Sotorasib in Advanced G12C-Mutated NSCLC: Results From the Global Expanded Access Program, Including Patients With Poor Performance Status and a History of CNS Metastases.
2/5 보강
PICO 자동 추출 (휴리스틱, conf 3/4)
유사 논문P · Population 대상 환자/모집단
268 patients (n = 150 [Study-436] and n = 118 [Study-442]) received oral sotorasib (960 mg daily).
I · Intervention 중재 / 시술
oral sotorasib (960 mg daily)
C · Comparison 대조 / 비교
추출되지 않음
O · Outcome 결과 / 결론
Improvement from ECOG PS 2 to ECOG PS 0 to 1 was observed by the end of first cycle of treatment (57.9%). [CONCLUSIONS] Safety and efficacy outcomes of sotorasib in this study were not affected with ECOG PS 2 and the history of CNS metastases and were consistent with those reported in key clinical trials.
OpenAlex 토픽 ·
Lung Cancer Treatments and Mutations
Lung Cancer Research Studies
HER2/EGFR in Cancer Research
[INTRODUCTION] Data from two global protocols under the expanded access program, Study-436 and Study-442, evaluating the safety and efficacy of sotorasib in patients with advanced G12C-mutated NSCLC
- 표본수 (n) 150
APA
Silvia Novello, Natalie Maimon Rabinovich, et al. (2026). Sotorasib in Advanced G12C-Mutated NSCLC: Results From the Global Expanded Access Program, Including Patients With Poor Performance Status and a History of CNS Metastases.. JTO clinical and research reports, 7(5), 100974. https://doi.org/10.1016/j.jtocrr.2026.100974
MLA
Silvia Novello, et al.. "Sotorasib in Advanced G12C-Mutated NSCLC: Results From the Global Expanded Access Program, Including Patients With Poor Performance Status and a History of CNS Metastases.." JTO clinical and research reports, vol. 7, no. 5, 2026, pp. 100974.
PMID
42006282
Abstract
[INTRODUCTION] Data from two global protocols under the expanded access program, Study-436 and Study-442, evaluating the safety and efficacy of sotorasib in patients with advanced G12C-mutated NSCLC beyond the traditional registrational trial setting are presented.
[METHODS] Patients were enrolled in 90 centers globally. Baseline characteristics and safety data for Study-436 and Study-442 and efficacy data for Study-436 were estimated. All data were summarized descriptively.
[RESULTS] A total of 268 patients (n = 150 [Study-436] and n = 118 [Study-442]) received oral sotorasib (960 mg daily). At baseline, 21.3% and 31.0% of patients had Eastern Cooperative Oncology Group performance status (ECOG PS) 2 and a history of central nervous system (CNS) metastases, respectively.Treatment-related adverse events occurred in 64.9% of patients; diarrhea (31.3%) was the most common. The incidence of treatment-related adverse events was similar between patients with ECOG PS 0 to 1 (67.8%) and PS 2 (54.4%) and those with (69.9%) and without (62.7%) a history of CNS metastases. The median real-world progression-free survival and overall survival was 6.3 and 9.5 months, respectively. The median real-world progression-free survival was numerically similar in patients with ECOG PS 0 to 1 versus PS 2 (6.5 versus 5.6 mo) and in patients with versus without a history of CNS metastases (5.7 versus 6.5 mo); median overall survival followed similar trends. Improvement from ECOG PS 2 to ECOG PS 0 to 1 was observed by the end of first cycle of treatment (57.9%).
[CONCLUSIONS] Safety and efficacy outcomes of sotorasib in this study were not affected with ECOG PS 2 and the history of CNS metastases and were consistent with those reported in key clinical trials.
[METHODS] Patients were enrolled in 90 centers globally. Baseline characteristics and safety data for Study-436 and Study-442 and efficacy data for Study-436 were estimated. All data were summarized descriptively.
[RESULTS] A total of 268 patients (n = 150 [Study-436] and n = 118 [Study-442]) received oral sotorasib (960 mg daily). At baseline, 21.3% and 31.0% of patients had Eastern Cooperative Oncology Group performance status (ECOG PS) 2 and a history of central nervous system (CNS) metastases, respectively.Treatment-related adverse events occurred in 64.9% of patients; diarrhea (31.3%) was the most common. The incidence of treatment-related adverse events was similar between patients with ECOG PS 0 to 1 (67.8%) and PS 2 (54.4%) and those with (69.9%) and without (62.7%) a history of CNS metastases. The median real-world progression-free survival and overall survival was 6.3 and 9.5 months, respectively. The median real-world progression-free survival was numerically similar in patients with ECOG PS 0 to 1 versus PS 2 (6.5 versus 5.6 mo) and in patients with versus without a history of CNS metastases (5.7 versus 6.5 mo); median overall survival followed similar trends. Improvement from ECOG PS 2 to ECOG PS 0 to 1 was observed by the end of first cycle of treatment (57.9%).
[CONCLUSIONS] Safety and efficacy outcomes of sotorasib in this study were not affected with ECOG PS 2 and the history of CNS metastases and were consistent with those reported in key clinical trials.