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Enrolling by invitationNCT06647836Updated Dec 12, 2024

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

An observational study in Squamous Cell Lung Cancer, sponsored by Wuhan Union Hospital, China. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-12-12.

Sponsored by Wuhan Union Hospital, China · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
1,000
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the detailed description

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

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Conditions studied

  • Squamous Cell Lung Cancer
03

In context

Carcinoma, Squamous Cell

1,774 studies on the registry are indexed under Carcinoma, Squamous Cell; 413 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 100 across 268 observational studies indexed under Carcinoma, Squamous Cell.

Browse Carcinoma, Squamous Cell studies →

Lead sponsor

Wuhan Union Hospital, China is the lead sponsor of 230 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
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.

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

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

Observational model
Cohort
Time perspective
Other
Enrollment
1,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • OtherEfficacy observation

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

06

What researchers measure

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.

    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)

Secondary outcomes

  1. Overall survival

    The survival time aftering receiving immunotherapy combined with or without chemotherapy as first-line treatment.

    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)

07

Study locations

1 site
  • Union Hospital, Tongji Medical college, Huazhong University of Science and Technology
    Wuhan, Hubei 430022, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06647836
Lead sponsor
Wuhan Union Hospital, China
Responsible party
Yang Jin (deputy dean, Wuhan Union Hospital, China) — Principal investigator
First posted
Oct 18, 2024
Start date
Jan 1, 2021
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Dec 12, 2024

Study contacts

Xueyun Tan, MD
study director · Wuhan Union Hospital, China
Yang Jin, PHD
principal investigator · Wuhan Union Hospital, China

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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