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This is a prospective, multicenter, randomized, uncontrolled Phase II study to assess the efficacy and safety of adebrelimab in combination with chemotherapy with or without bevacizumab for the treatment of resectable Stage II-IIIB (T3N2) NSQ-NSCLC and to explore biomarkers associated with efficacy.
Neoadjuvant therapy with experimental treatment followed by surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| four-drug combination group | Experimental | PD-L1 inhibitor with chemotherapy with Antiangiogenic therapy for neoadjuvant therapy |
|
| three-drug combination group | Experimental | PD-L1 inhibitor with chemotherapy for neoadjuvant therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adebellizumab | Drug | adebrelimab |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological complete response | Pathological complete response, pCR (primary tumor + lymph nodes).It refers to the proportion of subjects with no residual surviving tumor cells (including lymph nodes) in the postoperative specimen among the enrolled subjects | After 4 cycles of neoadjuvant therapy(3 weeks per cycle), surgical resection was performed at intervals of 4-6 weeks. Pathological response assessment results were assessed within one week after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Major Pathological response | It refers to the proportion of subjects with residual surviving tumor cells of ≤ 10% in the postoperative specimen among the enrolled subjects. | After 4 cycles of neoadjuvant therapy(3 weeks per cycle), surgical resection was performed at intervals of 4-6 weeks. Pathological response assessment results were assessed within one week after surgery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianxing He | Contact | +86-20-83062807 | jianxing.he@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jianxing He | The First Affiliated Hospital of Guangzhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Thoracic Surgery, The First Affiliated Hospital of Guangzhou Medical University | Recruiting | Guangzhou | China |
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| Bevacizumab |
| Drug |
bevacizumab |
|
| Platinum-based chemotherapy | Drug | paclitaxel or albuminotaxol or docetaxel combined with platinum, pemetrexed combined with platinum. Platinums include carboplatin, cisplatin and nedaplatin. |
|
|
| Overall response rate | It refers to the proportion of patients whose tumor shrinks to a certain extent and maintains it for a certain period of time, including CR and PR cases. | After 4 cycles of neoadjuvant therapy(3 weeks per cycle), before surgical resection was performed（at intervals of 4-6 weeks）. |
| event free survival | Defined as disease progression from randomization to imaging confirmation, local progression leading to inoperable tumors, unresectable tumors, local or distant recurrence, and death from any cause. | from randomization to imaging confirmation, local progression leading to inoperable tumors, unresectable tumors, local or distant recurrence, and death from any cause, whichever came first, assessed up to 24 months. |
| safety | Monitoring and recording of adverse events, including Incidence of serious adverse events and adverse events of special interest. | Safety follow-up will be conducted 30 ± 7 days after the last use of bevacizumab/chemotherapy or 90 ± 7 days after the last use of adebrelimab/surgery (whichever occurs later) to track the relief of AE. Incidence of AE/SAE/TRAE will be recorded. |
| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D017671 | Platinum Compounds |
| D017239 | Paclitaxel |
| D000077143 | Docetaxel |
| D000068437 | Pemetrexed |
| D016190 | Carboplatin |
| D002945 | Cisplatin |
| C053989 | nedaplatin |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D007287 | Inorganic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000600 | Amino Acids, Dicarboxylic |
| D056831 | Coordination Complexes |
| D017606 | Chlorine Compounds |
| D017672 | Nitrogen Compounds |
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