Non Small Cell Lung CancerNCT03906331
Expanded Access for the Treatment of Cancers With Rearranged During Transfection (RET) Activation
A study testing Selpercatinib in people with Non Small Cell Lung Cancer and Medullary Thyroid Cancer, run by Eli Lilly and Company at 64 sites in 13 countries.
Trial summary
Expanded access for participants with cancer with RET activation who are ineligible for an ongoing selpercatinib (also known as LOXO-292) clinical trial or have other considerations that prevent access to selpercatinib through an existing clinical trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, Medullary Thyroid Cancer, Colon Cancer
- What is being tested?
- Selpercatinib
- How many people
- Not given
- Where
- 64 sitesin 13 countries
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Diagnosis of cancer with RET activation, who are not eligible for an ongoing selpercatinib clinical trial and are medically suitable for treatment with selpercatinib
- Have progressed or are intolerant to standard therapy, or no standard therapy option exists, or in the opinion of the investigator, are unlikely to derive significant clinical benefit from standard therapy
- Have adequate organ function
Who cannot join
- Currently enrolled in an ongoing clinical study of selpercatinib or another RET inhibitor
- Clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to study treatment; ongoing cardiomyopathy; or current prolongation of the QT interval corrected for heart rate using Fridericia's formula (QTcF) interval greater than 470 milliseconds
Trial locations and contacts
64 sites in 13 countries.
64 sites in 13 countries
United States34 sites
University of Michigan
Ann Arbor, Michigan, 48109
University Cancer and Blood Center
Athens, Georgia, 30607
Emory University
Atlanta, Georgia, 30329-5102
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
University of Chicago Medicine-Comprehensive Cancer Center
Chicago, Illinois, 60637
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Ohio State University Medical Center
Columbus, Ohio, 43210
City of Hope National Medical Center
Duarte, California, 91010-0269
Virginia Cancer Specialists
Fairfax, Virginia, 22031
Cancer Treatment Centers of America
Goodyear, Arizona, 85338
START Midwest
Grand Rapids, Michigan, 49546
Memorial Cancer Institute
Hollywood, Florida, 33021
Oncology Consultants
Houston, Texas, 77030
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Mayo Clinic in Florida
Jacksonville, Florida, 32224
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169
UCLA Medical Center
Los Angeles, California, 90095
University of Wisconsin-Madison Hospital and Health Clinic
Madison, Wisconsin, 53792-4108
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Kaiser Permanente
Oakland, California, 94612
Irvine Medical Center
Orange, California, 92868
Florida Hospital
Orlando, Florida, 32803
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, 19104
Eastern Regional Medical Center
Philadelphia, Pennsylvania, 19124
Mayo Clinic
Rochester, Minnesota, 55905
University of California - San Diego
San Diego, California, 92103
Univ of California San Francisco
San Francisco, California, 94115
Kaiser Permanente
Santa Clara, California, 95051
Mayo Clinic of Scottsdale
Scottsdale, Arizona, 85259
Tallahassee Memorial Cancer Center
Tallahassee, Florida, 32308
Cancer Treatment Centers of America
Tulsa, Oklahoma, 74133
Kaiser Permanente Medical Center
Vallejo, California, 94589
Cancer Treatment Centers of America
Zion, Illinois, 60099
Japan6 sites
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, 920-8641
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577
Osaka City General Hospital
Osaka, 534-0021
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648
Tottori University Hospital
Yonago, Tottori, 683-8504
Australia5 sites
NSW Health - Sydney Local Health District
Camperdown, New South Wales, 2050
Queensland Health - Metro North Hospital and Health Service
Chermside, Queensland, 4032
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
Linear Clinical Research
Nedlands, Western Australia, 6009
Royal North Shore Hospital
St Leonards, New South Wales, 2065
France3 sites
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
Bordeaux, Aquitaine, 33076
AP-HM
Marseille, 13005
Gustave Roussy
Villejuif, 94805
Germany3 sites
Charité Campus Virchow-Klinikum
Berlin, 13353
Universitätsklinikum Köln
Cologne, North Rhine-Westphalia, 50937
Universitätsklinikum Würzburg A. ö. R.
Würzburg, Bavaria, 97080
Israel3 sites
Soroka Medical Center - Pediatric Outpatient Clinic
Beersheba, 8410101
Shaare Zedek Medical Center
Jerusalem, Jerusalem, 9103102
Sheba Medical Center
Ramat Gan, Central District, 5262100
Italy2 sites
Istituto Nazionale dei Tumori
Milan, Lombardy, 20133
Azienda Ospedaliero Universitaria Pisana
Pisa, PI, 56124
Poland2 sites
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-952
Centrum Onkologii Instytut im Marii Curie w Warszawie
Warsaw, 02-034
Spain2 sites
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona], 8035
Hospital Madrid Norte Sanchinarro
Madrid, 28050
Hong Kong1 site
Prince of Wales Hospital
Hong Kong, Shatin, New Territories, 999077
Singapore1 site
National Cancer Centre Singapore
Singapore, Central Singapore, 169610
About this study
Expanded access for participants with cancer with RET activation who are ineligible for an ongoing selpercatinib (also known as LOXO-292) clinical trial or have other considerations that prevent access to selpercatinib through an existing clinical trial.
