Advenced non-squamous, non-small cell lung cancer immediately after immune checkpoint inhibitors failure
Conditions
Interventions
Chemotherapy
Sponsors
Department of Respiratory Medicine, Faculty of Medical Sciences, University of Fukui
Japanese Red Cross Fukui Hospital, Municipal Tsuruga Hospital, Toyama Prefectural Central Hospital, and Toyama University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with advanced or recurrent non-small cell lung cancer excluding squamous cell carcinoma confirmed by histological or cytological diagnosis. 2) Patients within 12 weeks of completion of platinum-based chemotherapy plus ICI (PD-1,PD-L1, or CTLA-4 antibody) or its maintenance therapy, or ICI monotherapy, or ICI combination therapy (PD-(L)1 antibody + CTLA-4 antibody).Patients who experienced recurrence during durvalumab therapy following chemoradiotherapy for stage III non-small cell lung cancer, or during postoperative adjuvant therapy with a PD-(L)1 antibody, are also eligible. Reasons for discontinuation of prior therapy for progression, relapse, or adverse events are allowed. 3) Patient with evaluable lesion based on RECIST. 4) Age 18 or over. 5) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 6) No severe organ dysfunction and laboratory tests meet the following criteria. (a) White blood cell count greater than 3,000/mm3 (b) Neutrophil count greater than 1,500/mm3 (c) Hemoglobin greater than 9.0 g/dL (d) Platelet count greater than 100,000/mm3 (e) AST, ALT less than 100 IU/L (f) Total bilirubin less than 1.5 mg/dL (g) Creatinine less than 1.5 mg/dL (h) Urine protein: 1+ or less (i) PT-INR: 1.5 or less (j) PaO2 60 torr or higher or SpO2 90% or higher (room air) 7) Three months and more survival is expected. 8) Written informed consent.
Exclusion criteria
Exclusion criteria: 1) Allergy or hypersensitibity against the medicines in this trial or albumin. 2) Patients who previously treated with paclitaxel or nab-paclitaxel. 3) Peripheral neuropathy (grade 2 or more) before the treatment. 4) Uncontrolable pleural or pericardial effusion, or ascites. 5) Patients undergoing radiotherapy, or within 2 weeks after thoracic or brain radiotherapy completion and within 1 week after radiotherapy for bone metastasis. 6) Operation within 4 weeks. 7) Active double cancer. 8) High body temperature (38 degrees Celsius and more). 9) Severe complications including gastrointestinal bleeding, perforation of the gastrointestinal tract, fistulae, diverticulitis, intestinal paralysis, intestinal obstruction, superior vena cava syndrome, uncontrolled thromboembolism or hypertension, gastrointestinal ulcers, interstitial pneumonia or pulmonary fibrosis evident on chest X-ray, heart failure, hepatic failure, and renal failure. 10) Pregnant and breastfeeding woman. 11) HBs antigen positive. 12) Patients receiving systemic administration of more than 10 mg of prednisolone equivalent of corticosteroids at the time of enrollment. 13) Patients with untreated brain metastases or cerebral hemorrhage on CT or MRI within 2 months prior to enrollment. 14) Patients with hemoptysis (2.5 mL or more of fresh blood) within 2 months prior to enrollment. 15) Patients with major blood vessels tumor invasion or intratumour cavitation, or tumor exposure into the lumen of the central airway above the regional bronchus on CT. 16) The subjects whom the doctor excluded. 17) Patients taking anticoagulants (warfarin, dabigatran, edoxaban, rivaroxaban, apixaban) or antiplatelet agents (aspirin, clopidogrel, prasugrel, ticlopidine, cilostazol).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS), disease control rate (DCR), overall survival (OS), and saftey. Subset analysis of efficacy (ORR, DCR, PFS, and OS) stratified by presense of driver mutations (EGFR, ALK, ROS1, BRAF V600E, KRAS G12C, HER2, METex14skipping, NTRK), smoking history,degree of tumor PD-L1 expression, tumor TTF-1 expression, and tumor response and duration of response of previous treatment. | — |
Countries
Japan
Contacts
Public ContactYukihiro Umeda
Faculty of Medical Sciences, University of Fukui Department of Respiratory Medicine
Outcome results
None listed