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Lung Squamous Cell CarcinomaPhase 2NCT07618793

Intermittent Hypoxic Training as Neoadjuvant Therapy for Lung Squamous Cell Carcinoma

A Phase 2 study testing Intermittent Hypoxic Training (IHT) and Standard Neoadjuvant Chemo-immunotherapy in people with Lung Squamous Cell Carcinoma and Carcinoma, Non-Small-Cell Lung (NSCLC), run by zhang yi at 1 site in China.

Not yet recruiting

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

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to learn if adding intermittent hypoxic training (IHT) to standard neoadjuvant chemo-immunotherapy can increase the pathologic complete response (pCR) rate in patients aged 18 to 75 of both sexes with resectable stage II-IIIA lung squamous cell carcinoma. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Intermittent Hypoxic Training (IHT) and Standard Neoadjuvant Chemo-immunotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
Jun 2026to Dec 2028
Phase
Phase 2
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age between 18 and 75 years old (inclusive), regardless of sex.
  • Diagnosed with histologically confirmed stage II-IIIA (according to the AJCC 8th edition staging system) squamous cell lung carcinoma.
  • The primary tumor is evaluated by a multidisciplinary team (MDT) and deemed completely resectable.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
  • Life expectancy of at least 6 months.
  • Adequate organ, bone marrow, and coagulation functions, meeting the following laboratory criteria within 7 days prior to enrollment:
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  • Absolute neutrophil count (ANC) >= 1.5 x 10^9/L;
  • Platelet count >= 100 x 10^9/L;
  • Hemoglobin >= 90 g/L;
  • Total bilirubin <= 1.5 x upper limit of normal (ULN);
  • Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) <= 2.5 x ULN;
  • Serum creatinine <= 1.5 x ULN, or creatinine clearance >= 50 mL/min;
  • International normalized ratio (INR) and activated partial thromboplastin time (APTT) <= 1.5 x ULN.
  • Female participants of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose and agree to use effective contraception during the study and for at least 6 months after the last dose. Male participants must agree to use effective contraception during the study and for at least 6 months after the last dose.
  • Participant understands the study protocol, voluntarily participates, and signs the written Informed Consent Form (ICF).

Who cannot join

  • Histologically confirmed small cell lung cancer, adeno-squamous carcinoma, large cell neuroendocrine carcinoma, or adenocarcinoma (including components of these types).
  • Patients with driver gene mutations that have approved targeted therapies available (e.g., EGFR mutations, ALK rearrangements, ROS1 fusions, etc.).
  • Prior systemic antitumor therapy for lung cancer, including chemotherapy, radiotherapy, immunotherapy, targeted therapy, or definitive surgical resection.
  • Active, known, or suspected autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune hepatitis), or a history of autoimmune disease within the past 2 years.
  • History of other malignant tumors within the past 5 years, except for adequately treated cured skin basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ (e.g., cervical carcinoma in situ).
  • Severe cardiovascular or cerebrovascular diseases, including but not limited to:
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  • Myocardial infarction or unstable angina within the past 6 months;
  • New York Heart Association (NYHA) Class III or IV congestive heart failure;
  • Clinically significant ventricular arrhythmia or poorly controlled symptomatic arrhythmia;
  • Stroke or transient ischemic attack (TIA) within the past 6 months.
  • Poorly controlled hypertension (systolic blood pressure >= 160 mmHg and/or diastolic blood pressure >= 100 mmHg despite standard antihypertensive therapy).
  • Chronic obstructive pulmonary disease (COPD) or other respiratory diseases with severe lung function impairment (e.g., FEV1 < 50% predicted value, or requiring long-term home oxygen therapy).
  • Active infections requiring systemic intravenous anti-infective treatment within 2 weeks prior to enrollment (e.g., severe pneumonia, bacteremia), or active tuberculosis infection.
  • Known history of human immunodeficiency virus (HIV) infection, or active Hepatitis B (HBV DNA >= 500 IU/mL or copy number above detection limit) or active Hepatitis C (HCV RNA positive).
  • History of interstitial lung disease (ILD), drug-induced pneumonitis, radiation pneumonitis requiring steroid treatment, or evidence of active pneumonitis.
  • Severe claustrophobia, severe high-altitude sickness history, or other medical/psychological conditions that prevent compliance with intermittent hypoxic training (IHT) using the FLY-2265 low oxygen system.
  • Pregnant or breastfeeding women.
  • Any other medical condition, clinical laboratory abnormality, or social circumstance that, in the opinion of the investigator, may compromise participant safety, interfere with the evaluation of study interventions, or affect compliance with study procedures.

