Last updated: December 21, 2022
Sponsor: Jiangsu Healthy Life Innovation Medical Technology Co., Ltd
Overall Status: Active - Not Recruiting
Phase
2/3
Condition
N/ATreatment
N/AClinical Study ID
NCT05661240
P100-NSCLC2
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age ≥18 and ≤80, both sexes;
- Expected survival time ≥3 months;
- Non-small cell lung cancer was confirmed histologically or cytologically andclassified as stage IV NSCLC according to the American Joint Committee onCancer(AJCC)of eighth edition.
- Imaging progression (according to RECIST V1.1 criteria) or clinical progression duringprevious anti-PD - (L) 1 antibody and platinum-containing therapy or after treatment;
- Neoadjuvant or adjuvant therapy, such as disease recurrence or progression ≤6 monthsafter the end of treatment, counted as first-line treatment; - Prior treatment with atleast 2 cycles of anti-PD - (L) 1 antibody, allowed as a single agent or incombination 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 levelor Common Terminology Criteria for Adverse Events(CTCAE) grade 1;
- Voluntarily sign informed consent.
Exclusion
Exclusion Criteria:
- Epidermal growth factor receptor(EGFR)-activating mutations or Anaplastic LymphomaKinase(ALK) fusion gene was positive; However, if squamous non-small cell lung cancerhas 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 wereasymptomatic if they had been stable for at least 4 weeks on imaging beforerandomization and had stopped systemic hormone therapy (dose >10mg/ day prednisone orother equivalent hormone) for more than 2 weeks were eligible.
- Severe bone injury due to bone metastases, including severe bone pain that is poorlycontrolled, pathologic fractures of major sites that have occurred within the last 6months 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 todocetaxel;
- A history of diagnosis of a tumor other than small-cell lung cancer and antitumortherapy 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 skincancer;
- 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 HeartAssociation (NYHA) class II or worse congestive heart failure (mild physical activitylimitation; Comfortable at rest, but normal activities can cause fatigue,palpitations, or difficulty breathing);
- Patients who required systemic corticosteroid (other corticosteroid at a dose of morethan 10mg prednisone per day or an equivalent physiologic dose) or otherimmunosuppressive agents within 14 days prior to enrollment or during the study periodwere eligible for enrollment if: A. The use of topical or inhaled glucocorticoids ispermitted; B. Allow short-term (≤7 days) use of glucocorticoids for the prevention ortreatment of non-autoimmune allergic diseases;
- If she had severe infection before the first treatment, the investigator judged thatshe was not suitable to participate in this study.
- A history of human immunodeficiency virus (HIV) infection (known HIV1/2 antibodypositive);
- The presence of active hepatitis B, active hepatitis C, or other active infectionsthat 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 trialcompliance;
- Symptomatic ascites, pleural effusion, pericardial effusion, etc., except those whoare 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 bonenails;
- 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 appropriatefor the study.
Study Design
Total Participants: 348
Study Start date:
December 20, 2022
Estimated Completion Date:
July 31, 2025
Connect with a study center
Shanghai Pulmonary Hospital
Shanghai,
ChinaSite Not Available
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