non-small cell lung cancer (NSCLC)
Conditions
Interventions
Treatment-naive Cohort:Furmonertinib 240mg, po, qd
Treated Cohort:Furmonertinib 240mg, po, qd
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male or Female aged 18-75 years old; 2. Histologically or cytopathologically confirmed primary non-small cell lung cancer (NSCLC) with predominant non-squamous cell histology; 3. The treated patients must have radiological disease progression following the last anti-tumor therapy; and the treatment-naive patients must have documented positive HER2 20 insertion mutation by laboratory tests prior to enrollment; 4. Subjects meeting either of the following conditions (in accordance with the AJCC 8th edition TNM stage classification for lung cancer): (1) Treated patients: patients with locally advanced (judged by investigators as not suitable for surgery or radiotherapy) or metastatic NSCLC who are confirmed to have radiological or pathological disease progression during or after the last systematic anti-tumor therapy before the first dose of investigational product; (2) Newly diagnosed patients: patients with locally advanced (judged by investigators as not suitable for surgery or radiotherapy) or metastatic NSCLC who have no prior systematic anti-tumor therapy before the first dose of investigational product. If the time from the completion of adjuvant or neoadjuvant therapy to the first disease progression is > 6 months, the patients will be eligible for enrollment to the study; if it is = 1.5 x 10^9/L; PLT >= 100 x 10^9/L; HGB >= 90 g/L; (2) TBIL = 50 mL/min (according to Cockcroft-Gault formula); (4) PT 12 weeks after the first dose of investigational product; 9. Female of childbearing age are not pregnant and have no pregnancy plan. Female subjects at childbearing age and male subjects agree to take effective contraceptive measures during the study and within 6 months after drug discontinuation; 10. Being able to understand and voluntarily participate in the study, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. NSCLC with predominant squamous cell histology, small cell lung cancer or neuroendocrine carcinoma indicated by histology or cytology test; 2. Expected to receive other anti-tumor therapy other than the investigational product during the study; 3. Patients with other driver oncogenes (EGFR mutation, ALK fusion, ROS1 fusion, RET rearrangement, BRAF mutation, NTRK fusion, MET mutation, KRAS mutation, but not TP53, RB1, BRAC mutation, etc.); 4. (1) Treatment-naive patients: having previously received systematic anti-tumor therapy; (2) Treated patients: having previously received systematic antitumor therapy with targeted therapy for EGFR or HER2 (marketed drugs or drugs under development); 5. Having received the following therapies: (1) Having been irradiated for > 30% bone marrow or a large area within 4 weeks prior to the first dose of investigational product; (2) Having received major surgery within 4 weeks prior to the first dose of investigational product or plan to receive major surgery during the study with exception of the surgical procedures to establish vascular access, biopsy through mediastinoscopy or thoracoscopy; (3) Use of a potent CYP3A4 inhibitor within 7 days prior to the first dose of investigational product or a potent CYP3A4 inducer within 21 days prior to the first dose of investigational product; use of the traditional Chinese medicine or traditional Chinese medicine preparation with tumor indication, or traditional Chinese medicine or traditional Chinese medicine preparation with adjuvant anti-tumor effect within two weeks prior to the first dose of investigational product or expected to be required during the study; (4) Having participated in the clinical trial and received the investigational product or device within 4 weeks or at least 5 half-lives prior to the first dose of investigational product; (5) Having received other anti-tumor drugs within 14 days prior to the first dose of investigational product; 6. Concurrent spinal cord compression or symptomatic brain metastasis. Subjects with stable brain metastasis will be eligible. Stable brain metastasis is defined as the patients who have completed regular treatment for brain metastasis, are clinically stable or asymptomatic for at least two weeks and do not need steroid therapy. If the investigator considers there is no indication of immediate radical treatment, patients with asymptomatic brain metastasis will be eligible. 7. The toxicity caused by previous anti-tumor therapy has not recovered to <= CTCAE grade 1 (CTCAE 5.0) (except alopecia, sequelae of previous platinum-related neurotoxicity) or the level specified in the inclusion/exclusion criteria; 8. Unstable pleural effusion or peritoneal effusion with obvious symptoms; those with stable clinical symptoms for at least 14 days after drainage of pleural effusion or ascites will be eligible; 9. Having a history of other malignant tumor, or other concurrent malignant tumors (except those that have undergone radical operation and have no recurrence within 5 years post operation, e.g. cervical carcinoma in situ, basal cell carcinoma of skin and papillary thyroid carcinoma); 10. Previous interstitial lung disease (ILD), drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy; or having the clinical manifestations of suspected interstitial lung disease; 11. Having severe or uncontrolled systemic disease requiring treatment that is considered by investigators as ineligible for
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate (DCR);Duration of Response (DOR);Progression Free Survival (PFS);Central nervous system Objective Response Rate (CNS ORR) ;Overall survial (OS);Adverse Events; | — |
Countries
China
Contacts
Public ContactYi Hu
Chinese PLA General Hospital
Outcome results
None listed