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This is a phase II study. All patients are stage IIIB/C or IV non-small cell lung cancer(NSCLC), Eastern Cooperative Oncology Group (ECOG) performance status 0-1. The purpose of this study is to evaluate the efficacy and safety of AK112 in combination with chemotherapy in patients with NSCLC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part1 Cohort1(AK112 + Pemetrexed or Paclitaxel+Carboplatin) | Experimental | non-Squamous NSCLC:Subjects receive AK112 plus Pemetrexed and Carboplatin on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by AK112 plus Pemetrexed until progression. Squamous NSCLC:Subjects receive AK112 plus Paclitaxel and Carboplatin on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by AK112 until progression. |
|
| Part1 Cohort2(AK112 + Pemetrexed +Carboplatin) | Experimental | Subjects receive AK112 plus Pemetrexed and Carboplatin on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by AK112 plus Pemetrexed until progression. |
|
| Part1 Cohort3(AK112 + Docetaxel) | Experimental | Subjects receive AK112 plus Docetaxel on Day 1 of every 3-week cycle (Q3W) until progression. |
|
| Part2 (AK112 + Pemetrexed or Paclitaxel+Carboplatin) | Experimental | non-Squamous NSCLC:Subjects receive AK112 plus Pemetrexed and Carboplatin on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by AK112 plus Pemetrexed until progression. Squamous NSCLC:Subjects receive AK112 plus Paclitaxel and Carboplatin on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by AK112 until progression. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK112 | Drug | IV infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| ORR | ORR is the proportion of subjects with CR or PR , based on RECIST v1.1. | Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | PFS is defined as the time from the date of first dosing till the first documentation of disease progression (per RECIST v1.1 criteria) assessed by the investigator or death due to any cause (whichever occurs first). | Up to approximately 2 years |
| OS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Li Zhang, MD | Sun Yat-Sen University Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-Sen University Cancer Center | Guanzhou | Guangdong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37593227 | Derived | Zhao Y, Chen G, Chen J, Zhuang L, Du Y, Yu Q, Zhuang W, Zhao Y, Zhou M, Zhang W, Zhang Y, Wan Y, Li W, Song W, Wang ZM, Li B, Xia M, Yang Y, Fang W, Huang Y, Zhang L. AK112, a novel PD-1/VEGF bispecific antibody, in combination with chemotherapy in patients with advanced non-small cell lung cancer (NSCLC): an open-label, multicenter, phase II trial. EClinicalMedicine. 2023 Aug 3;62:102106. doi: 10.1016/j.eclinm.2023.102106. eCollection 2023 Aug. |
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| ID | Term |
|---|---|
| D000068437 | Pemetrexed |
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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| Part3 group A(AK112 + Docetaxel) | Experimental | Subjects receive AK112 plus Docetaxel on Day 1 of every 3-week cycle (Q3W) until progression. |
|
| Part3 group B(AK112) | Experimental | Subjects receive AK112 on Day 1 of every 3-week cycle (Q3W) until progression. |
|
| Part3 group C(Docetaxel) | Experimental | Subjects receive Docetaxel on Day 1 of every 3-week cycle (Q3W) until progression. |
|
| Pemetrexed | Drug | IV infusion |
|
| Paclitaxel | Drug | IV infusion |
|
| Carboplatin | Drug | IV infusion |
|
| Docetaxel | Drug | IV infusion |
|
OS is the time from the date of randomization or first dosing date to death due to any cause. |
| Up to approximately 2 years |
| Disease control rate | DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥8 weeks) based on RECIST Version 1.1 | Up to approximately 2 years |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |