Phase II Single Arm Study of AZD9291 to Treat NSCLC Patients in Asia Pacific

• Status: Active, not recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

A Phase II, Open Label, Single-arm Study to Assess the Safety and Efficacy of AZD9291 in Asia Pacific Patients with Locally Advanced/Metastatic Non-Small Cell Lung Cancer whose Disease has Progressed with Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and whose Tumours harbour a T790M mutation within the Epidermal Growth Factor Receptor Gene

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Mitogens; Osimertinib

Criteria

Inclusion Criteria:

• Aged at least 18 years. Patient from Asia Pacific will be enrolled only.

• Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy.

• Radiological documentation of disease progression on the last treatment administered prior to enrolling in the study: following 1st line EGFR TKI treatment but who have not received further treatment OR following prior therapy with an EGFR TKI and a platinum-based doublet chemotherapy. Patients may have also received additional lines of treatment.

• Documented EGFR mutation (at any time since the initial diagnosis of NSCLC) known to be associated with EGFR TKI sensitivity (including G719X, exon 19 deletion, L858R, L861Q).

• Patients must have central confirmation of tumour T790M mutation positive status from a biopsy sample taken after confirmation of disease progression on the most recent treatment regimen.

• World Health Organisation (WHO) performance status 0-1 with no deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks.

• At least one lesion, not previously irradiated and not chosen for biopsy during the study screening period, that can be accurately measured at baseline as ≥10mm in the longest diameter (except lymph nodes which must have short axis ≥15mm) with computerised tomography (CT) or magnetic resonance imaging (MRI) which is suitable for accurate repeated measurements.

• Females of child-bearing potential using contraception and must have a negative pregnancy test.

Exclusion Criteria:

• Treatment with an EGFR-TKI (eg, erlotinib, gefitinib, icotinib or afatinib) within 8 days or approximately 5x half-life of study entry; any cytotoxic chemotherapy, investigational agents or other anticancer drugs within 14 days of study entry; previous treatment with AZD9291 or a 3rd generation EGFR TKIs; Major surgery within 4 weeks of study entry; radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of study entry; currently receiving treatment with potent inhibitors or inducers of CYP3A4.

• Any unresolved toxicities from prior therapy.

• Unstable spinal cord compression or brain metastases.

• Severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses or infection.

• Refractory nausea and vomiting, chronic gastrointestinal diseases or bowel resection.

• Cardiac disease.

• Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.

• Inadequate bone marrow reserve or organ function.