Tislelizumab Plus Chemotherapy as First-Line Treatment for Locally Advanced or Metastatic Nonsquamous NSCLC (RATIONALE 304): A Randomized Phase 3 Trial
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INTRODUCTION: Tislelizumab, an anti-programmed cell death protein-1 antibody, was specifically engineered to minimize FcɣR macrophage binding to abrogate antibody-dependent phagocytosis. Compared with chemotherapy alone, tislelizumab plus chemotherapy may improve clinical outcomes in patients with advanced nonsquamous NSCLC (nsq-NSCLC). METHODS: In this open-label phase 3 trial (RATIONALE 304; NCT03663205), patients with histologically confirmed stage IIIB or IV nsq-NSCLC were randomized (2:1) to receive either arm A: tislelizumab plus platinum (carboplatin or cisplatin) and pemetrexed every 3 weeks (Q3Ws) or arm B: platinum and pemetrexed alone Q3W during induction treatment, followed by intravenous maintenance pemetrexed Q3W. The primary end point was progression-free survival (PFS) assessed by an independent review committee; clinical response and safety and tolerability were secondary end points. RESULTS: Overall, 332 patients (n = 222 [A]; n = 110 [B]) received treatment. With a median study follow-up of 9.8 months, PFS was significantly longer with tislelizumab plus chemotherapy compared with chemotherapy alone (median PFS: 9.7 versus 7.6 mo; hazard ratio = 0.645 [95% confidence interval: 0.462-0.902], p = 0.0044). In addition, response rates were higher and response duration was longer with combination therapy versus chemotherapy alone. Hematologic adverse events (AEs) were common in both treatment arms; the most reported AEs were grades 1 to 2 in severity. The most common grade greater than or equal to 3 AEs were associated with chemotherapy and included neutropenia (44.6% [A]; 35.5% [B]) and leukopenia (21.6% [A]; 14.5% [B]). CONCLUSIONS: Addition of tislelizumab to chemotherapy resulted in significantly prolonged PFS, higher response rates, and longer response duration compared with chemotherapy alone, identifying a new potential option for first-line treatment of advanced nsq-NSCLC irrespective of disease stage.
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In 2021, the NMPA approved camrelizumab plus gemcitabine and cisplatin for advanced nasopharyngeal carcinoma.
“Later in 2021, the NMPA approved camrelizumab plus gemcitabine and cisplatin (for advanced nasopharyngeal carcinoma) and tislelizumab plus chemotherapy (for NSCLC) [62–64].”
From Combination strategies with PD-1/PD-L1 blockade: current advances and future directions (2022) · cites this paper as [64]
In 2021, the NMPA approved tislelizumab plus chemotherapy for NSCLC.
“Later in 2021, the NMPA approved camrelizumab plus gemcitabine and cisplatin (for advanced nasopharyngeal carcinoma) and tislelizumab plus chemotherapy (for NSCLC) [62–64].”
From Combination strategies with PD-1/PD-L1 blockade: current advances and future directions (2022) · cites this paper as [64]
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Self-citation
- Authors
- Lu, S., Wang, J., Yu, Y., Yu, X., Hu, Y., Ai, X., Ma, Z., Li, X., Zhuang, W., Liu, Y., Li, W., Cui, J., Wang, D., Liao, W., Zhou, J., Wang, Z., Sun, Y., Qiu, X., Gao, J., Bao, Y., Liang, L., & Wang, M.
- Affiliations
- Chinese Academy of Medical Sciences & Peking Union Medical College (CN)
- Third Affiliated Hospital of Harbin Medical University (CN)
- Zhejiang Cancer Hospital (CN)
- Hubei Cancer Hospital (CN)
- Shanghai Chest Hospital (CN)
- Zhengzhou University (CN)
- First Affiliated Hospital of Zhengzhou University (CN)
- Fujian Provincial Cancer Hospital (CN)
- First Hospital of China Medical University (CN)
- Guangzhou Medical University Cancer Hospital (CN)
- First Hospital of Jilin University (CN)
- Army Medical University (CN)
- Nanfang Hospital (CN)
- First Affiliated Hospital Zhejiang University (CN)
- Shandong Tumor Hospital (CN)
- Jinan Central Hospital (CN)
- BeiGene (China) (CN)
- Peking Union Medical College Hospital (CN)
- ORCID
- Venue
- Journal of Thoracic Oncology
- Publisher
- Elsevier BV
- Published
- 2021-09
- Volume
- 16
- Issue
- 9
- Pages
- 1512-1522
- ISSN
- 1556-0864 (ISSN-L)
- OpenAlex
- W3164993995
- Cited by
- 284
- References
- 22
- Citations by year
- 2026: 41 · 2025: 59 · 2024: 57 · 2023: 62 · 2022: 54 · 2021: 11
- FWCI
- 29.83
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Journal of Thoracic Oncology (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Funders
- Roche
- Boehringer Ingelheim
- AstraZeneca
- BeiGene
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
- Keywords
- tislelizumab, non-squamous non-small cell lung cancer, first-line therapy, anti-PD-1 therapy, progression-free survival, Fcγ receptor binding, antibody-dependent phagocytosis, locally advanced or metastatic NSCLC, neutropenia, leukopenia
- MeSH terms
- Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Non-Small-Cell Lung, Humans, Lung Neoplasms, Antibodies, Monoclonal, Humanized
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