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Clinical Trials List

Protocol NumberJ2G-MC-JZJC
NCT Number(ClinicalTrials.gov Identfier)NCT04194944
Active

2020-01-06 - 2026-09-05

Phase III

Recruiting14

ICD-10C34.90

Malignant neoplasm of unspecified part of unspecified bronchus or lung

ICD-10C34.91

Malignant neoplasm of unspecified part of right bronchus or lung

ICD-10C34.92

Malignant neoplasm of unspecified part of left bronchus or lung

ICD-10C7A.090

Malignant carcinoid tumor of the bronchus and lung

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

LIBRETTO-431: A Multicenter, Randomized, Open-Label, Phase 3 Trial Comparing Selpercatinib to Platinum-Based and Pemetrexed Therapy With or Without Pembrolizumab as Initial Treatment of Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer

  • Trial Applicant

    ELI LILLY AND COMPANY(TAIWAN), INC.

  • Sponsor

    Eli Lilly and Company

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator 林聖皓 Division of Thoracic Medicine
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chien-Chung Lin Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Te-Chun Hsia Division of General Internal Medicine
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 黃文聰 Division of Hematology & Oncology
Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator CHIN-CHOU WANG Division of Thoracic Medicine
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yuh-Min Chen Division of Thoracic Medicine
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 魏裕峰 Division of Thoracic Medicine
E-DA Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator TSUNG -YING YANG Division of Thoracic Medicine
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator kang-Yun LEE Division of Thoracic Medicine
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 何景良 Division of Hematology & Oncology
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 賴俊良 Division of Thoracic Medicine
Dalin Tzu Chi Hospital Buddhist Tzu Chi Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Gee-chen Chang Division of Thoracic Medicine
Chung Shan Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator James Chih-Hsin Yang Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Cheng-Ta Yang Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Non-Small Cell Lung Cancer

Objectives

The reason for this study is to see if the study drug selpercatinib compared to a standard treatment is effective and safe in participants with rearranged during transfection (RET) fusion-positive non-squamous non-small cell lung cancer (NSCLC) that has spread to other parts of the body. Participants who are assigned to the standard treatment and discontinue due to progressive disease have the option to potentially crossover to selpercatinib.

Test Drug

Selpercatinib (LY3527723)

Active Ingredient

Selpercatinib (LY3527723)

Dosage Form

Capsule

Dosage

40mg/80mg

Endpoints

Primary Outcome Measures :
Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) (with Pembrolizumab) [ Time Frame: Baseline to Progressive Disease or Death from Any Cause (Estimated at up to 24 Months) ]
PFS by BICR (with Pembrolizumab)

PFS by BICR (with or without Pembrolizumab) [ Time Frame: Baseline to Progressive Disease or Death from Any Cause (Estimated at up to 24 Months) ]
PFS by BICR (with or without Pembrolizumab)


Secondary Outcome Measures :
Disease Control Rate (DCR) by BICR (with Pembrolizumab) [ Time Frame: Baseline to Progressive Disease or Death from Any Cause (Estimated at up to 24 Months) ]
DCR by BICR (with Pembrolizumab)

DCR by BICR (with or without Pembrolizumab) [ Time Frame: Baseline to Progressive Disease or Death from Any Cause (Estimated at up to 24 Months) ]
DCR by BICR (with or without Pembrolizumab)

PFS2 (with Pembrolizumab) [ Time Frame: Baseline to Second Disease Progression or Death from Any Cause (Estimated at up to 36 Months) ]
PFS2 (with Pembrolizumab)

PFS2 (with or without Pembrolizumab) [ Time Frame: Baseline to Second Disease Progression or Death from Any Cause (Estimated at up to 36 Months) ]
PFS2 (with or without Pembrolizumab)

Overall Response Rate (ORR): Percentage of Participants with Complete Response (CR) or Partial Response (PR) by BICR (with Pembrolizumab) [ Time Frame: Baseline through Disease Progression or Death (Estimated at up to 24 Months) ]
ORR: Percentage of Participants with CR or PR by BICR (with Pembrolizumab)

