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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AK104+albumin-bound paclitaxel+carboplatin | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK104 | Drug | 10 mg/kg via intravenous infusion on Day 1 of each 21-day cycle. |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Incidence of Surgical Complications |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huijuan Wang, MD | Contact | 18638561588 | 18638561588@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan Cancer Hospital | Recruiting | Zhengzhou | Henan | 450003 | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D000068196 | Albumin-Bound Paclitaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 |
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| Albumin-Bound Paclitaxel | Drug | 260mg/m^2 via intravenous infusion on Day 1 of each 21-day cycle. |
|
| Carboplatin | Drug | AUC 5 mg/mL/min via intravenous infusion on Day 1 of each 21-day cycle. |
|
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) |
| 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) |
| 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 |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D056831 | Coordination Complexes |