The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.
Read the detailed description
N/A for expanded access
- Conditions
- Non Small Cell Lung Cancer, Medullary Thyroid Cancer, Colon Cancer, Breast Cancer, Pancreatic Cancer, Papillary Thyroid Cancer
- Being tested
- Selpercatinib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Carcinoma, Medullary, Colonic Neoplasms, Breast Neoplasms, Pancreatic Neoplasms, Thyroid Cancer, Papillary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SelpercatinibDrug
Also called LOXO-292, LY3527723
Open-label expanded access
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non Small Cell Lung CancerStudies 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Contact Lilly at 1-800-LillyRx (1-800-545-5979), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03906331
- Sponsor's protocol ID
- 17494
- Other IDs
- Selpercatinib EAP, J2G-OX-Y001
- Status last verified
- Dec 2024
- First submitted
- 4 Apr 2019
- Last updated
- 17 Jan 2025
- Results posted
- No
Publications
Rotow J, Patel JD, Hanley MP, Yu H, Awad M, Goldman JW, Nechushtan H, Scheffler M, Kuo CS, Rajappa S, Harada G, Clifford S, Santucci A, Silva L, Tupper R, Oxnard GR, Kherani J, Drilon A. Osimertinib and Selpercatinib Efficacy, Safety, and Resistance in a Multicenter, Prospectively Treated Cohort of EGFR-Mutant and RET Fusion-Positive Lung Cancers. Clin Cancer Res. 2023 Aug 15;29(16):2979-2987. doi: 10.1158/1078-0432.CCR-22-2189.
PubMed 36996322Murciano-Goroff YR, Falcon CJ, Lin ST, Chacko C, Grimaldi G, Liu D, Wilhelm C, Iasonos A, Drilon A. Central Nervous System Disease in Patients With RET Fusion-Positive NSCLC Treated With Selpercatinib. J Thorac Oncol. 2023 May;18(5):620-627. doi: 10.1016/j.jtho.2023.01.008. Epub 2023 Jan 16.
PubMed 36657661
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access for the Treatment of Cancers With Rearranged During Transfection (RET) Activation
- ClinicalTrials.gov ID
- NCT03906331
- Acronym / sponsor ID
- 17494
- Conditions
- Non Small Cell Lung Cancer, Medullary Thyroid Cancer, Colon Cancer, Breast Cancer, Pancreatic Cancer, Papillary Thyroid Cancer
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- First posted
- 8 Apr 2019 (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.
Expanded access for participants with cancer with RET activation who are ineligible for an ongoing selpercatinib (also known as LOXO-292) clinical trial or have other considerations that prevent access to selpercatinib through an existing clinical trial.
The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.
Detailed description
N/A for expanded access
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of cancer with RET activation, who are not eligible for an ongoing selpercatinib clinical trial and are medically suitable for treatment with selpercatinib
- Have progressed or are intolerant to standard therapy, or no standard therapy option exists, or in the opinion of the investigator, are unlikely to derive significant clinical benefit from standard therapy
- Have adequate organ function
Key exclusion criteria (2 listed)
- Currently enrolled in an ongoing clinical study of selpercatinib or another RET inhibitor
- Clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to study treatment; ongoing cardiomyopathy; or current prolongation of the QT interval corrected for heart rate using Fridericia's formula (QTcF) interval greater than 470 milliseconds
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: LOXO-292, LY3527723Open-label expanded access | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Derived from this study: PubMed 36996322Rotow J, Patel JD, Hanley MP, Yu H, Awad M, Goldman JW, Nechushtan H, Scheffler M, Kuo CS, Rajappa S, Harada G, Clifford S, Santucci A, Silva L, Tupper R, Oxnard GR, Kherani J, Drilon A. Osimertinib and Selpercatinib Efficacy, Safety, and Resistance in a Multicenter, Prospectively Treated Cohort of EGFR-Mutant and RET Fusion-Positive Lung Cancers. Clin Cancer Res. 2023 Aug 15;29(16):2979-2987. doi: 10.1158/1078-0432.CCR-22-2189.
- Derived from this study: PubMed 36657661Murciano-Goroff YR, Falcon CJ, Lin ST, Chacko C, Grimaldi G, Liu D, Wilhelm C, Iasonos A, Drilon A. Central Nervous System Disease in Patients With RET Fusion-Positive NSCLC Treated With Selpercatinib. J Thorac Oncol. 2023 May;18(5):620-627. doi: 10.1016/j.jtho.2023.01.008. Epub 2023 Jan 16.
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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. This study is not recruiting at the moment.
Contact Lilly at 1-800-LillyRx (1-800-545-5979) study director
Eli Lilly and Company
64 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selpercatinib in people with Non Small Cell Lung Cancer and Medullary Thyroid Cancer, run by Eli Lilly and Company at 64 sites in 13 countries.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 64 sites in United States, Japan, Australia, France, Germany and 8 more countries. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03906331, which also lists 2 linked publications.
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 17 Jan 2025.