Trial purpose
Cancer treatment
Tumor type
Lung cancer
Age
18+
Trial acronym
LIBRETTO-432
Clinical summary
Summary
Eligible participants will be randomised to receive oral selpercatinib or a placebo. Participants assigned to receive a placebo will have the option to crossover to selpercatinib if their disease comes back or gets worse. Participation could last for up to three years.
Conditions
This trial is treating people with non-small cell lung cancer
Eligibility
Inclusion
- Must have histologically confirmed Stage IB, II, or IIIA NSCLC.
- Must have an activating RET gene fusion in tumor based on polymerase chain reaction (PCR), next generation sequencing (NGS), or another molecular test per sponsor's approval.
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Must have received definitive locoregional therapy with curative intent (surgery or radiotherapy) for Stage IB, II, or IIIA NSCLC.
-- Must have undergone the available anti-cancer therapy (including chemotherapy or durvalumab) or not be suitable for it, based on the investigator's discretion.
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Maximum time allowed between definitive therapy completion and randomization must be:
- 10 weeks if no chemotherapy was administered
- 26 weeks if adjuvant chemotherapy was administered
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- 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 the study and for at least 2 weeks after last dose of study drug.
Exclusion
- Additional oncogenic drivers in NSCLC, if known.
- Evidence of small cell lung cancer.
- Clinical or radiologic evidence of disease recurrence or progression following definitive therapy.
- Known or suspected interstitial fibrosis or interstitial lung disease or history of (noninfectious) pneumonitis that required steroids.
- Clinically significant active cardiovascular disease or history of myocardial infarction within six months prior to planned start of selpercatinib or prolongation of the QT interval corrected for heart rate using Fridericia's formula (QTcF) greater than 470 milliseconds.
- Have known uncontrolled human immunodeficiency virus (HIV)-1/2 infection.
- Have known active hepatitis B or C.
- Active uncontrolled systemic bacterial, viral, or fungal infection or serious ongoing intercurrent illness, such as hypertension or diabetes, despite optimal treatment.
- Major surgery within 4 weeks prior to planned start of selpercatinib.
- Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of the study drug.
- Other malignancy unless nonmelanoma skin cancer, carcinoma in situ of the cervix or other in situ cancers or a malignancy diagnosed greater than or equal to two years previously and not currently active.
- Pregnancy or lactation.
- Prior treatment with a selective RET inhibitor (e.g. selpercatinib or pralsetinib).
Inclusion
- You have had a certain type of treatment or surgical procedure.
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Loxo Oncology, Inc.
Scientific Title
A Placebo-controlled Double-Blinded Randomized Phase 3 Study of Adjuvant Selpercatinib Following Definitive Locoregional Treatment in Participants With Stage IB-IIIA RET Fusion-Positive NSCLC
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