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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: AK104; Drug: Albumin-Bound Paclitaxel; Drug: Carboplatin

• Study Type: Interventional
• Enrollment (Estimated): 43
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Huijuan Wang, MD; Phone Number: 18638561588; Email: 18638561588@163.com

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450003
      • Recruiting
      • Henan Cancer Hospital
      • Contact: Huijuan Wang, MD; Phone Number: 18638561588; Email: 18638561588@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AK104+albumin-bound paclitaxel+carboplatin; Participants receive 3 cycles of AK104 in combination with albumin-bound paclitaxel and carboplatin as neoadjuvant therapy prior to surgery; followed by surgery; followed by adjuvant AK104 for 9 cycles.	Drug: AK104; 10 mg/kg via intravenous infusion on Day 1 of each 21-day cycle.; Other Names: Cadonilimab; Drug: Albumin-Bound Paclitaxel; 260mg/m^2 via intravenous infusion on Day 1 of each 21-day cycle.; Drug: Carboplatin; AUC 5 mg/mL/min via intravenous infusion on Day 1 of each 21-day cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathological Complete Response (pCR) Rate	defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes following completion of neoadjuvant therapy.	At time of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Surgical Complications	defined as ≥ grade 3 or severe intraoperative and perioperative complications.	Up to approximately 30 days following surgery
Complete (R0) Resection Rate	defined as the percentage of participants achieving complete surgical resection following completion of neoadjuvant therapy.	After surgery (approximately 7 weeks)
Event Free Survival (EFS)	defined as the time from the first dose of study drug to disease progression per RECIST 1.1 that precludes surgery, local or distant recurrence, or death due to any cause, whichever occurs first.	Up to approximately 5 years
Adverse Events (AEs)		From the first dose of neoadjuvant treatment until 90 days after the last dose of adjuvant treatment
Major Pathological Response (MPR) Rate	defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes following completion of neoadjuvant therapy.	At time of surgery
Objective Response Rate (ORR)	defined as the percentage of participants having complete response or partial response to protocol treatment. Objective response will be measured by RECIST 1.1.	At the end of 3 cycles of neoadjuvant therapy (each cycle is 21 days)

Collaborators and Investigators

• Sponsor: Henan Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: May 10, 2022
• First Submitted That Met QC Criteria: May 16, 2022
• First Posted (Actual): May 17, 2022

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: bispecific antibody; neoadjuvant and adjuvant therapy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Carboplatin; Paclitaxel; Albumin-Bound Paclitaxel
• Other Study ID Numbers: AK104-IIT-005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No