NCT07243899Completed
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 · Last updated 24 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 3000 (actual)
- First submitted
- 15 Nov 2025
- Start date
- 1 Jan 2020
- Primary completion date
- 28 Feb 2025
- Lead sponsor
- Shanghai Zhongshan Hospital
- Diseases
- Lung cancer
- NCT number
- NCT07243899
What you commit to
- Study type: Observational
- Participants enrolled: 3000
- From 1 Jan 2020 to the primary completion date, 28 Feb 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous exposure to immunotherapy or systemic chemotherapy;
- Organ transplantation;
Other illness
- Presence of other malignant tumors;
- 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;
Other
- Pregnant or lactating women;
- Incomplete clinical treatment or follow-up information.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| 180 Fenglin Road Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.