The reason for this study is to see if the study drug, selpercatinib, compared to placebo is effective and safe in delaying cancer return in participants with early-stage non-small cell lung cancer (NSCLC), who have already had surgery or radiation. Participants who are assigned to placebo and stop the study drug because their disease comes back or gets worse have the option to potentially crossover to selpercatinib. Participation could last up to three years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
152
Administered orally.
Administered orally.
Event-Free Survival (EFS)
EFS by Investigator Assessment in the Primary Analysis Population
Time frame: Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years)
EFS
EFS by investigator assessment in the overall population
Time frame: Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years)
Overall Survival (OS)
OS
Time frame: Randomization to death from any cause (estimated as up to 9 years)]
EFS
EFS by blinded independent central review (BICR)
Time frame: Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years)]
Time to Distant Disease Recurrence in the Central Nervous System (CNS)
Time to distant disease recurrence in the CNS by investigator assessment and BICR
Time frame: Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years)
Progression Free Survival on the Next Line of Treatment (PFS2)
PFS2 by investigator assessment
Time frame: Randomization to disease progression on the next line of treatment or death from any cause (estimated as up to 9 years)
Positive Predictive Value (PPV) of Rearranged during Transfection (RET) Tests from Investigator-Identified Laboratories with Respect to the Lilly-Designated RET Test
PPV of RET Tests from Investigator-Identified Laboratories with Respect to the Lilly-Designated RET Test
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UCLA Hematology/Oncology - Santa Monica
Los Angeles, California, United States
Stockton Hematology Oncology Group
Stockton, California, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, United States
GenesisCare
Aventura, Florida, United States
GenesisCare - Boca Raton
Boca Raton, Florida, United States
USO-Cancer Care Center of Brevard, Inc.
Palm Bay, Florida, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Mayo Clinic in Rochester, Minnesota
Rochester, Minnesota, United States
USO-New York Oncology Hematology, P.C
Latham, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
...and 201 more locations
Time frame: Baseline
Mean Change from Baseline over Time in NSCLC Symptoms
NSCLC symptoms will be measured using the 7-item NSCLC Symptom Assessment Questionnaire (NSCLC-SAQ). The NSCLC-SAQ measures the severity/frequency of the following core symptoms: Cough, pain, dyspnea, fatigue, and appetite. Raw scores range from 0 to 4 and the total score ranges from 0-20. Higher scores represent worse symptoms.
Time frame: Baseline to treatment discontinuation (estimated as up to 3 years)
Mean Change from Baseline over Time in Physical Function
Physical function will be measured by the 5 physical function items in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) (also known as the EORTC IL 19 questionnaire). Raw scores range from 0-20. Higher scores indicate worst function.
Time frame: Baseline to treatment discontinuation (estimated as up to 3 years)