SYHX2011 in Combination With Carboplatin and Enlonstobart as First-Line Therapy for Squamous Non-Small Cell Lung Cancer

Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Chest Hospital

About this trial

Efficacy and Safety of SYHX2011 Combined with Carboplatin and Enlonstobart versus Nab-Paclitaxel Combined with Carboplatin and Tislelizumab as First-Line Treatment for Squamous Non-Small Cell Lung Cancer

Eligibility criteria

Qualifiers

Age: ≥18 years old

Histologically or cytologically confirmed locally advanced or metastatic squamous non-small cell lung cancer (Stage IIIB, IIIC, or IV according to the IASLC 9th Edition TNM Staging System), ineligible for radical surgery and/or radical radiotherapy

Confirmed negative for driver genes (including EGFR mutation, ALK fusion, ROS1 fusion, etc.)

Tumor cell PD-L1 expression in tumor tissue ≥1% (TPS ≥1%)

Disqualifiers

History of or current with other malignant tumors (excluding non-melanoma skin cancer, in situ breast cancer, in situ cervical cancer, and superficial bladder cancer that have been effectively controlled within the past 5 years)

Active leptomeningeal disease or poorly controlled, untreated brain metastases (excluding patients with brain metastases that are well-controlled with local therapy)

Interstitial lung disease (ILD), drug-induced interstitial pneumonitis, or non-infectious pneumonitis (including radiation pneumonitis, pulmonary fibrosis, acute lung disease requiring steroid therapy), and patients with severe impairment of pulmonary function

Active autoimmune disease or a history of autoimmune disease (e.g., ulcerative colitis, Crohn's disease, etc.). However, participants with the following conditions are eligible for further screening: well-controlled type 1 diabetes mellitus; well-controlled hypothyroidism requiring only hormone replacement therapy; dermatological diseases not requiring systemic therapy (e.g., vitiligo, psoriasis, alopecia); or participants with diseases not expected to relapse in the absence of external triggers

Trial design

Treatments tested in this trial

  • SYHX2011
  • Carboplatin
  • Enlonstobart
  • Nab-Paclitaxel
  • Carboplatin
  • Tislelizumab

Treatment groups

396 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators