Multimodal Model Predicts Treatment Efficacy and CIP Risk in Advanced NSCLC With Immunotherapy an… (NCT07243899) | Clinical Trial Compass
CompletedNot Applicable
Multimodal Model Predicts Treatment Efficacy and CIP Risk in Advanced NSCLC With Immunotherapy and Chemotherapy
China3,000 participantsStarted 2020-01-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. Presence of other malignant tumors;
✕
What they're measuring
1
Progression-free survival (PFS)
Timeframe: From first dose through 31 August 2025, corresponding to a maximum follow-up of approximately 5.5 years (~290 weeks).