For Healthcare Professionals

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

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About the study

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
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. Aged at least 18 years. Patient from Asia Pacific will be enrolled only.
  2. Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy.
  3. 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.
  4. 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).
  5. 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.
  6. World Health Organisation (WHO) performance status 0-1 with no deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks.
  7. 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.
  8. Females of child-bearing potential using contraception and must have a negative pregnancy test.

EXCLUSION CRITERIA

  1. 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.
  2. Any unresolved toxicities from prior therapy.
  3. Unstable spinal cord compression or brain metastases.
  4. Severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses or infection.
  5. Refractory nausea and vomiting, chronic gastrointestinal diseases or bowel resection.
  6. Cardiac disease.
  7. 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.
  8. Inadequate bone marrow reserve or organ function.
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 1-877-240-9479Email iconEmail Study Center

Study’s details


Contition

Non-Small Cell Lung Cancer

Age (in years)

18 - 130

Phase

Phase 2

Participants needed

171

Est. Completion Date

Dec 2022

Treatment type

Interventional


Sponsor

AstraZeneca

ClinicalTrials.gov identifier

NCT02442349

Study number

D5160C00017

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