Squamous Cell Lung CancerNCT06647836
The Therapeutic Effect of Immunotherapy in Patients With Advanced Lung Squamous Carcinoma
An observational study of Squamous Cell Lung Cancer, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Squamous Cell Lung Cancer
- What is being tested?
- Efficacy observation
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- History of cancer treatment;
- History of other malignant tumors;
- Irregular treatment or poor compliance;
- Incomplete clinical information or lost to follow-up.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Union Hospital, Tongji Medical college, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
About this study
Official title: 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.
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.
- Conditions
- Squamous Cell Lung Cancer
- Being tested
- Efficacy observation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efficacy observationOther
Observation about the efficacy of sq-NSCLC patients receiving immunotherapy combined with or without chemotherapy as first-line treatment.
| Study group | Role | What they receive |
|---|---|---|
| untreated sq-NSCLC patients | Patients diagnosed with sq-NSCLC for the first time Receives: 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. Receives: 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. Receives: 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. Receives: Other: Efficacy observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
The time of disease progression is evaluated according to the Response Evaluation Criteria in Solid Tumors, version 1.1.
Measured: 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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start1 Jan 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Jin, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Investigators
- Xueyun Tan, MD, Study director, Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyYang Jin, PHD, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06647836
- Sponsor's protocol ID
- XHJY20240908
- Status last verified
- Dec 2024
- First submitted
- 11 Sep 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of the Treatment Trajectory and Drug Resistance Mechanism of Immunotherapy Combined With Chemotherapy in Patients With Advanced Lung Squamous Carcinoma
- ClinicalTrials.gov ID
- NCT06647836
- Acronym / sponsor ID
- XHJY20240908
- Conditions
- Squamous Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| untreated sq-NSCLC patients | – | Other: Efficacy observationPatients diagnosed with sq-NSCLC for the first time |
| sq-NSCLC patients treated with immunotherapy for -2-3 cycles | – | Other: Efficacy observationsq-NSCLC patients treated with immunotherapy combined with or without chemotherapy as first-line treatment for 2-3 cycles. |
| sq-NSCLC patients receiving immunotherapy with poor efficacy | – | Other: Efficacy observationsq-NSCLC patients treated with immunotherapy combined with or without chemotherapy as first-line treatment and experience disease progression within six months. |
| sq-NSCLC patients receiving immunotherapy with good efficacy | – | Other: Efficacy observationsq-NSCLC patients treated with immunotherapy combined with or without chemotherapy as first-line treatment and having progression-free survival longer than six months. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- History of cancer treatment;
- History of other malignant tumors;
- Irregular treatment or poor compliance;
- Incomplete clinical information or lost to follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Efficacy observationObservation about the efficacy of sq-NSCLC patients receiving immunotherapy combined with or without chemotherapy as first-line treatment. | Other | 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 |
Primary outcome
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.
1 secondary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xueyun Tan, MD study director
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Yang Jin, PHD principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Squamous Cell Lung Cancer, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.