non-small-cell lung cancer
Conditions
Interventions
Single Arm Group(phase II):TTFields combine with docetaxel injection
Experimental Group (Phase III):TTFields combine with docetaxel injection
Control Group (phase III):Docetaxel injection
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 and = 3 months; 3. Non-small cell lung cancer was confirmed histologically or cytologically and classified as stage IV NSCLC according to the AJCC of eighth edition. 4. 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. 5. At least one measurable or evaluable lesion according to RECIST version 1.1; 6. ECOG 0-1; 7. Concomitant AE after previous treatment should return to normal level or CTCAE grade 1; 8. Voluntarily sign informed consent.
Exclusion criteria
Exclusion criteria: 1. EGFR-activating mutations or 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. 2. 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. 3. 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. 4. Previous docetaxel therapy or docetaxel-containing combination therapy; 5. There are contraindications to docetaxel treatment or a known severe allergy to docetaxel; 6. 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; 7. Abnormal bone marrow, heart, liver and kidney function: A. Neutrophil count 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; 8. 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); 9. 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; 10. If she had severe infection before the first treatment, the investigator judged that she was not suitable to participate in this study. 11. A history of human immunodeficiency virus (HIV) infection (known HIV1/2 antibody positive); 12. The presence of active hepatitis B, active hepatitis C, or other active infections that the investigator determines may affect the patient's treatment; 13. 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; 14. Symptomatic ascites, pleural effusion, pericardial effusion, etc., except those who are stable after clinical treatment (including therapeutic puncture); 15. Infection, ulceration and unhealed wound on the skin where the electrode is applied; 16. Currently participating in other antitumor therapy clinical trials; 17. Implantable electronic medical devices, such as pacemakers; 18. Chest and abdomen have implanted metal materials of medical instruments, such as bone nails; 19. Allergic to conductive hy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| adverse event;serious adverse event;Tumor Treating Fields Adverse Events;Objective Response Rate;Overall Survival;Progress Free Survival;Duration of Response;Instrument performance of Tumor Treating Fields; | — |
Countries
China
Contacts
Public ContactZhou Caicun
Shanghai Pulmonary Hospital
Outcome results
None listed