A Phase II trial of alternating osimertinib and gefitinib therapy in advanced EGFR-T790M positive non-small cell lung cancer: OSCILLATE

Lavinia Tan; Chris Brown; Antony Mersiades; Chee Khoon Lee; Thomas John; Steven Kao; Genni Newnham; Kenneth O'Byrne; Sagun Parakh; Victoria Bray; Kevin Jasas; Sonia Yip; Stephen Q Wong; Sarah Ftouni; Jerick Guinto; Sushma Chandrashekar; Stephen Clarke; Nick Pavlakis; Martin R Stockler; Sarah-Jane Dawson; Benjamin J Solomon

Journal article

A Phase II trial of alternating osimertinib and gefitinib therapy in advanced EGFR-T790M positive non-small cell lung cancer: OSCILLATE

Lavinia Tan, Chris Brown, Antony Mersiades, Chee Khoon Lee, Thomas John, Steven Kao, Genni Newnham, Kenneth O'Byrne, Sagun Parakh, Victoria Bray, Kevin Jasas, Sonia Yip, Stephen Q Wong, Sarah Ftouni, Jerick Guinto, Sushma Chandrashekar, Stephen Clarke, Nick Pavlakis, Martin R Stockler, Sarah-Jane Dawson Show all

Nature Communications | Nature Portfolio | Published : 2024

DOI: 10.1038/s41467-024-46008-1

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Abstract

In this phase II, single arm trial (ACTRN12617000720314), we investigate if alternating osimertinib and gefitinib would delay the development of resistance to osimertinib in advanced, non-small cell lung cancer (NSCLC) with the epidermal growth factor receptor (EGFR) T790M mutation (n = 47) by modulating selective pressure on resistant clones. The primary endpoint is progression free-survival (PFS) rate at 12 months, and secondary endpoints include: feasibility of alternating therapy, overall response rate (ORR), overall survival (OS), and safety. The 12-month PFS rate is 38% (95% CI 27.5–55), not meeting the pre-specified primary endpoint. Serial circulating tumor DNA (ctDNA) analysis revea..

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University of Melbourne Researchers

Tom John Author

Genni Newnham Author

Stephen Wong Author

Sarah-Jane Dawson Author

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Awarded by AstraZeneca

Funding Acknowledgements

The authors thank the patients and their families for participating in this study. OSCILLATE was supported by AstraZeneca, which provided osimertinib and gefitinib to support trial conducts. Additional support for translation research of the trial was supported by a National Health and Medical Research Council (NHMRC) grant (1158345, SJ-D, NP, BJS).