Non-small Cell Lung Cancer (NSCLC)Phase 2/3NCT05661240
Phase Ⅱ/Ⅲ Clinical Study of Tumor Treating Fields （EFE-P100）Combined With Docetaxel in the Treatment of Stage IV Non-small Cell Lung Cancer Patients With Disease Progression After Platinum-based Chemotherapy and Anti-programmed Death 1（PD-1)/Programmed Cell Death-Ligand 1(PD-L1) Antibody Treatment
A Phase 2/3 study testing Tumor treating fields（EFE-P100） and Docetaxel injection in people with Non-small Cell Lung Cancer (NSCLC), run by Jiangsu Healthy Life Innovation Medical Technology Co., Ltd at 1 site in China.
Trial summary
The tumor treating fields（EFE-P100）generates alternating electric field during operation, and the tumor treating fields（EFE-P100）has a specific frequency and a specific field intensity. The tumor treating fields（EFE-P100）patch acts on the corresponding part of the patient and prevents the mitosis of tumor cells. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-small Cell Lung Cancer (NSCLC)
- What is being tested?
- Tumor treating fields（EFE-P100） and Docetaxel injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 348 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2022to 31 Jul 2025
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 and ≤80, both sexes;
- Expected survival time ≥3 months;
- Non-small cell lung cancer was confirmed histologically or cytologically and classified as stage IV NSCLC according to the American Joint Committee on Cancer（AJCC）of eighth edition.
- Imaging progression (according to RECIST V1.1 criteria) or clinical progression during previous anti-PD - (L) 1 antibody and platinum-containing therapy or after treatment; - Neoadjuvant or adjuvant therapy, such as disease recurrence or progression ≤6 months after the end of treatment, counted as first-line treatment; - Prior treatment with at least 2 cycles of anti-PD - (L) 1 antibody, allowed as a single agent or in combination with platinum-based chemotherapy.
- At least one measurable or evaluable lesion according to RECIST version 1.1;
- ECOG 0-1;
- Concomitant Adverse Event（AE） after previous treatment should return to normal level or Common Terminology Criteria for Adverse Events（CTCAE） grade 1;
- Voluntarily sign informed consent.
Who cannot join
- Epidermal growth factor receptor（EGFR）-activating mutations or Anaplastic Lymphoma Kinase（ALK） fusion gene was positive; However, if squamous non-small cell lung cancer has not been tested before, it can no longer be tested and allowed to be enrolled.
- Untreated brain metastases, or with meningeal metastases, spinal cord compression, etc. Patients who had received previous treatment for brain metastases and were asymptomatic if they had been stable for at least 4 weeks on imaging before randomization and had stopped systemic hormone therapy (dose >10mg/ day prednisone or other equivalent hormone) for more than 2 weeks were eligible.
- Severe bone injury due to bone metastases, including severe bone pain that is poorly controlled, pathologic fractures of major sites that have occurred within the last 6 months or are expected to occur in the near future.
- Previous docetaxel therapy or docetaxel-containing combination therapy;
- There are contraindications to docetaxel treatment or a known severe allergy to docetaxel;
- A history of diagnosis of a tumor other than small-cell lung cancer and antitumor therapy within 5 years prior to enrollment, excluding treated stage I prostate cancer, cervical or uterine cancer in situ, breast cancer in situ, and non-melanoma skin cancer;
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- Abnormal bone marrow, heart, liver and kidney function: A. Neutrophil count <1.5×109/L, platelet count <100×109/L, hemoglobin <90 g/L; TBiL> upper normal value (ULN); AST and/or ALT>2.5×ULN; ALP>2.5×ULN (>5×ULN if bone metastases are present); C. Serum creatinine >1.5×ULN; Creatinine clearance rate <50 mL/min;
- A history of severe cardiovascular disease, including second/third degree heart block; Severe ischemic heart disease; Poor control of hypertension; New York Heart Association (NYHA) class II or worse congestive heart failure (mild physical activity limitation; Comfortable at rest, but normal activities can cause fatigue, palpitations, or difficulty breathing);
- Patients who required systemic corticosteroid (other corticosteroid at a dose of more than 10mg prednisone per day or an equivalent physiologic dose) or other immunosuppressive agents within 14 days prior to enrollment or during the study period were eligible for enrollment if: A. The use of topical or inhaled glucocorticoids is permitted; B. Allow short-term (≤7 days) use of glucocorticoids for the prevention or treatment of non-autoimmune allergic diseases;
- If she had severe infection before the first treatment, the investigator judged that she was not suitable to participate in this study.
