Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

Antibodies, Bispecific

Immunoglobulins

Tubulin Modulators

Antimitotic Agents

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.

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

AK104

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

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

Huijuan Wang, MD

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.

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

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.

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.

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

defined as the percentage of participants achieving complete surgical resection following completion of neoadjuvant therapy.

defined as the percentage of participants having complete response or partial response to protocol treatment. Objective response will be measured by RECIST 1.1.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
AK104 With Chemotherapy as Neoadjuvant and Adjuvant Therapy for Resectable Non-small Cell Lung Cancer	NCT05377658	Non-small Cell ...	AK104 Albumin-Bound P... Carboplatin	18 Years - 75 Years	Henan Cancer Hospital
AK104 With Chemotherapy as Neoadjuvant and Adjuvant Therapy for Resectable Non-small Cell Lung Cancer	NCT05377658	Non-small Cell ...	AK104 Albumin-Bound P... Carboplatin	18 Years - 75 Years	Henan Cancer Hospital

Spots Global Cancer Trial Database for neoadjuvant and adjuvant therapy