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Pre-operative Tumor Treating Fields in Patients With Resectable Lung Cancer

Phase 0 Trial of Pre-operative Tumor Treating Fields in Patients With Resectable Lung Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
22 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 5 visits
  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants in this study will have a blood sample collected as well as vital signs along with a tumor tissue sample and tumor scan."
  • "Once it has been determined the participant can enroll into this study, he/she will come to the clinic for 5 scheduled visits over a period of 2 months ."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how Tumor Treating Fields (TTFields) affect lung cancer and the body before surgery. TTFields use weak electrical fields to treat cancer without entering the body. The study is for adults age 22 or older with stage I–IIIA non-small cell lung cancer who plan to have surgery to remove it.

The purpose of this study is to study the clinical and biologic effects of Tumor Treatment Fields (TTFields) in patients undergoing resection of stage I-IIIA Non-Small Cell Lung Cancer (NSCLC). TTField is a non-invasive treatment that uses low-intensity electrical fields to treat cancer. Resection is the medical term for surgically removing part or all of a tissue, structure, or organ.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have stage I–IIIA non-small cell lung cancer and plan to have surgery to remove it.
  • Be age 22 or older at screening.
  • Be able to care for yourself and be up and about for at least half the day (ECOG activity score 0–2).
  • Be willing and able to have study tests, including imaging scans.
  • Have a fresh biopsy sample from routine care, with 10–15 slides for study tests. If no sample is available, the study leaders may approve an exception.
  • Be able to understand the study and sign a form agreeing to join.
  • All men and women who could become pregnant must use birth control or avoid sex before joining, during the study, and for 30 days after treatment. Tell the doctor right away about any pregnancy or suspected pregnancy.

Who can't join

  • Have already received treatment for the current lung cancer.
  • Plan to have another cancer treatment before surgery.
  • Have had a severe allergic reaction to the adhesive or materials in the TTFields device.
  • Have an uncontrolled illness, such as an active infection, heart failure with symptoms, unstable chest pain, or an abnormal heartbeat. Mental health or social problems that could prevent following study rules may also exclude you.
  • Are pregnant or breastfeeding.
  • Use an electronic device or prosthetic, such as a pacemaker, implanted heart shock device, or spinal drug pump. Specific cases may be discussed with the study leaders.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Diagnosis of stage I-IIIA NSCLC planned for surgical resection. 2. Eastern Cooperative Oncology Group (ECOG) 0-2 performance status. 3. Willingness and ability to undergo planned correlative studies, including imaging tests. 4. Fresh biopsy diagnostic material obtained from standard of care procedure to perform baseline correlatives (10-15 slides)-if not available, enrollment will be considered on a case-by-case basis after discussion with and approval by the Lead Site PI or Lead Site Co-Principal Investigator. 5. Ability to understand and the willingness to sign a written informed consent. 6. All men, as well as women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 30 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. * 6a. A female of child-bearing potential is any woman (regardless of sexual orientation, marital status, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: * • Has not undergone a hysterectomy or bilateral oophorectomy; or * • Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). 7. Age ≥22 years at time of screening. Exclusion Criteria: 1. Receipt of prior therapy for the current NSCLC. 2. Planned neoadjuvant therapy for the current NSCLC. 3. History of major allergic reactions attributed to adhesive or compounds in TTFields micro-array. 4. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements. 5. Pregnant or nursing patients due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants. 6. Use of electronic devices or prosthetics - i.e., pacemakers, defibrillators, spinal infusion pumps. Specific scenarios can be discussed with the Lead Site PI or Lead Site Co-Principal Investigator.

Study sites (1)

TX