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

NCT06647836 | Enrolling By Invitation

• 1 other identifier: XHJY20240908
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Squamous Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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)

Study Arms (4)

untreated sq-NSCLC patients

Patients diagnosed with sq-NSCLC for the first time

Other: Efficacy observation

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

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

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

Interventions

Efficacy observation OTHER

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 receiving immunotherapy with poor efficacy; sq-NSCLC patients treated with immunotherapy for -2-3 cycles; untreated sq-NSCLC patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

Union Hospital, Tongji Medical college, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples and tumor tissues will be retained.

Study Officials

• Xueyun Tan, MD

  Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  STUDY DIRECTOR

• Yang Jin, PHD

  Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: deputy dean

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: October 18, 2024
• Study Start: January 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)