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Report for Clinical Trial NCT02132598

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Single-Arm Phase II Clinical Trial of Cabozantinib (XL184) in Patients With Previously Treated Non-Small Cell Lung Cancer (NSCLC) With Brain Metastases With and Without C Met Amplification

This is an open-label phase II clinical trial designed to allow a preliminary assessment of the efficacy and safety of cabozantinib in unselected Non-Small Cell Lung Cancer (NSCLC) patients with metastases to the brain and in the subset of patients with c-MET amplified Non-Small Cell Lung Cancer with metastases to the brain. Previously treated patients with non-squamous NSCLC who have had brain metastases at any point in their treatment history are eligible for enrollment on this clinical trial. Patients with clinically asymptomatic untreated brain metastases will be allowed on trial at the discretion of the treating investigator. Patients who have undergone treatment for their brain metastases with Whole-Brain Radiation Therapy (WBRT), stereotactic radiosurgery (SRS) or surgery must be clinically stable and recovered from all procedures at the time of study enrollment.

NCT02132598 Non Small Cell Lung Cancer (NSCLC) Metastases to the Brain
MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung Neoplasm Metastasis Neoplasms, Second Primary
HPO:Neoplasm of the lung Non-small cell lung carcinoma

1 Interventions

Name: cabozantinib

Type: Drug
Group Labels: 1

Cabozantinib (XL184)

Primary Outcomes

Measure: To assess the Overall Response Rate (ORR)

Time: 12 months

Secondary Outcomes

Measure: To assess the Disease Control Rate (DCR)

Time: 16 weeks

Measure: To assess the Progression-free Survival (PFS)

Time: 12 months

Measure: To assess the Overall Survival (OS)

Time: 24 months

Description: Seriousness, severity/ grade and relationship to study treatment will be assessed by the investigator. Severity/ grade will be defined by the National Cancer Institute (NCI) CTCAE v4.0. Subjects will be monitored continuously for Adverse Events (AE's) throughout the study and for 30 days after the last dose of study treatment and for any serious adverse event (SAE) assessed as related to study treatment or study procedures, even if the SAE occurs more than 30 days after the last dose of study treatment.

Measure: Number of Participants with Serious and Non-Serious Adverse Events

Time: Monitor AE's continuously during study and for 30 days after the last dose of study treatment and SAE's assessed as related to study treatment until resolution

Description: For this study, computed tomography scans will be performed every 8 weeks for assessment of extra-cranial disease. An MRI of the brain with contrast (or CT brain with contrast in patients who are unable to obtain an MRI, e.g., has a pacemaker) will be performed every 8 weeks to assess intracranial disease. In patients whose first site of disease progression is extra-cranial disease, a brain MRI (or CT brain with contrast in patients who are unable to obtain an MRI) will be performed at the time of extra-cranial disease progression and every 12 weeks in the study follow-up period. Subjects continuing to show benefit, (complete response [CR], partial response [PR], or stable disease [SD]) as defined by RECIST v1.1 may continue on study. Subjects with PD as defined by RECIST v1.1 should have their treatment discontinued, and they should enter the post-treatment phase of the study. The same method for tumor assessment should be employed at every assessment

Measure: Time to Progression (TTP) of intra-cranial disease

Time: Baseline at 28 days prior to 1st dose, then every 8 weeks till Progressive Disease followed by every 12 weeks for 5 years

Purpose: Treatment

Allocation: N/A

Single Group Assignment

There is one SNP


1 L858R

Patients must agree to submission of these specimens as defined in Section 9. - c-MET amplification will be determined by FISH ratio (c-MET/CEP7) > 2.0, based on testing of the primary tumor and/or site of metastatic disease - Patients' tumors must undergo testing for Epidermal Growth Factor Receptor (EGFR) exon 19 deletion, EGFR exon 21 L858R substitution, and anaplastic lymphoma kinase (ALK) rearrangements. --- L858R ---

HPO Nodes