Protocol: ECOG – EA5162
Please Note: Below is partial eligibility, for full eligibility requirements, please contact the Genesys Hurley Cancer Institute Research Department at (810)762-8181, (810)762-8079 and/or (810)762-8038. Thank you!
- Participants must have a pathologically-confirmed diagnosis of nonsmall cell lung cancer (NSCLC).
- Participants must have advanced disease – either stage IV disease, stage IIIB disease not amenable to definitive multi-modality therapy, or recurrent disease after a prior diagnosis of stage I-III disease.
- An EGFR exon 20 insertion mutation must be detected in the tumor tissue. Patients may be enrolled in the study based on an exon 20 insertion EGFR mutation detected by any CLIA-certified tissue assay.
- Patients must have measurable disease. Baseline measurements and ALL sites of disease must be obtained within 4 weeks prior to registration.
- Patients must have previously received at least one line of therapy for their advanced lung cancer. There are no restrictions on the maximum number of prior therapies allowed.Participants must not have previously received osimertinib. Participants must have not previously received therapies targeting PDL1, PD1 or CTLA4 within 6 months (180 days) prior to registration.
- Age ≥ 18 years.
- ECOG performance status ≤1.
- Participants may not have clinically active or symptomatic interstitial lung disease or interstitial pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention), or a history of clinically
significant interstitial lung disease or radiation pneumonitis.
- Participants may not have had radiation to the lung fields within four weeks (28 days) of starting treatment. For patients receiving palliative radiation to thoracic vertebrae, ribs or other sites where the radiation field includes the lungs, radiation must be completed at least two weeks before starting treatment. For all palliative radiation to all other sites, at least 7 days must have elapsed prior to starting treatment. At least six months (180 days) must have elapsed prior to starting treatment for radiation given with curative intent. Palliative radiotherapy to control symptoms (including gamma knife technique) is permitted. For stereotactic radiosurgery (SRS) to CNS lesions, osimertinib can be held on the day of radiation only. For palliative RT to other sites of disease outside of the thorax, osi should be held for a minimum of 3 days before radiation and 3 days after RT is completed, but the duration of washout can be adjusted at the
investigator’s discretion with the approval of the study PI. For thoracic radiation, a 7-10 day washout period before the procedure and one week period after procedure before restarting osimertinib is advised to minimize the risk of pneumonitis. All radiotherapy related toxicities should be managed and ideally resolved before restarting osimertinib. Investigators should consider the radiotherapy when assessing causality if there are any localized AEs following the procedure.
10. Participants may not have clinically symptomatic brain metastases, leptomeningeal disease or spinal cord compression. Patients may be on a stable dose of corticosteroids to control brain metastases if they have been on a stable dose for two weeks (14 days) prior to study treatment and are clinically asymptomatic.
11. Patients must have an ECHO or a nuclear study (MUGA or First Pass) within 4 weeks (28 days) prior to registration to treatment and must not have a left ventricular ejection fraction (LVEF) < institutional lower limit of normal (LLN). If the LLN is not defined at a site, the LVEF must be ≥ 50% for the patient to be eligible.
12. Participants may not have a second, clinically active, cancer. Patients with second cancers which have been treated with curative intent and/or are currently inactive are allowed.
13. Participants may not be receiving any other investigational agents. Patients previously treated with investigational agents must complete a washout period of at least two weeks or five half-lives, whichever is longer, before starting treatment.
14. Patients with refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption
of AZD9291 (osimertinib) are ineligible.
15. No unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment, with the exception of alopecia and grade 2, prior platinum-therapy–related neuropathy.