Recruiting PHASE2 Non-small Cell Lung Cancer

New treatment option for Non-small Cell Lung Cancer

Official title AK104 With Chemotherapy as Neoadjuvant and Adjuvant Therapy for Resectable Non-small Cell Lung Cancer

ClinicalTrials.gov ID: NCT05377658

What this study is testing

What is AK104?

AK104 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for non-small cell lung cancer.

Also referred to as Cadonilimab.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
AK104, a tetravalent bispecific antibody targeting PD-1 and CTLA-4, is designed to retain the efficacy benefit of combination of PD-1 and CTLA-4 and improve on the safety profile of the combination therapy. The aim of this study is to evaluate the efficacy and safety of AK104 with chemotherapy as neoadjuvant and adjuvant therapy for patients with resectable stage II-IIIA NSCLC.
  • Phase 2: a mid-size study of how well it works

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 75

You may be able to join if

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

You likely can't join if

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

The study team makes the final eligibility decision.

Where it's taking place

  • Zhengzhou, Henan, China

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Zhengzhou, Henan, China. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.