Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 to 75

Using AK104 with chemotherapy for lung cancer treatment

Official title: A Single-Arm, Phase II Study of AK104 With Chemotherapy as Neoadjuvant and Adjuvant Therapy for Resectable Non-small Cell Lung Cancer

Run by Henan Cancer Hospital · NCT05377658 · Data updated 2026-11-12

This study is testing if adding a new drug called AK104 to standard chemotherapy can help people with early-stage lung cancer do better and feel safer during treatment.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment43 (estimated)
SponsorHenan Cancer Hospital
Government
Drugs / interventionschemotherapy
Locations1 site (Zhengzhou, Henan)
StatusRecruiting
StartedJuly 26, 2022
Main results expectedDecember 31, 2024
Study endsDecember 31, 2027
Registry record updatedFebruary 21, 2024
Trial IDNCT05377658 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are patients with untreated, pathologically confirmed resectable stage II-IIIA NSCLC and an ECOG performance status of 0 or 1.

Probably not a fit

Patients with mixed NSCLC and small cell lung cancer histology or those with active autoimmune diseases may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the efficacy and safety of AK104, a bispecific antibody targeting PD-1 and CTLA-4, in combination with chemotherapy for patients with resectable stage II-IIIA non-small cell lung cancer (NSCLC). Participants will receive AK104 along with Albumin-Bound Paclitaxel and Carboplatin as both neoadjuvant and adjuvant therapy. The goal is to improve treatment outcomes while enhancing safety compared to traditional therapies. The study will assess measurable lesions to determine the effectiveness of the treatment.

Why it matters

Potential benefit: If successful, this approach could provide a more effective and safer treatment option for patients with resectable NSCLC.

How similar studies have gone: Other studies have shown promising results with similar bispecific antibody approaches, indicating potential for success in this novel application.

Who can join: the full rules

Show full inclusion / exclusion criteria
Key Inclusion Criteria:

1. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
2. Have previously untreated and pathologically confirmed resectable Stage II-IIIA NSCLC.
3. Have at least one measurable lesion per RECIST 1.1 assessed by investigator.
4. Have adequate organ function.

Key Exclusion Criteria:

1. Mixed NSCLC and small cell lung cancer histology.
2. Patients with other active malignancies within 3 years prior to enrollment.
3. Known active autoimmune diseases.
4. Use of immunosuppressive agents within 14 days prior to the first dose of study treatment.
5. Presence of other uncontrolled serious medical conditions.

Where it's running

  • Henan Cancer Hospital
    Zhengzhou, Henan, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.