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

Exploration of the Treatment Trajectory and Drug Resistance Mechanism of Immunotherapy Combined With Chemotherapy in Patients With Advanced Lung Squamous Carcinoma

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Squamous Cell Lung Cancer
• Intervention / Treatment: Other: Efficacy observation

Detailed Description

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

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

From January 2021 to December 2025, about 1000 patients with sq-NSCLC receiving immunotherapy combined with or without chemotherapy as first-line treatment will be enrolled in this cohort study.

Description

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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
untreated sq-NSCLC patients; Patients diagnosed with sq-NSCLC for the first time	Other: Efficacy observation; Observation about the efficacy of sq-NSCLC patients receiving immunotherapy combined with or without chemotherapy as first-line treatment.
sq-NSCLC patients treated with immunotherapy for -2-3 cycles; sq-NSCLC patients treated with immunotherapy combined with or without chemotherapy as first-line treatment for 2-3 cycles.	Other: Efficacy observation; Observation about the efficacy of sq-NSCLC patients receiving immunotherapy combined with or without chemotherapy as first-line treatment.
sq-NSCLC patients receiving immunotherapy with poor efficacy; sq-NSCLC patients treated with immunotherapy combined with or without chemotherapy as first-line treatment and experience disease progression within six months.	Other: Efficacy observation; Observation about the efficacy of sq-NSCLC patients receiving immunotherapy combined with or without chemotherapy as first-line treatment.
sq-NSCLC patients receiving immunotherapy with good efficacy; sq-NSCLC patients treated with immunotherapy combined with or without chemotherapy as first-line treatment and having progression-free survival longer than six months.	Other: Efficacy observation; Observation about the efficacy of sq-NSCLC patients receiving immunotherapy combined with or without chemotherapy as first-line treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
progression-free survival	The time of disease progression is evaluated according to the Response Evaluation Criteria in Solid Tumors, version 1.1.	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	The survival time aftering receiving immunotherapy combined with or without chemotherapy as first-line treatment.	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)

Collaborators and Investigators

• Sponsor: Wuhan Union Hospital, China
• Investigators: Principal Investigator: Yang Jin, PHD, Wuhan Union Hospital, China; Study Director: Xueyun Tan, MD, Wuhan Union Hospital, China

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: September 11, 2024
• First Submitted That Met QC Criteria: October 17, 2024
• First Posted (Actual): October 18, 2024

Study Record Updates

• Last Update Posted (Estimated): December 12, 2024
• Last Update Submitted That Met QC Criteria: December 11, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Neoplasms, Squamous Cell; Carcinoma, Squamous Cell
• Other Study ID Numbers: XHJY20240908

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No