Analysis of Deoxyribonucleic Acid and Ribonucleic Acid Next-Generation Sequencing in Non-Small Ce… (NCT07179445) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Analysis of Deoxyribonucleic Acid and Ribonucleic Acid Next-Generation Sequencing in Non-Small Cell Lung Cancer Patients Without Pathological Complete Response Following Neoadjuvant Immunotherapy
China300 participantsStarted 2025-09-20
Plain-language summary
This multicenter, retrospective cohort study plans to enroll patients with lung adenocarcinoma who received neoadjuvant immunotherapy prior to surgery and did not achieve pathological complete response (non-pCR) upon postoperative pathological evaluation. Using Deoxyribonucleic Acid(DNA) and Ribonucleic Acid(RNA) next-generation sequencing (NGS), the investigators aim to detect driver genetic alterations to investigate the real-world frequency of driver gene positivity in postoperative samples from patients with lung adenocarcinoma-whose EGFR and ALK status had been previously excluded via pathological complete response(pCR) or DNA-based next-generation sequencing-yet still did not attain pathological complete response(pCR) after neoadjuvant immunotherapy. Additionally, the study will characterize the driver-positive patient subgroup and compare the efficacy of postoperative adjuvant immunotherapy between driver-positive and driver-negative populations.
Who can participate
Age range
18 Years – 100 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:
* Aged 18 years or older, regardless of sex.
* Pathologically confirmed, resectable non-small cell lung cancer (NSCLC); having received neoadjuvant therapy containing immune checkpoint inhibitors prior to surgery; without achieving pathological complete response (non-pCR) upon postoperative pathological assessment.
* Molecular characteristics: Pre-treatment biopsy specimens tested negative for EGFR mutations and ALK fusions by DNA-based NGS or PCR methods.
* Sample requirements: Availability of 5-10 formalin-fixed, paraffin-embedded (FFPE) sections prepared from surgical tissue specimens, with ≥5% tumor cell content confirmed by H\&E staining.
Exclusion Criteria:
* Failure to meet any one of the requisite eligibility criteria specified in the inclusion criteria.
* History of a concurrent or prior malignancy at other sites.
* Failure to complete the planned cycles of neoadjuvant immunotherapy due to treatment-related toxicities.
* Any other condition that, in the judgment of the investigator, renders the patient unsuitable for participation in this study.
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.
What they're measuring
1
Proportion of driver-alteration-positive patients detected by combined DNA+RNA testing
Timeframe: through study completion, an average of 1 year
Trial details
NCT IDNCT07179445
SponsorTianjin Medical University Cancer Institute and Hospital