ClinicalTrials.gg
Not yet recruitingNCT07822880Updated Oct 8, 2026

A Study of Selpercatinib (LY3527723) in Participants With Rearranged During Transfection (RET)-Altered Cancers in India

A Phase 4 interventional study of Selpercatinib in Thyroid Neoplasms and Carcinoma, Non-Small-Cell Lung, sponsored by Eli Lilly and Company. Not yet recruiting at 10 sites in India. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-10-08.

Sponsored by Eli Lilly and Company · Phase 4, Interventional, and Treatment

Updated Oct 8, 20267 sites addedGo to Updates ↓
Phase
Phase 4
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
12 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Thyroid Neoplasms
  • Carcinoma, Non-Small-Cell Lung
03

In context

Thyroid Neoplasms

785 studies on the registry are indexed under Thyroid Neoplasms; 204 are open to participants now.

This study's planned enrollment of 30 is below the median of 53 across 520 interventional studies indexed under Thyroid Neoplasms.

Browse Thyroid Neoplasms studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,106 studies on the registry; 152 are open to participants now.

Of its 536 completed or terminated interventional studies of FDA-regulated products, 357 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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 (RECIST) 1.1 at screening
  • performance status score of 0 to 2
  • Have not received more than 1 cycle of non-targeted therapy
  • Men and women of must agree to use a highly effective 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

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 , carcinomatous meningitis, or untreated spinal cord compression.
  • active cardiovascular disease or history of heart attack within 6 months, history of Torsades de Pointes, or prolongation of the >470 milliseconds on more than 1 (ECG) during screening.
  • History of (HIV)
  • Active (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 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 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 for the use of selpercatinib
  • Are pregnant or intend to become pregnant or breastfeed during the study
Terms in these criteria, in plain language(14)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Selpercatinib

    Administered orally

    Drug: Selpercatinib

Interventions

  • Tablet administered orally

    Also known as: LY3527723

06

What researchers measure

Primary outcomes

  1. Number of Participants Treatment Emergent Adverse Event(s) (TEAEs)

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

Secondary outcomes

  1. Number of Participants Undergoing Dose Modification

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

  2. 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)

07

Study locations

10 sites
  • The Gujarat Cancer & Research Institute (GCRI)
    Ahmedabad, 380016, India
    • Kajal shah · Principal investigator
  • SRV Hospitals
    Bengaluru, 560027, India
    • Lokesh K.N · Principal investigator
  • AIIMS, Bhubaneshwar
    Bhubaneswar, 751019, India
    • Sourav Mishra · Principal investigator
  • Aadhar Health Institute
    Hisar, 125005, India
    • · Contact9896539142
    • Lovenish Goyal · Principal investigator
  • Ruby General Hospital Pvt. Ltd
    Kolkata, 411005, India
    • Barnini Ghosh · Principal investigator
  • Government Medical College, Kozhikode
    Kozhikode, 673008, India
    • Sanudev Sadanandan Vadakke Puthiyottil · Principal investigator
  • Mumbai Oncocare Center
    Mumbai (E), 400057, India
    • Ashish Joshi · Principal investigator
  • Institute Rotary Cancer Hospital
    New Delhi, 110029, India
    • Deepam Pushpam · Principal investigator
  • Vardhman Mahavir Medical College & Safdarjung Hospital
    New Delhi, 110029, India
    • Kaushal Kalra · Principal investigator
  • MPMMCC(Mahamana Cancer Hospital)
    Varanasi, 221005, India
    • Akhil Kapoor · Principal investigator
08

References and documents

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

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.

Data sharing details ↗ · vivli.org

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Sites
7 sites added
Show 7 added (7 India)
  • SRV Hospitals · Bengaluru, India
  • Aadhar Health Institute · Hisar, India
  • Ruby General Hospital Pvt. Ltd · Kolkata, India
  • Government Medical College, Kozhikode · Kozhikode, India
  • Mumbai Oncocare Center · Mumbai (E), India
  • Institute Rotary Cancer Hospital · New Delhi, India
  • Vardhman Mahavir Medical College & Safdarjung Hospital · New Delhi, India
Oct 8, 2026
Site contacts
Changed at 1 site. See the sites
Show the site
  • The Gujarat Cancer & Research Institute (GCRI) · Ahmedabad, IndiaContact person changed (no phone or email listed)
Oct 8, 2026
Show all 1 update
  1. Oct 8, 2026
    7 sites added
    Show 7 added (7 India)
    • SRV Hospitals · Bengaluru, India
    • Aadhar Health Institute · Hisar, India
    • Ruby General Hospital Pvt. Ltd · Kolkata, India
    • Government Medical College, Kozhikode · Kozhikode, India
    • Mumbai Oncocare Center · Mumbai (E), India
    • Institute Rotary Cancer Hospital · New Delhi, India
    • Vardhman Mahavir Medical College & Safdarjung Hospital · New Delhi, India
    Site contacts Changed at 1 site. See the sites
    Show the site
    • The Gujarat Cancer & Research Institute (GCRI) · Ahmedabad, IndiaContact person changed (no phone or email listed)
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07822880
Responsible party
Sponsor
First posted
Sep 16, 2026
Start date
Oct 2026 (estimated)
Primary completion
Oct 2029 (estimated)
Completion
Oct 2029 (estimated)
Last update
Oct 8, 2026

Study contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Contact
LillyTrials@Lilly.com
1-317-615-4559
Physicians interested in becoming principal investigators please contact
Contact
clinical_inquiry_hub@lilly.com
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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Selpercatinib

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