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
  • Xuanwu Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100053

    Yi Zhang, PhD, +86-13141370703, zhangyixwhosp@xwh.ccmu.edu.cn

Other trials in China

About this study

Official title: Study on the Novel Application of Intermittent Hypoxic Training in Neoadjuvant Therapy for Lung Squamous Cell Carcinoma

The goal of this clinical trial is to learn if adding intermittent hypoxic training (IHT) to standard neoadjuvant chemo-immunotherapy can increase the pathologic complete response (pCR) rate in patients aged 18 to 75 of both sexes with resectable stage II-IIIA lung squamous cell carcinoma. The main questions it aims to answer are:Can the addition of IHT to standard neoadjuvant chemo-immunotherapy significantly improve the pathologic complete response (pCR) rate compared to standard therapy alone? Is IHT safe and well-tolerated in this perioperative setting, and can it improve 2-year recurrence-free survival (RFS) without increasing complications? Researchers will compare the experimental group (standard neoadjuvant chemo-immunotherapy combined with IHT) to the control group (standard neoadjuvant chemo-immunotherapy alone) to see if the combination safely enhances anti-tumor immune responses, improves tumor regression, and extends long-term survival. Participants will:Receive standard neoadjuvant chemo-immunotherapy for 4 cycles (21 days per cycle), consisting of nab-paclitaxel, carboplatin, and pembrolizumab. Undergo Intermittent Hypoxic Training (IHT) if randomized to the experimental group, using the FLY-2265 low oxygen system (13% $FiO_2$ for 5 minutes followed by 21% $FiO_2$ for 5 minutes per cycle; 10 cycles per session, twice daily) for 7 consecutive days starting on Day 1 of each chemo-immunotherapy cycle. Undergo surgery (VATS lobectomy and systematic lymph node dissection) 3 to 4 weeks after the completion of the 4th cycle, provided that the disease has not progressed. Complete regular post-operative follow-up visits (including chest CT scans, brain MRIs, bone scans, tumor markers, and peripheral blood immune monitoring) for up to 5 years to evaluate long-term outcomes.

Being tested
Intermittent Hypoxic Training (IHT), Standard Neoadjuvant Chemo-immunotherapy
Keywords
Lung Squamous Cell Carcinoma, Intermittent Hypoxic Training, Neoadjuvant Chemoimmunotherapy, CD8-Positive T-Lymphocytes, Non-Small Cell Lung Cancer, Pathologic Complete Response
Medical subject headings
Carcinoma, Carcinoma, Non-Small-Cell Lung, Pathologic Complete Response

What participants receive

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

  • Intermittent Hypoxic Training (IHT)Device

    Participants will undergo Intermittent Hypoxic Training (IHT) using the FLY-2265 low oxygen system. The training protocol consists of cycles of inhaling 13% FiO2 (fraction of inspired oxygen) for 5 minutes, followed by 21% FiO2 (room air) for 5 minutes. Each session comprises 10 cycles, administered twice daily, for 7 consecutive days. This 7-day training course starts on Day 1 of each 21-day neoadjuvant treatment cycle, for a total of 4 courses.

  • Standard Neoadjuvant Chemo-immunotherapyCombination product

    Also called Nab-paclitaxel, Carboplatin, Pembrokizumab

    Participants will receive standard clinical doses of neoadjuvant chemo-immunotherapy for 4 cycles (21 days per cycle) prior to surgery. The regimen includes: 1) Nab-paclitaxel; 2) Carboplatin; 3) Pembrolizumab. All agents will be administered via intravenous infusion according to standard clinical oncology guidelines.

