Trial reportESMO open2024
Tislelizumab plus chemotherapy versus chemotherapy alone as first-line treatment for advanced squamous non-small-cell lung cancer: final analysis of the randomized, phase III RATIONALE-307 trial.
Trial report in ESMO open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 44 papers, 4 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
44 citing papers in PubMed, 4 syntheses or guidelines pooled it.
- Effect of histology on the efficacy of first-line immune checkpoint inhibitors in advanced non-small cell lung cancer: a systematic review and network meta-analysis.Frontiers in immunology · 2026Pooled it
- PD-1/PD-L1 inhibitors plus chemotherapy versus chemotherapy alone for Chinese patients with advanced non-small-cell lung cancer: an updated meta-analysis based on phase 3 randomized controlled trials.World journal of surgical oncology · 2025Pooled it
- First-line immunochemotherapy for advanced NSCLC in Asian patients: a meta-analysis of phase 3 RCTs.Frontiers in oncology · 2025Pooled it
- The benefits and risks of adding PD-1/PD-L1 inhibitors to chemotherapy for stage IIIb-IV non-small-cell lung cancer: an updated meta-analysis based on phase 3 randomized controlled trials.Frontiers in oncology · 2025Pooled it
- Prognostic associations between patient-reported outcomes and overall survival among patients with advanced squamous non-small cell lung cancer: results from the RATIONALE-307 trial.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2026Trial
- Trial
- Nutritional inflammatory hematological risk index predicts clinical outcomes in patients with advanced NSCLC receiving immunotherapy.Medical oncology (Northwood, London, England) · 2026Article
- Efficacy and safety of PD-1/PD-L1 inhibitors plus chemotherapy versus chemotherapy alone in stage IIIB-IV squamous non-small cell lung cancer: a systematic review and meta-analysis of phase 3 randomized controlled trials.Translational cancer research · 2026Article
- Long-term survival with tocilizumab treatment for tislelizumab-related pneumonitis in a patient with non-small cell lung cancer: A case report.Oncology letters · 2026Article
- Efficacy of nab-paclitaxel combined with immune checkpoint inhibitors in solid tumors: a systematic review and meta-analysis of randomized controlled trials.Translational cancer research · 2026Article
- Optimal drug regimens for squamous non-small cell lung cancer: a systematic review and a Bayesian network meta-analysis of randomized trials.Journal of thoracic disease · 2026Article
- First-Line Tislelizumab Plus Chemotherapy for Advanced or Metastatic Squamous Non-Small Cell Lung Cancer: 4-Year Long-Term Follow-Up from RATIONALE-307.Oncology and therapy · 2026Article
- Subcutaneously Administered Tislelizumab in Locally Advanced or Metastatic Non-Small Cell Lung Cancer: Pharmacokinetics and Safety Results from the BGB-A317-103 Phase I Study.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026Article
- Circulating low-density neutrophils as biomarkers of resistance to first-line anti-PD-1/PD-L1 immunotherapy in non-small cell lung cancer.Translational oncology · 2026Article
- Article
- Initial stage analysis of tislelizumab in combination with chemotherapy for patients with advanced HIV-positive non-small-cell lung cancer: a comparative clinical trial.Anti-cancer drugs · 2026Article
- [Heterogeneity of Response to PD-1/PD-L1 Inhibitors in Elderly Patients with Advanced NSCLC under the Background of Immunosenescence and Intervention Strategies].Zhongguo fei ai za zhi = Chinese journal of lung cancer · 2026Review
- Article
- Review
- Cost-Effectiveness Analysis of Ivonescimab Plus Chemotherapy versus Tislelizumab Plus Chemotherapy as First-Line Treatment for Advanced Squamous Non-Small-Cell Lung Cancer in China Based on the HARMONi-6 Trial.Risk management and healthcare policy · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeFirst-line tislelizumab plus chemotherapy significantly improved progression-free survival (PFS) versus chemotherapy alone in advanced squamous non-small-cell lung cancer (sq-NSCLC) at the interim analysis of the phase III RATIONALE-307 trial. We present the final analysis of this trial. PATIENTS AND
methodsPatients with treatment-naive, stage IIIB/IV, sq-NSCLC were randomized (1 : 1: 1) to 21-day cycles of i.v.: tislelizumab plus paclitaxel and carboplatin (arm A); tislelizumab plus nab-paclitaxel and carboplatin (arm B); or paclitaxel and carboplatin (arm C). The primary endpoint was independent review committee-assessed PFS; overall survival was a secondary endpoint.
resultsIn total, 360 patients were randomized; 355 received treatment. At the final analysis (median study follow-up: 16.7 months), tislelizumab plus chemotherapy had a manageable safety profile, consistent with that at the interim analysis. Improvement in PFS was maintained for arms A and B versus C {hazard ratio (HR) 0.45 [95% confidence interval (CI) 0.33-0.62] and 0.43 (95% CI 0.31-0.60), respectively}. Overall survival HRs for arms A and B versus C were 0.68 (95% CI 0.46-1.01) and 0.75 (95% CI 0.50-1.12), respectively.
conclusionsThe RATIONALE-307 final analysis demonstrated superior clinical benefit with addition of tislelizumab to chemotherapy, and a manageable safety profile, as first-line treatment of advanced sq-NSCLC.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.