Exploration of Predictive Markers of Neoadjuvant Immunotherapy in Non-Small Cell Lung Cancer

ConditionLung Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorGeneplus-Beijing Co. Ltd.

About this trial

Neoadjuvant immunotherapy has become the standard perioperative treatment in lung cancer, but its effective predictive biomarkers are lacking. A small cohort reported that homologous recombination deficiency (HRD) can be used as a reliable biomarker to predict the efficacy of neoadjuvant immunotherapy, but the findings need to be validated in larger cohorts. Moreover, circulating tumor DNA (ctDNA) has the potential to predict the therapeutic efficacy of neoadjuvant immunotherapy.

This study intends to prospectively collect patients with driver-negative stage II-IIIB NSCLC who are scheduled to receive neoadjuvant immunotherapy and surgical resection and verify the value of HRD in predicting the efficacy of neoadjuvant immunotherapy. Meanwhile, the blood samples before and after neoadjuvant immunotherapy were collected for high-depth ctDNA detection to explore the correlation between the dynamic changes of ctDNA and the efficacy and prognosis of neoadjuvant immunotherapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Stage II-IIIB NSCLC

EGFR/ALK negative

The subjects voluntarily joined the study, signed informed consent, had good compliance, and cooperated with follow-up

Disqualifiers

A history of other malignancies within the past 5 years

Patients with autoimmune disease are not suitable for PD1 monoclonal antibody therapy

Trial population

Stage II-IIIB NSCLC who are undergoing neoadjuvant immunotherapy and surgical resection

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Correlation between HRD and MPR rate/2 years DFS

Correlation between homologous recombination deficiency (HRD) events and major pathological response (MPR) rate and DFS of 2 years

Time frame
2023/12-2025/12

Secondary outcomes

Other outcomes

Sponsors and contacts

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