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RATIONALE-303: Long-Term Outcomes of Tislelizumab in Previously Treated Advanced/Metastatic NSCLC
Pedro de Marchi1, Yun Fan2, Zhiyong Ma3
1Oncoclinicas - Praia de Botafogo, Rio de Janeiro, RJ, Brazil; OncoClinic, Riyadh, Saudi Arabia.
JTO Clinical and Research Reports
|July 30, 2026
Summary
Tislelizumab significantly improved overall survival and progression-free survival in advanced NSCLC patients compared to docetaxel. This immunotherapy demonstrated a favorable safety profile in long-term follow-up results.
Area of Science:
- Oncology
- Immunotherapy
- Clinical Trials
Background:
- Non-small cell lung cancer (NSCLC) is a leading cause of cancer-related mortality.
- Treatment options for pretreated advanced NSCLC remain limited, highlighting the need for more effective therapies.
- Immune checkpoint inhibitors have emerged as a promising treatment modality in NSCLC.
Purpose of the Study:
- To evaluate the long-term efficacy and safety of tislelizumab compared to docetaxel in patients with pretreated advanced NSCLC.
- To assess overall survival (OS) as a primary endpoint in the overall patient population and in those with high PD-L1 expression.
- To investigate secondary endpoints including progression-free survival (PFS), objective response rate (ORR), duration of response (DoR), and safety.
Main Methods:
- An open-label, randomized, phase 3 trial (RATIONALE-303, NCT03358875) involving 805 patients with advanced NSCLC who progressed on platinum-based chemotherapy.
- Patients were randomized (2:1) to receive either tislelizumab or docetaxel.
- Dual primary endpoints were OS in the intent-to-treat (ITT) population and OS in patients with PD-L1 tumor cell expression ≥ 25%.
Main Results:
- With a median follow-up of 46.5 months for tislelizumab and 41.0 months for docetaxel, median OS was significantly improved with tislelizumab (16.9 months vs. 11.9 months in ITT; 19.3 months vs. 11.5 months in PD-L1 ≥ 25% group).
- Tislelizumab demonstrated superior PFS (median 4.2 vs. 2.6 months), higher ORR (22.6% vs. 7.8%), and longer DoR (median 13.5 vs. 6.1 months) in the ITT population.
- Grade 3 or higher treatment-related adverse events were substantially less frequent with tislelizumab (16.1%) compared to docetaxel (66.3%), with no new safety signals identified.
Conclusions:
- Long-term follow-up of the RATIONALE-303 trial confirms that tislelizumab offers clinically meaningful improvements in OS and other efficacy outcomes compared to docetaxel.
- Tislelizumab presents a favorable and manageable safety profile for patients with previously treated advanced or metastatic NSCLC.
- These findings support tislelizumab as a valuable treatment option for this patient population.