scholarly journals Characterization of distinct types of KRAS mutation and its impact on first‑line platinum‑based chemotherapy in Chinese patients with advanced non‑small cell lung cancer

Author(s):  
Yijun Jia ◽  
Tao Jiang ◽  
Xuefei Li ◽  
Chao Zhao ◽  
Limin Zhang ◽  
...  
2019 ◽  
Vol 37 (15_suppl) ◽  
pp. TPS9127-TPS9127
Author(s):  
Anne-Marie C. Dingemans ◽  
Egbert F. Smit ◽  
Joop De Langen ◽  
Harm van Tinteren ◽  

TPS9127 Background: In a retrospective analysis of KRAS mutated non-small cell lung cancer (NSCLC) patients response and progression free survival (PFS) to first line chemotherapy was better for carboplatin-paclitaxel-bevacizumab then other first line combinations (Mellema Lung Cancer, 2015:90:249-54). Methods: Trial Design: Multi-center open label randomized phase III study. After stratification for KRAS mutation (G12V versus G12C versus other), performance status (0-1 vs. 2) and brain metastasis (yes of no) patients will be 1:1 randomized to carboplatin-paclitaxel-bevacizumab or cisplatin-pemetrexed q3wks for up to six cycles. Continuation maintenance with bevacizumab and pemetrexed is allowed until progression. Study population: histologically or cytologically confirmed stage IIIB or stage IV KRAS mutated NSCLC patients who are eligible for platinum-based chemotherapy and are chemotherapy naïve. Previous anti-PD(L1) therapy for advanced disease is allowed (amendment 25.1.2018). Response will be assessed according to RECIST 1.1, CT scans will be made every 6 weeks until progression. Blood and archival tissue will be optionally collected for translational research. This may help to identify subgroups of patients who are likely better treated with a specific treatment regimen. Statistical analysis: The trial was designed to demonstrate superiority of the carboplatin-paclitaxel-bevacizumab treatment over cisplatin-pemetrexed with an assumed hazard ratio of 0.67. In total 201 events are required for the final analysis, corresponding to a total sample size of 240 patients to be accrued. There is a single interim analysis planned after 101 events have been observed. Primary endpoint: PFS defined by the response criteria in solid tumors (RECIST) and assessed by independent review. Secondary endpoints: Overall response rate, Overall Survival, outcome according to type of KRAS mutation, response assessed by CRABB criteria. Study progress: Currently 25 sites are open across the Netherlands and 170 of the 240 required patients are randomized (February 12, 2019). Clinical trial information: NCT02743923.


2021 ◽  
pp. molcanther.0201.2021
Author(s):  
Julia Judd ◽  
Nagla Abdel Karim ◽  
Hina Khan ◽  
Abdul Rafeh Naqash ◽  
Yasmine Baca ◽  
...  

Lung Cancer ◽  
2018 ◽  
Vol 125 ◽  
pp. 273-281 ◽  
Author(s):  
Shirish M. Gadgeel ◽  
James P. Stevenson ◽  
Corey J. Langer ◽  
Leena Gandhi ◽  
Hossein Borghaei ◽  
...  

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