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

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05377658
• Other study ID #: AK104-IIT-005
• Status: Recruiting
• Phase: Phase 2
• Start date: July 26, 2022
• Est. completion date: December 31, 2027

Study information

• Verified date: February 2024
• Source: Henan Cancer Hospital
• Contact: Huijuan Wang, MD
• Phone: 18638561588
• Email: 18638561588[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 43
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• AK104
10 mg/kg via intravenous infusion on Day 1 of each 21-day cycle.
• Albumin-Bound Paclitaxel
260mg/m^2 via intravenous infusion on Day 1 of each 21-day cycle.
• Carboplatin
AUC 5 mg/mL/min via intravenous infusion on Day 1 of each 21-day cycle.

Locations

Country	Name	City	State
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Henan Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Incidence of Surgical Complications	defined as = grade 3 or severe intraoperative and perioperative complications.	Up to approximately 30 days following surgery
Secondary	Complete (R0) Resection Rate	defined as the percentage of participants achieving complete surgical resection following completion of neoadjuvant therapy.	After surgery (approximately 7 weeks)
Secondary	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)
Secondary	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
Secondary	Adverse Events (AEs)		From the first dose of neoadjuvant treatment until 90 days after the last dose of adjuvant treatment