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Intermittent Hypoxic Training as Neoadjuvant Therapy for Lung Squamous Cell Carcinoma

NCT07618793 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-06-01

No results posted yet for this study

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. 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.

Conditions

  • Lung Squamous Cell Carcinoma
  • Carcinoma, Non-Small-Cell Lung (NSCLC)

Interventions

DEVICE

Intermittent Hypoxic Training (IHT)

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.

COMBINATION_PRODUCT

Standard Neoadjuvant Chemo-immunotherapy

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.

Sponsors & Collaborators

  • Capital Medical University

    collaborator OTHER

  • zhang yi

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07618793 on ClinicalTrials.gov