The Therapeutic Effect of Immunotherapy in Patients With Advanced Lung Squamous Carcinoma

• Conditions: Squamous Cell Lung Cancer

• Registration Number: NCT06647836
• Lead Sponsor: Wuhan Union Hospital, China

Brief Summary

The aim of this observational study is to investigate the treatment trajectory of immunotherapy in patients with squamous non-small cell lung cancer (sq-NSCLC). The primary objective is to identify potential indicators that can predict the efficacy of immunotherapy and explore strategies to prolong its effectiveness in sq-NSCLC patients. Biological specimens and medical imaging data will be collected from patients already receiving immunotherapy as a first-line treatment, and follow-up will be conducted to analyze prognosis based on different patterns.

Detailed Description

The medical imaging data will be collected retrospectively and prospectively and the blood samples and tumor tissues will be collected prospectively.

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2024-09-11
• Study First Submitted QC: 2024-10-17
• Study First Posted: 2024-10-18
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-11
• Last Update Posted: 2024-12-12
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Diagnosed with sq-NSCLC;
• Receiving immunotherapy combined with or without chemotherapy as first-line treatment;
• ≥ 18 years and ≤ 80 years old;
• No previous treatment in the lungs or any other organ.

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Exclusion Criteria

• History of cancer treatment;
• History of other malignant tumors;
• Irregular treatment or poor compliance;
• Incomplete clinical information or lost to follow-up.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
progression-free survival	A two-year period after starting treatment (Regular follow-up every three months after receiving immunotherapy combined with or without chemotherapy as first-line treatment)	The time of disease progression is evaluated according to the Response Evaluation Criteria in Solid Tumors, version 1.1.

Secondary Outcome Measures

Name	Time	Method
Overall survival	A three-year period after starting treatment (Regular follow-up every six months after receiving immunotherapy combined with or without chemotherapy as first-line treatment)	The survival time aftering receiving immunotherapy combined with or without chemotherapy as first-line treatment.

Trial Locations

Locations (1)

Union Hospital, Tongji Medical college, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China