Novel Triple-Combination Approach for Treating Lung Cancer Yields Promising Results

Researchers from Sichuan University have made a significant breakthrough in the treatment of lung cancer, specifically squamous non-small cell lung cancer (sqNSCLC). A new study has demonstrated the efficacy of combining stereotactic body radiotherapy (SBRT), low-dose radiation (LDRT), sintilimab, and chemotherapy to improve outcomes for patients with locally advanced or metastatic sqNSCLC.

Key Takeaways:

  • The study found that the combination of SBRT, LDRT, sintilimab, and chemotherapy resulted in a significantly higher objective response rate (ORR) compared to sintilimab and chemotherapy alone.
  • The ORR for the experimental group was 75%, while the ORR for the control group was 55%, demonstrating a 20% difference.
  • The study was a randomized, controlled, open-label, multicentre phase II clinical trial, involving 114 patients with locally advanced or metastatic sqNSCLC.
  • The primary endpoint was the objective response rate, and the secondary endpoints included disease control rate, progression-free survival, overall survival, and safety.
  • The study's experimental arm included patients receiving SBRT and LDRT combined with sintilimab and chemotherapy, while the control arm consisted of patients receiving sintilimab and chemotherapy alone.
  • Randomization was stratified by PD-L1 expression and the presence of brain metastases.

Statistics:

  • The expected ORR for the experimental group was 75%, while the expected ORR for the control group was 55%.
  • The calculated power of the study was 80.1%, with a two-sided alpha level of 0.2.
  • The required sample size for the study was 114 patients, with 57 patients per group, accounting for a 10% dropout rate.
  • The ORR difference between the experimental and control group was 20%.

Sources:

  • [1] News Reporter-Staff News Editor at Immunotherapy Weekly, "New study results on lung cancer have been published."
  • [2] Sichuan University, "Low-dose radiation and stereotactic body radiotherapy with PD-1 inhibitor sintilimab and chemotherapy for first-line treatment of locally advanced or metastatic squamous lung cancer: protocol for a randomised phase II trial (IHC002 study)".
  • [3] BMJ Open, 2025,15(8) published by BMJ Publishing Group.