A Study of Selpercatinib (LY3527723) in Participants With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer (LIBRETTO-431)

STATUS

Recruiting
End date

Aug 18, 2025
participants needed

250
sponsor

Loxo Oncology, Inc.

Send

Updated on 13 June 2022

See if I qualify

progressive disease

pemetrexed

carboplatin

pembrolizumab

RET

kidney function test

lung carcinoma

squamous non-small cell lung cancer

non-squamous non-small cell lung cancer

Summary

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.

Details

Condition	Non-Small Cell Lung Cancer
Treatment	cisplatin, carboplatin, Pembrolizumab, Pemetrexed, Selpercatinib
Clinical Study Identifier	NCT04194944
Sponsor	Loxo Oncology, Inc.
Last Modified on	13 June 2022

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Histologically or cytologically confirmed, Stage IIIB-IIIC or Stage IV non-squamous NSCLC that is not suitable for radical surgery or radiation therapy
	A RET gene fusion in tumor and/or blood from a qualified laboratory
	Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
	Adequate hematologic, hepatic and renal function
	Willingness of men and women of reproductive potential to observe conventional and highly effective birth control for the duration of treatment and for 6 months after
	Ability to swallow capsules
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

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A Study of Selpercatinib (LY3527723) in Participants With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer (LIBRETTO-431)