Untreated advanced non-small cell lung cancer with EGFR-mutattion(exon 19 deletion or exon 21 L858R)
Conditions
Interventions
Preventive dermatologic intervention
- Standard skin care (cleansing, moisturizing, protection)
- Oral minocycline hydrochloride or doxycycline hydrochloride 100 - 200 mg/day for 12 weeks (continuat
Sponsors
Yamamoto Nobuyuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged at least 18 years at the time of informed consent. 2. Written informed consent obtained from the patient prior to enrollment, after a thorough explanation of the study. 3. Histologically or cytologically diagnosed non-small cell lung cancer (NSCLC). 4. Clinical stage IVA or IVB, or postoperative recurrence. 5. Presence of at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Lesions previously treated with radiotherapy are not considered measurable. 6. Confirmed EGFR sensitizing mutations (exon 19 deletion or exon 21 L858R) in tumor tissue or cytology samples, tested with any method approved in Japan. 7. No prior systemic therapy for NSCLC at the time of enrollment. 8. Sufficient washout period from prior therapies or procedures before enrollment: a. Thoracic surgery: >= 4 weeks b. Palliative radiotherapy: >= 2 weeks c. Blood transfusion or administration of hematopoietic growth factors: >= 2 weeks 9. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1. 10. Adequate organ function.
Exclusion criteria
Exclusion criteria: 1. Presence of active double cancer. 2. Presence of uncontrolled malignant pleural effusion, pericardial effusion, or ascites. 3. Presence of symptomatic brain metastases. 4. Presence or history of active leptomeningeal disease. 5. Presence of untreated spinal cord compression. 6. Presence of Uncontrolled tumor-related pain. 7. Presence of local or active systemic infection requiring treatmen. 8. Patients with positive hepatitis B surface antigen (HBsAg) or positive hepatitis C antibody. 9. Male patients unwilling to use contraception, or female patients who are pregnant, breastfeeding, positive for pregnancy test, or unwilling to use contraception. 10. Patients considered unable to participate due to psychiatric disorders. 11. History of interstitial lung disease (ILD), drug-induced ILD, idiopathic pulmonary fibrosis, or radiation pneumonitis requiring steroids, or presence of current active ILD. 12. Patients with uncontrolled nausea/vomiting, chronic gastrointestinal disorders, difficulty in swallowing, history of total gastrectomy, or major intestinal resection that may interfer with adequate absorption of lazertinib or doxycycline/minocycline. 13. Patients with heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or family history of unexplained sudden death in a first- degree relative aged less than 40, or receiving concomitant medications known to prolong QT interval or induce torsade de pointes. 14. Patients with severe or uncontrolled systemic diseases including uncontrolled hypertension or active bleeding diathesis. 15. History of uncontrolled comorbidities. 16. History of clinically significant cardiovascular disease, including but not limited to: - Venous thromboembolism (VTE) diagnosed within 3 months prior to first dose - Hereditary predisposition to VTE - VTE detected at screening 17. History of major surgery (except for vascular access placement or tumor biopsy) within 4 weeks prior to enrollment, recent significant traumatic injury, incomplete recovery from surgery, or planned major surgery during the study. 18. History of hypersensitivity to amivantamab, lazertinib, minocycline, doxycycline, any excipients, or drugs with similar chemical structures or classes. 19. History of hypersensitivity to direct oral anticoagulants (DOACs). 20. Presence of liver disease with coagulopathy. 21. Presence of active bleeding or conditions at high risk of bleeding. 22. History of grade >= 3 bleeding within 3 months prior to enrollment. 23. Current use of aspirin >= 100 mg/day or >= 2 antiplatelet agents. 24. Patients considered inappropriate for prophylactic anticoagulation by the investigator. 25. Any patient deemed inappropriate by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with grade >= 2 dermatologic adverse events of interest (DAEIs) within 12 weeks from initiation of amivantamab plus lazertinib | — |
Secondary
| Measure | Time frame |
|---|---|
| - Proportion of patients with DAEIs within 12 weeks from initiation of amivantamab plus lazertinib. - Time to onset of grade >= 2 DAEIs within 12 weeks from initiation of amivantamab plus lazertinib. - Incidence of dose reduction, interruption, or discontinuation of amivantamab and/or lazertinib due to DAEIs during the study treatment period. - Objective response rate (ORR) per RECIST v1.1 (investigator assessment). - Duration of response (DoR) per RECIST v1.1. - Progression-free survival (PFS) rate at prespecified time points. | — |
Contacts
Public ContactKoji Takeda
West Japan Oncology Group
Outcome results
None listed