Non-small cell lung cancer Non-small cell lung cancer
Conditions
Interventions
Infliximab: The first course is administered over 14 days, and subsequent courses are administered over 28 days. On day 1 of each course, 5 mg/kg is administered by intravenous infusion.
Osimertinib:
Sponsors
Iwama Eiji
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients meeting all of the following criteria will be eligible for inclusion: 1) Histologically or cytologically confirmed non-squamous NSCLC. 2) Fulfills any of the following criteria: - Stage III or IV disease that is inoperable or ineligible for curative radiotherapy - Postoperative recurrence - Recurrence following curative radiotherapy 3) Positive for EGFR mutation (Ex19del or L858R). 4) Positive for TP53-gain-of-function (GOF) mutation. TP53-GOF mutations are defined as 10 mutations (R175H, G245S, R248Q, R248W, R249S, R273H, R273L, R273C, R282Q, R282W). 5) Radiological confirmation of disease progression in osimertinib treatment. Disease progression during post-operative adjuvant osimertinib treatment is allowed. 6) Have clinical benefit more than stable disease (SD) with 3 months or more in previous osimertinib treatment. In post-operative adjuvant osimertinib treatment, 6 months or more disease-free survival is required. 7) Have treatment history of at least 1 regimen of chemotherapy including platinum-doublet. 8) Patients for whom it has not been determined that they have undergone histological transformation to a non-squamous non-small cell lung cancer histology after developing resistance to osimertinib. 9) ECOG Performance Status of 0 or 1. 10) Survival with 12 weeks or more is expected. 11) Aged 18 years or older. 12) Has measurable lesions based on RECIST Guidelines Version 1.1. 13) Without CTCAEv5.0 grade 3 or higher superior vena cava syndrome, pericardial effusion, pleural effusion, and ascites. 14) The following periods of time have elapsed since the completion of prior treatment or procedures at the time of registration. a) Surgical treatment with general anesthesia: 2 weeks b) Biopsy with incision, treatment for trauma: 2 weeks c) Palliative radiation therapy for metastatic lesions: 2 weeks 15) Laboratory values within 14 days prior to enrollment must meet all the following criteria. 1. Neutrophil count 1500 per mm3 or higher 2. Hemoglobin 9.0 g/dL or more 3. Platelet count 100,000 per mm3 or higher 4. Total bilirubin less than or equal to 1.5 times the upper limit of normal (ULN) 5. AST (GOT) less than or equal to 2.5 times the upper limit of normal (ULN) 6. ALT (GPT) less than or equal to 2.5 times the upper limit of normal (ULN) 7. Serum creatinine less than or equal to 1.5 times the upper limit of normal (ULN) 16) Reports showing the results confirming TP53-GOF mutations are available. 17) Has provided written informed consent after receiving a full explanation of the study.
Exclusion criteria
Exclusion criteria: Patients meeting any of the following criteria will be excluded: 1) With infections requiring systemic treatment. 2) With active tuberculosis. If the interferon-gamma release assay (IGRA) result is positive, prophylactic administration of antituberculosis drugs must be administered for 3 weeks prior to enrollment in this clinical trial. 3) Whom administration of osimertinib 80 mg is not possible due to adverse events or other reasons. 4) With a history of immune checkpoint inhibitor administration within the past 3 months. 5) With demyelinating diseases (such as multiple sclerosis) or a history of such diseases. 6) With congestive heart failure (left ventricular ejection fraction of 35% or less or New York Heart Association [NYHA] classification class III or higher). 7) With a history of hypersensitivity to any component of infliximab. 8) With psychiatric disorders or psychiatric symptoms that make participation in the trial difficult. 9) With symptomatic brain metastases. 10)With carcinomatous meningitis. 11)With active concurrent cancer. 12) With uncontrolled hypertension or diabetes. 13) With positive HBs antigen. 14) With positive HBc antibody or HBs antibody. However, inclusion is permitted if HBV-DNA is less than 20 IU/mL. 15) HCV antibody is positive. However, inclusion is permitted if HCV-RNA is negative. 16) Has obvious interstitial pneumonia on chest CT. 17) Has a history of interstitial lung disease requiring steroid therapy (including drug-induced pneumonia). 18) Electrocardiogram showing a QT interval (QTcF) exceeding 470 msec (female) or 450 msec (male). 19) With ongoing severe toxicity from prior anticancer therapy. 20) Received treatment for systemic cancer, including investigational drugs, within 4 weeks prior to or within 5 half-lives (whichever is shorter) of the start of the investigational treatment. 21) Received other investigational drugs or investigational medical devices within 4 weeks prior to administration of the investigational drug. 22) Pregnant or breastfeeding women, and women of childbearing potential with a positive urine pregnancy test result within 14 days prior to enrollment. 23) Other cases deemed inappropriate for participation in this trial by the principal investigator or sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate as evaluated by independent central review | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival Overall Survival Duration of Response Safety | — |
Contacts
Public ContactEiko Ishida
Kyushu University Hospital
Outcome results
None listed