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

NCT07158840 | Not Yet Recruiting Phase 2

• 1 other identifier: AK112-215
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Overall response (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator

  Proportion of subjects who have a complete or partial response as assessed according to RECIST v1.1.

  up to 2 years

Secondary Outcomes (9)

• Overall survival (OS)

  up to 2 years

• Progression-free survival (PFS)

  up to 2 years

• Duration of response (DoR)

  up to 2 years

• Disease control rate (DCR)

  up to 2 years

• Time to response (TTR)

  up to 2 years

Study Arms (1)

Experimental Arm

EXPERIMENTAL

Drug: AK112

Interventions

AK112 DRUG

AK112 Monotherapy

Experimental Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Akeso: lead

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Ting Liu

CONTACT

0760-89873925; clinicaltrials@akesobio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: September 8, 2025
• Study Start: September 5, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: September 8, 2025

Record last verified: 2025-09

Locations

CN (1)