Using AK104 with chemotherapy for lung cancer treatment

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

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

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 43 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Henan Cancer Hospital (other gov)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Zhengzhou, Henan)
• Trial ID: NCT05377658 on ClinicalTrials.gov

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.

Who should consider this trial

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

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.

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

Eligibility 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 this trial is running

Zhengzhou, Henan

• Henan Cancer Hospital — Zhengzhou, Henan, China (RECRUITING)

Study contacts

• Study coordinator: Huijuan Wang, MD

Conditions: Non-small Cell Lung Cancer, neoadjuvant and adjuvant therapy, bispecific antibody