Status:
NOT_YET_RECRUITING
AK112 in Non-squamous Non-small Cell Lung Cancer (NSCLC)Patients With Actionable Genomic Alterations (AGA) Who Have Failed to Previous Tyrosine Kinase Inhibitor (TKI) Treatment
Lead Sponsor:
Akeso
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
AK112 in non-squamous non-small cell lung cancer patients with actionable genomic alterations (AGA) who have failed to previous tyrosine kinase inhibitor (TKI) treatment
Eligibility Criteria
Inclusion
- Signed the Informed Consent Form (ICF) voluntarily。
- Participants must be aged between 18 and 75 years (inclusive), regardless of gender.
- ECOG performance status of 0 or 1.
- With a life expectancy of ≥3 months.
- Histologically or cytologically confirmed locally advanced (stage IIIB/IIIC) or metastatic (stage IV) non-squamous NSCLC.
- Prior to enrollment, participants must have at least one actionable genomic alteration (AGA) confirmed by tumor histology, cytology, or blood-based testing, including: EGFR, ALK, ROS1, NTRK, RET, BRAF and MET. Participants must provide a prior AGA test report; otherwise, AGA testing must be performed at the study site or at a site-designated laboratory before enrollment.
- Previous treatment failure with an AGA-targeted TKI.
- At least one measurable extracranial lesion as defined by RECIST v1.1.
- Adequate organ function confirmed.
Exclusion
- Histological or cytological pathology confirming the presence of a small-cell carcinoma component or a predominant squamous cell carcinoma component.
- AGA test report showing the presence of a common EGFR sensitizing mutation.
- Prior receipt of immunotherapy.
- Prior receipt of any systemic anti-tumor therapy for advanced-stage (IIIB-IV) NSCLC other than AGA-targeted TKIs.
- Concurrent participation in another clinical study, unless it is a non-interventional study or the follow-up phase of an interventional study.
- Receipt of AGA-targeted TKI therapy within 2 weeks prior to the first dose; receipt of non-specific immunomodulatory therapy within 2 weeks prior to the first dose.
- Imaging during the screening period shows tumor encasement of major blood vessels or significant necrosis/cavitation, and the investigator determines that study participation would pose a bleeding risk.
- Imaging during the screening period shows tumor invasion of surrounding vital organs or blood vessels.
- Central nervous system metastases: participants assessed by the investigator as not requiring local treatment may be eligible; leptomeningeal metastases are not eligible.
- History of malignancy other than NSCLC within 3 years prior to the first dose; participants with other malignancies that have been cured by local treatment are allowed.
- Active autoimmune disease requiring systemic therapy within 2 years prior to the first dose.
- History of major medical conditions within 1 year prior to the first dose.
Key Trial Info
Start Date :
September 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2029
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07158840
Start Date
September 5 2025
End Date
June 1 2029
Last Update
September 8 2025
Active Locations (1)
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1
Guangdong Provincial People's Hospital
Guangzhou, China