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

NCT07243899 | Completed

• 1 other identifier: B2025-594R
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

NSCLC

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  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)

  Within 4 months after the initiation of immunotherapy combined with chemotherapy.

Study Arms (3)

Training cohort

for feature selection and model construction

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

Internal validation cohort

for hyperparameter optimization and overfitting monitoring

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

External validation cohort

an independent cohort for final model validation

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

Interventions

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

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

External validation cohort; Internal validation cohort; Training cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with inoperable stage IIIB to IV NSCLS using immune checkpoint inhibitors in combination with chemotherapy.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

180 Fenglin Road

Shanghai, Shanghai Municipality, 200032, China

Location

Study Officials

• Nuo Xu

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2025
• First Posted: November 24, 2025
• Study Start: January 1, 2020
• Primary Completion: February 28, 2025
• Study Completion: August 31, 2025
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)