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AzTrials

Lung Squamous Cell Carcinoma Stage IVPhase 4NCT07567313

Stage IV Lung Squamous Cell Carcinoma Treated With or Without Bronchial Artery Chemoembolization After First-line Chemotherapy and Immunotherapy

A Phase 4 study testing Immunotherapy combined with interventional therapy group and Immunotherapy group in people with Lung Squamous Cell Carcinoma Stage IV, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

This study intends to carry out prospective, randomized controlled clinical trials in many centers across the country to compare the efficacy and safety of immunotherapy after standard first-line chemotherapy or immunotherapy combined with interventional bronchial artery chemoembolization for stage IV lung squamous… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Lung Squamous Cell Carcinoma Stage IV
What is being tested?
Immunotherapy combined with interventional therapy group and Immunotherapy group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
166 participants
Where
No sites listed yet
Study dates
20 Apr 2026to 30 Jun 2028
Phase
Phase 4
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

Who may be able to join

  • Squamous cell carcinoma of the lung confirmed by histology or cytology;
  • According to the TNM staging system of the 9th edition of American Cancer Association, it was assessed as stage IV.
  • Has received standard first-line chemotherapy immunotherapy for 4~6 cycles, and achieved partial remission or disease stability according to the efficacy evaluation of RECIST1.1;
  • The patient is 18-80 years old;
  • ECOG PS score is 0-1;
  • The main organ functions meet the following criteria: (1) Blood routine examination: hemoglobin (HB) ≥ 90g/L; Leukocyte (ANC) ≥ 3.0× 109/L; Neutrophils ≥ 1.5× 109/L; Platelet (PLT) ≥ 75× 109/L; (2) Biochemical examination: albumin (ALB)≥29g/L; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2uln; Total bilirubin (TBIL) ≤ 1.5 ULN; Creatinine ≤ 1.5 ULN;
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  • Patients and/or their families agree to participate in clinical trials and sign informed consent forms;
  • No history of other malignant tumors;
  • No active infection;
  • Be able to cooperate with research follow-up;
  • At least one measurable lesion (according to RECIST 1.1);
  • The expected survival time is more than 3 months.

Who cannot join

  • There is epidermal growth factor receptor (EGFR) sensitive mutation or anaplasticlymphomakinase (ALK) gene translocation;
  • Have a history of allergy to contrast agents or chemotherapy drugs;
  • Received other anti-tumor treatments other than standard first-line chemotherapy immunotherapy;
  • Arrhythmia with myocardial ischemia or myocardial infarction above grade II and poor control (including QTc interval ≥450ms for men and ≥ 470 ms for women);
  • Coagulation function is seriously abnormal and cannot be corrected;
  • Hypertension patients still have poor blood pressure control (systolic blood pressure > >160mmHg, diastolic blood pressure > 100 mmhg) after antihypertensive drugs treatment;
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  • Pregnant or lactating female patients;
  • Have a history of mental illness or psychotropic drug abuse;
  • Patients with symptomatic brain metastasis;
  • Patients with autoimmune diseases;

About this study

Official title: Prospective, Multicenter, Open-label, Randomized Controlled Clinical Study of Patients With Stage IV Lung Squamous Cell Carcinoma Treated With or Without Bronchial Artery Chemoembolization After First-line Chemotherapy and Immunotherapy

This study intends to carry out prospective, randomized controlled clinical trials in many centers across the country to compare the efficacy and safety of immunotherapy after standard first-line chemotherapy or immunotherapy combined with interventional bronchial artery chemoembolization for stage IV lung squamous cell carcinoma.

Read the detailed description

This study aimed to evaluate the differences in efficacy (e.g., progression-free survival, overall survival, objective response rate, and incidence of adverse events) and safety (e.g., incidence of adverse events) between tislelizumab therapy combined with 1-3 cycles of bronchial artery chemoembolization (with gemcitabine) and tislelizumab monotherapy in patients with stage IV squamous cell lung cancer who achieved partial remission or disease stabilization after standard first-line treatment (carboplatin + paclitaxel chemotherapy + tislelizumab immunotherapy, 4-6 cycles). The goal was to explore ways to optimize first-line treatment strategies and further improve the overall efficacy of first-line treatment for patients with advanced squamous cell lung cancer.

