A Phase I/II Clinical Study to Evaluate JS111 Capsules in Patients With Locally Advanced, Metastatic, or Recurrent Non-Small Cell Lung Cancer (NSCLC) Harboring Epidermal Growth Factor Receptor (EGFR) Mutations.
To evaluate the safety, tolerability, and preliminary efficacy of JS111 capsules in patients with locally advanced, metastatic, or recurrent NSCLC harboring EGFR mutations;to determine the recommended Phase II dose (RP2D).
• Male or female subjects aged ≥18 years at the time of signing informed consent.
• Histologically or cytologically confirmed locally advanced, metastatic, or recurrent NSCLC that is unresectable and unsuitable for curative chemoradiotherapy.
• No prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC.
• Confirmed presence of EGFR-sensitizing mutations (exon 19 deletion or L858R mutation), either alone or co-occurring with other EGFR mutations (including T790M-positive cases). Local laboratory results are acceptable if the test is well-validated, qualified through external quality assessment or molecular diagnostics certification, or approved by NMPA.
• At least one measurable lesion according to RECIST v1.1.
• ECOG performance status of 0 or 1.
• Life expectancy of ≥12 weeks.
• Adequate function of key organs.
• Women of childbearing potential (WOCBP) with non-sterilized male partners must have a negative serum pregnancy test within 7 days prior to first dosing and agree to use effective contraception from informed consent signing until 2 months after the last dose.
⁃ Non-sterilized male subjects with female partners of childbearing potential must agree to use effective contraception (as described in Section 10.3.2) from informed consent signing until 4 months after the last dose and must refrain from sperm donation during this period.
⁃ Willingness to participate and signed informed consent provided by the subject.