 · Status: RECRUITING · Phase: Phase 1 · Sponsor: Memorial Sloan Kettering Cancer Center · Started: 2023-08-04 · Est. Completion: 2027-08

Plain English Summary

A Study of Tumor-Treating Fields (TTFields) in People With Lung Adenocarcinoma is a Phase 1 clinical trial sponsored by Memorial Sloan Kettering Cancer Center studying Adenocarcinoma of Lung. This trial tests a device called Tumor-Treating Fields (TTFields) to see if it's safe and practical before surgery for early-stage lung cancer. It is for patients with a specific type of lung cancer called adenocarcinoma, who are eligible for surgery. Participants will use the TTFields device for about 18 hours a day for 3 weeks before their surgery. Currently, standard treatment for this condition involves surgery, and this trial explores an additional therapy to potentially enhance the body's own cancer-fighting abilities. The trial aims to enroll 25 participants.

Official Summary

The researchers are doing this study to find out if treatment with TTFields using the NovoTTF-200T System is safe and practical (feasible) before surgical removal (resection) of lung adenocarcinoma (ADC). The researchers will also look at how the treatment may help the body's immune system to fight cancer.

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you are 22 years or older and have been diagnosed with early-stage lung adenocarcinoma that can be surgically removed. You cannot join if you are currently receiving treatment for another active cancer or have a history of heart rhythm problems or pacemaker use. The trial is looking for patients with lung nodules larger than 1 cm that are suspected to be adenocarcinoma and are planned for a biopsy. Patients with certain types of lung nodules, like those that are less than 50% solid or are pure ground glass opacities, cannot participate. This trial is studying Adenocarcinoma of Lung, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures how often and how severe any side effects occur, helping researchers understand the safety of using TTFields before lung cancer surgery. The specific primary outcome measures are: Adverse events, severity and frequency (1 year). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 1, the first major stage of clinical testing. Phase 1 trials typically involve 20-100 participants and focus on safety, dosage levels, and side effects. The primary goal is not to test whether the treatment works but to establish that it is safe enough for further testing. About 70% of Phase 1 drugs advance to Phase 2. If successful, the treatment will proceed to Phase 2 efficacy testing.

Why This Trial Matters

This trial matters because it explores a novel approach to potentially enhance the immune system's ability to fight early-stage lung cancer before surgery, addressing a gap in treatments that focus so This research targets Adenocarcinoma of Lung, where improved treatment options are needed.

Investor Insight

This Phase 1 trial investigating TTFields for early-stage lung adenocarcinoma represents an early-stage investment signal in a growing field of cancer therapy, with potential for future market expansi Phase 1 trials have approximately a 10% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor if TTFields is a suitable option for your specific type and stage of lung cancer. Understand that you will need to wear the TTFields device for approximately 18 hours each day for three weeks leading up to your surgery. Be prepared to discuss any pre-existing heart conditions or pacemaker use with your medical team. This trial is currently recruiting participants. The trial is being conducted at 7 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Full Eligibility Criteria

Inclusion Criteria:

* The participant (or legally acceptable representative \[LAR\], if applicable) provides written informed consent for the study.
* The participant is ≥22 years of age on the day of signing informed consent.
* The participant has clinical stage 1A2, 1A3 or IB biopsy-proven lung ADC and is eligible for anatomical resection.
* The participant has a lung nodule \>1 cm and suspected lung ADC with a plan to undergo biopsy.
* The participant with multiple nodules has one nodule that meets the criteria.
* The participant has no history of prior malignancy in the chest or has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy.

Exclusion Criteria:

* Patients receiving therapy for concurrent active malignancy
* Patients with a history of cardiac arrhythmias and/or pacemaker use
* Patients with lung nodules \<1cm
* Patients with lung nodules that are pure ground glass opacities (GGOs) of any size
* Patients with lung nodules that are \<50% solid of any size

Trial Locations

Frequently Asked Questions

What is clinical trial NCT05764954?

NCT05764954 is a Phase 1 INTERVENTIONAL study titled "A Study of Tumor-Treating Fields (TTFields) in People With Lung Adenocarcinoma." It is currently recruiting and is sponsored by Memorial Sloan Kettering Cancer Center. The trial targets enrollment of 25 participants.

What conditions does NCT05764954 study?

This trial investigates treatments for Adenocarcinoma of Lung. The primary condition under study is Adenocarcinoma of Lung.

What treatments are being tested in NCT05764954?

The interventions being studied include: NovoTTF-200T System (DEVICE). The device is applied continuously for an average duration of 18 hours per day for 3 weeks (+/- 1 week).

What does Phase 1 mean for NCT05764954?

Phase 1 trials are the first stage of testing a new treatment in humans. They focus on safety, dosage, and side effects, usually involving 20-100 healthy volunteers or patients.

What is the current status of NCT05764954?

This trial is currently "Recruiting." It started on 2023-08-04. The estimated completion date is 2027-08.

Who is sponsoring NCT05764954?

NCT05764954 is sponsored by Memorial Sloan Kettering Cancer Center. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT05764954?

The trial aims to enroll 25 participants. The trial is currently recruiting and accepting new participants.

How is NCT05764954 designed?

This is a interventional study, uses na allocation, follows a single_group design, employs none masking.

What are the primary outcomes being measured in NCT05764954?

The primary outcome measures are: Adverse events, severity and frequency (1 year). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT05764954 being conducted?

This trial is being conducted at 7 sites, including Basking Ridge, New Jersey; Middletown, New Jersey; Montvale, New Jersey; Commack, New York and 3 more sites (United States).

Where can I find official information about NCT05764954?

The official record for NCT05764954 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT05764954. This government database provides the most up-to-date and detailed information about the trial.

What is NCT05764954 testing in simple terms?

This trial tests a device called Tumor-Treating Fields (TTFields) to see if it's safe and practical before surgery for early-stage lung cancer. It is for patients with a specific type of lung cancer called adenocarcinoma, who are eligible for surgery.

Why is this trial significant?

This trial matters because it explores a novel approach to potentially enhance the immune system's ability to fight early-stage lung cancer before surgery, addressing a gap in treatments that focus so

What are the potential risks of participating in NCT05764954?

The most common side effects are related to skin irritation where the device pads are placed. Potential risks include temporary discomfort or pain at the treatment site. As this is a new treatment approach, there may be other unforeseen side effects that will be closely monitored. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT05764954?

Ask your doctor if TTFields is a suitable option for your specific type and stage of lung cancer. Understand that you will need to wear the TTFields device for approximately 18 hours each day for three weeks leading up to your surgery. Be prepared to discuss any pre-existing heart conditions or pacemaker use with your medical team. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT05764954 signal from an investment perspective?

This Phase 1 trial investigating TTFields for early-stage lung adenocarcinoma represents an early-stage investment signal in a growing field of cancer therapy, with potential for future market expansi This is a Phase 1 trial, which is in early development stages.

What happens if the treatment in this trial doesn't work?

Participants will use the TTFields device for about 18 hours a day for 3 weeks before their surgery. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.