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Glecirasib in KRASG12C-mutated nonsmall-cell lung cancer: a phase 2b trial
Yuankai Shi1, Jian Fang2, Ligang Xing3
1Department of Medical Oncology, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China. syuankai@cicams.ac.cn.
Abstract:
Glecirasib (JAB-21822) is a new covalent oral KRAS-G12C inhibitor. This multicenter, single-arm phase 2b study assessed the efficacy and safety of glecirasib administered orally at 800 mg daily in patients with locally advanced or metastatic KRASG12C-mutated nonsmall-cell lung cancer. The primary endpoint was the objective response rate (ORR) assessed by an independent review committee (IRC). Between 15 September 2022 and 28 September 2023, 119 patients with a median age of 62 years were enrolled. As of the data cut-off date on 28 March 2024, the ORR assessed by IRC was 47.9% (56/117; 95% confidence interval: 38.5-57.3%). The incidence of treatment-related adverse events (TRAEs) of any grade was 97.5% (116/119). The incidence of grades 3 and 4 TRAEs was 38.7% (46/119). A total of 5.0% (6/119) of patients discontinued the treatment due to TRAEs. No treatment-related deaths occurred. Glecirasib exhibited promising clinical efficacy and manageable safety profiles in these patient populations. ClinicalTrials.gov identifier: NCT05009329 .
Insights
Glecirasib, a KRAS-G12C inhibitor, demonstrated a 47.9% objective response rate in patients with advanced non-small cell lung cancer. The treatment showed promising efficacy with manageable side effects.
Area of Science:
- Oncology
- Pharmacology
- Clinical Trials
Background:
- Non-small cell lung cancer (NSCLC) frequently harbors KRAS mutations, particularly KRAS-G12C.
- Targeted therapies are crucial for improving outcomes in advanced NSCLC.
- Glecirasib is an investigational covalent oral KRAS-G12C inhibitor.
Purpose of the Study:
- To evaluate the efficacy and safety of glecirasib in patients with locally advanced or metastatic KRAS G12C-mutated NSCLC.
- To determine the objective response rate (ORR) as the primary endpoint.
- To assess treatment-related adverse events (TRAEs).
Main Methods:
- A multicenter, single-arm, phase 2b clinical study.
- 119 patients with KRAS G12C-mutated NSCLC were enrolled.
- Glecirasib was administered orally at 800 mg daily, with efficacy assessed by an independent review committee (IRC).
Main Results:
- The IRC-assessed ORR was 47.9% (56/117), with a 95% confidence interval of 38.5-57.3%.
- Treatment-related adverse events (TRAEs) occurred in 97.5% of patients; Grade 3/4 TRAEs were observed in 38.7%.
- Discontinuation due to TRAEs was 5.0%, with no treatment-related deaths.
Conclusions:
- Glecirasib demonstrated promising clinical efficacy in patients with KRAS G12C-mutated NSCLC.
- The safety profile of glecirasib was manageable in this patient population.
- Further investigation of glecirasib is warranted for advanced NSCLC treatment.
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