Trial · NCT04280081
A Study of Selpercatinib (LY3527723) in Participants With Advanced Solid Tumors Including RET Fusion-positive Solid Tumors, Medullary Thyroid Cancer and Other Tumors With RET Activation
NCT04280081, Phase 2, Active not recruiting, Eli Lilly and Company; results first posted 2022-06-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Selpercatinib (LY3527723) in Participants With Advanced Solid Tumors Including RET Fusion-positive Solid Tumors, Medullary Thyroid Cancer and Other Tumors With RET Activation. Trials, record NCT04280081. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04280081
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Selpercatinib (LY3527723) in Participants With Advanced Solid Tumors Including RET Fusion-positive Solid Tumors, Medullary Thyroid Cancer and Other Tumors With RET Activation
- NCT number
- NCT04280081
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 77 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Solid Tumor, Medullary Thyroid Cancer
- Interventions
- Selpercatinib
- First posted
- 2020-02-21
- Last updated
- 2026-08-07
- Results first posted
- 2022-06-02
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Primary Analysis Set: Overall Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR) as Assessed by Independent Review Committee (IRC) | Date of First Dose to Disease Progression or Death (up to 12 Months) | ORR is the summary measure of best overall response (BOR) as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. BOR is defined as the best response designation for each participant that is recorded between the date of the first dose of selpercatinib and the date of documented disease progression per RECIST 1.1 or the date of subsequent therapy, whichever occurs first, and subsequently confirmed. BOR will be categorized as complete response (CR), partial response (PR). CR is defined as Disappearance of all target lesions. Any pathologic nodes (whether target or non-target lesions) must have a reduction in short axis diameter (SAD) to less than 10 mm. PR At least 30% decrease in the sum of the diameters (SOD) (LD for non-nodal lesions and SAD for nodal lesions) of target lesions, taking as reference the baseline sum LD. |
| Primary | Enrolled Population: Overall Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR) as Assessed by IRC | Date of First Dose to Disease Progression or Death (Up to 12 months) | ORR is the summary measure of best overall response (BOR) as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. BOR is defined as the best response designation for each participant that is recorded between the date of the first dose of selpercatinib and the date of documented disease progression per RECIST 1.1 or the date of subsequent therapy, whichever occurs first, and subsequently confirmed. BOR will be categorized as complete response (CR), partial response (PR). CR is defined as Disappearance of all target lesions. Any pathologic nodes (whether target or non-target lesions) must have a reduction in short axis diameter (SAD) to less than 10 mm. PR At least 30% decrease in the sum of the diameters (SOD) (LD for non-nodal lesions and SAD for nodal lesions) of target lesions, taking as reference the baseline sum LD. |
| Secondary | Enrolled Population: Duration of Response (DoR) as Assessed by IRC | Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Up to 11 Months) | DOR is defined as the number of months from the start date of PR or CR (whichever response is recorded first), and subsequently confirmed, to the date of disease progression or death, whichever occurs earlier. |
| Secondary | Enrolled Population: Time to Response (TTR) as Assessed by IRC | Date of First Dose to First Occurrence of Confirmed Tumor Response (Up to 6 months) | TTR is defined as the number of months elapsed between the date of the first dose of selpercatinib and the first documentation of objective response (CR or PR, whichever occurs earlier) that is subsequently confirmed. |
| Secondary | Enrolled Population: Time to Best Response (TTBR) as Assessed by IRC | Date of First Dose to First Occurrence of PR (If Subject's Best Overall Response [BOR] is PR) or CR (If Subject's BOR is CR) (Up to 8 months) | TTR is defined as the number of months elapsed between the date of the first dose of selpercatinib and the first documentation of objective response (CR or PR, whichever occurs earlier) that is subsequently confirmed. |
