Can simulated High-Altitude breathing boost lung cancer treatment?
NCT ID NCT07618793
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tests whether adding intermittent hypoxic training (IHT) – short sessions of breathing low-oxygen air – to standard chemo-immunotherapy can improve outcomes for people with stage II-IIIA lung squamous cell carcinoma. About 60 participants will receive either standard treatment alone or standard treatment plus IHT before surgery. The main goal is to see if the combination leads to a higher rate of complete tumor disappearance at the time of surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Intermittent hypoxic training (IHT) using a low-oxygen device
- What this could lead to
- If successful, this approach could boost the effectiveness of standard cancer therapy, leading to higher rates of tumor disappearance before surgery and potentially longer survival.
- What could go wrong
- This is an early phase 2 trial with only 60 participants, so results may not apply broadly. The added training may cause discomfort or side effects, and it is unclear if it will meaningfully improve outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age between 18 and 75 years old (inclusive), regardless of sex. 2. Diagnosed with histologically confirmed stage II-IIIA (according to the AJCC 8th edition staging system) squamous cell lung carcinoma. 3. The primary tumor is evaluated by a multidisciplinary team (MDT) and deemed completely resectable. 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. 5. Life expectancy of at least 6 months. 6. Adequate organ, bone marrow, and coagulation functions, meeting the following laboratory criteria within 7 days prior to enrollment: * 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. 7. 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. 8. Participant understands the study protocol, voluntarily participates, and signs the written Informed Consent Form (ICF). Exclusion Criteria: 1. Histologically confirmed small cell lung cancer, adeno-squamous carcinoma, large cell neuroendocrine carcinoma, or adenocarcinoma (including components of these types). 2. Patients with driver gene mutations that have approved targeted therapies available (e.g., EGFR mutations, ALK rearrangements, ROS1 fusions, etc.). 3. Prior systemic antitumor therapy for lung cancer, including chemotherapy, radiotherapy, immunotherapy, targeted therapy, or definitive surgical resection. 4. 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. 5. 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). 6. Severe cardiovascular or cerebrovascular diseases, including but not limited to: * 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. 7. Poorly controlled hypertension (systolic blood pressure \>= 160 mmHg and/or diastolic blood pressure \>= 100 mmHg despite standard antihypertensive therapy). 8. 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). 9. Active infections requiring systemic intravenous anti-infective treatment within 2 weeks prior to enrollment (e.g., severe pneumonia, bacteremia), or active tuberculosis infection. 10. 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). 11. History of interstitial lung disease (ILD), drug-induced pneumonitis, radiation pneumonitis requiring steroid treatment, or evidence of active pneumonitis. 12. 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. 13. Pregnant or breastfeeding women. 14. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053, China
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