NSCLCNCT07243899
Multimodal Model Predicts Treatment Efficacy and CIP Risk in Advanced NSCLC With Immunotherapy and Chemotherapy
An observational study of NSCLC, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
Immunotherapy is a crucial first-line treatment for advanced non-small cell lung cancer (NSCLC) without gene mutations. However, chemotherapy-induced pneumonitis (CIP) is a common adverse effect of immunotherapy, with severe cases even posing a threat to life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC
- What is being tested?
- This study is an observational study; the intervention is not applicable.
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 31 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients diagnosed with inoperable stage IIIB to IV NSCLS using immune checkpoint inhibitors in combination with chemotherapy.
Who may be able to join
- Consistent with the "Chinese Medical Association Guidelines for the Diagnosis and Treatment of Lung Cancer (2018 Edition)," histologically confirmed as NSCLC;
- According to the 8th edition of the AJCC TNM staging system, it is stage III B to IV and not suitable for surgery;
- Age ≥18 years;
- First-time recipients of immunotherapy combined with chemotherapy;
- Baseline data within 1 month before the start of treatment is complete (at least including chest CT, pulmonary function, and laboratory tests);
- At least 1 measurable lesion according to RECIST 1.1;
- Receiving immune checkpoint inhibitor therapy for more than 2 cycles;
- Clinical data is complete.
Who cannot join
- Presence of other malignant tumors;
- Previous exposure to immunotherapy or systemic chemotherapy;
- Patients with severe dysfunction of vital organs (heart, liver, lungs, kidneys) and bone marrow at baseline;
- Presence of severe infectious diseases, active autoimmune diseases, or immune deficiencies that significantly affect immune function;
- Organ transplantation;
- Pregnant or lactating women;
- Incomplete clinical treatment or follow-up information.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Multimodal Model Predicts the Efficacy of Immunotherapy Checkpoint Inhibitors Combined With Chemotherapy for the Treatment of Advanced Non-small Cell Lung Cancer and the Occurrence Risk of Chemotherapy-induced Pneumonitis
Immunotherapy is a crucial first-line treatment for advanced non-small cell lung cancer (NSCLC) without gene mutations. However, chemotherapy-induced pneumonitis (CIP) is a common adverse effect of immunotherapy, with severe cases even posing a threat to life. Therefore, identifying effective biomarkers and models for predicting the efficacy of immunotherapy in NSCLC is of great significance. At present, there is still a lack of effective predictive indicators in clinical practice. This study aims to construct a multimodal model based on factors such as chest CT, pulmonary function, cellular immunity, and cytokine levels to accurately predict the efficacy of combined therapy and the occurrence of related adverse reactions in NSCLC, in order to provide a reference for individualized treatment.
Read the detailed description
This is an observational cross-sectional retrospective study.
- Conditions
- NSCLC
- Being tested
- This study is an observational study; the intervention is not applicable.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This study is an observational study; the intervention is not applicable.Other
This study is an observational study; the intervention is not applicable.
| Study group | Role | What they receive |
|---|---|---|
| Training cohort | for feature selection and model construction Receives: Other: This study is an observational study; the intervention is not applicable. | |
| Internal validation cohort | for hyperparameter optimization and overfitting monitoring Receives: Other: This study is an observational study; the intervention is not applicable. | |
| External validation cohort | an independent cohort for final model validation Receives: Other: This study is an observational study; the intervention is not applicable. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Time from the first dose of immune-checkpoint inhibitor plus chemotherapy to the earliest date of radiologic progression (per RECIST 1.1) or death from any cause.
Measured: From first dose through 31 August 2025, corresponding to a maximum follow-up of approximately 5.5 years (~290 weeks).
Secondary outcomes (2)
The disease control rate (DCR)
Proportion of patients achieving complete response (CR), partial response (PR), or stable disease (SD) as best overall response per RECIST 1.1.
Measured: Tumor response assessed every 6 weeks (±1 week) for up to 24 weeks or until progression/death/cut-off (31 Aug 2025); the proportion will be calculated from the best response recorded within the first 24 weeks (4 cycles) per RECIST 1.1.
Checkpoint inhibitor pneumonitis (CIP)
an immune-related adverse event (irAE) endpoint refers to new pulmonary infiltrates on chest imaging after immune checkpoint inhibitor (ICI) treatment, accompanied by dyspnea and/or other respiratory signs/symptoms (including cough and exertional dyspnea), excluding new pulmonary infections or tumor progression.
