Non-Small Cell Lung Cancer
Conditions
Interventions
Oshimertinib 80mg/day with cisplatin 75mg/m2 or carboplatin AUC 5 plus pemetrexed 500mg/m2 every3week are administred up to 4cycles,followed by osimertinib 80mg/day and pemetrexed 500mg/m2 every 3week
Sponsors
Asahina Hajime
Nonprofit Organization, North East Japan Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Non-squamous cell NSCLC confirmed using histology or cytology. (2) Cases of clinical stage IIIB, IIIC, IVA, or IVB* or postoperative recurrence in which surgery and radical irradiation are impossible. *General rules for clinical and pathological records of lung cancer (January 2017 [8th edition]) Edited by The Japan Lung Cancer Society (3) Patients harboring uncommon EGFR mutation (other than exon 19 deletion/exon 21 L858R mutation/exon 20 insertion. Patients with compound mutations may be enrolled if one or more uncommon mutations are present. * EGFR mutation should diagnosed using test methods that are covered by insurance in Japan. * Sensitive uncommon mutation is defined as a mutation in the exon 18-21 part of the EGFR kinase domain, excluding exon 19 deletion and exon 21 L858R. (4) Patients with measurable lesions based on RECIST version 1.1. (5) Patients without a history of chemotherapy using cytotoxic anticancer drugs, drugs with EGFR-inhibiting effects, and immune checkpoint inhibitors for NSCLC. *Preoperative and postoperative adjuvant chemotherapy, except for drugs with EGFR-inhibiting effects, will be accepted if 6 months have passed since the last administration. *Pleurodesis will be accepted. (6) Patients aged >= 20 years at the time of informed consent. (7) Patients with an Eastern Cooperative Oncology Group performance status (PS) of 0-1. (8) Patients who meet the following criteria for major organ function within 14 days before registration (The same day of the week, that is, 2 weeks before the day of registration, is acceptable. If more than one examination result exists within the applicable period, the result closest to the day of registration will be adopted. Blood transfusion and administration of hematopoietic factor preparations will not be conducted 14 days before the day of examination.): 1) Absolute neutrophil count >= 1.5 x109/L 2) Hemoglobin: >= 9.0 g/dL 3) Platelet count: >= 100 x 109/L 4) Aspartate aminotransferase (AST): 50 ml/min (measured or calculated by Cockcroft and Gault equation); confirmation of creatinine clearance is only required when creatinine is >1.5 times ULN. 8)SpO2: >= 95% 9) Left ventricular ejection fraction: >=55% (9) Patients who have received a thorough explanation of the contents of the study and have provided written informed consent.
Exclusion criteria
Exclusion criteria: (1) Any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment, with the exception of alopecia and grade 2 neuropathy due to perioperative chemotherapy. (2) Patients with a history of interstitial lung disease (ILD), drug-induced ILD, or radiation pneumonitis requiring steroid therapy or patients with active ILD. (3) Patients with clinically unstable brain metastases or spinal cord compression. (However, patients will be eligible if they are not on steroids and have a stable neurological status for at least 2 weeks after the completion of definitive therapy and steroids.) (4) Patients who have received radiation for the primary lesion and the lesion for evaluation. *Patients who received radiation for metastatic lesions in the brain or bone not 20 IU/mL. or Positive for HBsAg, but have had transaminases levels below ULN and HBV DNA levels 6 months. In addition, patients must be receiving anti-viral prophylaxis for 2-4 weeks prior to study treatment. Patients with HIV are only eligible for inclusion if they meet all the following criteria: -Demonstrated absence of HBV/ HCV co-infection -Undetectable viral RNA load for 6 months -CD4+ count of >350 cells/micro L -No history of AIDS-defining opportunistic infection within the past 12 months -Stable for at least 4 weeks on the same anti-HIV medications (8) Men without the intention to use contraception measures, pregnant women, lactating women,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety, Progression-Free Survival, Overall Survival, PFS and OS in patients with/without central nervous system metastases at the start of treatment, and PFS, OS, ORR according to mutation type (single mutation or compound mutation) | — |
Contacts
Public ContactHajime Asahina
Hokkaido Cancer Center
Outcome results
None listed