Predicting outcomes of pre-surgery treatment for non-small cell lung cancer

A Study on Multimodal Data Prediction of Outcome to Neoadjuvant Therapy in NSCLC

This project will try to use clinical, imaging, and molecular data to predict which patients with non-small cell lung cancer will respond to neoadjuvant chemo‑immunotherapy before surgery.

Quick facts

• Study type: Observational
• Enrollment: 500 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Tongji Hospital (Academic / other)
• Drugs / interventions: immunotherapy
• Locations: 2 sites (Wuhan, Hubei and 1 other locations)
• Trial ID: NCT07388771 on ClinicalTrials.gov

What this trial studies

This observational study will enroll patients with pathologically confirmed NSCLC who receive neoadjuvant chemo‑immunotherapy followed by surgical resection at two tertiary hospitals in China. Investigators will collect clinical information, imaging, pathological response data, and available molecular markers to build a multimodal predictive model. Machine learning methods will be used to train the model on part of the cohort and validate performance on held‑out and external center cases when available. The aim is to produce a tool that forecasts pathological response to neoadjuvant therapy and can inform preoperative decision making.

Who should consider this trial

Good fit: Adults with pathologically confirmed non‑small cell lung cancer who are planned to receive neoadjuvant chemo‑immunotherapy followed by surgical resection and do not have distant metastases or other primary tumors are ideal candidates.

Not a fit: Patients with recurrent or metastatic lung cancer or with other concurrent primary tumors are excluded and would not be expected to benefit from the model.

Why it matters

Potential benefit: If successful, the model could help doctors identify which patients are likely to benefit from neoadjuvant chemo‑immunotherapy and personalize preoperative treatment plans.

How similar studies have performed: Previous radiomics and genomic studies have shown promise in predicting response to neoadjuvant therapy in NSCLC, but fully integrated multimodal prediction models remain emerging and need broader validation.

Eligibility criteria

Inclusion Criteria:

1. pathologically diagnosed non-small cell lung cancer
2. The treatment plan is：receiving neoadjuvant chemo-immunotherapy during the study period, followed by surgical resection

Exclusion Criteria:

1. recurrent or metastatic lung cancer;
2. patients with other primary tumors

Where this trial is running

Wuhan, Hubei and 1 other locations

• Tongji hospital — Wuhan, Hubei, China (Recruiting)
• Sir Run Run Shaw Hospital — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Minghao Hu

Conditions NSCLC; Neoadjuvant Therapy