Adebrelimab + Chemotherapy as Neoadjuvant Therapy for Resectable NSCLC (NCT07035392) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Adebrelimab + Chemotherapy as Neoadjuvant Therapy for Resectable NSCLC
32 participantsStarted 2025-06-20
Plain-language summary
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).
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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);
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. The expected survival period is at least 12 weeks;
. Other major organs (liver, kidney, blood system, etc.) are functioning well:
Exclusion criteria
. 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;
. Exclude evidence of past or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiological pneumonia, drug-induced pneumonia, imaging confirmed active pneumonia, and severe impairment of lung function;
. Subjects who have received systemic therapy with corticosteroids (\>10 mg/day of prednisone or other equivalent hormones) or other immunosuppressive agents within 2 weeks prior to their first administration. In the absence of active autoimmune diseases, inhalation or topical use of corticosteroids is allowed, as well as adrenal hormone replacement therapy with a dose of ≤ 10 mg/day effective dose of prednisone;
. Imaging (CT or MRI) shows tumor invasion into large blood vessels or blurred boundaries with blood vessels; Or imaging (CT or MRI) shows the presence of any pulmonary cavities or necrotic lesions, as determined by the researcher;
. Individuals who have experienced arterial/venous thrombotic events within the first 6 months of enrollment, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;