Adjuvant Selpercatinib following definitive locoregional treatment in male or female patients with stage IB-IIIA RET fusion positive NSCLC MedDRA version: 21.1 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Retsevmo
Product Name: SELPERCATINIB
Product Code: SUB193120
Pharmaceutical Form: Capsule
INN or Proposed INN: Selpercatinib
Other descriptive name: Retsevmo
Concentration unit: mg milligr
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Must have histologically confirmed Stage IB, II, or IIIA NSCLC. Staging will be according to the Tumor, Node, Metastasis staging system for lung cancer -Must have an activating RET gene fusion in tumor based on polymerase chain reaction (PCR) or next generation sequencing (NGS) -Must have received definitive locoregional therapy with curative intent (surgery or radiotherapy) for Stage IB, II, or IIIA NSCLC a. Participants must have undergone the available anti-cancer therapy (including chemotherapy or durvalumab) or not be suitable for it, based on the investigator's discretion -Patients must have completely recovered from definitive therapy (surgery or radiotherapy) as well as adjuvant therapy at the time of randomization -Must have Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 -Adequate hematologic, hepatic and renal function -Willingness of men and women of reproductive potential to observe conventional and effective birth control for the duration of treatment and for 2 weeks after. Men must refrain from donating sperm and must agree to using condom. Women of child-bearing potential must not be breastfeeding during treatment and for at least 2 weeks after the last dose of study drug -Written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 85 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 85
Exclusion criteria
Exclusion criteria: -Additional oncogenic driver mutations of NSCLC, e.g., ALK fusion, or activating mutations of EGFR -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 6 months prior to planned start of study treatment or prolongation of the QT interval corrected for heart rate using Fridericia’s formula (QTcF) >470 msec on more than 1 ECG obtained during the baseline period -Uncontrolled human immunodeficiency virus (HIV)-1/2 infection -Has 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 (e.g., hypertension, diabetes, clinically active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, or peritoneal carcinomatosis, pericardial effusion, or pleural effusion). Screening for chronic conditions is not required -Major surgery, excluding placement of vascular access, within 4 weeks of study drug -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 =2 years previously and not currently active -Have a known hypersensitivity to any of the excipients of selpercatinib -Prior treatment with selpercatinib or pralsetinib -Taking a concomitant medication that is known to cause QTc prolongation -Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study. -have participated, within the last 30 days; (3 months in the UK), in a clinical study involving an investigational product. If the previous investigational product has a long half-life, 5 half-lives or 30 days (3 months in the UK), whichever is longer, should have passed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare EFS of participants in the primary analysis population with Stage II-IIIA RET fusion-positive NSCLC treated with selpercatinib versus placebo.;Secondary Objective: -To compare EFS of participants in the overall population with Stage IB-IIIA RET fusion-positive NSCLC treated with selpercatinib versus placebo -To compare other efficacy outcomes achieved with selpercatinib versus placebo in the primary analysis and overall populations -To evaluate the safety and tolerability of selpercatinib versus placebo in the primary analysis and overall populations -To assess/evaluate performance of RET tests from investigator identified laboratories compared to a single Lilly-designated RET test -To compare onset or worsening of NSCLC symptoms in participants treated with selpercatinib versus placebo -To compare physical functioning in participants treated with selpercatinib versus placebo;Primary end point(s): EFS by investigator assessment in the primary analysis population.;Timepoint(s) of evaluation of this end point: Randomization to disease recurrence/progression or death from any cause (Estimated at up to 7 years) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Time to distant disease recurrence in the CNS by investigator assessment and BICR 2. PFS2 by investigator assessment 3. OS 4. Safety per CTCAE v5.0 (including, but not limited to): incidence and severity of TEAEs, SAEs, deaths, and clinical laboratory abnormalities 5. The positive predictive value of RET tests from investigator-identified laboratories with respect to the Lilly-designated RET test 6. Mean change from baseline over time in NSCLC symptoms as measured by NSCLC-SAQ. 7. Time to onset or worsening of NSCLC symptoms as measured by NSCLC-SAQ. 8. Mean change from baseline overtime in physical functioning as measured by EORTC-IL19 or Physical Functioning Scale (items 1-5) of the EORTC QLQ-C30. 9. Time to deterioration of physical functioning as measured by 'EORTC-IL19' or Physical Functioning Scale (items 1-5) of the EORTC QLQ-C30 10. EFS by investigator assessment in overall population as secondary endpoint 11. EFS by BICR;Timepoint(s) of evaluation of this end point: 1. Randomization to disease recurrence/progression or death from any cause (Estimated at up to 7 years) 2. Randomization to Second Disease Progression or Death from Any Cause (Estimated at up to 9 years) 3. Randomization to Date of Death from Any Cause (Estimated at up to 9 years) 4. Baseline to study discontinuation (Estimated at up to 3 years) 5. Baseline 6. Baseline to study discontinuation (Estimated at up to 3 years) 7. Baseline to study discontinuation (Estimated at up to 3 years) 8. Baseline to study discontinuation (Estimated at up to 3 years) 9. Baseline to study discontinuation (Estimated at up to 3 years) 10. Randomization to disease recurrence up to 7 years 11. Randomization to disease recurrence up to 7 years | — |
Countries
Australia, Austria, Belgium, Brazil, Canada, China, Czechia, Czech Republic, Denmark, France, Germany, Greece, Hong Kong, India, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Norway, Poland, Romania, Russian Federation, Singapore, Spain, Sweden, Taiwan, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly
Outcome results
None listed