Being tested
Immunotherapy combined with interventional therapy group, Immunotherapy group
Keywords
quamous cell carcinoma of the lung, interventional bronchial artery chemoembolization

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Immunotherapy combined with interventional therapy groupProcedure or surgery

    Tislelizumab 200mg, intravenous infusion, every 3 weeks, for 2 years. Simultaneously, the patient undergoes 1-3 sessions of transbronchial chemoembolization (BACE). A follow-up enhanced CT scan of the lungs and mediastinum is performed 4-6 weeks after BACE. Based on the results, the investigator will assess whether further BACE is necessary, with a maximum of 3 BACE sessions per patient.

  • Immunotherapy groupDrug

    Tislelizumab 200 mg, IV infusion, Q3W, maintenance for 2 years. Follow up with enhanced CT scans of the lungs and mediastinum every 4-6 weeks, and assess efficacy according to RECIST 1.1 criteria.

Study groups in NCT07567313
Study groupRoleWhat they receive
Immunotherapy groupActive comparatorNot described
Receives: Drug: Immunotherapy group
Immunotherapy combined with interventional therapy groupExperimentalNot described
Receives: Procedure: Immunotherapy combined with interventional therapy group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival

    From date of randomization until the date of first documented progression or date of death from any cause

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.

Secondary outcomes (3)

  1. Overall Survival

    From date of randomization until the date of death from any cause

    Measured: From date of randomization until the date of death from any cause, 6,12, 24 months or more, through study completion.

  2. Objective response rate

    Proportion of patients with reduction in stable in tumor burden of a predefined amount

    Measured: 2, 4, 6 months after the first Immunotherapy/BACE treatment, up to death or 24 months

  3. Disease control rate

    Proportion of patients with reduction or keeping in stable in tumor burden of a predefined amount

    Measured: 2, 4, 6 months after the first Immunotherapy/BACE treatment, up to death or 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2026
  2. Study start20 Apr 2026 (estimated)
  3. Primary completion1 Jan 2028 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
166 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07567313
Sponsor's protocol ID
UHCT250797
Status last verified
Jan 2026
First submitted
2 Apr 2026
Last updated
5 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Involving patient privacy

Publications

  • 1. Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin 2024, 74(3): 229-263. 2. Lortet-Tieulent J, Soerjomataram I, Ferlay J, Rutherford M, Weiderpass E, Bray F. International trends in lung cancer incidence by histological subtype: adenocarcinoma stabilizing in men but still increasing in women. Lung Cancer 2014, 84(1): 13-22. 3. Cheng TY, Cramb SM, Baade PD, Youlden DR, Nwogu C, Reid ME. The International Epidemiology of Lung Cancer: Latest Trends, Disparities, and Tumor Characteristics. J Thorac Oncol 2016, 11(10): 1653-1671. 4. Socinski MA, Obasaju C, Gandara D, Hirsch FR, Bonomi P, Bunn PA, Jr., et al. Current and Emergent Therapy Options for Advanced Squamous Cell Lung Cancer. J Thorac Oncol 2018, 13(2): 165-183. 5. He G, Yang K, Zhang X, Pan J, Han A, Gao Z, et al. Bronchial artery chemoembolization with drug-eluting beads versus bronchial artery infusion followed by polyvinyl alcohol particles embolization for advanced squamous cell lung cancer: A retrospective study. Eur J Radiol 2023, 161: 110747. 6. Network NCC. Non-small cell lung cancer (version 4.2025). 2025. 7. Lu S, Chen Z, Hu C, Zhang J, Chen Y, Song Y, et al. Nedaplatin Plus Docetaxel Versus Cisplatin Plus Docetaxel as First-Line Chemotherapy for Advanced Squamous Cell Carcinoma of the Lung - A Multicenter, Open-label, Randomized, Phase III Trial. J Thorac Oncol 2018, 13(11): 1743-1749. 8. Novello S, Kowalski DM, Luft A, Gumus M, Vicente D, Mazieres J, et al. Pembrolizumab Plus Chemotherapy in Squamous Non-Small-Cell Lung Cancer: 5-Year Update of the Phase III KEYNOTE-407 Study. J Clin Oncol 2023, 41(11): 1999-2006.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Immunotherapy combined with interventional therapy group and Immunotherapy group in people with Lung Squamous Cell Carcinoma Stage IV, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.

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 12 inclusion and 10 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: opening soon, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07567313, which also lists 1 linked publication.

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 5 May 2026.

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