Status:
UNKNOWN
Study of AZD9291 in NSCLC Patients Harboring T790M Mutation Who Failed EGFR TKI and With Brain and/or LMS
Lead Sponsor:
Samsung Medical Center
Conditions:
Non-Small Cell Lung Cancer With EGFR T790M Mutation
With Brain and/or Leptomeningeal Metastasis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
AZD9291 is an oral potent irreversible EGFR TKI selective for sensitizing EGFR mutation and T790M resistance mutation but sparing wild-type EGFR. Preclinical studies indicate that AZD9291 has signific...
Detailed Description
1. Primary end points * Overall response rate (ORR) in CNS -brain metastasis cohort * Overall survival - Leptomeningeal with or without brain metastasis cohort 2. Secondary end points * Who...
Eligibility Criteria
Inclusion
- EGFR activating mutant NSCLC patients who failed EGFR TKIs (gefitinib, erlotinib, or afatinib) and develop CNS disease (BM and/or LM) with T790M mutation either tissue or plasma. For patients with intracranial progression, prior radiation therapy is not mandatory. Extracranial progression is allowed.
- Patients who failed to 3rd generation EGFR TKIs (AZD9291 (80mg), Rociletinib, HM61713) and develop CNS progression but stable extracranial disease
- Age ≥18 years
- ECOG performance status of 0 to 2
- For BM, at least one measurable intracranial lesion as ≥ 10mm in the longest diameter by magnetic resonance imaging (MRI)
- For LM, at least one site of CNS leptomeningeal disease that can be assessed by MRI
- Adequate organ function as evidenced by the following;
- Absolute neutrophil count \> 1.5 x 109/L;
- platelets \> 100 x 109/L;
- total bilirubin ≤1.5 UNL;
- AST and/or ALT \< 5 UNL;
- CCr ≥ 50mL/min.
- Female subjects must either be of non-reproductive potential
- Subject is willing and able to comply with the protocol
- Signed written informed consent
Exclusion
- Radiotherapy with a wide field of radiation within 4 weeks or radiotherapy with a limited field of radiation for palliation within 1 week
- Any unresolved toxicities from prior therapy, greater than CTCAE grade 1
- Mean QT interval corrected for heart rate (QTc) ≥ 470 ms
- Uncontrolled systemic illness including uncontrolled hypertension, active bleeding, or active infection.
- Past medical history of interstitial lung disease, drug induced interstitial lung disease, radiation pneumonitis which required steroid treatment
- History of hypersensitivity to AZD9291
- Known intracranial haemorrahge which is unrelated to tumor Refractory nausea and vomiting
Key Trial Info
Start Date :
May 8 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03257124
Start Date
May 8 2017
End Date
December 31 2021
Last Update
August 16 2021
Active Locations (1)
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1
Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul, South Korea, 135-710