Extensive Stage Lung Small Cell Carcinoma, Limited Stage Lung Small Cell Carcinoma, Stage I Lung Cancer AJCC v8, Stage IA1 Lung Cancer AJCC v8, Stage IA2 Lung Cancer AJCC v8, Stage IA3 Lung Cancer AJCC v8, Stage IB Lung Cancer AJCC v8, Stage II Lung Cancer AJCC v8, Stage IIA Lung Cancer AJCC v8, Stage IIB Lung Cancer AJCC v8, Stage III Lung Cancer AJCC v8, Stage IIIA Lung Cancer AJCC v8, Stage IIIB Lung Cancer AJCC v8, Stage IIIC Lung Cancer AJCC v8, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8
Conditions
Brief summary
This phase II single-arm pilot study will evaluate the safety and preliminary efficacy of Optune-Tumor Treating Fields (TTFields) therapy as a prophylactic approach to reducing small cell lung cancer (SCLC) that has spread to the brain (brain metastases). Optune is a portable battery powered device that produces alternating electrical fields, termed tumor treatment fields (TTFields) within the human body. These TTFields are applied to the patient by electrically insulated surface transducer arrays, which function to disrupt the rapid cell division of cancer cells.
Detailed description
PRIMARY OBJECTIVE: I. Observed rate of brain metastases following TTFields therapy at 6 months. SECONDARY OBJECTIVES: I. Observed rate of brain metastases following TTFields therapy at 12 months. II. Survival of participants with SCLC after using TTFields therapy. III. Usage and overall safety characteristics of TTFields therapy. IV. Quality of life among participants using TTFields therapy. V. Observed rate of SCLC brain metastases at 6 months from the beginning of the 4th cycle of chemotherapy to development of brain metastases. OUTLINE: Participants will receive TTFields therapy on a continuous basis (i.e., 18-24 hours a day, 7 days a week) for a period of 12 months or until the development of brain metastases, whichever comes first. Participants will be able to carry the device in an over-the-shoulder bag or backpack so that they can receive continuous at-home treatment. The investigator or other designated healthcare provider will provide detailed instructions regarding the placement/replacement and positioning of the transducer arrays on the participants head. TTFields are applied to the shaved scalp via two pairs of orthogonally positioned transducer arrays. Each pair of transducer arrays will be centered on the participants shaved head such that one pair is placed on the left and right side of the head, and the second pair placed anteriorly and posteriorly. Transducer arrays should be replaced every 2 to 3 days, with a slight relocation of the new arrays \ 2 cm from the prior location. After completion of study treatment, patients are followed up periodically.
Interventions
OTHERQuestionnaire Administration
Ancillary studies
Optune-Tumor Treating Fields (TTFields). Transducer arrays affixed to scalp, worn continuously.
Sponsors
NovoCure Ltd.
Oregon Health and Science University
OHSU Knight Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ability to understand and the willingness to sign a written informed consent document * Pathologically confirmed limited stage (LS)-SCLC or extensive stage (ES)-SCLC * LS-SCLC - stage I-III (Tany, Nany, M0) that can be safely treated with radiation doses. Excludes T3-4 due to multiple nodules that are too extensive of have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan * ES-SCLC - stage IV (Tany, Nany, M1), or T3-4 due to multiple nodules that are too extensive of have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan * Must be no more than 6 weeks from having received last dose of chemo- and/or radiotherapy for primary tumor to anticipated start of TTField therapy * Partial response to standard of care (chemo- and/or radiotherapy) as judged by treating physicians with no evidence of recurrence as observed by thoracoabdominal computed tomography (CT) within 12 weeks of enrollment * No brain metastases as observed by gadolinium (gd)-magnetic resonance imaging (MRI) within 12 weeks of enrollment * No previous or currently active second malignancy, with exception of non-metastatic prostate cancer, treated stage I breast cancer, skin malignancies * Life expectancy of at \>= 3 months * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60) * Participants must be willing and able to fully comply with the minimum required 18 hours/day of TTField therapy * Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
Exclusion criteria
