About this trial
To evaluate the major pathological response rate of Adibelimab combined with Apatinib neoadjuvant therapy in resectable non-small cell lung cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years old ≤ age ≤70 years old, male or female;
ECOG PS score 0-1;
Patients who have not received systematic treatment before and agree to receive radical surgical treatment; Thoracic surgeons judge patients with no contraindications to surgery;
Stage II, IIIA, or selective stage IIIB (T3N2M0 only) squamous cell or non-squamous non-small cell lung cancer confirmed by histopathology or cytology and determined by the investigator to be capable of R0 resection for curative purposes. Staging should be based on the American Joint Committee on Cancer (AJCC)/Union International Against Cancer (UICC) NSCLC Staging System Version 8;
Disqualifiers
have received any anti-tumor therapy in the past, including radiotherapy, chemotherapy, immunotherapy and traditional Chinese medicine anti-tumor therapy (except the treatment of malignant tumors with radical treatment and no recurrence and metastasis for more than 5 years);
Subjects with non-squamous cell histological types of NSCLC with EGFR mutation positive or ALK positive. Non-squamous cell carcinoma subjects must undergo EGFR gene testing and ALK gene and/or immunohistochemical testing;
Patients with distant metastases (including M1a, M1b, and M1c);
Have any active autoimmune disease or history of autoimmune disease (such as uveitis, enteritis, hepatitis, pituitaritis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (may be included after hormone replacement therapy), tuberculosis); Skin conditions (such as vitiligo, psoriasis, or alopecia) with complete remission of childhood asthma that do not require any intervention in adulthood and do not require systemic treatment may be included, but patients requiring medical intervention with bronchodilators may not be included;
Trial design
Single group
Treatments tested in this trial
Adebrelimab
DrugAdebrelimab 1200mg, iv, D1,Q3W
Apatinib
DrugApatinib 250mg,P.O,qd,Q3W
Treatment groups
Trial outcomes
Primary outcomes
Major pathological response (MPR)
When the tumor was surgically resected, the active tumor tissue in the surgical specimen was less than 10%
Secondary outcomes
Pathological complete response (pCR)
R0 resection rate
Objective response rate (ORR)
The incidence of adverse events (including serious adverse events) and rank
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: