NCT07822880

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
37mo left

Started Oct 2026

Typical duration for phase_4

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 16, 2026

Completed
15 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2029

Last Updated

September 23, 2026

Status Verified

September 1, 2026

Enrollment Period

3 years

First QC Date

September 11, 2026

Last Update Submit

September 21, 2026

Conditions

Thyroid NeoplasmsCarcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Treatment Emergent Adverse Event(s) (TEAEs)

    Cycle 1 Day 1, End of Study (approximately 56 weeks) (Cycle = 28 days)

Secondary Outcomes (2)

  • 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)

Study Arms (1)

Selpercatinib

EXPERIMENTAL

Administered orally

Drug: Selpercatinib

Interventions

SelpercatinibDRUG

Tablet administered orally

Also known as: LY3527723
Selpercatinib

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

The Gujarat Cancer & Research Institute (GCRI)

Ahmedabad, 380016, India

Location

AIIMS, Bhubaneshwar

Bhubaneswar, 751019, India

Location

MPMMCC(Mahamana Cancer Hospital)

Varanasi, 221005, India

Location

MeSH Terms

Conditions

Thyroid NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

selpercatinib

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid DiseasesCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Call 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

    STUDY DIRECTOR

Central Study Contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

1-317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2026

First Posted

September 16, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

October 1, 2029

Study Completion (Estimated)

October 1, 2029

Last Updated

September 23, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will share

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria
A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.
More information

Locations

IN(3)