An interventional study of Adaptive therapy of de-escalation and escalation based on MRD testing and pathological response in Lung Neoplasms, Neoadjuvant Therapy and Immunotherapy, sponsored by Peking University People's Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Peking University People's Hospital · Not applicable, Interventional, and Treatment
This study is a prospective single-arm clinical trial targeting patients with stage IB-IIIA non-small cell lung cancer (NSCLC) who have received neoadjuvant immunotherapy. The primary objective is to evaluate whether a personalized follow-up and adjuvant treatment strategy-based on the combination of ctDNA-based minimal residual disease (MRD) testing and pathological response-can effectively improve the 2-year postoperative recurrence-free survival (RFS). The study will enroll 100 patients scheduled for radical surgery who have undergone neoadjuvant immunotherapy (in combination with platinum-based chemotherapy). Patients will receive individualized follow-up and adjuvant therapy based on dynamic changes in ctDNA at various preoperative and postoperative timepoints, as well as pathological response. Adjuvant therapy will be recommended if patients do not achieve pathological complete response (pCR) after surgery, or if ctDNA testing is positive after neoadjuvant therapy or post-surgery. Only patients who achieve pCR and have negative ctDNA at both specified timepoints will forgo adjuvant therapy; these patients will undergo blood sampling at each routine follow-up, with adjuvant therapy initiated upon ctDNA seroconversion to positive. The primary endpoint is 2-year RFS after surgery; secondary endpoints include overall survival (OS) and the diagnostic rate of recurrence/metastasis based on ctDNA-MRD testing. This project aims to explore the refinement of adaptive treatment strategies in the neoadjuvant immunotherapy lung cancer population, with the ultimate goal of improving overall therapeutic efficacy and establishing a standardized, integrated postoperative management system suitable for lung cancer patients.
7,334 studies on the registry are indexed under Lung Neoplasms; 1,554 are open to participants now.
This study's planned enrollment of 100 is above the median of 60 across 5,345 interventional studies indexed under Lung Neoplasms.
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Other: Adaptive therapy of de-escalation and escalation based on MRD testing and pathological response
Postoperative adjuvant therapy is administered if any of the following criteria are met: absence of pathological complete response (pCR), positive preoperative ctDNA after neoadjuvant therapy, or positive postoperative ctDNA. Treatment regimens are determined by multidisciplinary review. Monthly blood sampling is performed during adjuvant therapy. Based on current evidence, treatment de-escalation based solely on ctDNA status is not supported in lung cancer patients receiving neoadjuvant immunotherapy. Thus, patients achieving pCR with negative ctDNA at both predefined timepoints receive no adjuvant therapy. Blood is collected at routine follow-up visits, and adjuvant therapy is initiated upon ctDNA seroconversion to positive.
Two-year recurrence-free survival rate
Time frame: Time from curative surgery to confirmation of clinical progression (recurrence or metastasis) within two years.
Overall survival
Time frame: Time from curative surgery to confirmation of death (any cause)，assessed up to 60 months.
Timely diagnosis rate by the novel MRD monitoring technique
The proportion of patients with recurrence signals detected by non-invasive methods prior to clinical confirmation of recurrence/metastasis, and quantify the mean lead time.
Time frame: two years
Plan to share: Undecided
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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