NCT07388771

Brief Summary

This observational study aims to construct and validate the performance of a multimodal predictive model in forecasting the outcomes of neoadjuvant therapy in patients with NSCLC. The core research question is: Can a multi-model approach predict outcomes of neoadjuvant therapy for non-small cell lung cancer and provide clinical recommendations?

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
3mo left

Started Dec 2025

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Dec 2025Oct 2026

Study Start

First participant enrolled

December 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 5, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

10 months

First QC Date

January 28, 2026

Last Update Submit

March 18, 2026

Conditions

NSCLCNeoadjuvant Therapy

Outcome Measures

Primary Outcomes (1)

  • pathologic response

    Perioperative

Secondary Outcomes (1)

  • EFS

    One year after the treatment ended

Study Arms (2)

NSCLC with neoadjuvant therapy but without surgery

NSCLC with neoadjuvant therapy and surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

NSCLC patients suitable for neoadjuvant therapy

You may qualify if:

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

You may not qualify if:

  • recurrent or metastatic lung cancer;
  • patients with other primary tumors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tongji hospital

Wuhan, Hubei, 430030, China

RECRUITING

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, 430030, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Preoperative pathological biopsy puncture specimens

Central Study Contacts

Minghao Hu

CONTACT

8613396366466huminghao2010@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of the Thoracic Oncology Department

Study Record Dates

First Submitted

January 28, 2026

First Posted

February 5, 2026

Study Start

December 1, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

March 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Due to patient and hospital ethical requirements, this project does not currently meet the criteria for Individual Patient Data (IPD).

Locations

CN(2)