2019 ASCO Annual Meeting!
Session: Lung Cancer—Non-Small Cell Metastatic
Type: Poster Session
Time: Sunday June 2, 8:00 AM to 11:00 AM
Location: Hall A
Chemotherapy in KRAS-mutated chemotherapy naive non-small cell lung cancer patients: A phase III comparing cisplatin-pemetrexed with carboplatin-paclitaxel-bevacizumab: NVALT 22 (NCT02743923).
Metastatic Non-Small Cell Lung Cancer
Lung Cancer—Non-Small Cell Metastatic
2019 ASCO Annual Meeting
Poster Board Number:
Poster Session (Board #443b)
J Clin Oncol 37, 2019 (suppl; abstr TPS9127)
Author(s): Anne-Marie C. Dingemans, Egbert F. Smit, Joop De Langen, Harm van Tinteren, NVALT ONCOLOGY; Maastricht University Medical Center, Maastricht, Netherlands; Vrije Universiteit VU Medical Centre, Amsterdam, Netherlands; VU University Medical Center, Amsterdan, Netherlands; Netherlands Cancer Institute (NKI-AVL), Amsterdam, Netherlands
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