Adebrelimab + Chemotherapy as Neoadjuvant Therapy for Resectable NSCLC
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorZhangzhou Municipal Hospital
About this trial
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).
Eligibility criteria
Qualifiers
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;
Disqualifiers
Previously received any anti-tumor treatment, including radiotherapy, chemotherapy, immunotherapy, and traditional Chinese medicine anti-tumor treatment (excluding treatment for malignant tumors that have been cured and have no recurrence or metastasis for ≥ 5 years);
Non squamous cell carcinoma histological types of NSCLC with EGFR mutation positive or ALK positive subjects. Non squamous cell carcinoma subjects must undergo EGFR gene testing and ALK gene and/or immunohistochemical testing;
Patients with distant metastases (including M1a, M1b, M1c);
Suffering from any active autoimmune disease or history of autoimmune disease (such as uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (which can be included after hormone replacement therapy), tuberculosis); Skin diseases that have completely relieved childhood asthma and do not require any intervention or systemic treatment in adulthood (such as vitiligo, psoriasis, or hair loss) can be included, but patients who require medical intervention with bronchodilators cannot be included;
Trial design
Treatments tested in this trial
- Adebrelimab
- chemotherapy
Treatment groups
32 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov