ABSK043 plus osimertinib for EGFR-mutated advanced non-small cell lung cancer

Who can take part

• Aged 18 or above, male or female
• Participants must understand and voluntarily participate in this study and must have been provided informed consent for study participation
• NSNLC confirmed by tissue or cytological pathology. NSCLC with a mixed histology is eligible, if adenocarcinoma is the predominant histology
• Diagnosed locally advanced or metastatic NSCLC
• Different requirements for specific cohort:; Dose escalation and backfill cohorts:; Participants with disease in the adjuvant setting, post chemoradiotherapy setting, locally advanced stage or metastatic stage, who have received at least one prior line of third-generation EGFR-TKI-based monotherapy or combination therapy and experienced disease progression; Participants must have received ≥2 prior lines of frontline systemic therapy; Documented or central laboratory test report confirms that the tumor is PD-L1 expression positive (TPS/TC≥1%); Documented genetic testing report confirms the presence of EGFR alteration(s) in tumor or plasma; Expansion cohort(s):; Participants must not have received any other prior systemic cancer therapies in the locally advanced/metastatic setting for locally advanced or metastatic disease; Central laboratory test report confirms that the tumor is PD-L1 expression positive (TPS/TC≥1%); Documented genetic testing reports confirm the presence of EGFR
• Presence of at least one measurable tumor lesion
• ECOG score 0-1 at screening
• The expected life expectancy after the first dose is >12 weeks

Who cannot take part

• 1. Histological or cytological examinations suggest that NSCLC squamous cells is the predominant histology, or contains small cell lung cancer, neuroendocrine carcinoma, etc; Has a history of interstitial lung disease (ILD)/pneumonitis or active ILD 3. Spinal cord compression and unstable brain metastases. 4.Any unresolved toxicities from prior systemic therapy greater than CTCAE v6.0 Grade 1 at the time of starting study treatment; Participants with obvious and unstable pleural effusion, peritoneal effusion or pericardial effusion ; Has a history of other malignant tumors, or currently have other malignant tumors; Participants with known HIV infection