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Closed (no longer recruiting)Last updated: 29 January 2024

OSCILLATE: This phase II trial is alternating the use of two oral drugs (Osimertinib and Gefitinib) in patients with advanced EGFR-T790M positive Non-Small Cell (NSC) Lung CancerPhase 2 trial to determine the efficacy, safety, and feasibility of alternating osimertinib with gefitinib in patients with EGFR-T790M mutation positive advanced non-small cell lung cancer

Clinical summary

Summary

Osimertinib 80 mg daily for 8 weeks (Induction Phase). Gefitinib 250 mg daily for 4 weeks then osimertinib 80 mg daily for 4 weeks, and continue alternating (i.e. alternating 4 weekly cylces of each drug) until disease progression or unacceptable toxicity (Alternating Phase). Following disease progression and if deemed appropriate by the treating Investigator, Osimertinib 80 mg daily until further progression or unacceptable toxicity (Post-Progression Phase). Both Osimertinib and Gefitinib will be supplied as tablets for oral administration. Adherence will be monitored by counting returned empty drug packets

Conditions

This trial is treating patients with Non-Small Cell (NSC) Lung Cancer.

Cancer

Lung Cancers Lung cancer

Age

People18+

Phase

II

Trial Acronym

OSCILLATE

More information

Trial Identifiers

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Trial sponsor

AstraZeneca, University of Sydney

Scientific Title

Phase 2 trial to determine the efficacy, safety, and feasibility of alternating osimertinib with gefitinib in patients with EGFR-T790M mutation positive advanced non-small cell lung cancer

Eligibility

Inclusion

1. Adults, aged 18 years and older, with histologically or cytologically confirmed metastatic or unresectable locally advanced NSCLC
2. Prior therapy with an EGFR-TKI. Patients may also have received additional lines of treatment
3. Documented evidence of EGFR-T790M mutation on tissue and/or plasma sample following disease progression on the most recent EGFR-TKI therapy (T790M mutation status will need to be re-confirmed in the event of an alternative systemic treatment following progression on the most-recent EGFR-TKI therapy).
4. Measurable disease according to RECIST version 1.1.
5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Exclusion

1. Previous or current treatment with osimertinib or other drugs that target EGFR-T790M mutations, e.g. CO-1686, HM61713, TAS-121
2. Contraindications to investigational product
3. Any unresolved toxicity from prior therapy worse than CTCAE grade 1, except alopecia and grade 2 neuropathy due to prior platinum-based chemotherapy
4. Major surgery within 4 weeks, or palliative radiation therapy within 5 days before enrollment
5. Treatment with prohibited medications (e.g. concurrent anti-cancer therapy including other chemotherapy, or immunotherapy within 14 days prior to treatment)
6. Patients currently receiving (or unable to stop at least 1 week before starting osimertinib) potent inhibitors or inducers of cytochrome P450 (CYP) 3A4
7. Patient with symptomatic central nervous system (CNS) metastases who are neurologically unstable, or require increasing doses of steroids to manage CNS symptoms within 2 weeks prior to starting osimertinib. Patients with leptomeningeal carcinomatosis are also excluded
8. Known history of interstitial lung disease from any cause
9. Life expectancy of less than 3 months
10. Mean QT interval corrected for heart rate (QTc) >= 470 ms OR any clinically important abnormalities in rhythm, conduction or morphology of resting ECG OR any factors that increases the risk of QTc prolongation or risk of arrhythmic events

Inclusion

  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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