* Malignant disease, other than that being treated in this study, with exception of non-metastatic prostate cancer, treated stage I breast cancer, skin malignancies * Implanted pacemaker, defibrillator or deep brain stimulator, or documented clinically significant arrhythmias * Active implanted medical device (e.g. deep brain stimulators, spinal cord stimulators, vagus nerve stimulators, pacemakers, defibrillators, and programmable shunts) * External medical devices (e.g., insulin pumps) are permitted * Skull defect (e.g. missing bone with no replacement) * Shunt * Bullet fragments * Evidence of increased intracranial pressure (midline shift \> 5 mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness) * Sensitivity to conductive hydrogels * Pregnant or lactating women * Underlying serious skin condition on the scalp, which in the opinion of the investigator, would prevent or interfere with TTField therapy * Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of participant safety or study results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Small Cell Lung Cancer (SCLC) Brain Metastases at 6 Months | 6 months following start of tumor treating fields (TTFields) therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | Death or last follow up following start of TTFields therapy, whichever comes first (assessed at 6, 12, 24, 36 and 60 months) | Overall survival of participants with SCLC after using TTFields therapy. The distribution of overall survival will be graphically described using Kaplan-Meier plot, for all subjects together, and for each disease group (extensive stage and limited stage). |
| Incidence of TTfield Related Adverse Events | Continuously following start of TTFields therapy (up to 12 months) | — |
| Incidence of SCLC Brain Metastases at 12 Months | 12 months following start of TTFields therapy | — |
| Change in Quality of Life Over Time: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) | 6 and 12 months following start of TTFields therapy | Quality of life (QoL) among participants using TTFields therapy evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30). The EORTC QLQ-C30 uses for the questions 1 to 28 a 4-point scale. The scale scores from 1 to 4: 1 (Not at all), 2 (A little), 3 (Quite a bit) and 4 (Very much). For questions 29 and 30, a 7-points scale is used. The scale scores from 1 to 7: 1 (very poor) to 7 (excellent). Summary of QoLs and its change over time will be presented graphically. |
| Incidence of SCLC Brain Metastases | Up to 180 days from Day 1 of the 4th cycle of chemotherapy (each cycle is 28 days) | — |
| Incidence of Cognitive Adverse Events (AEs) Using Mini Mental State Exam (MMSE) | Continuously following start of TTFields therapy (up to 12 months) | Incidence of cognitive AEs will be assessed by measuring changes in MMSE scores over time. Descriptive statistical analysis will be conducted. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Prevention (TTFields Therapy, Questionnaire) Patients undergo TTFields therapy over 18-24 hours daily. Cycles repeat every 4 weeks for 12 months in the absence of disease progression or unacceptable toxicity.
Questionnaire Administration: Ancillary studies
Tumor Treating Fields Therapy: Optune-Tumor Treating Fields (TTFields). Transducer arrays affixed to scalp, worn continuously. | 3 |
| Total | 3 |
Baseline characteristics
| Characteristic | Prevention (TTFields Therapy, Questionnaire) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Region of Enrollment United States | 3 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 3 |
| other Total, other adverse events | 1 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
Primary
Incidence of Small Cell Lung Cancer (SCLC) Brain Metastases at 6 Months
Time frame: 6 months following start of tumor treating fields (TTFields) therapy
Population: Data not collected.
Secondary
Change in Quality of Life Over Time: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30)
Quality of life (QoL) among participants using TTFields therapy evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30). The EORTC QLQ-C30 uses for the questions 1 to 28 a 4-point scale. The scale scores from 1 to 4: 1 (Not at all), 2 (A little), 3 (Quite a bit) and 4 (Very much). For questions 29 and 30, a 7-points scale is used. The scale scores from 1 to 7: 1 (very poor) to 7 (excellent). Summary of QoLs and its change over time will be presented graphically.
Time frame: 6 and 12 months following start of TTFields therapy
Population: Data not collected.
Secondary
Incidence of Cognitive Adverse Events (AEs) Using Mini Mental State Exam (MMSE)
Incidence of cognitive AEs will be assessed by measuring changes in MMSE scores over time. Descriptive statistical analysis will be conducted.
Time frame: Continuously following start of TTFields therapy (up to 12 months)
Population: Data not collected.
Secondary
Incidence of SCLC Brain Metastases
Time frame: Up to 180 days from Day 1 of the 4th cycle of chemotherapy (each cycle is 28 days)
Population: Data not collected.
Secondary
Incidence of SCLC Brain Metastases at 12 Months
Time frame: 12 months following start of TTFields therapy
Population: Data not collected.
Secondary
Incidence of TTfield Related Adverse Events
Time frame: Continuously following start of TTFields therapy (up to 12 months)
Population: Data not collected.
Secondary
Overall Survival
Overall survival of participants with SCLC after using TTFields therapy. The distribution of overall survival will be graphically described using Kaplan-Meier plot, for all subjects together, and for each disease group (extensive stage and limited stage).
Time frame: Death or last follow up following start of TTFields therapy, whichever comes first (assessed at 6, 12, 24, 36 and 60 months)
Population: Data not collected.