- A history of human immunodeficiency virus (HIV) infection (known HIV1/2 antibody positive);
- The presence of active hepatitis B, active hepatitis C, or other active infections that the investigator determines may affect the patient's treatment;
- There is a definite history of neurological or psychiatric disorders (e.g., epilepsy, dementia) or drug use or alcohol abuse within the last year that may affect trial compliance;
- Symptomatic ascites, pleural effusion, pericardial effusion, etc., except those who are stable after clinical treatment (including therapeutic puncture);
- Infection, ulceration and unhealed wound on the skin where the electrode is applied;
- Currently participating in other antitumor therapy clinical trials;
- Implantable electronic medical devices, such as pacemakers;
- Chest and abdomen have implanted metal materials of medical instruments, such as bone nails;
- Allergic to conductive hydrogels or medical adhesives;
- Pregnant or trying to become pregnant or breastfeeding;
- Poor compliance or other factors as judged by the investigator were not appropriate for the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase Ⅱ/Ⅲ Clinical Study of Tumor Treating Fields（EFE-P100） Combined With Docetaxel in the Treatment of Stage IV Non-small Cell Lung Cancer Patients With Disease Progression After Platinum-based Chemotherapy and Anti-programmed Death 1(PD-1)/Programmed Cell Death-Ligand 1(PD-L1) Antibody Treatment
The tumor treating fields（EFE-P100）generates alternating electric field during operation, and the tumor treating fields（EFE-P100）has a specific frequency and a specific field intensity. The tumor treating fields（EFE-P100）patch acts on the corresponding part of the patient and prevents the mitosis of tumor cells. This study was divided into two phases including phase II and phase III clinical trials. The main purpose of phase II clinical trial is to evaluate the safety of tumor treating fields（EFE-P100） combined with docetaxel injection in the second-line treatment of stage IV non-small Cell Lung Cancer (NSCLC) patients who failed after platinum-containing chemotherapy and anti-programmed Death 1（PD-1)/Programmed Cell Death-Ligand 1(PD-L1) antibody treatment. The main purpose of phase III clinical trial is to compare the efficacy of tumor treating fields（EFE-P100） combined with docetaxel injection and docetaxel injection alone in the second-line treatment of stage IV non-small cell lung cancer (NSCLC) patients who failed after platinum-containing chemotherapy and anti-programmed Death 1（PD-1)/Programmed Cell Death-Ligand 1(PD-L1) antibody treatment.
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Being tested
- Tumor treating fields（EFE-P100）, Docetaxel injection
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor treating fields（EFE-P100）Device
Device: Tumor treating fields（EFE-P100） Subjects will use EFE-P100 until disease progression or for a maximum of 24 months.
Docetaxel injectionDrug
Drug: Docetaxel injection Subjects will receive Docetaxel injection until disease progression or for a maximum of 24 months.
| Study group | Role | What they receive |
|---|---|---|
| Tumor treating fields combined with docetaxel injection | Experimental | Medical device：Tumor treating fields（EFE-P100） Tumor treating fields（EFE-P100）will be used each day. Drug: docetaxel each cycle is 21 days，docetaxel will be administered intravenously，75 mg/m2 on the first day of each cycle. Receives: Device: Tumor treating fields（EFE-P100）; Drug: Docetaxel injection |
| docetaxel injection | Active comparator | Drug: docetaxel each cycle is 21 days，docetaxel will be administered intravenously，75 mg/m2 on the first day of each cycle. Receives: Drug: Docetaxel injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Progression-free survival is defined as the time from the start of treatment with Tumor Treating Fields（EFE-P100） and Docetaxel until the first documentation of disease progression or death due to any cause, whichever occurs first
Measured: Up to 2 years
Secondary outcomes (5)
Number of participants with adverse events (AEs)
Will be defined as the incidence, frequency and severity of adverse events (AEs) noted in patients treated with study treatments
Measured: The whole study period，an average of 2 year
Objective response rate (ORR)
ORR is defined as the proportion of subjects with confirmed CR or PR, based on RECIST v1.1.
