Can a targeted pill be safely used for RET-Driven cancers in india?
NCT ID NCT07822880
First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time
Summary
Researchers are studying the safety of selpercatinib, an oral drug, in people in India with advanced cancers that have changes in the RET gene. The trial includes adults with RET fusion-positive non-small cell lung cancer and adults and children aged 12 and older with RET-mutant medullary thyroid cancer or RET fusion-positive thyroid cancer. About 30 participants will take selpercatinib tablets and be followed for up to 56 weeks, with up to 16 clinic visits. The study tracks side effects, dose changes, and reasons people stop treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- selpercatinib, an oral drug that targets cancers with RET gene changes
- What this could lead to
- If selpercatinib proves safe and tolerable in this population, it could support wider use for people in India with RET-altered thyroid and lung cancers.
- What could go wrong
- This is a small, single-arm safety study with no comparison group, so it cannot prove how well the drug works. Participants may still experience side effects or need dose changes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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12 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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AIIMS, Bhubaneshwar
Bhubaneswar, 751019, India
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The Gujarat Cancer & Research Institute (GCRI)
Ahmedabad, 380016, India
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