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

NCT ID: NCT07158840

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-05
• Study Completion Date: 2029-06-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental Arm

Group Type: EXPERIMENTAL

AK112

Intervention Type: DRUG

AK112 Monotherapy

Interventions

AK112

AK112 Monotherapy

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Signed the Informed Consent Form (ICF) voluntarily。

2. Participants must be aged between 18 and 75 years (inclusive), regardless of gender.

3. ECOG performance status of 0 or 1.

4. With a life expectancy of ≥3 months.

5. Histologically or cytologically confirmed locally advanced (stage IIIB/IIIC) or metastatic (stage IV) non-squamous NSCLC.

6. 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.

7. Previous treatment failure with an AGA-targeted TKI.

8. At least one measurable extracranial lesion as defined by RECIST v1.1.

9. Adequate organ function confirmed.

Exclusion Criteria

1. Histological or cytological pathology confirming the presence of a small-cell carcinoma component or a predominant squamous cell carcinoma component.

2. AGA test report showing the presence of a common EGFR sensitizing mutation.

3. Prior receipt of immunotherapy.

4. Prior receipt of any systemic anti-tumor therapy for advanced-stage (IIIB-IV) NSCLC other than AGA-targeted TKIs.

5. Concurrent participation in another clinical study, unless it is a non-interventional study or the follow-up phase of an interventional study.

6. 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.

7. 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.

8. Imaging during the screening period shows tumor invasion of surrounding vital organs or blood vessels.

9. Central nervous system metastases: participants assessed by the investigator as not requiring local treatment may be eligible; leptomeningeal metastases are not eligible.

10. 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.

11. Active autoimmune disease requiring systemic therapy within 2 years prior to the first dose.

12. History of major medical conditions within 1 year prior to the first dose.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Akeso

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Guangdong Provincial People's Hospital

Guangzhou, , China

Countries

China

Central Contacts

Ting Liu

Role: CONTACT

clinicaltrials@akesobio.com

0760-89873925

Facility Contacts

Chongrui Xu

Role: primary

xuchongrui@gdph.org.cn

Other Identifiers

AK112-215

Identifier Type: -

Identifier Source: org_study_id