non-small cell lung cancer non-small cell lung cancer, NSCLC
Conditions
Interventions
Induction therapy with cisplatin (or carboplatin), pemetrexed, and osimertinib will be administered for four cycles, with each cycle given every 3 weeks. Thereafter, maintenance therapy with pemetrexe
Sponsors
Nakanishi Yoichi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age at obtaining consent must be at least 18 years old. 2) Patients diagnosed with non-squamous non-small cell lung cancer by histology or cytology. 3) Patients diagnosed with clinical stage IV or postoperative recurrence, for whom radical surgery or radiotherapy is not feasible. 4) Patients with symptomatic brain metastases on head MRI within 28 days prior to enrollment. 5) Patients with confirmed positive EGFR mutation (exon19 del or L858R) in tumor specimens. 6) No chemotherapy has been performed for the cancers in this study. Preoperative, postoperative adjuvant chemotherapy or radical radiotherapy or radiation chemotherapy is acceptable if the last administration (treatment) was at least 12 months prior to the date of enrollment in this study. However, EGFR-TKI included in preoperative, postoperative, or radiation chemotherapy is not acceptable. 7) ECOG performance status (PS) of 0 to 2. 8) Written consent is obtained from the patients themselves after a full explanation of the study is given prior to enrollment in the study.
Exclusion criteria
Exclusion criteria: 1) Patients with driver gene mutation other than EGFR gene mutation. 2) Patients who are using potent CYP3A4 inducers prior to initiation of protocol treatment and have difficulty discontinuing their use. 3) Patients with adverse events persisting at CTCAE Grade 2 or higher due to prior therapy. 4) Patients with severe or poorly controlled systemic diseases, metabolic diseases, or non-neoplastic organ diseases that may be medically high-risk conditions or life threatening. 5) Patients with active double cancers. 6) Patients with unstable angina, or who have developed cardiovascular or cerebrovascular disease, other arterial thromboembolism within 180 days prior to enrollment. 7) Patients with a history of interstitial lung disease or active interstitial lung disease. 8) Refractory nausea and vomiting, chronic gastrointestinal disease, inability to swallow oral medications, or a history of significant bowel resection that would interfere with the absorption of osimertinib. 9) Patients with hypersensitivity or contraindication to any component or additive of the protocol therapeutic agent. 10) Other patients who are deemed inappropriate for this study by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2y-PFS rate, 2year Progression-free survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS ORR iPFS, intracranial Progression-free survival iORR, intracranial Overall response rate iDCR, intracranial Disease control rate OS, Overall survival Quality of life safety | — |
Contacts
Public ContactHayato Kawachi
University Hospital Kyoto Prefectural University of Medicine
Outcome results
None listed