B7461006 - A PHASE 3, RANDOMIZED, OPEN-LABEL STUDY OF LORLATINIB (PF-06463922) MONOTHERAPY VERSUS CRIZOTINIB MONOTHERAPY IN THE FIRST-LINE TREATMENT OF PATIENTS WITH ADVANCED ALK-POSITIVE NON-SMALL CELL LUNG CANCER

Conditions

Advanced ALK positive non-small cell lung cancer

Brief summary

• PFS based on blinded independent central review (BICR) assessment (RECIST v.1.1).

Detailed description

• Efficacy: OS, PFS based on Investigator’s assessment, OR based on BICR and on Investigator’s assessment; intracranial OR (IC OR), IC TTP, DR and IC-DR, TTR and IC-TTR all by BICR (RECIST v. 1.1) and PFS2; IC-OR, IC-TTP, IC-DR, IC-TTR and DR based on the investigator’s assessment., • Safety: AEs (as graded by NCI CTCAE v.4.03); laboratory abnormalities (as graded by NCI CTCAE v.4.03); vital signs (blood pressure, pulse rate) and body weight; electrocardiograms (ECGs); echocardiogram or MUGA scan; ophthalmologic data., • PROs as assessed by EORTC QLC C30, EORTC QLQ LC13, EQ 5D 5L., • Tumor tissue biomarkers including, but not limited to, ALK gene rearrangement and/or mutation as measured by next generation sequencing (NGS) and/or immunohistochemistry (IHC)., • Peripheral blood cfDNA (circulating free Deoxyribonucleic acid) biomarkers including, but not limited to, ALK gene rearrangement and/or ALK kinase domain mutations.

Related papers

No related papers found yet.

Interventions

DRUGLORLATINIB

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
• PFS based on blinded independent central review (BICR) assessment (RECIST v.1.1).	—

Secondary

Measure	Time frame
• Efficacy: OS, PFS based on Investigator’s assessment, OR based on BICR and on Investigator’s assessment; intracranial OR (IC OR), IC TTP, DR and IC-DR, TTR and IC-TTR all by BICR (RECIST v. 1.1) and PFS2; IC-OR, IC-TTP, IC-DR, IC-TTR and DR based on the investigator’s assessment., • Safety: AEs (as graded by NCI CTCAE v.4.03); laboratory abnormalities (as graded by NCI CTCAE v.4.03); vital signs (blood pressure, pulse rate) and body weight; electrocardiograms (ECGs); echocardiogram or MUGA scan; ophthalmologic data., • PROs as assessed by EORTC QLC C30, EORTC QLQ LC13, EQ 5D 5L., • Tumor tissue biomarkers including, but not limited to, ALK gene rearrangement and/or mutation as measured by next generation sequencing (NGS) and/or immunohistochemistry (IHC)., • Peripheral blood cfDNA (circulating free Deoxyribonucleic acid) biomarkers including, but not limited to, ALK gene rearrangement and/or ALK kinase domain mutations.	—

Measure

Time frame

• Efficacy: OS, PFS based on Investigator’s assessment, OR based on BICR and on Investigator’s assessment; intracranial OR (IC OR), IC TTP, DR and IC-DR, TTR and IC-TTR all by BICR (RECIST v. 1.1) and PFS2; IC-OR, IC-TTP, IC-DR, IC-TTR and DR based on the investigator’s assessment., • Safety: AEs (as graded by NCI CTCAE v.4.03); laboratory abnormalities (as graded by NCI CTCAE v.4.03); vital signs (blood pressure, pulse rate) and body weight; electrocardiograms (ECGs); echocardiogram or MUGA scan; ophthalmologic data., • PROs as assessed by EORTC QLC C30, EORTC QLQ LC13, EQ 5D 5L., • Tumor tissue biomarkers including, but not limited to, ALK gene rearrangement and/or mutation as measured by next generation sequencing (NGS) and/or immunohistochemistry (IHC)., • Peripheral blood cfDNA (circulating free Deoxyribonucleic acid) biomarkers including, but not limited to, ALK gene rearrangement and/or ALK kinase domain mutations.

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Countries

Belgium, Czechia, France, Germany, Italy, Netherlands, Poland, Spain

Outcome results

None listed