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Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research

6007 - Randomized phase II trial of osimertinib with or without local consolidation therapy (LCT) for patients with EGFR-mutant metastatic NSCLC (NORTHSTAR)

Date

20 Oct 2018

Session

Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research

Topics

Targeted Therapy

Tumour Site

Presenters

Yasir Elamin

Citation

Annals of Oncology (2018) 29 (suppl_8): viii493-viii547. 10.1093/annonc/mdy292

Authors

Y.Y. Elamin1, M. Antonoff2, C. Blakely3, M. Baggstorm4, T. Bivona5, X. Le1, A.V. Louie6, R.C. Doebele7, C. Rusthoven8, P. Lee3, R. Govindan4, S.G. Swisher9, V.A. Papadimitrakopoulou10, J.V. Heymach11, D.R. Gomez12

Author affiliations

  • 1 Thoracic/head And Neck Medical Oncology, UT MD Anderson Cancer Center, TX 77030 - Houston/US
  • 2 Thoracic And Cardiovascular Surgery, UT MD Anderson Cancer Center, 77030 - Houston/US
  • 3 Thoracic Medical Oncology, University of California San Francisco, 94115 - San Francisco/US
  • 4 Internal Medicine, Division Of Oncology, Washington University in St. Louis, St. Louis/US
  • 5 Medical Oncology, University of California San Fransesco, 80045 - Aurora/US
  • 6 Radiation oncology, London Health Science Centre, N6A5W9 - London/CA
  • 7 Medical Oncology, University of Colorado, 80045 - Aurora/US
  • 8 Radiation oncology, University of Colorado, 80045 - Aurora/US
  • 9 Thoracic And Cardiovascular Surgery, The University of Texas MD Anderson Cancer Center, 77030 - Houston/US
  • 10 Thoracic/head And Neck Medical Oncology, MD Anderson Cancer Center, 77030-4095 - Houston/US
  • 11 Thoracic Head And Neck, MD ANDERSON CANCER CENTER, 77030 - HOUSTON/US
  • 12 Radiation oncology, UT MD Anderson Cancer Center, TX 77030 - Houston/US

Resources

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Abstract 6007

Background

Osimertinib has been shown to be superior to erlotinib or gefitinib in previously untreated patients with EGFR mutant (exon 19 deletion/L858R) NSCLC. Osimertinib is approved for the treatment of patients with metastatic T790M+ NSCLC who have disease progression after EGFR-TKI therapy. The majority of EGFR mutant NSCLC patients who are treated with a TKI ultimately acquire resistance, including those treated with osimertinib. We have recently completed a phase 2 randomized clinical trial demonstrating that patients with oligometastatic NSCLC treated with aggressive local consolidation therapy (surgery or radiation) have improved progression-free survival compared to those patients treated with systemic therapy alone (Gomez et al., Lancet Oncol, 2016). A retrospective review of EGFR-mutant subset of patients enrolled in the trial suggests that EGFR-mutant patients may derive greater benefit from this approach. Thus, two premises underlie the current randomized trial: 1) osimertinib is standard of care for treatment of primary and TKI resistant EGFR-mutant metastatic NSCLC, and 2) the majority of patients treated with osimertinib ultimately become resistant, and LCT has been found to improve outcomes compared to systemic therapy alone.

Trial design

A phase 2 randomized, multicenter, study to evaluate the efficacy of osimertinib with or without LCT for patients with EGFR-mutant metastatic NSCLC. Eligible patients include 1) Previously untreated patients with EGFR-mutant NSCLC (L858R or exon 19 deletion) or 2) NSCLC patients with acquired EGFR T790M that was acquired following progression on first or second generation TKI, this subset of patients must have not received prior third generation TKI. Patients who don’t have disease progression after 6-12 weeks of induction osimertinib will be randomized 1:1 to osimertinib continuation or to osimertinib continuation with LCT Primary end point is progression free survival Exploratory biomarkers associated with resistance to osimertinib will be evaluated in tumor tissue and plasma collected at baseline and progression. 140 patients will be enrolled in 5 centers in North America.

Clinical trial identification

NCT03410043.

Legal entity responsible for the study

UT MD Anderson Cancer Center.

Funding

National Comprehensive Cancer Network NCCN, AZ grant.

Editorial Acknowledgement

Disclosure

All authors have declared no conflicts of interest.

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