Measured: Up to 2 years
Overall survival (OS)
From date of enrollment until the date of death from any cause
Measured: up to 12 months after the last study treatment
12-month OS rate
12-month Overall survival rate
Measured: 12 months
Progression Free Survival rate at 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start20 Dec 2022 (estimated)
- Primary completion25 May 2024 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 348 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Healthy Life Innovation Medical Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhou, Principal investigator, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05661240
- Sponsor's protocol ID
- P100-NSCLC2
- Status last verified
- Dec 2022
- First submitted
- 7 Dec 2022
- Last updated
- 22 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ⅱ/Ⅲ Clinical Study of Tumor Treating Fields（EFE-P100） Combined With Docetaxel in the Treatment of Stage IV Non-small Cell Lung Cancer Patients With Disease Progression After Platinum-based Chemotherapy and Anti-programmed Death 1(PD-1)/Programmed Cell Death-Ligand 1(PD-L1) Antibody Treatment
- ClinicalTrials.gov ID
- NCT05661240
- Acronym / sponsor ID
- P100-NSCLC2
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 348 participants (estimated)
- Lead sponsor
- Jiangsu Healthy Life Innovation Medical Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2022 (estimated)
- Primary completion
- 25 May 2024 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 22 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The tumor treating fields（EFE-P100）generates alternating electric field during operation, and the tumor treating fields（EFE-P100）has a specific frequency and a specific field intensity. The tumor treating fields（EFE-P100）patch acts on the corresponding part of the patient and prevents the mitosis of tumor cells. This study was divided into two phases including phase II and phase III clinical trials. The main purpose of phase II clinical trial is to evaluate the safety of tumor treating fields（EFE-P100） combined with docetaxel injection in the second-line treatment of stage IV non-small Cell Lung Cancer (NSCLC) patients who failed after platinum-containing chemotherapy and anti-programmed Death 1（PD-1)/Programmed Cell Death-Ligand 1(PD-L1) antibody treatment. The main purpose of phase III clinical trial is to compare the efficacy of tumor treating fields（EFE-P100） combined with docetaxel injection and docetaxel injection alone in the second-line treatment of stage IV non-small cell lung cancer (NSCLC) patients who failed after platinum-containing chemotherapy and anti-programmed Death 1（PD-1)/Programmed Cell Death-Ligand 1(PD-L1) antibody treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tumor treating fields combined with docetaxel injection | Experimental | Device: Tumor treating fields（EFE-P100）, Drug: Docetaxel injectionMedical device：Tumor treating fields（EFE-P100） Tumor treating fields（EFE-P100）will be used each day. Drug: docetaxel each cycle is 21 days，docetaxel will be administered intravenously，75 mg/m2 on the first day of each cycle. |
| docetaxel injection | Active comparator | Drug: Docetaxel injectionDrug: docetaxel each cycle is 21 days，docetaxel will be administered intravenously，75 mg/m2 on the first day of each cycle. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 and ≤80, both sexes;
- Expected survival time ≥3 months;
- Non-small cell lung cancer was confirmed histologically or cytologically and classified as stage IV NSCLC according to the American Joint Committee on Cancer（AJCC）of eighth edition.
- Imaging progression (according to RECIST V1.1 criteria) or clinical progression during previous anti-PD - (L) 1 antibody and platinum-containing therapy or after treatment; - Neoadjuvant or adjuvant therapy, such as disease recurrence or progression ≤6 months after the end of treatment, counted as first-line treatment; - Prior treatment with at least 2 cycles of anti-PD - (L) 1 antibody, allowed as a single agent or in combination with platinum-based chemotherapy.
- At least one measurable or evaluable lesion according to RECIST version 1.1;
Key exclusion criteria (21 listed)
- Epidermal growth factor receptor（EGFR）-activating mutations or Anaplastic Lymphoma Kinase（ALK） fusion gene was positive; However, if squamous non-small cell lung cancer has not been tested before, it can no longer be tested and allowed to be enrolled.
- Untreated brain metastases, or with meningeal metastases, spinal cord compression, etc. Patients who had received previous treatment for brain metastases and were asymptomatic if they had been stable for at least 4 weeks on imaging before randomization and had stopped systemic hormone therapy (dose >10mg/ day prednisone or other equivalent hormone) for more than 2 weeks were eligible.
- Severe bone injury due to bone metastases, including severe bone pain that is poorly controlled, pathologic fractures of major sites that have occurred within the last 6 months or are expected to occur in the near future.
- Previous docetaxel therapy or docetaxel-containing combination therapy;
- There are contraindications to docetaxel treatment or a known severe allergy to docetaxel;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tumor treating fields（EFE-P100）Device: Tumor treating fields（EFE-P100） Subjects will use EFE-P100 until disease progression or for a maximum of 24 months. | Device | Tumor treating fields combined with docetaxel injection |
| Docetaxel injectionDrug: Docetaxel injection Subjects will receive Docetaxel injection until disease progression or for a maximum of 24 months. | Drug | Tumor treating fields combined with docetaxel injection, docetaxel injection |
Primary outcome
Progression-free survival (PFS)
Time frame: Up to 2 years
Progression-free survival is defined as the time from the start of treatment with Tumor Treating Fields（EFE-P100） and Docetaxel until the first documentation of disease progression or death due to any cause, whichever occurs first
5 secondary outcomes
Number of participants with adverse events (AEs)
Time frame: The whole study period，an average of 2 year
Objective response rate (ORR)
Time frame: Up to 2 years
Overall survival (OS)
Time frame: up to 12 months after the last study treatment
12-month OS rate
Time frame: 12 months
Progression Free Survival rate at 6 months
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhou principal investigator
MD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Tumor treating fields（EFE-P100） and Docetaxel injection in people with Non-small Cell Lung Cancer (NSCLC), run by Jiangsu Healthy Life Innovation Medical Technology Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhou (02165115006, caicunzhou@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2022.