Intermittent Hypoxic Training as Neoadjuvant Therapy for Lung Squamous Cell Carcinoma

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
Sponsorzhang yi

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Intermittent Hypoxic Training (IHT)
  • Standard Neoadjuvant Chemo-immunotherapy

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators

zhang yi

Lead sponsor

Xuanwu Hospital, Beijing

Sponsor institution

Capital Medical University

Collaborator