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Not yet recruiting NCT07158840

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

Phase II Interventional Non-Small Cell Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AK112.
Who it may be relevant to
Registry conditions: Non-Small Cell Lung Cancer. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Single Arm, Multi-center, Phase II Study of 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

Overview

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

Interventions

  • Drug AK112
    AK112 Monotherapy

Primary outcome measures

  • Overall response (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator [Time frame: up to 2 years]
Secondary outcome measures (9)
  • Overall survival (OS) [Time frame: up to 2 years]
  • Progression-free survival (PFS) [Time frame: up to 2 years]
  • Duration of response (DoR) [Time frame: up to 2 years]
  • Disease control rate (DCR) [Time frame: up to 2 years]
  • Time to response (TTR) [Time frame: up to 2 years]
  • Percentage of participants with adverse event (AE) [Time frame: From the subject signs the Informed Consent Form to 30 days (AE) and 90 days (Serious AE) after the last dose of study treatment or initiation of other anti-tumor therapy, whichever occurs first,up to 2 years]
  • Observed concentrations of AK112 [Time frame: From date of enrollment until the end of treatment, assessed up to 2 years]
  • Number of participants who develop detectable anti-drug antibodies (ADAs) [Time frame: From first dose of AK112 through 90 days after last dose of AK112,up to 2 years]
  • Number of participants with programmed cell death ligand 1 (PD-L1) expression positive who achieve CR/PR [Time frame: From date of enrollment until the end of treatment, assessed up to 2 years]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Guangdong Provincial People's Hospital — Guangzhou

Identifiers

NCT: NCT07158840 · AK112-215

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