Multimodal Model Predicts Treatment Efficacy and CIP Risk in Advanced NSCLC With Immunotherapy and Chemotherapy

NCT ID: NCT07243899

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 3000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2025-08-31

Brief 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. 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.

Conditions

NSCLC

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

External validation cohort

an independent cohort for final model validation

This study is an observational study; the intervention is not applicable.

Intervention Type: OTHER

This study is an observational study; the intervention is not applicable.

Training cohort

for feature selection and model construction

This study is an observational study; the intervention is not applicable.

Intervention Type: OTHER

This study is an observational study; the intervention is not applicable.

Internal validation cohort

for hyperparameter optimization and overfitting monitoring

This study is an observational study; the intervention is not applicable.

Intervention Type: OTHER

This study is an observational study; the intervention is not applicable.

Interventions

This study is an observational study; the intervention is not applicable.

This study is an observational study; the intervention is not applicable.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Consistent with the "Chinese Medical Association Guidelines for the Diagnosis and Treatment of Lung Cancer (2018 Edition)," histologically confirmed as NSCLC;

2. According to the 8th edition of the AJCC TNM staging system, it is stage III B to IV and not suitable for surgery;

3. Age ≥18 years;

4. First-time recipients of immunotherapy combined with chemotherapy;

5. Baseline data within 1 month before the start of treatment is complete (at least including chest CT, pulmonary function, and laboratory tests);

6. At least 1 measurable lesion according to RECIST 1.1;

7. Receiving immune checkpoint inhibitor therapy for more than 2 cycles;

8. Clinical data is complete.

Exclusion Criteria

1. Presence of other malignant tumors;

2. Previous exposure to immunotherapy or systemic chemotherapy;

3. Patients with severe dysfunction of vital organs (heart, liver, lungs, kidneys) and bone marrow at baseline;

4. Presence of severe infectious diseases, active autoimmune diseases, or immune deficiencies that significantly affect immune function;

5. Organ transplantation;

6. Pregnant or lactating women;

7. Incomplete clinical treatment or follow-up information.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nuo Xu

Role: PRINCIPAL_INVESTIGATOR

Shanghai Zhongshan Hospital

Locations

180 Fenglin Road

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

B2025-594R

Identifier Type: -

Identifier Source: org_study_id