Clinical Trials List
2016-01-01 - 2019-08-31
Phase III
Terminated8
ICD-10C34
Malignant neoplasm of bronchus and lung
ICD-9162.9
Malignant neoplasm of bronchus and lung, unspecified
An international, randomised, multi-centre, active controlled, open-label Phase III study evaluating the efficacy of in patients with T790M-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease progressed on one epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) treatment
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Trial Applicant
PAREXEL INTERNATIONAL CO., LTD.
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Sponsor
AstraZeneca AB
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Trial scale
Multi-Regional Multi-Center
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Update
2025/11/11
Investigators and Locations
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
None
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
19 Stop recruiting
Audit
None
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Taiwan National PI
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
26 Stop recruiting
Audit
None
Co-Principal Investigator
Audit
CRO
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
None
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
tablet
Dosage
80
Endpoints
locally advanced or metastatic NSCLC whose disease progressed on or after one prior 1st line EGFR-TKI therapy and whose tumours carry at least one EGFR activating mutation and a T790M mutation versus standard platinum doublet chemotherapy
Inclution Criteria
1. Pathologically confirmed diagnosis of adenocarcinoma of the lung.
Patients with mixed histology are eligible if adenocarcinoma is the
predominant histology.
2. Locally advanced stage IIIb or metastatic stage IV NSCLC
Exclusion Criteria
metastatic stage IV NSCLC.
a. Radiotherapy alone is not counted as a line of therapy
b. Radiosensitisers and/or intrapleural administration of anti-cancer agents
are not counted as a line of therapy
2. Previous treatment with BI 1482694, or other 3rd generation EGFR
inhibiting drugs that target T790M-positive mutant EGFR (e.g. AZD9291,
CO-1686).
3. Previous treatment with an approved 1st or 2nd generation EGFR-TKI i.e.
erlotinib, gefitinib, and afatinib within 8 days or 5 half-lives, whichever is
longer, prior to randomisation. Treatment with an approved 1st or 2nd
generation EGFR-TKI during screening is allowed as long as the washout
period of 8 days or 5 half-lives is guaranteed.
4. Previous chemotherapy and experimental anticancer therapy within 4
weeks, anticancer immunotherapy within 2 weeks, or anticancer hormonal
treatment within 2 weeks, of the first administration of study drug.
5. Radiotherapy within 4 weeks prior to randomisation except as follows;
a. Palliative radiotherapy to regions other than the chest is allowed up to 2
weeks prior to randomisation
b. Single dose palliative radiotherapy for symptomatic metastasis within 2
weeks prior to randomisation may be allowed but must be discussed with the
sponsor Major surgery within 4 weeks prior to randomisation or scheduled during
the projected course of the study.
The Estimated Number of Participants
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Taiwan
189 participants
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Global
3500 participants