Measured: Within 4 months after the initiation of immunotherapy combined with chemotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start1 Jan 2020
- Primary completion28 Feb 2025
- Study completion31 Aug 2025
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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nuo Xu, Principal investigator, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07243899
- Sponsor's protocol ID
- B2025-594R
- Status last verified
- Nov 2025
- First submitted
- 15 Nov 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Multimodal Model Predicts the Efficacy of Immunotherapy Checkpoint Inhibitors Combined With Chemotherapy for the Treatment of Advanced Non-small Cell Lung Cancer and the Occurrence Risk of Chemotherapy-induced Pneumonitis
- ClinicalTrials.gov ID
- NCT07243899
- Acronym / sponsor ID
- B2025-594R
- Conditions
- NSCLC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 24 Nov 2025 (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.
Immunotherapy is a crucial first-line treatment for advanced non-small cell lung cancer (NSCLC) without gene mutations. However, chemotherapy-induced pneumonitis (CIP) is a common adverse effect of immunotherapy, with severe cases even posing a threat to life. Therefore, identifying effective biomarkers and models for predicting the efficacy of immunotherapy in NSCLC is of great significance. At present, there is still a lack of effective predictive indicators in clinical practice. This study aims to construct a multimodal model based on factors such as chest CT, pulmonary function, cellular immunity, and cytokine levels to accurately predict the efficacy of combined therapy and the occurrence of related adverse reactions in NSCLC, in order to provide a reference for individualized treatment.
Detailed description
This is an observational cross-sectional retrospective study.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Training cohort | – | Other: This study is an observational study; the intervention is not applicable.for feature selection and model construction |
| Internal validation cohort | – | Other: This study is an observational study; the intervention is not applicable.for hyperparameter optimization and overfitting monitoring |
| External validation cohort | – | Other: This study is an observational study; the intervention is not applicable.an independent cohort for final model validation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with inoperable stage IIIB to IV NSCLS using immune checkpoint inhibitors in combination with chemotherapy.
Key inclusion criteria (8 listed)
- Consistent with the "Chinese Medical Association Guidelines for the Diagnosis and Treatment of Lung Cancer (2018 Edition)," histologically confirmed as NSCLC;
- According to the 8th edition of the AJCC TNM staging system, it is stage III B to IV and not suitable for surgery;
- Age ≥18 years;
- First-time recipients of immunotherapy combined with chemotherapy;
- Baseline data within 1 month before the start of treatment is complete (at least including chest CT, pulmonary function, and laboratory tests);
Key exclusion criteria (7 listed)
- Presence of other malignant tumors;
- Previous exposure to immunotherapy or systemic chemotherapy;
- Patients with severe dysfunction of vital organs (heart, liver, lungs, kidneys) and bone marrow at baseline;
- Presence of severe infectious diseases, active autoimmune diseases, or immune deficiencies that significantly affect immune function;
- Organ transplantation;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This study is an observational study; the intervention is not applicable.This study is an observational study; the intervention is not applicable. | Other | External validation cohort, Internal validation cohort, Training cohort |
Primary outcome
Progression-free survival (PFS)
Time frame: From first dose through 31 August 2025, corresponding to a maximum follow-up of approximately 5.5 years (~290 weeks).
Time from the first dose of immune-checkpoint inhibitor plus chemotherapy to the earliest date of radiologic progression (per RECIST 1.1) or death from any cause.
2 secondary outcomes
The disease control rate (DCR)
Time frame: Tumor response assessed every 6 weeks (±1 week) for up to 24 weeks or until progression/death/cut-off (31 Aug 2025); the proportion will be calculated from the best response recorded within the first 24 weeks (4 cycles) per RECIST 1.1.
Checkpoint inhibitor pneumonitis (CIP)
Time frame: Within 4 months after the initiation of immunotherapy combined with chemotherapy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Nuo Xu principal investigator
Shanghai Zhongshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NSCLC, run by Shanghai Zhongshan Hospital at 1 site 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 8 inclusion and 7 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: finished, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: From first dose through 31 August 2025, corresponding to a maximum follow-up of approximately 5.5 years (~290 weeks).). 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 24 Nov 2025.