Inclution Criteria

Inclusion Criteria:
1. Histologically confirmed Stage IIIB-IIIC or Stage IV NSCLC that is not suitable for
radical surgery or radiation therapy (Lim et al. 2018). The histology of the tumor must be
predominantly non-squamous. Squamous cell and/or mixed small cell/non-small cell
histology is not permitted.
2. Must have a RET gene fusion in tumor using PCR or NGS. Results in blood using NGS
are also acceptable.
 The RET gene fusion result should be generated from a laboratory with CLIA,
ISO/EIC, CAP, or other similar certification that clearly denotes the presence of a
RET alteration. Blood results must be determined on a platform that meets these
standards and is also Lilly approved.
 In all cases, the presence of the RET fusion must be confirmed upon review of the
pathology report by Lilly or designee prior to enrollment.
 An unstained, archived tumor tissue sample in a quantity sufficient to allow for
retrospective central analysis of RET fusion/mutation status (for confirmation
purposes) must be available at the time of randomization. Please refer to Section
8.8.1 for details
3. Must have measurable disease per RECIST 1.1 (Eisenhauer et al. 2009) as assessed by
the investigator. Target lesions situated in a previously irradiated area are considered
measurable if progression has been determined in such lesions, and the location of
previously irradiated lesions is clearly documented.
4. Must have Eastern Cooperative Oncology Group (ECOG) performance status score of
0-2 (Oken et al. 1982)
5. Must have life expectancy of at least 3 months.
6. Must have adequate organ function, as defined subsequently. These values must be met
during the baseline visit as well as predose Cycle 1 Day 1.
7. Ability to swallow capsules.
8. Men with partners of childbearing potential or women of childbearing potential must
agree to use a highly effective contraceptive method (e.g., intrauterine device or birth
control pill) during treatment with study drug and for 6 months following the last dose of
study drug. See Appendix 3. In addition, male subjects randomized to Arm B should use
a condom while on study treatment and for 91 days following the last dose of
pemetrexed.
9. Women of childbearing potential must:
 Have a negative pregnancy test (serum or urine, consistent with local regulations)
documented within 24 hours prior to treatment with study drug.
 Not be breast-feeding during treatment and for at least 4 months after the last dose
of study drug.
10. The participant or his/her legally authorized representative must be capable of
demonstrating an understanding of the nature, significance and implications of
participation in the trial and giving signed informed consent as described in Appendix 1,
which includes compliance with the requirements and restrictions listed in the informed
consent form (ICF) and in this protocol.
11. Are of an acceptable age to provide informed consent according to local regulations and
are at least 18 years of age.

Exclusion Criteria

Exclusion Criteria:

Additional validated oncogenic drivers in NSCLC if known.
Prior systemic therapy for metastatic disease. Treatment (chemotherapy, immunotherapy, or biological therapy) in the adjuvant/neoadjuvant setting is permitted if it was completed at least 6 months prior to randomization.
Major surgery within 3 weeks prior to planned start of selpercatinib.
Radiotherapy for palliation within 1 week of the first dose of study treatment or any radiotherapy within 6 months prior to the first dose of study treatment if more than 30 Gy to the lung.
Symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or untreated spinal cord compression.
Clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to planned start of selpercatinib or prolongation of the QT interval corrected for heart rate using Fridericia's formula (QTcF) > 470 milliseconds.
Active uncontrolled systemic bacterial, viral, or fungal infection or serious ongoing intercurrent illness, such as hypertension or diabetes, despite optimal treatment.
Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of the study drug.
Pregnancy or lactation.
Other malignancy unless nonmelanoma skin cancer, carcinoma in situ of the cervix or other in situ cancers or a malignancy diagnosed ≥2 years previously and not currently active.
Uncontrolled, disease related pericardial effusion or pleural effusion.
Requiring chronic treatment with steroids.
Exclusion Criteria for Participants Receiving Pembrolizumab:

History of interstitial lung disease or interstitial pneumonitis.
Active autoimmune disease or any illness or treatment that could compromise the immune system.

The Estimated Number of Participants

  • Taiwan

    42 participants

  • Global

    400 participants

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