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NCT Number: NCT07243899

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

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.

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Key information

Conditions

NSCLC

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

180 Fenglin Road

Shanghai, Shanghai Municipality, 200032, China

About this study

This is an observational cross-sectional retrospective study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;
  • 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.

Treatment and study plan

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

Other

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

Primary outcomes

  1. Progression-free survival (PFS)

    Time frame: From first dose through 31 August 2025, corresponding to a maximum follow-up of approximately 5.5 years (~290 weeks).

    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.

Secondary outcomes

  1. The disease control rate (DCR)

    Time frame: 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.

    Proportion of patients achieving complete response (CR), partial response (PR), or stable disease (SD) as best overall response per RECIST 1.1.

  2. Checkpoint inhibitor pneumonitis (CIP)

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

    an immune-related adverse event (irAE) endpoint refers to new pulmonary infiltrates on chest imaging after immune checkpoint inhibitor (ICI) treatment, accompanied by dyspnea and/or other respiratory signs/symptoms (including cough and exertional dyspnea), excluding new pulmonary infections or tumor progression.

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Nov 24, 2025
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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