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This study is a single arm, prospective, multicenter clinical trial, and eligible patients will receive the following treatment regimen: Adebrelimab combined with chemotherapy.The study includes a screening period (from the signing of informed consent by the subjects to no more than 28 days before the first medication, imaging examinations are allowed to be performed within 28 days before the first medication, and tumor tissue biopsy is allowed to be archived within 6 months before the first medication), a treatment period (including neoadjuvant and surgical treatment), and a follow-up period (including safety follow-up and survival follow-up).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adebrelimab in combination chemotherapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adebrelimab | Drug | Adebrelimab 1200mg,ivgtt,D1,Q3W |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Main pathological relief (MPR) | Main pathological relief (MPR) is defined as less than or equal to 10% of active tumor tissue in the surgical specimen during tumor resection. | Four weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| pathologic complete response(pCR) | Four weeks after surgery | |
| Surgical R0 resection rate | Four weeks after surgery | |
| objective response rate(ORR) |
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Inclusion Criteria:
18 years old ≤ age ≤ 70 years old, male or female not limited;
ECOG PS score 0-1 points;
Patients who have not received systematic treatment in the past and agree to undergo radical surgery; Patients without surgical contraindications judged by thoracic surgeons;
Stage II, IIIA, or selective IIIB (T3N2M0 only) squamous or non squamous cell non-small cell lung cancer confirmed by histopathology or cytology and judged by researchers to be capable of undergoing R0 surgical resection for the purpose of cure. Disease staging should be based on the American Joint Committee on Cancer (AJCC)/International Union Against Cancer (UICC) NSCLC staging system, 8th edition;
There is sufficient tumor tissue to detect PD-L1 expression level and PD-L1 ≥ 1%;
At least one measurable lesion (according to RECIST 1.1 criteria);
The expected survival period is at least 12 weeks;
Other major organs (liver, kidney, blood system, etc.) are functioning well:
Expected to be completely resected;
Good lung function can tolerate surgical treatment;
Female participants with fertility must undergo a pregnancy test (serum or urine) within 72 hours before starting the study medication, and the result must be negative. They must also be willing to use a medically recognized and effective contraceptive measure (such as intrauterine device, contraceptive pill, or condom) during the study period and within 90 days after the last administration of the study medication; For male participants whose partners are women of childbearing age, they must agree to use effective methods of contraception or have undergone surgical sterilization during the study period and within 90 days after the last study administration;
The subjects voluntarily joined this clinical study and signed an informed consent form.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhen Huang | Contact | 13960025158 | huangzhen640@163.com |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| chemotherapy |
| Drug |
Queue A (lung squamous cell carcinoma patients): Albumin paclitaxel 260mg/m2, ivgtt,D1 , Q3W Carboplatin AUC=5, D1,Q3W Queue B (lung adenocarcinoma patients): Pemetrexed 500 mg/m2, ivgtt,D1,Q3W Carboplatin AUC=5, D1,Q3W |
|
| Up to 3 months per two cycles (21 days per cycle) |
| The incidence and severity of adverse events (including serious adverse reactions) | Up to 24 weeks |