| Secondary | Enrolled Population: Clinical Benefit Rate (CBR): Percentage of Participants Who Achieve CR, PR, or Stable Disease (SD) With a Duration of At Least 16 or More Weeks as Assessed by IRC | Baseline through Disease Progression or Death Due to Any Cause (Up to 12 Months) | CBR based on the percentage of participants with best overall response of CR, PR, or stable disease (SD) lasting 16 or more weeks following initiation of selpercatinib as assessed by IRC. CR is defined as disappearance of all target lesions. Any pathologic nodes (whether target or non-target lesions) must have a reduction in short axis diameter (SAD) to less than 10 mm. PR is defined as at least a 30% decrease in the sum of the diameters (SOD) (LD for non-nodal lesions) and SAD for nodal lesions) of target lesions, taking as reference the baseline sum LD. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. |
| Secondary | Enrolled Population: Progression Free Survival (PFS) as Assessed by IRC | Baseline to Progressive Disease or Death from Any Cause (Up to 12 Months) | PFS is defined as the number of months elapsed between the date of the first dose and the earliest date of documented disease progression or death (whatever the cause). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest sum on study) for target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5.0 mm. Progressive disease for non-target lesion is defined as the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. |
| Secondary | Enrolled Population: Overall Survival (OS) | Baseline to Date of Death from Any Cause (Up to 12 Months) | OS is defined as the number of months elapsed between the date of the first dose and the date of death (whatever the cause). Participants who are alive or lost to follow-up as of the data cutoff date will be right-censored. |
| Secondary | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Selpercatinib | PK: Cycle 1 Day 1: Predose, 1 h, 2, h, 4 h, 8 h, 12 h postdose PK: Cycle 1 Day 8: Predose, 1 h, 2, h, 4 h, 8 h postdose | Serial blood samples for intensive PK monitoring will be collected for 12 participants. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Primary Analysis Set: Overall Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR) as Assessed by Independent Review Committee (IRC) | Date of First Dose to Disease Progression or Death (up to 12 Months) | All treated participants who have confirmed RET fusion positive solid tumor NSCLC,TC, or RET mutant MTC by central lab, respectively. | percentage of participants | NUMBER |
| PRIMARY | Enrolled Population: Overall Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR) as Assessed by IRC | Date of First Dose to Disease Progression or Death (Up to 12 months) | All eligible participants. | percentage of participants | NUMBER |
| SECONDARY | Enrolled Population: Duration of Response (DoR) as Assessed by IRC | Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Up to 11 Months) | All eligible participants with confirmed response. Number of participants censored: All NSCLC = 30, All TC = 1, and All MTC = 16. | months | MEDIAN |
| SECONDARY | Enrolled Population: Time to Response (TTR) as Assessed by IRC | Date of First Dose to First Occurrence of Confirmed Tumor Response (Up to 6 months) | All eligible participants with confirmed response. | months | MEDIAN |
| SECONDARY | Enrolled Population: Time to Best Response (TTBR) as Assessed by IRC | Date of First Dose to First Occurrence of PR (If Subject's Best Overall Response [BOR] is PR) or CR (If Subject's BOR is CR) (Up to 8 months) | All eligible patients with confirmed response. | months | GEOMETRIC_MEAN |
| SECONDARY | Enrolled Population: Clinical Benefit Rate (CBR): Percentage of Participants Who Achieve CR, PR, or Stable Disease (SD) With a Duration of At Least 16 or More Weeks as Assessed by IRC | Baseline through Disease Progression or Death Due to Any Cause (Up to 12 Months) | All eligible participants. | percentage of participants | NUMBER |
| SECONDARY | Enrolled Population: Progression Free Survival (PFS) as Assessed by IRC | Baseline to Progressive Disease or Death from Any Cause (Up to 12 Months) | All eligible participants. Number of participants censored: All NSCLC = 40; All TC = 1, and All MTC = 28 | months | MEDIAN |
| SECONDARY | Enrolled Population: Overall Survival (OS) | Baseline to Date of Death from Any Cause (Up to 12 Months) | All eligible participants. Number of participants censored: All NSCLC = 42, All TC = 1, and All MTC = 28. | months | MEDIAN |
| SECONDARY | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Selpercatinib | PK: Cycle 1 Day 1: Predose, 1 h, 2, h, 4 h, 8 h, 12 h postdose PK: Cycle 1 Day 8: Predose, 1 h, 2, h, 4 h, 8 h postdose | All randomized participants who received at least one dose of study drug and had evaluable intensive PK data per protocol. | nanogram * hour per milliliter (ng*h/mL) | GEOMETRIC_MEAN |
Source ClinicalTrials.gov
Results by group38
