Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Signed written informed consent.
Age ≥18 years.
Newly diagnosed, unresectable, locally advanced (ineligible for curative concurrent - chemoradiotherapy) or metastatic NSCLC per AJCC 9th edition.
KRAS G12C mutation confirmed by validated testing.
PD-L1 TPS ≥1%.
≥1 measurable lesion per RECIST v1.1.
No prior systemic therapy for advanced/metastatic NSCLC; prior adjuvant therapy allowed if completed \>6 months before dosing and toxicities recovered to ≤Grade 1.
ECOG PS 0-2.
Life expectancy \>3 months
Adequate organ function (hematologic, hepatic, renal, coagulation per protocol thresholds)
Negative pregnancy test for women of childbearing potential; adequate contraception for men and women through 3 months post-treatment
Willing and able to comply with study procedures and follow-up.
You may not be if
History of other malignancies (exceptions: cured basal cell carcinoma, cervical carcinoma in situ)
Predominant squamous NSCLC, small cell carcinoma, or neuroendocrine carcinoma.
