Carcinoma, Non-Small-Cell Lung, Thyroid Neoplasms
Conditions
Brief summary
This study will evaluate the safety of selpercatinib in participants with RET-altered cancers in India. The study will also assess the number of changes and why participants stop study treatment. For each participant, the study is expected to last 56 weeks and will include up to 16 protocol-specific visits.
Interventions
DRUGSelpercatinib
Tablet administered orally
Sponsors
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants with one of the following RET-altered cancers: * Adults with advanced RET fusion-positive Non-small cell lung cancer (NSCLC) who require systemic therapy * Adults and pediatric participants (greater than or equal to 12 years) with advanced RET-mutant Medullary Thyroid Cancer (MTC) who require systemic therapy * Adults and pediatric participants (greater than or equal to 12 years) with advanced RET fusion-positive thyroid cancer who require systemic therapy, or * Adults and pediatric participants (greater than or equal to 12 years) with advanced or metastatic RET fusion-positive solid tumors with disease progression on or after prior systemic therapies or who have no satisfactory therapeutic options * RET gene fusion or mutation in tumor identified using polymerase chain reaction (PCR) or next-generation sequencing (NGS) * Radiographic progressive disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at screening * Eastern Cooperative Oncology Group performance status score of 0 to 2 * Have not received more than 1 cycle of first-line non-targeted therapy * Men and women of childbearing potential must agree to use a highly effective contraceptive method during treatment with study drug and for 2 weeks following the last dose of study drug * Must have adequate organ function, as defined in the protocol.
Exclusion criteria
* Additional validated oncogenic drivers in NSCLC if known OR have additional validated oncogenic driver in MTC if known that could cause resistance to selpercatinib treatment. * Symptomatic central nervous system metastases, carcinomatous meningitis, or untreated spinal cord compression. * Clinically significant active cardiovascular disease or history of heart attack within 6 months, history of Torsades de Pointes, or prolongation of the QTcF \>470 milliseconds on more than 1 electrocardiogram (ECG) during screening. * History of human immunodeficiency virus (HIV) * Active hepatitis B (HBV) or C (HVC) * Active uncontrolled systemic bacterial, viral or fungal infection or serious ongoing incurrent illness (such as high blood pressure or diabetes, interstitial lung disease) * Uncontrolled, disease related, pericardial effusion, or pleural effusion * Uncontrolled symptomatic overactive or underactive thyroid * Uncontrolled symptomatic high or low levels of calcium in the blood * Active hemorrhage or at significant risk for hemorrhage * Active malabsorption syndrome or other conditions likely to affect gastrointestinal (GI) absorption of study drug * Other malignancy unless non-melanoma skin cancer, carcinoma in situ of the cervix or other in situ cancers, or malignancy diagnosed greater than or equal to 2 years previously and not currently active. Participants receiving adjuvant hormone therapy for breast cancer or prostate cancer with no evidence of disease are eligible. Participants with multiple endocrine neoplasia type 2 (MEN2) associated pheochromocytoma may be eligible. * History of receiving any RET-inhibitor treatment * Are participants who are contraindicated for the use of selpercatinib * Are pregnant or intend to become pregnant or breastfeed during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Treatment Emergent Adverse Event(s) (TEAEs) | Cycle 1 Day 1, End of Study (approximately 56 weeks) (Cycle = 28 days) |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants Undergoing Dose Modification | Cycle 1 Day 1, End of Study (approximately 56 weeks) (Cycle = 28 days) |
| Number of Adverse Events (AEs) Leading to Discontinuation of Study Intervention | Cycle 1 Day 1, End of Study (approximately 56 weeks) (Cycle = 28 days) |
Countries
India
Contacts
CONTACTTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACTPhysicians interested in becoming principal investigators please contact
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Outcome results
None listed