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New treatment option for Non Small Cell Lung Cancer
Official title Adebrelimab Plus Chemo and Recaticimab in Perioperative Treatment of Resectable NSCLC
ClinicalTrials.gov ID: NCT06467617
What this study is testing
What is Adebrelimab plus albumin-bound paclitaxel, carboplatin and recaticimab?
Adebrelimab plus albumin-bound paclitaxel, carboplatin and recaticimab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for non small cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Current studies confirmed that the immune perioperative treatment with combination chemotherapy curative effect and safety of resectable NSCLC, but its short-term curative effect and long-term survival benefit remains to be further improved to explore the new way of immune combination therapy. Experimental study showed that the inhibition of PCSK9 could significantly increase in tumor cells of the immune response in mice, inhibit the PCSK9 enhanced anti-tumor immune response of mice can be further coordinate with immune checkpoint therapy, forming a lasting anti-tumor immune effect.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 18-75 years old, male and female;
- ECOG PS 0-1;
- Histologically or cytologically confirmed operable stage II-III NSCLC (stages II, IIIA, and T3N2M0 IIIB) according to the UICC and AJCC 8th edition...
- With a measurable lesions (per RECIST 1.1 standard, tumor lesions on CT scan length to diameter 10 mm, or lymph node lesions on CT scans short...
- Anti-tumor treatment (radiotherapy, chemotherapy, surgery, and targeted therapy) naive enrollment;
You likely can't join if
- Known EGFR or ALK mutation;
- T4 tumors invading the heart, great vessels, trachea, recurrent laryngeal nerve, esophagus, vertebral body, tracheal carina, Upper sulcus lung cancer;
- Use of immunosuppressive drugs within 4 weeks before the first dose of study drug, excluding nasal spray and inhaled corticosteroids or physiological...
- Received immunoregulatory effects of herbal medicine or Immune regulating effect of drugs (including thymosin, interferon, interleukin, except for...
- Malignant tumors other than NSCLC occurred within 5 years before enrollment.
- Administered Live attenuated vaccine ≤ 4 weeks before the first dose or will be planned for the duration of the study；
See the full eligibility criteria
- 18-75 years old, male and female;
- ECOG PS 0-1;
- Histologically or cytologically confirmed operable stage II-III NSCLC (stages II, IIIA, and T3N2M0 IIIB) according to the UICC and AJCC 8th edition TNM staging system. Non-massive metastases (short diameter ≤2cm Lymph...
- With a measurable lesions (per RECIST 1.1 standard, tumor lesions on CT scan length to diameter 10 mm, or lymph node lesions on CT scans short diameter 15 mm or higher);
- Anti-tumor treatment (radiotherapy, chemotherapy, surgery, and targeted therapy) naive enrollment;
- Enough of lung function to go through R0 resection with a purpose of cure;
- Normal main organs function, should meet the following criteria: (1) the blood routine examination shall meet within 14 days (without blood transfusion, hematopoietic factor not used and unused drugs to correct) a...
- Known EGFR or ALK mutation;
- T4 tumors invading the heart, great vessels, trachea, recurrent laryngeal nerve, esophagus, vertebral body, tracheal carina, Upper sulcus lung cancer;
- Use of immunosuppressive drugs within 4 weeks before the first dose of study drug, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroids (i.e., ≤10 mg/day of prednisolone or other...
- Received immunoregulatory effects of herbal medicine or Immune regulating effect of drugs (including thymosin, interferon, interleukin, except for local control Pleural effusion use) within 4 weeks before the first use...
- Malignant tumors other than NSCLC occurred within 5 years before enrollment.
- Administered Live attenuated vaccine ≤ 4 weeks before the first dose or will be planned for the duration of the study；
- Current are participating in clinical research and treatment of intrusive, or within 4 weeks before the first delivery received study drugs or other treatments; Not fully recovered from any intervention-related toxicity...
- Severe infection (e.g., requiring intravenous antibiotics, antifungal or antiviral drugs) within 4 weeks before the first dose, or unexplained fever during screening/before the first dose. 38.5°C；
- Have or suspected a history of pneumonia/interstitial lung disease or any lung disease that would interfere with pulmonary function testing;
- With any active history of autoimmune disease or autoimmune diseases; Patients with complete remission of childhood asthma without any intervention in adulthood or with vitiligo were eligible;
- With congenital or acquired immune function defects, such as human immunodeficiency virus (HIV) infection, active hepatitis B, hepatitis C, hepatitis B and hepatitis C infection together and alcoholic liver cirrhosis...
- Patients with grade II or higher myocardial ischemia or myocardial infarction, poorly controlled arrhythmia (including QTc interval ≥450ms in men and ≥470ms in women). According to NYHA standard, grade III \~ Ⅳ cardiac...
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST) more than 2 times the upper limit of normal value, or total bilirubin more than 1.5 times the upper limit of normal value (ULN); Creatine kinase (CK) was...
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- Known allergy, hypersensitivity, or intolerance to the study drug or its excipients;
- Any condition considered by the investigator to be present that could harm the subject or cause the subject to be unable to meet or perform the requirements of the study.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.