Study Introduction
Screening Criteria for a Randomized, Open, Multicenter Phase III Clinical Study to Evaluate the Efficacy and Safety of YK-029A Tablets Versus Platinum-Containing Two-Drug Chemotherapy for the First-Line Treatment of Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutation
Participation Criteria

Subjects must voluntarily enroll, sign the informed consent form, and comply with the trial treatment regimen and study visit schedule.

Male or female, 18-75 years old (including boundary values).

Patients with histologically or cytologically confirmed locally advanced (Stage IIIB/IIIC), metastatic, or recurrent (Stage IV) non-squamous NSCLC who are unable to receive surgical treatment or radical concurrent radiochemotherapy according to the TNM Staging of Lung Cancer (8th Edition) of the International Association for the Study of Lung Cancer (IASLC) and the American Joint Committee on Cancer (AJCC).

Patients have at least one radiologically measurable lesion according to RECIST v1.1. Note: the measurable lesions should neither be treated locally with radiotherapy nor biopsied during the screening period; if there is only one measurable lesion, biopsy of that lesion is permitted, but baseline imaging examination of that lesion should be performed at least 14 days after biopsy.

Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.

Expected survival of more than 12 weeks.

Apply
Study Introduction
A Phase I/IIa, Open-label, Multicenter, Dose-escalation and Expansion Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of PH009-1 in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer with EGFR Mutations
Participation Criteria

Subjects must voluntarily enroll, sign the informed consent form, and comply with the trial treatment regimen and study visit schedule.

Male or female, >18 years old.

Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic non-small cell lung cancer.

EGFR mutations confirmed by prior genetic testing (genetic testing reports obtained after disease progression during or following the last course of EGFR inhibitor treatment) or screening-stage genetic testing (if the reports are unavailable, blood samples shall be provided for NGS testing during the screening period).

Patients have at least one radiologically measurable lesion according to RECIST v1.1.

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Expected survival of more than 12 weeks.

Apply