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AK112 and AK104 With or Without Chemotherapy in Advanced Non-small Cell Lung Cancer | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

AK112 and AK104 With or Without Chemotherapy in Advanced Non-small Cell Lung Cancer

A Phase Ib/II Clinical Trial of AK112 and AK104 With or Without Chemotherapy in Advanced Non-small Cell Lung Cancer

NCT05904379•Akeso

Summary

This trial is a Phase Ib/II study. All patients are stage IIIB/C (unsuitable for radical therapy) or IV non-small cell lung cancer(NSCLC), Eastern Cooperative Oncology Group (ECOG) performance status 0-1. The purpose of this study is to evaluate the safety and efficacy of AK112 and AK104 with or without chemotherapy in subjects with advanced NSCLC.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Has a histologically or cytologically confirmed diagnosis of NSCLC.
•Has Stage IIIB/C or IV NSCLC (American Joint Committee on Cancer \[AJCC 8th\]).
•18-75 years old (at the time consent is obtained).
•Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures).
•Be able to provide formalin fixed, paraffin-embedded (FFPE) tumor tissue.
•Has a life expectancy of at least 3 months.
•Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
•Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as determined by the site study team.
•Has no EGFR-sensitive mutations or ALK gene translocations.
•Has adequate organ function.
+2 more criteria

Exclusion Criteria

•Has any histologically small cell carcinoma component.
•Is currently participating in a study of an investigational agent or using an investigational device.
•Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy within 2 years prior to the first dose of study treatment.
•Has undergone major surgery within 30 days of Study Day 1.
•Has a known additional malignancy that is progressing or requires systemic treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
•Has known active central nervous system (CNS) metastases.
•Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
•Has an active infection requiring systemic therapy.
•Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \[qualitative\] is detected).
•Has a history of myocardial infarction, unstable angina, congestive heart failure within 12 months prior to day 1 of study treatment.
+4 more criteria

Locations (2)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Shanghai Pulmonary Hospital

Shanghai, China

Key Dates

Start Date

July 13, 2023

Primary Completion Date

June 30, 2026

Completion Date

January 31, 2027

Last Updated

March 9, 2026

Enrollment

233

ESTIMATED participants

Conditions

Advanced Non-small-cell Lung Cancer

Interventions

AK112

DRUG

AK104

DRUG

Carboplatin

DRUG

paclitaxel

DRUG

pemetrexed

DRUG

Docetaxel

DRUG

Osimertinib Plus Capivasertib in NSCLC With PIK3CA/AKT1/PTEN Alterations Following Prior 1L Osimertinib

NCT07486648

Lung Cancer (NSCLC)Lung Cancer (Non-Small Cell)+1 more

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TERMINATED

Gefitinib Long-term Survivor Study

NCT02932345

EGFR Mutation Positive Advanced Non-small-cell Lung Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 9, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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