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

NCT05904379 | Active Not Recruiting Phase 1

• 1 other identifier: AK112-208
• Study Type: interventional
• Target: 233
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Advanced Non-small-cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Safety reflected by AE

  Safety will be reflected by AE, which is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.

  Up to 2 approximately years

• ORR per RECIST v1.1

  ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1.

  Up to 2 approximately years

Secondary Outcomes (10)

• OS

  Up to 2 approximately years

• DoR per RECIST v1.1

  Up to 2 approximately years

• DCR per RECIST v1.1

  Up to 2 approximately years

• TTR per RECIST v1.1

  Up to 2 approximately years

• PFS per RECIST v1.1

  Up to 2 approximately years

Study Arms (7)

AK112, AK104 dose 1 plus carboplatin and paclitaxel

EXPERIMENTAL

Drug: AK112; Drug: AK104; Drug: Carboplatin; Drug: paclitaxel

AK112, AK104 dose 1 plus carboplatin and pemetrexed

EXPERIMENTAL

Drug: AK112; Drug: AK104; Drug: Carboplatin; Drug: pemetrexed

AK112, AK104 dose 2 plus carboplatin and paclitaxel

EXPERIMENTAL

Drug: AK112; Drug: AK104; Drug: Carboplatin; Drug: paclitaxel

AK112, AK104 dose 2 plus carboplatin and pemetrexed

EXPERIMENTAL

Drug: AK112; Drug: AK104; Drug: Carboplatin; Drug: pemetrexed

AK112 plus AK104

EXPERIMENTAL

Drug: AK112; Drug: AK104

AK112, AK104 plus docetaxel

EXPERIMENTAL

Drug: AK112; Drug: AK104; Drug: Docetaxel

docetaxel

ACTIVE COMPARATOR

Drug: Docetaxel

Interventions

Docetaxel DRUG

Subjects receive docetaxel intravenously.

AK112, AK104 plus docetaxel; docetaxel

AK112 DRUG

Subjects receive AK112 intravenously.

AK112 plus AK104; AK112, AK104 dose 1 plus carboplatin and paclitaxel; AK112, AK104 dose 1 plus carboplatin and pemetrexed; AK112, AK104 dose 2 plus carboplatin and paclitaxel; AK112, AK104 dose 2 plus carboplatin and pemetrexed; AK112, AK104 plus docetaxel

AK104 DRUG

Subjects receive AK104 intravenously.

AK112 plus AK104; AK112, AK104 dose 1 plus carboplatin and paclitaxel; AK112, AK104 dose 1 plus carboplatin and pemetrexed; AK112, AK104 dose 2 plus carboplatin and paclitaxel; AK112, AK104 dose 2 plus carboplatin and pemetrexed; AK112, AK104 plus docetaxel

Carboplatin DRUG

Subjects receive carboplatin intravenously.

AK112, AK104 dose 1 plus carboplatin and paclitaxel; AK112, AK104 dose 1 plus carboplatin and pemetrexed; AK112, AK104 dose 2 plus carboplatin and paclitaxel; AK112, AK104 dose 2 plus carboplatin and pemetrexed

paclitaxel DRUG

Subjects receive paclitaxel intravenously.

AK112, AK104 dose 1 plus carboplatin and paclitaxel; AK112, AK104 dose 2 plus carboplatin and paclitaxel

pemetrexed DRUG

Subjects receive pemetrexed intravenously.

AK112, AK104 dose 1 plus carboplatin and pemetrexed; AK112, AK104 dose 2 plus carboplatin and pemetrexed

Eligibility Criteria

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

You may qualify if:

• Has a histologically or cytologically confirmed diagnosis of NSCLC.
• Has Stage IIIB/C or IV NSCLC (American Joint Committee on Cancer \[AJCC 8th\]).
• 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.
• Has recovered from the effects of any prior radiotherapy or surgery.
• All female and male subjects of reproductive potential must agree to use an effective method of contraception, during and for 120 days after the last dose of study treatment.

You may not qualify if:

• 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.
• Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of this subject to participate, in the opinion of the treating investigator.
• Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
• Has received a live virus vaccine within 30 days of the planned first dose of study therapy.
• Has any concurrent medical condition that, in the opinion of the Investigator, would complicate or compromise compliance with the study or the well-being of the subject.

Sponsors & Collaborators

• Akeso: lead

Study Sites (2)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Location

Shanghai Pulmonary Hospital

Shanghai, China

Location

MeSH Terms

Interventions

Carboplatin; Paclitaxel; Pemetrexed; Docetaxel

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2023
• First Posted: June 15, 2023
• Study Start: July 13, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: March 9, 2026

Record last verified: 2026-03

Locations

CN (2)