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

Phase 2RecruitingNCT05377658

Henan Cancer Hospital43 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-small Cell Lung Cancer

Interventions

AK104DRUG

10 mg/kg via intravenous infusion on Day 1 of each 21-day cycle.

Albumin-Bound PaclitaxelDRUG

260mg/m\^2 via intravenous infusion on Day 1 of each 21-day cycle.

CarboplatinDRUG

AUC 5 mg/mL/min via intravenous infusion on Day 1 of each 21-day cycle.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Henan Cancer Hospital

Zhengzhou, Henan, China

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: At time of surgery

Secondary Outcomes

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.

Time frame: At time of surgery

Incidence of Surgical Complications

defined as ≥ grade 3 or severe intraoperative and perioperative complications.

Time frame: 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.

Time frame: After surgery (approximately 7 weeks)

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.

Time frame: At the end of 3 cycles of neoadjuvant therapy (each cycle is 21 days)

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.

Time frame: Up to approximately 5 years

Adverse Events (AEs)

Central Contacts

Huijuan Wang, MD

CONTACT

18638561588 18638561588@163.com

Data from ClinicalTrials.gov

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