Thyroid NeoplasmsPhase 4NCT07822880
A Study of Selpercatinib (LY3527723) in Participants With Rearranged During Transfection (RET)-Altered Cancers in India
A Phase 4 study testing Selpercatinib in people with Thyroid Neoplasms and Carcinoma, Non-Small-Cell Lung, run by Eli Lilly and Company at 10 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Thyroid Neoplasms, Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Selpercatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 10 sitesIndia
- Study dates
- Oct 2026to Oct 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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)
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- 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
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
10 sites in 1 country
India10 sites
The Gujarat Cancer & Research Institute (GCRI)
Ahmedabad, 380016
Kajal shah
SRV Hospitals
Bengaluru, 560027
Lokesh K.N
AIIMS, Bhubaneshwar
Bhubaneswar, 751019
Sourav Mishra
Aadhar Health Institute
Hisar, 125005
9896539142
Lovenish Goyal
Ruby General Hospital Pvt. Ltd
Kolkata, 411005
Barnini Ghosh
Government Medical College, Kozhikode
Kozhikode, 673008
Sanudev Sadanandan Vadakke Puthiyottil
Mumbai Oncocare Center
Mumbai (E), 400057
Ashish Joshi
Institute Rotary Cancer Hospital
New Delhi, 110029
Deepam Pushpam
Vardhman Mahavir Medical College & Safdarjung Hospital
New Delhi, 110029
Kaushal Kalra
MPMMCC(Mahamana Cancer Hospital)
Varanasi, 221005
Akhil Kapoor
About this study
Official title: A Phase 4, Single-Arm Study to Evaluate the Safety of Selpercatinib in Participants With RET-Altered Cancers in India
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.
- Conditions
- Thyroid Neoplasms, Carcinoma, Non-Small-Cell Lung
- Being tested
- Selpercatinib
- Medical subject headings
- Thyroid Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SelpercatinibDrug
Also called LY3527723
Tablet administered orally
| Study group | Role | What they receive |
|---|---|---|
| Selpercatinib | Experimental | Administered orally Receives: Drug: Selpercatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Treatment Emergent Adverse Event(s) (TEAEs)
Measured: Cycle 1 Day 1, End of Study (approximately 56 weeks) (Cycle = 28 days)
Secondary outcomes (2)
Number of Participants Undergoing Dose Modification
Measured: Cycle 1 Day 1, End of Study (approximately 56 weeks) (Cycle = 28 days)
Number of Adverse Events (AEs) Leading to Discontinuation of Study Intervention
Measured: Cycle 1 Day 1, End of Study (approximately 56 weeks) (Cycle = 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2029 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid NeoplasmsStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07822880
- Sponsor's protocol ID
- 27787
- Other IDs
- J2G-IN-JZPC
- Status last verified
- Oct 2026
- First submitted
- 11 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4, Single-Arm Study to Evaluate the Safety of Selpercatinib in Participants With RET-Altered Cancers in India
- ClinicalTrials.gov ID
- NCT07822880
- Acronym / sponsor ID
- 27787
- Conditions
- Thyroid Neoplasms, Carcinoma, Non-Small-Cell Lung
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 16 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Selpercatinib | Experimental | Drug: SelpercatinibAdministered orally |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Participants with one of the following RET-altered cancers:
- 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
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SelpercatinibAlso: LY3527723Tablet administered orally | Drug | Selpercatinib |
Primary outcome
Number of Participants Treatment Emergent Adverse Event(s) (TEAEs)
Time frame: Cycle 1 Day 1, End of Study (approximately 56 weeks) (Cycle = 28 days)
2 secondary outcomes
Number of Participants Undergoing Dose Modification
Time frame: Cycle 1 Day 1, End of Study (approximately 56 weeks) (Cycle = 28 days)
Number of Adverse Events (AEs) Leading to Discontinuation of Study Intervention
Time frame: Cycle 1 Day 1, End of Study (approximately 56 weeks) (Cycle = 28 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
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) study director
Eli Lilly and Company
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Selpercatinib in people with Thyroid Neoplasms and Carcinoma, Non-Small-Cell Lung, run by Eli Lilly and Company at 10 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Treatment Emergent Adverse Event(s) (TEAEs) (time frame: Cycle 1 Day 1, End of Study (approximately 56 weeks) (Cycle = 28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.