Advanced NSCLC with KRAS-G12C mutation
Conditions
Interventions
Treatment of non-small cell lung cancer with fluzereme observation group:None
Sponsors
Cancer Hospital Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. NSCLC confirmed by pathology; 2. Patients with histologically or cytologically confirmed locally advanced (stage IIIB/IIIC), metastatic or recurrent (stage IV) NSCLC according to the International Association for the Study of Lung Cancer and American Joint Committee on Classification of Cancer 9th Edition TNM staging system for lung cancer, who are inoperable for surgical resection and cannot receive definitive concurrent chemoradiotherapy; 3.KRAS G12C mutation was identified by molecular analysis; 4. Intention to receive fluzeresel, as assessed by the investigator.
Exclusion criteria
Exclusion criteria: 1. Driver gene positive patients who responded to standard therapy, including but not limited to EGFR/MET/ROS1/ALK, have not received standard therapy, or have not progressed after standard therapy. 2. Pregnant or lactating women. 3. Uncontrolled co-morbidity, as assessed by investigators in patients not receiving targeted therapy, including but not limited to: 1) patients with HIV infection (HIV antibody positive). 2) severe infections that are active or poorly controlled clinically. 3) evidence of severe or uncontrolled systemic illness (e.g., severe psychiatric, neurological illness, epilepsy, or dementia, unstable or decompensated respiratory, cardiovascular, hepatic, or renal disease, uncontrolled hypertension [i.e., hypertension greater than or equal to CTCAE class 2 despite medical treatment]). 4) patients with active bleeding, new thrombotic disease taking therapeutic dose of anticoagulant drugs, or bleeding tendency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival;Overall survival;Adverse event; | — |
Countries
China
Contacts
Public ContactWang Yan
Cancer Hospital Chinese Academy of Medical Sciences
Outcome results
None listed