Study groups in NCT07618793
Study groupRoleWhat they receive
Intermittent Hypoxic Training + Chemo-immunotherapyExperimentalParticipants will receive standard neoadjuvant chemo-immunotherapy (nab-paclitaxel + carboplatin + pembrolizumab) for 4 cycles (21 days per cycle). Concurrently, participants will undergo Intermittent Hypoxic Training (IHT) using the FLY-2265 system (13% FiO2 for 5 min, 21% FiO2 for 5 min per cycle; 10 cycles/session, twice daily) for 7 consecutive days starting on Day 1 of each chemo-immunotherapy cycle. Surgery will be performed 3-4 weeks after completing the 4th cycle.
Receives: Device: Intermittent Hypoxic Training (IHT); Combination Product: Standard Neoadjuvant Chemo-immunotherapy
Standard Neoadjuvant Chemo-immunotherapy AloneActive comparatorParticipants will receive standard neoadjuvant chemo-immunotherapy alone for 4 cycles (21 days per cycle). The regimen consists of nab-paclitaxel, carboplatin, and pembrolizumab at standard clinical doses, identical to the experimental group. No intermittent hypoxic training will be administered. Surgery will be performed 3-4 weeks after completing the 4th cycle.
Receives: Combination Product: Standard Neoadjuvant Chemo-immunotherapy

What is being measured

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

  1. Pathologic Complete Response (pCR) Rate

    The percentage of participants who achieve pathologic complete response, defined as the complete disappearance of all invasive tumor cells in the completely resectable lung cancer specimen and all sampled regional lymph nodes (ypT0N0) following neoadjuvant therapy.

    Measured: At the time of surgery (approximately 3 to 4 weeks after the completion of the 4th cycle of neoadjuvant therapy).

Secondary outcomes (4)
  1. Major Pathological Response (MPR) Rate

    The percentage of participants with 10% or less viable tumor cells remaining in the resected primary tumor specimen following neoadjuvant therapy.

    Measured: At the time of surgery (approximately 3 to 4 weeks after the completion of the 4th cycle of neoadjuvant therapy).

  2. Incidence of Treatment-Emergent Adverse Events (TEAEs)

    Safety and tolerability evaluated by grading and recording adverse events, compliance with intermittent hypoxic training, and delay or discontinuation of neoadjuvant therapy, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

    Measured: From the start of neoadjuvant therapy up to 30 days after surgery (approximately 5 months).

  3. 2-Year Recurrence-Free Survival (RFS) Rate

    The percentage of participants who are alive without tumor recurrence or progression at 2 years after surgery.

    Measured: 2 years post-surgery.

  4. Changes in Peripheral Blood Immune Cell Subsets

    Evaluation of tumor immune microenvironment factors and systemic immunity, including the percentage of CD8+ T cells, CD4+ T cells, and the CD4+/CD8+ T-cell ratio measured by flow cytometry.

    Measured: Baseline (before therapy) and prior to surgery (approximately 12 weeks after baseline).

Timeline

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

  1. First posted1 Jun 2026
  2. Study startJun 2026 (estimated)
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a prospective, randomized, open-label, parallel-controlled, single-center clinical trial. Eligible participants with resectable stage II-IIIA lung squamous cell carcinoma will be randomly assigned in a 1:1 ratio to either the experimental group (receiving standard neoadjuvant chemo-immunotherapy combined with intermittent hypoxic training) or the control group (receiving standard neoadjuvant chemo-immunotherapy alone).
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07618793
Sponsor's protocol ID
KS2026139
Other IDs
CFH-2026-2-2014
Status last verified
May 2026
First submitted
25 May 2026
Last updated
1 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Intermittent Hypoxic Training (IHT) and Standard Neoadjuvant Chemo-immunotherapy in people with Lung Squamous Cell Carcinoma and Carcinoma, Non-Small-Cell Lung (NSCLC), run by zhang yi 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 15 inclusion and 18 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 1 Jun 2026. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Contact Yi Zhang, PhD (+86-13141370703, zhangyixwhosp@xwh.ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathologic Complete Response (pCR) Rate (time frame: At the time of surgery (approximately 3 to 4 weeks after the completion of the 4th cycle of neoadjuvant therapy).). 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 1 Jun 2026.

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