Combining AK112 and AK104 with or without chemotherapy for advanced lung cancer

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

This study is testing if two new drugs, AK112 and AK104, with or without chemotherapy, can help people with advanced lung cancer feel better and live longer.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 233 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Akeso (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 2 sites (Hangzhou, Zhejiang and 1 other locations)
• Trial ID: NCT05904379 on ClinicalTrials.gov

What this trial studies

This trial evaluates the safety and efficacy of two investigational drugs, AK112 and AK104, in combination with or without chemotherapy for patients with advanced non-small cell lung cancer (NSCLC) who are not suitable for radical therapy. It targets patients with stage IIIB/C or IV NSCLC and aims to determine the effectiveness of these treatments in improving patient outcomes. The study includes patients aged 18-75 with specific performance status and measurable disease, and it will assess both the safety profile and therapeutic benefits of the interventions.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with stage IIIB/C or IV NSCLC and an ECOG performance status of 0-1.

Not a fit: Patients with EGFR-sensitive mutations or ALK gene translocations may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced non-small cell lung cancer.

How similar studies have performed: Other studies have shown promise in using similar combination therapies for advanced lung cancer, indicating potential for success.

Eligibility criteria

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.
* 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.

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.
* 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.

Where this trial is running

Hangzhou, Zhejiang and 1 other locations

• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Recruiting)
• Shanghai Pulmonary Hospital — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Jie Yang, MD

Conditions Advanced Non-small-cell Lung Cancer