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Introduction <p>Squamous nonsmall cell lung cancer (sq-NSCLC) is challenging to treat, with shorter survival when compared with other NSCLC subtypes. Tislelizumab has demonstrated efficacy when combined with chemotherapy for sq-NSCLC. We report 4-year follow-up results from the phase 3 randomized RATIONALE-307 trial evaluating tislelizumab plus chemotherapy as first-line treatment for advanced or metastatic sq-NSCLC.</p> Methods <p>Patients with treatment-naive advanced or metastatic sq-NSCLC were randomized to receive tislelizumab plus paclitaxel/carboplatin (arm A), tislelizumab plus nab-paclitaxel/carboplatin (arm B), or paclitaxel/carboplatin alone (arm C) until disease progression/intolerable toxicity. Crossover was permitted from arm C to tislelizumab monotherapy. The primary end point was progression-free survival (PFS) per independent review. Key secondary end points included overall survival (OS) and safety.</p> Results <p>At median OS follow-up of 44.8&#xa0;months, tislelizumab plus chemotherapy demonstrated durable survival benefit. Median PFS was 7.7&#xa0;months (95% confidence interval [CI] 6.7–9.9) in arm A, 9.5&#xa0;months (95% CI 7.4–10.1) in arm B, and 5.5&#xa0;months (95% CI 4.2–5.6) in arm C. Median OS was 26.1&#xa0;months (95% CI 19.0–33.8) in arm A, 23.3&#xa0;months (95% CI 18.8–26.4) in arm B, and 19.4&#xa0;months (95% CI 16.0–23.4) in arm C. The 4-year OS rates were 32.2%, 26.0%, and 19.2% for arms A, B, and C, respectively. Crossover occurred in 58.7% of patients from arm C. OS and PFS benefits were observed across most subgroups. Grade ≥ 3 treatment-emergent adverse events occurred in 89.2%, 89.0%, and 84.6% of patients in arms A, B, and C, respectively. No new safety signals emerged.</p> Conclusions <p>At 4-year follow-up, patients with advanced sq-NSCLC who received tislelizumab plus chemotherapy experienced long-term OS and PFS benefits versus chemotherapy alone, despite high crossover rates. The combination was well-tolerated with no new safety concerns. This regimen may be a promising first-line treatment option for patients with advanced or metastatic sq-NSCLC.</p> Trial Registration <p>ClinicalTrials.gov NCT03594747.</p>

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First-Line Tislelizumab Plus Chemotherapy for Advanced or Metastatic Squamous Non-Small Cell Lung Cancer: 4-Year Long-Term Follow-Up from RATIONALE-307

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年3月11日

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  • Zhijie Wang,
  • Xinmin Yu,
  • Jun Zhao,
  • Yan Yu,
  • Jingxun Wu,
  • Rui Ma,
  • Zhiyong Ma,
  • Jiuwei Cui,
  • Jiayuan Zhang,
  • Yuanyuan Bao,
  • Shiangjiin Leaw,
  • Jie Wang

摘要

Introduction

Squamous nonsmall cell lung cancer (sq-NSCLC) is challenging to treat, with shorter survival when compared with other NSCLC subtypes. Tislelizumab has demonstrated efficacy when combined with chemotherapy for sq-NSCLC. We report 4-year follow-up results from the phase 3 randomized RATIONALE-307 trial evaluating tislelizumab plus chemotherapy as first-line treatment for advanced or metastatic sq-NSCLC.

Methods

Patients with treatment-naive advanced or metastatic sq-NSCLC were randomized to receive tislelizumab plus paclitaxel/carboplatin (arm A), tislelizumab plus nab-paclitaxel/carboplatin (arm B), or paclitaxel/carboplatin alone (arm C) until disease progression/intolerable toxicity. Crossover was permitted from arm C to tislelizumab monotherapy. The primary end point was progression-free survival (PFS) per independent review. Key secondary end points included overall survival (OS) and safety.

Results

At median OS follow-up of 44.8 months, tislelizumab plus chemotherapy demonstrated durable survival benefit. Median PFS was 7.7 months (95% confidence interval [CI] 6.7–9.9) in arm A, 9.5 months (95% CI 7.4–10.1) in arm B, and 5.5 months (95% CI 4.2–5.6) in arm C. Median OS was 26.1 months (95% CI 19.0–33.8) in arm A, 23.3 months (95% CI 18.8–26.4) in arm B, and 19.4 months (95% CI 16.0–23.4) in arm C. The 4-year OS rates were 32.2%, 26.0%, and 19.2% for arms A, B, and C, respectively. Crossover occurred in 58.7% of patients from arm C. OS and PFS benefits were observed across most subgroups. Grade ≥ 3 treatment-emergent adverse events occurred in 89.2%, 89.0%, and 84.6% of patients in arms A, B, and C, respectively. No new safety signals emerged.

Conclusions

At 4-year follow-up, patients with advanced sq-NSCLC who received tislelizumab plus chemotherapy experienced long-term OS and PFS benefits versus chemotherapy alone, despite high crossover rates. The combination was well-tolerated with no new safety concerns. This regimen may be a promising first-line treatment option for patients with advanced or metastatic sq-NSCLC.

Trial Registration

ClinicalTrials.gov NCT03594747.