Evaluating tumor DNA in lung cancer patients treated with immune therapies
Therapeutic ResistAnce and Clonal Evolution Assessed With Liquid Biopsy of NSCLC Patients Treated With Immune Checkpoint Inhibitors (ICIs) or Targeted Therapy
This study is trying to see if checking for tumor DNA in the blood can help doctors understand how well immune therapies work for patients with advanced lung cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Geneplus-Beijing Co. Ltd. Industry-sponsored |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT04566432 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the predictive value of circulating tumor DNA (ctDNA) in patients with advanced non-small cell lung cancer (NSCLC) who are receiving immune checkpoint inhibitors or targeted therapies. A total of 250 patients will be recruited, all of whom will undergo both tissue biopsy and liquid biopsy to monitor mutation status. The study will focus on patients without actionable mutations in EGFR or ALK, as well as those with specific actionable mutations receiving targeted therapy. The study will conclude once over 70% of participants experience disease progression.
Who should consider this trial
Good fit: Ideal candidates include newly diagnosed patients with stage IIIB-IV lung adenocarcinoma or squamous cell carcinoma who have not shown EGFR mutations and are receiving immune checkpoint inhibitors.
Not a fit: Patients with other primary cancers, symptomatic brain metastasis, or those who have failed quality control for plasma or tissue samples may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of tumor evolution and treatment response in lung cancer, potentially leading to more personalized treatment strategies.
How similar studies have performed: Other studies utilizing liquid biopsy and ctDNA monitoring in cancer treatment have shown promising results, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Provision of informed consent * Newly diagnosed and histological or cytological confirmed stage IIIB-IV lung adenocarcinoma or squamous cell carcinoma patients according to the AJCC staging system. The stage IV lung cancer and brain metastasis can be diagnosed by imaging and enhanced CT respectively * No EGFR mutation in tissue and ctDNA * Received immune checkpoint inhibitors as the first line therapy * ECOG performance status 0-2 with expected more than 6 months of survival time * Willingness to comply with required protocols and give permission to use the data for clinical research and products development Exclusion Criteria: * Patients have other primary cancers * Patients have symptomatic brain metastasis, complications that are associated with brain metastasis or cognitive disorders * Patients failed in either plasma or tissue sample QC
Where this trial is running
Shanghai
- Shanghai Chest Hospital — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Rongrong Chen, MD, PhD
- Email: chenrr@geneplus.org.cn
- Phone: 86-10-53955678
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.