Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Gland and Hormone Related Diseases

Nervous System Diseases

Rare Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Thyroid Neoplasms

Thyroid Diseases

Carcinoma, Neuroendocrine

Brain Stem Neoplasms

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Infratentorial Neoplasms

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Thyroid Cancer, Medullary

Neuroendocrine Tumor

Neuroepithelioma

Selpercatinib 160 milligrams (mg) administered orally twice daily (BID).

Selpercatinib

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM

The reason for this study is to see if the study drug selpercatinib is safe and effective in participants in China with rearranged during transfection (RET) fusion-positive solid tumors, medullary thyroid cancer (MTC) and other tumors with RET activation.

A Study of Selpercatinib (LY3527723) in Participants With Advanced Solid Tumors Including RET Fusion-positive Solid Tumors, Medullary Thyroid Cancer and Other Tumors With RET Activation

A Phase 2 Study of Oral Selpercatinib (LOXO-292) in Patients With Advanced Solid Tumors, Including Rearranged in Transfection (RET) Fusion-Positive Solid Tumors, Medullary Thyroid Cancer and Other Tumors With RET Activation

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

ORR is the summary measure of best overall response (BOR) as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. BOR is defined as the best response designation for each participant that is recorded between the date of the first dose of selpercatinib and the date of documented disease progression per RECIST 1.1 or the date of subsequent therapy, whichever occurs first, and subsequently confirmed. BOR will be categorized as complete response (CR), partial response (PR). CR is defined as Disappearance of all target lesions. Any pathologic nodes (whether target or non-target lesions) must have a reduction in short axis diameter (SAD) to less than 10 mm. PR At least 30% decrease in the sum of the diameters (SOD) (LD for non-nodal lesions and SAD for nodal lesions) of target lesions, taking as reference the baseline sum LD.

DOR is defined as the number of months from the start date of PR or CR (whichever response is recorded first), and subsequently confirmed, to the date of disease progression or death, whichever occurs earlier.

TTR is defined as the number of months elapsed between the date of the first dose of selpercatinib and the first documentation of objective response (CR or PR, whichever occurs earlier) that is subsequently confirmed.

CBR based on the percentage of participants with best overall response of CR, PR, or stable disease (SD) lasting 16 or more weeks following initiation of selpercatinib as assessed by IRC. CR is defined as disappearance of all target lesions. Any pathologic nodes (whether target or non-target lesions) must have a reduction in short axis diameter (SAD) to less than 10 mm. PR is defined as at least a 30% decrease in the sum of the diameters (SOD) (LD for non-nodal lesions) and SAD for nodal lesions) of target lesions, taking as reference the baseline sum LD. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.

PFS is defined as the number of months elapsed between the date of the first dose and the earliest date of documented disease progression or death (whatever the cause). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest sum on study) for target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5.0 mm. Progressive disease for non-target lesion is defined as the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.

OS is defined as the number of months elapsed between the date of the first dose and the date of death (whatever the cause). Participants who are alive or lost to follow-up as of the data cutoff date will be right-censored.

Serial blood samples for intensive PK monitoring will be collected for 12 participants.

Eli Lilly and Company

Loxo Oncology, Inc.

All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.

160 mg Selpercatinib administered orally twice daily (BID).

160 mg Selpercatinib administered orally BID.

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

China

Region of Enrollment

All enrolled participants who received at least one dose of study drug.

Chief Medical Officer

Complete Response

Partial Response

Overall Response (CR/PR)

RET Fusion Positive Non-small Cell Lung Cancer (NSCLC) Cohort 1

RET Fusion Positive Thyroid Cancer (TC) Cohort 1

RET Mutant Medullary Thyroid Cancer (MTC) Cohort 2

All treated participants who have confirmed RET fusion positive solid tumor NSCLC,TC, or RET mutant MTC by central lab, respectively.

Primary Analysis Set: Overall Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR) as Assessed by Independent Review Committee (IRC)

Non-small Cell Lung Cancer (All NSCLC)

Thyroid Cancer (All TC)

Medullary Thyroid Cancer (All MTC)

Enrolled Population: Overall Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR) as Assessed by IRC

All NSCLC

All TC

All MTC

All eligible participants with confirmed response. Number of participants censored: All NSCLC = 30, All TC = 1, and All MTC = 16.

Enrolled Population: Duration of Response (DoR) as Assessed by IRC

All eligible participants with confirmed response.

Enrolled Population: Time to Response (TTR) as Assessed by IRC

All eligible patients with confirmed response.

Enrolled Population: Time to Best Response (TTBR) as Assessed by IRC

Enrolled Population: Clinical Benefit Rate (CBR): Percentage of Participants Who Achieve CR, PR, or Stable Disease (SD) With a Duration of At Least 16 or More Weeks as Assessed by IRC

All eligible participants. Number of participants censored: All NSCLC = 40; All TC = 1, and All MTC = 28

Enrolled Population: Progression Free Survival (PFS) as Assessed by IRC

All eligible participants. Number of participants censored: All NSCLC = 42, All TC = 1, and All MTC = 28.

Enrolled Population: Overall Survival (OS)

Cycle 1 Day 1

Cycle 1 Day 8

All randomized participants who received at least one dose of study drug and had evaluable intensive PK data per protocol.

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Selpercatinib

160 milligram (mg) Selpercatinib administered orally twice daily (BID).

Spots Global Cancer Trial Database for A Study of Selpercatinib (LY3527723) in Participants With Advanced Solid Tumors Including RET Fusion-positive Solid Tumors, Medullary Thyroid Cancer and Other Tumors With RET Activation

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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