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NCT04977791Recruiting

Analysis of Drug Resistance in Immune Checkpoint Inhibitors of Non-small Cell Lung Cancer

Molecular Landscape of Primary and Acquired Resistance to Immune Checkpoint Inhibitors in Patients With Chinese Advanced Non-small Cell Lung Cancer

Source: ClinicalTrials.gov · Last updated 22 May 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

Immunotherapy has improved the prognosis of non-small cell lung cancer (NSCLC) patients, but about 80% of patients do not respond at all, which is called primary resistance. Absence of the PD-L1 expression is regarded as one of primary resistant reasons to immunotherapy, there are some other reasons which have been reported to be related with the primary resistance, including tumor mutation burden (TMB), microsatellite instability (MSI), tumor neoantigen burden (TNB), HLA genotype, loss of heterozygosity (LOH), intra tumoral heterogeneity (ITH), genome wide doubling (WGD), and ploidy. While some patients initially respond to immunotherapy, later relapse and develop disease progression, which is called acquired resistance, like escaping of interferon signaling pathways or mutations in some important genes such as B2M/JAK1/JAK2. So the objective of this research is to explore the comprehensive immune molecular markers of primary and acquired resistance to immunotherapy in patients with Chinese advanced NSCLC based on the results of whole exome sequencing (WES) and targeted sequencing (TS)

Status (registry)
Recruiting
Study type
Observational
Enrollment
250 (estimated)
First submitted
9 Jul 2021
Start date
21 Jul 2016
Primary completion date
1 Dec 2026
Lead sponsor
Shanghai Chest Hospital
Diseases
Lung cancer
NCT number
NCT04977791

What you commit to

  • Study type: Observational
  • Planned participants: 250
  • From 21 Jul 2016 to the primary completion date, 1 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients with other tumors. Except for basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin or cervical cancer in situ, subjects who have received potential radical treatment and have not relapsed within 5 years before the start of treatment can be included in the study;
  • Have received any approved systemic anti-tumor immunotherapy before starting the research treatment;
  • Known human immunodeficiency virus infection; previous allogeneic stem cell transplantation or organ transplantation;

Other illness

  • A history of interstitial lung disease, non-infectious pneumonia or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung disease, etc.;
  • Severe chronic or active infections that require systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection;

Other

  • The investigator judged that the patient's compliance during the study period was insufficient

Who the study is looking for

  • Be able to provide informed consent, and understand and agree to follow the research requirements;
  • Advanced non-small cell lung cancer;
  • Patients receiving immune checkpoint inhibitor treatment represented by anti-PD-1/PD-L1 monoclonal antibody;
  • The patient must be able to provide fresh tumor tissue before- and after- ICIs (50mg of tumor tissue sample/ 2 needles of 18G thick needle puncture) or tumor tissue archived within one year (FFPE tissue block or about 15 pieces \[10- 15 sheets\] Freshly cut, unstained FFPE slides) and pathology reports (except for advanced non-small cell lung cancer other than neuroendocrine cancer); provide matched 10mL peripheral whole blood samples at the same time;
  • ECOG physical fitness status ≤1;
  • The patient must have at least one measurable lesion (assessed according to RECIST v1.1);
  • Life expectancy ≥ 12 weeks;
  • The patient must have adequate organ function, and must be reached absolute neutrophil count (ANC) ≥1.5x10\^9/L, platelets ≥100x10\^9/L, hemoglobin ≥90g/L, international normalized ratio (INR) or prothrombin time ≤ 1.5x ULN , activated partial thromboplastin time (aPTT)≤1.5x ULN, serum total bilirubin≤1.5x ULN (Patients with Gilbert syndrome can be enrolled if total bilirubin\<3x ULN), Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤2.5x ULN(Patient with liver metastases, this standard is AST and ALT≤5x ULN) within 7 days before treatment;

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Xiaomin Niu
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.