Clinical trial · Observational
Multimodal Model Predicts Treatment Efficacy and CIP Risk in Advanced NSCLC With Immunotherapy and Chemotherapy
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| This study is an observational study; the intervention is not applicable. | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Training cohort
- description
- for feature selection and model construction
- interventionNames
- Other: This study is an observational study; the intervention is not applicable.
- label
- Internal validation cohort
- description
- for hyperparameter optimization and overfitting monitoring
- interventionNames
- Other: This study is an observational study; the intervention is not applicable.
- label
- External validation cohort
- description
- an independent cohort for final model validation
- interventionNames
- Other: This study is an observational study; the intervention is not applicable.
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
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