NSCLC
Conditions
Interventions
Vormetinib concurrent radiotherapy group A:Firmonertinib with Concurrent Radiotherapy, followed by Firmonertinib Consolidation Therapy
Platinum-containing chemotherapy concurrent radiotherapy group B:Chemoradiation, followed by Firmonertinib Consolidation Therapy
Furmetinib concurrent radiotherapy group C:Firmonertinib with Concurrent Radiotherapy, followed by Firmonertinib Consolidation Therapy
Sponsors
Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital &Institute)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age 18-75(including 18 and 75); 2.Histologically or cytologically confirmed patients with stage II-III lung adenocarcinoma who are unresectable, inoperable, or refuse surgery (according to AJCC 9th Edition lung cancer staging criteria); 3.Not received any systemic antitumor therapy or local antitumor therapy for locally advanced/metastatic non-small cell lung cancer; 4.EGFR-sensitive mutations(Ex19 Del, L858R, either alone or in combination with other EGFR mutations,including T790M mutation); 5.ECOG 0-1 with unresectable stage III NSCLC,ECOG 0-2 with inoperable stage II-III NSCLC,no worse at 2 weeks pior to administration,and expected minimum life expectancy 12 weeks; 6.At least one measurable lesion with no prior radiotherapy at baseline, with longest diameter as =10 mm (a lymph node must be =15 mm in short axis) . Measurable methods should be repeatable, either CT or MRI. If there is only one measurable lesion, the baseline radiologic examination should be performed for this lesion at least 14 days after biopsy. 7.Women of childbearing age should use appropriate contraception and should not breastfeed for 6 months from screening to discontinuation of study treatment. Before starting the drug, the pregnancy test is negative or one of the following criteria is met to demonstrate that there is no risk of pregnancy: a. Postmenopausal was defined as amenorrhea over 50 years of age and at least 12 months after discontinuation of all exogenous hormone replacement therapy; b. Women younger than 50 years of age may also be considered postmenopausal if they have had ammenia for 12 months or more after discontinuation of all exogenous hormone therapy and if luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels are within the laboratory postmenopausal reference range; c. Has undergone irreversible sterilization, including hysterectomy, bilateral ovariectomy, or bilateral tubal resection, except bilateral tubal ligation; 8.Male patients should use barrier contraception (i.e., condoms) for 6 months from screening to discontinuation of study treatment; 9.The patient himself voluntarily participated in and signed the informed consent in person.
Exclusion criteria
Exclusion criteria: 1.Have received any of the following treatment: a. Patients with first diagnosis of advanced and metastatic NSCLC have previously used radiotherapy, chemotherapy, or other systemic antitumor agents (such as tyrosine kinase inhibitors, EGFR inhibitors, antivascular agents, chemotherapy, and ICIs); Patients with early NSCLC who had previously received surgery as adjuvant or neoadjuvant therapy were allowed to be enrolled if the end time before randomized treatment was =6 months. Patients who had previously received radiotherapy were not allowed to be enrolled. b. Patients underwent major surgery (e.g., craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to the first administration of the study drug; c. Use of a CYP3A4 booster, inducer, or drug or herbal supplement with a narrow therapeutic window that is a CYP3A4-sensitive substrate within 7 days prior to initial administration of the investigational drug; Or need to continue taking these medications during the study; d. is receiving medications known to prolong the QT interval or that may cause tip torsion ventricular tachycardia; or continue to be treated with these drugs during the study period and the risk of tip torsion ventricular tachycardia cannot be ruled out; e. Within 5 half-lives of investigational drugs enrolled as study participants in other clinical trials or still in other clinical trials within 4 weeks prior to initial administration of the investigational drug; 2.With other malignancies (other than adequately treated non-melanoma skin cancer or malignant lentigo, effectively treated carcinoma in situ or other effectively treated solid tumors) that show no signs of disease for > 5 years after the end of treatment and, in the opinion of the treating physician, Patients without a greater risk of recurrence of previous malignancies) who required standard treatment or major surgery within 2 years of the first dosing of the study treatment; 3.At the start of the study treatment, there was unmitigable residual toxicity of previous treatment greater than NCI-CTCAE grade 1, except for alopecia and grade 2 neurotoxicity caused by previous chemotherapy; 4.Patient has malignant pleural effusion (only exception: pleural effusion on CT scan (not visible on CXR) or considered too little) and pericardial effusion (only exception: pleural effusion on CT scan (not visible on CXR) or considered too little); 5.Any serious or poorly controlled systemic disease, as determined by the investigator, such as poorly controlled hypertension, an active bleeding prone constitution, or an active infection; 6.Refractory nausea, vomiting, or chronic gastrointestinal disease, inability to swallow study drugs, or prior extensive bowel resection may affect adequate absorption of Furmonertinib; 7.Meet any of the following cardiac test results: a. The mean corrected QT interval (QTc) from 3 electrocardiogram (ECG) tests at rest is > 470 msec, and QT interval correction (QTcF) is performed using the Fridericia formula; b. The resting ECG indicates a variety of clinically significant rhythms, conduction, or ECG morphological abnormalities (e.g., complete left bundle branch block, 3rd degree atrioventricular block, 2nd degree atrioventricular block, and PR interval > 250 msec); c. The presence of any factors that increase the risk of prolonged QTc or arrhythmia events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or sudden unexplained deat
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival, OS;Safety;Progression-Free Survival, PFS; | — |
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate, ORR; | — |
Countries
China
Contacts
Public ContactWang Linlin
Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital &Institute)
Outcome results
None listed