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OpenTrials
Enrolling by Invitation

NCT Number: NCT06647836

The Therapeutic Effect of Immunotherapy 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.

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Key information

Conditions

Squamous Cell Lung Cancer

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Wuhan, Hubei, 430022, China

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Efficacy observation

Other

Observation about the efficacy of sq-NSCLC patients receiving immunotherapy combined with or without chemotherapy as first-line treatment.

Primary outcomes

  1. progression-free survival

    Time frame: 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 outcomes

  1. Overall survival

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Oct 18, 2024
Registry last updated
Dec 12, 2024

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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