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A multicenter, prospective real-world study of adebrelimab injection in the treatment of non-small cell lung cancer

A multicenter, prospective real-world study of adebrelimab injection in the treatment of non-small cell lung cancer

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400081790
Enrollment
Unknown
Registered
2024-03-12
Start date
2024-03-12
Completion date
Unknown
Last updated
2024-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small cell lung cancer

Interventions

Case series:None

Sponsors

The Eighth Medical Center of Chinese People's Liberation Army General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Sign the informed consent form and voluntarily join this study; 2. Non-small cell lung cancer was confirmed by histopathological/ cytopathology examination; 3. Age =18 years old; 4. The researcher determined that patients can receive adebelizumab monotherapy or combination therapy; 5. Fertile female subjects should be negative in urine or serum pregnancy test within 7 days before receiving the first drug administration (the first cycle, the first day). If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required; For fertile women and men, they must agree to use appropriate methods of contraception or surgical sterilization during the trial and within 90 days after the last administration of the test drug. 6. Be able to follow the research and follow-up procedures.

Exclusion criteria

Exclusion criteria: 1. Patients who have received other immune drugs or therapies at the same time; 2. Patients who are participating in other intervention studies, or who have received other research drugs or used research equipment within 4 weeks before the first administration; 3. Patients with other malignant tumors at the same time, or malignant tumors other than NSCLC within 5 years before enrollment, except fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery. 4. Confirmed pregnant and lactating women; 5. Patients with known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive); 6. Patients with missing data information related to key research; 7. Patients who are known to be allergic to adebelizumab or any of its drugs and accessories; 8. Any other circumstances that the researcher considers that the patient is not suitable to participate in this study, including but not limited to the following circumstances: (1) Patients with autoimmune diseases (AIDs), especially nervous system AIDs, or AIDs is moderate or severe or in active phase, and immunosuppressants can't control or need high-dose immunosuppressants to control symptoms; (2) The patient is accompanied by tuberculosis infection and active tuberculosis, and the subjects suspected of active TB need to check chest X-ray and sputum and be excluded through clinical symptoms and signs; (3) The patient is accompanied by untreated active hepatitis B; (4) Patients have received or will receive solid organ transplantation or hematopoietic stem cell transplantation in the past; (5) The patient was accompanied by thymic tumor; (6) Patients need to use antibiotics, glucocorticoids, proton pump inhibitors and other drugs for a long time; (7) Patients with major organ dysfunction and PS=3.

Design outcomes

Primary

MeasureTime frame
Safety (occurrence of = grade 3 AE);

Secondary

MeasureTime frame
Healing effect;Safety (the incidence of AE/SAE) ;

Countries

China

Contacts

Public ContactZheng Mengli

The Eighth Medical Center of Chinese People's Liberation Army General Hospital

13311394905@163.com+86 157 0112 7527

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026