Stage IV advanced NSCLC with KRAS G12 mutation
Conditions
Interventions
Observation group:None
Sponsors
Shanghai Chest Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Pathological confirmed of NSCLC; 2.histologically or cytologically confirmed locally advanced (stage III B/III C), metastatic or recurrent (stage IV) NSCLC,according to 9th edition AJCC cancer staging manual, that is unresectable and not eligible for definitive concurrent chemoradiotherapy; 3.Molecular assay identified KRAS G12C mutation; 4.Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 2; 5.Proposed treatment with Fulzerasib evaluated by the investigator.
Exclusion criteria
Exclusion criteria: 1. Patients with positive driver genes who have a standard treatment regimen and are effective after treatment, including but not limited to EGFR/MET/ROS1/ALK, etc.; 2. Female patients who are pregnant or breastfeeding; 3. Uncontrolled intercurrent illness, as assessed by the investigator for patients not receiving targeted therapy, including but not limited to: (1) HIV-infected individuals (HIV antibody positive); (2) Serious infection in the active phase or poorly controlled clinically; (3) Evidence of severe or uncontrolled systemic diseases (such as severe psychiatric, neurological diseases, epilepsy or dementia, unstable or uncompensated respiratory, cardiovascular, hepatic or renal diseases, uncontrolled hypertension [i.e., hypertension greater than or equal to CTCAE grade 2 after drug treatment]); 4. Those who have active bleeding or new thrombotic disease, are taking therapeutic anticoagulant drugs, or have a tendency to bleed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate(ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to Treatment Failure (TTF);Safety;Disease-Free Sunival(PFS);Disease Control Rate(DCR);Overall Survival(OS); | — |
Countries
China
Contacts
Public ContactHua Zhong
Shanghai Chest Hospital
Outcome results
None listed