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| Name | Class |
|---|---|
| Guardant Health AMEA, Inc. | UNKNOWN |
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The investigators plan to understand a comprehensive molecular profiling via the plasma, with the primary aim of using this form on analysis to guide subsequent treatment selection. This study will provide a better understanding of ALK resistance in the treatment of Asian lung cancers and allow for improved clinical outcomes by 'matching' the secondary mutations to an ALK inhibitor which would allow for the greatest coverage ultimately leading to lasting duration of response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prior 2nd generation ALKi | |||
| Prior 1st and 2nd generation ALKi |
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| Measure | Description | Time Frame |
|---|---|---|
| Molecular profiling of plasma | Profiling of the collected plasma samples at a molecular level to evaluate the molecular epidemiology of ALK fusion oncogene positive lung cancer | 2 to 4 weeks after collection of plasma |
| Measure | Description | Time Frame |
|---|---|---|
| Patient survival status | After molecular profiling has been completed, every few months up to 2 years | |
| Subsequent patient treatment status | After molecular profiling has been completed, every few months up to 2 years |
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Inclusion Criteria:
Patients with advanced ALK fusion oncogene positive lung adenocarcinoma that have progressed after 1-2 ALK inhibitors, with at least one prior line of 2nd generation ALKi (i.e. Ceritinib, Alectinib, Brigatinib or Ensartinib)
The availability of sufficient plasma
Age ≥ 21 years
WHO performance status ≤ 2
Life expectancy of ≥ 21 weeks
Patients should have adequate organ function for potential consideration into clinical trials (routine blood tests are valid within 14 days before enrollment):
Willing to provide signed informed consent
Patients whom do not fulfill the above criteria may be discussed on a case-by-case basis within the study team, for potential enrolment
Exclusion Criteria:
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Two cohorts will be enrolled, the first cohort will consist of patients that have received prior 2nd generation ALKi only, and the second cohort with patients that have received prior 1st and 2nd generation ALKi.
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| Name | Affiliation | Role |
|---|---|---|
| Daniel SW Tan, BSc, MBBS, PhD | National Cancer Centre of Singapore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Chinese University of Hong Kong | Hong Kong | Hong Kong | ||||
| University Malaya Medical Centre |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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15-20mL of plasma
| Clinical outcomes of the subsequent treatments the patients receive | After molecular profiling has been completed, every few months up to 2 years |
| Kuala Lumpur |
| Malaysia |
| National Cancer Center Singapore | Singapore | 169690 | Singapore |
| Asan Medical Centre | Seoul | 05505 | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |