Not yet taking people in ChinaPhase 2

Breathing low-oxygen air before surgery for squamous cell lung cancer

Tests adding low-oxygen breathing sessions to chemo-immunotherapy before surgery for lung squamous cell carcinoma.

Key facts

Who runs it: zhang yi
Where: Beijing, ChinaSee the site
Trial code: NCT07618793
Registry title: Intermittent Hypoxic Training as Neoadjuvant Therapy for Lung Squamous Cell Carcinoma
Status: Not yet recruiting
Phase: Phase 2
People taking part: 60 people, planned
Started: Jun 2026
Expected to end: Dec 2028
Type of study: Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested: Intermittent Hypoxic Training (IHT)
Standard Neoadjuvant Chemo-immunotherapy
Record updated: 1 June 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with stage II-IIIA lung squamous cell carcinoma that surgery can fully remove. It tests adding intermittent hypoxic training to chemo-immunotherapy before surgery.

Age: 18 to 75 years old
Sex: Both men and women can join.
Disease stage: Stage II-IIIA squamous cell lung cancer confirmed by tissue testing, judged completely removable by surgery. Performance status (ECOG) of 0 or 1 and life expectancy of at least 6 months.
Earlier treatment: People cannot have had earlier cancer treatment for lung cancer, such as chemotherapy, radiotherapy, immunotherapy, targeted therapy or surgery to remove the tumor.
Biomarker or test result: People with gene changes that have approved targeted drugs (for example EGFR mutations, ALK rearrangements, ROS1 fusions) cannot join.

Main reasons for not taking part

Small cell, adeno-squamous, large cell neuroendocrine or adenocarcinoma lung cancer
Active or past autoimmune disease, or another cancer in the past 5 years (with few exceptions)
Serious heart or brain blood vessel disease, or poorly controlled high blood pressure
Severe lung disease (COPD with FEV1 < 50%), interstitial lung disease or pneumonitis
HIV infection, active hepatitis B or C, or pregnancy or breastfeeding

The registry criteria, word for word

Show all 22 criteriaShow less

Who can take part

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:; 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 take part

Prior systemic antitumor therapy for lung cancer, including chemotherapy, radiotherapy, immunotherapy, targeted therapy, or definitive surgical resection
Active infections requiring systemic intravenous anti-infective treatment within 2 weeks prior to enrollment (e.g., severe pneumonia, bacteremia), or active tuberculosis infection
Histologically confirmed small cell lung cancer, adeno-squamous carcinoma, large cell neuroendocrine carcinoma, or adenocarcinoma (including components of these types)
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:; 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)
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
Patients with driver gene mutations that have approved targeted therapies available (e.g., EGFR mutations, ALK rearrangements, ROS1 fusions, etc.)
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
Pregnant or breastfeeding women

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 75 years old?

Where in China

Xuanwu Hospital, Capital Medical UniversityBeijing, ChinaContact: Yi Zhang, PhDNo longer taking part

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

Intermittent Hypoxic Training + Chemo-immunotherapyTreatment being tested
Participants 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.
Treatment: Intermittent Hypoxic Training (IHT) and Standard Neoadjuvant Chemo-immunotherapy
Standard Neoadjuvant Chemo-immunotherapy AloneExisting treatment, for comparison
Participants 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.
Treatment: Standard Neoadjuvant Chemo-immunotherapy