NCT06940401 JS111 in Patients With Advanced NSCLC Harboring EGFR Mutations
| NCT ID | NCT06940401 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Suzhou Junjing BioSciences Co., Ltd. |
| Condition | NSCLC |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2025-04-30 |
| Primary Completion | 2025-12-31 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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).
Eligibility Criteria
Inclusion Criteria: 1. Male or female subjects aged ≥18 years at the time of signing informed consent. 2. Histologically or cytologically confirmed locally advanced, metastatic, or recurrent NSCLC that is unresectable and unsuitable for curative chemoradiotherapy. 3. No prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC. 4. 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. 5. At least one measurable lesion according to RECIST v1.1. 6. ECOG performance status of 0 or 1. 7. Life expectancy of ≥12 weeks. 8. Adequate function of key organs. 9. Women of childbearing potential (WOCBP) with non-sterilized male partners must have a negative serum pregnancy test within 7 d