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Primary Analysis Set: Overall Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR) as Assessed by Independent Review Committee (IRC) | RET Fusion Positive Non-small Cell Lung Cancer (NSCLC) Cohort 1 | Complete Response | 3.8 | 95% Confidence Interval 0.1 to 19.6 | percentage of participants |
| Primary Analysis Set: Overall Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR) as Assessed by Independent Review Committee (IRC) | RET Fusion Positive Thyroid Cancer (TC) Cohort 1 | Complete Response | 0 | 95% Confidence Interval 0.0 to 97.5 | percentage of participants |
| Primary Analysis Set: Overall Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR) as Assessed by Independent Review Committee (IRC) | RET Mutant Medullary Thyroid Cancer (MTC) Cohort 2 | Complete Response | 7.7 | 95% Confidence Interval 0.9 to 25.1 | percentage of participants |
| Primary Analysis Set: Overall Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR) as Assessed by Independent Review Committee (IRC) | RET Fusion Positive Non-small Cell Lung Cancer (NSCLC) Cohort 1 | Partial Response | 65.4 | 95% Confidence Interval 44.3 to 82.8 | percentage of participants |
| Primary Analysis Set: Overall Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR) as Assessed by Independent Review Committee (IRC) | RET Fusion Positive Thyroid Cancer (TC) Cohort 1 | Partial Response | 100.0 | 95% Confidence Interval 2.5 to 100.0 | percentage of participants |
| Primary Analysis Set: Overall Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR) as Assessed by Independent Review Committee (IRC) | RET Mutant Medullary Thyroid Cancer (MTC) Cohort 2 | Partial Response | 50.0 | 95% Confidence Interval 29.9 to 70.1 | percentage of participants |
| Primary Analysis Set: Overall Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR) as Assessed by Independent Review Committee (IRC) | RET Fusion Positive Non-small Cell Lung Cancer (NSCLC) Cohort 1 | Overall Response (CR/PR) | 69.2 | 95% Confidence Interval 48.2 to 85.7 | percentage of participants |
| Primary Analysis Set: Overall Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR) as Assessed by Independent Review Committee (IRC) | RET Fusion Positive Thyroid Cancer (TC) Cohort 1 | Overall Response (CR/PR) | 100.0 | 95% Confidence Interval 2.5 to 100.0 | percentage of participants |
| Primary Analysis Set: Overall Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR) as Assessed by Independent Review Committee (IRC) | RET Mutant Medullary Thyroid Cancer (MTC) Cohort 2 | Overall Response (CR/PR) | 57.7 | 95% Confidence Interval 36.9 to 76.6 | percentage of participants |
| Enrolled Population: Overall Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR) as Assessed by IRC | Non-small Cell Lung Cancer (All NSCLC) | Complete Response | 6.4 | 95% Confidence Interval 1.3 to 17.5 | percentage of participants |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Selpercatinib | 77 | |
| Overall Study | Enrolled: All NSCLC | Selpercatinib | 47 | |
| Overall Study | Enrolled: All TC | Selpercatinib | 1 | |
| Overall Study | Enrolled: All MTC | Selpercatinib | 29 | |
| Overall Study | PAS: RET Fusion Positive NSCLC | Selpercatinib | 26 | |
| Overall Study | PAS: RET Fusion Positive TC | Selpercatinib | 1 | |
| Overall Study | PAS: Advance RET-mutant MTC | Selpercatinib | 26 | |
| Overall Study | COMPLETED | Selpercatinib | 65 | |
| Overall Study | NOT COMPLETED | Selpercatinib | 12 |
Source ClinicalTrials.gov
Adverse events83
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Selpercatinib | 13 | 77 | 14 |
| other | Leukopenia | Blood and lymphatic system disorders | Selpercatinib | 5 | 77 | 9 |
| other | Neutropenia | Blood and lymphatic system disorders | Selpercatinib | 5 | 77 | 8 |
| other | Sinus bradycardia | Cardiac disorders | Selpercatinib | 5 | 77 | 6 |
| other | Sinus tachycardia | Cardiac disorders | Selpercatinib | 6 | 77 | 7 |
| other | Hypothyroidism | Endocrine disorders | Selpercatinib | 8 | 77 | 11 |
| other | Thyroid disorder | Endocrine disorders | Selpercatinib | 8 | 77 | 12 |
| other | Ascites | Gastrointestinal disorders | Selpercatinib | 4 | 77 | 4 |
| other | Constipation | Gastrointestinal disorders | Selpercatinib | 11 | 77 | 12 |
| other | Diarrhoea | Gastrointestinal disorders | Selpercatinib | 25 | 77 | 136 |
1 to 10 of 83Source ClinicalTrials.gov
See all 83 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Selpercatinib | 3 | 77 |
| Total, other adverse events | Selpercatinib | 75 | 77 |
| Total, serious adverse events | Selpercatinib | 17 | 77 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04280081
GET https://conductscience.org/api/trials/v1/NCT04280081/results?page=2