Clinical Trials

16/005 OSCILLATE

Phase 2 trial of alternating osimertinib with gefitinib in patients with EGFR-T790M mutation positive advanced non-small cell lung cancer

Recruitment target:

(Final recruitment number)

Status:

Published

(Closed to recruitment: 12/6/19)

Summary:

OSCILLATE measured the duration before progression when patients with EGFR-T790 mutation positive advanced NSCLC were treated with osimertinib and gefitinib. It was hypothesised that alternating therapy with the gefitinib and osimertinib would modulate the populations of EGFR-T790M positive and negative tumour clones, delaying the emergence of resistance to osimertinib. Sixty-eight percent of participants in OSCILLATE were able to complete 6 months of treatment without any delays or interruptions due to side effects, suggesting that the alternating approach was safe and feasible. The lung cancer was still under control 12 months after starting treatment in 38% of the participants, but this was not a statistically significant outcome. The side effects of treatment in OSCILLATE were similar to those seen in trials using either drug on its own. Accompanying translational research studies on samples obtained from patients have contributed to current understanding of resistance to EGFR tyrosine kinase inhibitor therapy.

Clinical trial design:

Single arm Phase II clinical trial

Indication:

EGFR-T790M mutation positive advanced non-small cell lung cancer (NSCLC) patients who have received prior therapy with an EGFR-tyrosine kinase inhibitor (TKI)

Intervention:

All participants enrolled in this clinical trial will begin with Induction therapy of 80mg Osimertinib daily for 8 weeks. Participants will then move onto the ‘Oscillating’ phase and take 250mg gefitinib daily for 4 weeks, then 80mg Osimertinib for 4 weeks, and continue ‘oscillating’ (i.e. alternating 4 weekly cycles of each drug) until disease progression or unacceptable toxicity (Alternating Phase). Following disease progression and if deemed appropriate by the treating Investigator, continuation of alternating therapy OR continuous Osimertinib 80 mg daily until further progression or unacceptable toxicity (Post-Progression Phase).

More information:

For patients

For clinicians

Contact: oscillate.study@sydney.edu.au

Results: Click here to view the results summary

Click here to view the published manuscript

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