EGFR-mutant non-small cell lung cancer
Conditions
Interventions
Amivantamab and lazertinib will be administered in 4-week (28days) cycles until tumor progression. (For details, see "7. Treatment Plan and Treatment Change Criteria.")
Amivantamab and lazertinib will
Sponsors
Nakanishi Yoichi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria are eligible. 1Patients aged 18 years or older at the time of obtaining informed consent 2ECOG Performance Status (PS) of 0 to 1 3Non-small cell lung cancer (NSCLC) confirmed by tissue or cytology diagnosis. 4 EGFR gene mutations in tissue or cytology samples are characterized by either an exon 19 deletion or an exon 21 L858R point mutation*. *Compound mutations are acceptable. 5Patients diagnosed with unresectable stage III or IV disease, either progressive or post-recurrence, based on comprehensive imaging-including contrast-enhanced CT of the chest and abdomen (including pelvis), FDG-PET (or PET/CT), and contrast-enhanced brain imaging via CT (or MRI)# within 28 days prior to registration. #Contrast imaging must be performed; cases without contrast are not allowed. 6Patients confirmed to have no VTE (PE and/or DVT) by contrast-enhanced CT or lower limb venous ultrasound within 28 days prior to registration ##. Note: The imaging must include at least up to the popliteal fossa. ## Lower extremity venous ultrasound is not required if contrast-enhanced CT confirms the absence of DVT. 7No systemic chemotherapy has been administered. However, patients who have received postoperative adjuvant therapy following curative surgery or who have experienced recurrence after chemoradiotherapy are eligible if more than 24 weeks (168 days) have elapsed since the last dose of chemotherapy or the last day of thoracic radiation therapy. (Exclude patients with a history of Osimertinib treatment.) 8No brain metastases requiring emergency radiation therapy or surgery. However, patients may be enrolled if they meet the following criteria: - Asymptomatic (regardless of whether they have received treatment) - Symptomatic patients who have already received treatment for cranial and nervous system metastases and are neurologically stable (stable for at least two weeks prior to enrollment with steroid therapy, anticonvulsants, etc.) 9No severe damage to major organs (bone marrow, heart, lungs, liver, etc.) and meet the following criteria: (The most recent data within 14 days of the registration date will be used for registration. The registration date is used as the reference date, and data from the same day 14 days prior is acceptable.) - Neutrophil count: >- 1,500 /mm3 - Hemoglobin:>- 9.0 g/dL - Platelet count:>- 75,000 /mm3 - AST, ALT: 45 mL/min (Cockcroft-Gault method* or actual measurement) *Cockcroft-Gault formula Men: Ccr = {(140 - age) x weight (kg)} / {72 x serum creatinine (mg/dL)} Women: Ccr = 0.85 x {(140 - age) x weight (kg)} / {72 x serum creatinine (mg/dL)} - Total bilirubin: = 90% or PaO2: >= 60 torr 10The details of the study have been fully explained to patients prior to enrollment, and written consent to participate in the study has been obtained.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria are excluded. 0.Patients have been diagnosed with VTE (DVT and/or PE) within one month prior to enrollment. 1.Patients have active multiple cancers (synchronous multiple cancers requiring treatment and metachronous multiple cancers with a disease-free interval of less than one year). However, lesions equivalent to intraepithelial carcinoma/intramucosal carcinoma that are considered curable with local treatment, even if the disease-free interval is less than one year, are not considered active multiple cancers. 2.Received a live attenuated vaccine within 30 days prior to enrollment. 3.Diagnosed with carcinomatous meningitis. 4.History of hypersensitivity to protocol treatment. 5.Active local or systemic infection requiring surgical treatment such as drainage. 6.Pericardial effusion requires treatment. 7.Post-allogeneic hematopoietic stem cell transplantation. 8.Active hepatitis B, active hepatitis C, or active pulmonary tuberculosis. (Even if HBs antibody or HBs antigen is positive, if the viral load is below the sensitivity level and there is no active hepatitis, the patient is eligible. Even if HCV antibody is positive, the patient is eligible if there is no active hepatitis. In addition, if an HIV test is performed according to the facility regulations and the result is positive, the patient is ineligible.) 9.Patients with interstitial lung disease as determined by chest CT scans. (a history of radiation pneumonitis or its organization within the radiation field is acceptable.) 10.Patients with the following serious complications: - Patients with frequent transient ischemic attacks - Patients with symptomatic congestive heart failure, unstable angina, or a history of myocardial infarction within 6 months prior to enrollment - Patients with clinically significant arrhythmias on electrocardiogram (complete left bundle branch block, third-degree atrioventricular block, or second-degree atrioventricular block) - Patients with gastrointestinal perforation or fistula, or a history of such within the past year - Patients with uncontrolled diabetes - Patients with uncontrolled infections - Patients with uncontrolled peptic ulcers 11.At the time of registration, the following prior treatments or procedures must not have been completed within 4 weeks. - Surgery*: 4 weeks - Palliative radiation therapy: 2 weeks - Thoracic drainage therapy: 1 week *Local surgery for isolated lesions for palliative purposes is permitted. 12.Patients are diagnosed with a psychiatric disorder that makes them ineligible to participate in this study. 13.Pregnant women, nursing women, women who may be pregnant, and men and women who are not willing to use contraception during treatment and for 30 days after the final dose. 14.Participating in other clinical trials. 15.Patients who are judged by the physician to be ineligible to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The cumulative incidence of VTE at 12 months after initiation of protocol therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| The cumulative incidence of Grade 3 or higher VTE, the cumulative incidence VTE in 4 months after protocol treatment initiation, cumulative incidence of VTE during the entire observation period, Rate of treatment interruption or discontinuation due to VTE, safety | — |
Contacts
Public ContactKen Masuda
Kurume University Hospital
Outcome results
None listed