A Phase 2 Study of ABSK043 Combined With Osimertinib

Other illness

• 1\. Histological or cytological examinations suggest that NSCLC squamous cells is the predominant histology, or contains small cell lung cancer, neuroendocrine carcinoma, etc.
  • 2\. 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.
  • 5\. Participants with obvious and unstable pleural effusion, peritoneal effusion or pericardial effusion .
  • 6\. Has a history of other malignant tumors, or currently have other malignant tumors.
  • 7\. Participants with known HIV infection.

• 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.