NSCLCNCT07388771
Prediction of Outcome to Neoadjuvant Therapy in Non-small Cell Lung Cancer（NSCLC）
An observational study of NSCLC and Neoadjuvant Therapy, run by Qian Chu at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC, Neoadjuvant Therapy
- How many people
- 500 participants
- Where
- 2 sitesChina
- Study dates
- 1 Dec 2025to Oct 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: NSCLC patients suitable for neoadjuvant therapy
Who may be able to join
- pathologically diagnosed non-small cell lung cancer
- The treatment plan is：receiving neoadjuvant chemo-immunotherapy during the study period, followed by surgical resection
Who cannot join
- recurrent or metastatic lung cancer;
- patients with other primary tumors
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, 430030
Minghao Hu, 8613396366466, huminghao2010@126.com
- Recruiting
Tongji hospital
Wuhan, Hubei, 430030
Minghao Hu, 8613396366466
About this study
Official title: A Study on Multimodal Data Prediction of Outcome to Neoadjuvant Therapy in NSCLC
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?
- Conditions
- NSCLC, Neoadjuvant Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| NSCLC with neoadjuvant therapy but without surgery | Not described | |
| NSCLC with neoadjuvant therapy and surgery | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathologic response
Measured: Perioperative
Secondary outcomes (1)
EFS
event free survival
Measured: One year after the treatment ended
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start1 Dec 2025
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Qian Chu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qian Chu, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07388771
- Sponsor's protocol ID
- TJ-IRB202512147
- Status last verified
- Mar 2026
- First submitted
- 28 Jan 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to patient and hospital ethical requirements, this project does not currently meet the criteria for Individual Patient Data (IPD).
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Multimodal Data Prediction of Outcome to Neoadjuvant Therapy in NSCLC
- ClinicalTrials.gov ID
- NCT07388771
- Acronym / sponsor ID
- TJ-IRB202512147
- Conditions
- NSCLC, Neoadjuvant Therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Qian ChuUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 5 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NSCLC with neoadjuvant therapy but without surgery | – | – |
| NSCLC with neoadjuvant therapy and surgery | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- NSCLC patients suitable for neoadjuvant therapy
Key inclusion criteria (2 listed)
- pathologically diagnosed non-small cell lung cancer
- The treatment plan is：receiving neoadjuvant chemo-immunotherapy during the study period, followed by surgical resection
Key exclusion criteria (2 listed)
- recurrent or metastatic lung cancer;
- patients with other primary tumors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
pathologic response
Time frame: Perioperative
1 secondary outcome
EFS
Time frame: One year after the treatment ended
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: No. Due to patient and hospital ethical requirements, this project does not currently meet the criteria for Individual Patient Data (IPD).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NSCLC and Neoadjuvant Therapy, run by Qian Chu at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Minghao Hu (8613396366466, huminghao2010@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathologic response (time frame: Perioperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.