Non-small cell lung cancer
Conditions
Interventions
Arm A: Osimertinib maintenance therapy
* Osimertinib is administered orally at a dose of 80 mg once daily on a continuous basis. Treatment is continued until disease progression.
Arm B: Durvalumab con
Sponsors
KENMOTSU Hirotsugu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Histologically or cytologically proven non-small cell lung cancer (NSCLC). (2) Presence of activating EGFR mutations, defined as an exon 19 deletion or an exon 21 L858R point mutation. (3) Not judged as progressive disease (PD) according to the RECIST criteria, based on comparison between pre-chemoradiotherapy (CRT) contrast-enhanced chest and abdominal CT and post-CRT imaging. In addition, no evidence of brain metastases on post-CRT contrast-enhanced brain MRI or CT. (4) Unresectable locally advanced NSCLC, treated with definitive concurrent CRT, that met all of the following criteria (a)-(c). Patients with postoperative recurrence are not eligible. (a) Diagnosed as clinical stage IIB with N2a disease or clinical stage III before concurrent CRT (UICC-TNM 9th edition). (b) Concurrent CRT must meet all of the following criteria (i)-(iii). (i) Chemotherapy, satisfying one of the following: *At least one cycle of platinum-based chemotherapy regimen with a planned course length of 3 or 4 weeks. *At least three cycles of platinum-based chemotherapy regimen with a planned course length of 1 week. *Low-dose carboplatin administered >=10 times. (ii) RT: a total dose of 60 Gy +-10% (range, 54-66 Gy) with lung V20 = 1,000 /mm3 (ii) Hemoglobin >= 8.0 g/dL (iii) Platelet count >= 75,000 /mm3 (iv) T-bil = 92% (14) Written informed consent.
Exclusion criteria
Exclusion criteria: (1) Simultaneous or metachronous (within five years) double cancers, with the exception of intramucosal tumor curable with local therapy. (2) Active infection requiring systemic therapy. (3) Fever over 38 degrees Celsius. (4) Female during pregnancy, within 28 days of post parturition, or during lactation. (5) Psychological disorder difficult to participate in this clinical study. (6) Receiving continuous systemic corticosteroid or immunosuppressant treatment. (7) Uncontrolled diabetes mellitus. (8) History of unstable angina pectoris within three weeks or myocardial infarction within 6 months before the enrollment. (9) Uncontrolled heart valve disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy. (10) Positive for HIV antibody. (11) Interstitial pneumonia and/or pulmonary fibrosis diagnosed on chest CT before initiation of concurrent CRT.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Restricted mean survival time for overall survival, progression-free survival, intracranial progression-free survival, frequency of adverse events, frequency of serious adverse events | — |
Contacts
Public ContactHirotsugu KENMOTSU
Shizuoka Cancer Center
Outcome results
None listed