Trial · NCT04194944
A Study of Selpercatinib (LY3527723) in Participants With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer
NCT04194944, Phase 3, Active not recruiting, Eli Lilly and Company; results first posted 2024-06-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Selpercatinib (LY3527723) in Participants With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer. Trials, record NCT04194944. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04194944
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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 or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer
- NCT number
- NCT04194944
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 261 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- Selpercatinib, Carboplatin, Cisplatin, Pemetrexed, Pembrolizumab
- First posted
- 2019-12-11
- Last updated
- 2026-10-21
- Other registries' IDs
- eudract:2019-001979-36
- Results first posted
- 2024-06-20
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) (With Pembrolizumab) | Baseline to Progressive Disease or Death from Any Cause Up to 31 Months | PFS is defined as the time from randomization until the occurrence of documented disease progression by the BICR, per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, or death from any cause in the absence of BICR-documented progressive disease. |
| Primary | PFS by BICR (With or Without Pembrolizumab) | Baseline to Progressive Disease or Death from Any Cause Up to 31 Months | PFS is defined as the time from randomization until the occurrence of documented disease progression by the BICR, per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, or death from any cause in the absence of BICR-documented progressive disease. |
| Secondary | Percentage of Participant With Disease Control Rate (DCR) by BICR (With Pembrolizumab) | Baseline to Progressive Disease or Death from Any Cause Up to 31 Months | DCR by BICR (with Pembrolizumab) is defined as the number of participants who achieve a BOR of complete response (CR), partial response (PR), or stable disease (SD) lasting 16 or more weeks divided by the total number of participants randomized to each treatment arm. |
| Secondary | Percentage of Participant With DCR by BICR (With or Without Pembrolizumab) | Baseline to Progressive Disease or Death from Any Cause Up to 31 Months | DCR by BICR (with or without Pembrolizumab) is defined as the number of participants who achieve a BOR of CR, PR, or SD lasting 16 or more weeks divided by the total number of participants randomized to each treatment arm. |
| Secondary | PFS2 (With Pembrolizumab) | Baseline to Second Disease Progression or Death from Any Cause Up to 38 Months | PFS2 is defined as the time from randomization to disease progression on the next line of treatment or death from any cause in the absence of observed disease progression. |
| Secondary | PFS2 (With or Without Pembrolizumab) | Baseline to Second Disease Progression or Death from Any Cause Up to 38 Months | PFS2 is defined as the time from randomization to disease progression on the next line of treatment or death from any cause in the absence of observed disease progression. |
| Secondary | Overall Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR) by BICR (With Pembrolizumab) | Baseline through Disease Progression or Death Up to 31 Months | ORR is defined as the number of participants who achieve a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the total number of participants randomized to each treatment arm. |
| Secondary | ORR: Percentage of Participants With CR or PR by BICR (With or Without Pembrolizumab) | Baseline through Disease Progression or Death Up to 31 Months | ORR is defined as the number of participants who achieve a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the total number of participants randomized to each treatment arm. |
| Secondary | Duration of Response (DoR) by BICR (With Pembrolizumab) | Date of CR or PR to Date of Disease Progression or Death Due to Any Cause Up to 31 Months | DoR was defined as the time from the date that measurement criteria for CR or PR (whichever is first recorded) were first met until the first date that disease was recurrent or documented disease progression was observed, or the date of death from any cause in the absence of documented disease progression or recurrence. The DOR according to both BICR and investigator-assessed BOR was evaluated per RECIST 1.1 criteria. |
| Secondary | DOR by BICR (With or Without Pembrolizumab) | Date of CR or PR to Date of Disease Progression or Death Due to Any Cause Up to 31 Months | DoR was defined as the time from the date that measurement criteria for CR or PR (whichever is first recorded) were first met until the first date that disease was recurrent or documented disease progression was observed, or the date of death from any cause in the absence of documented disease progression or recurrence. The DOR according to both BICR and investigator-assessed BOR was evaluated per RECIST 1.1 criteria. |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) (With Pembrolizumab) | Baseline to Progressive Disease or Death from Any Cause Up to 31 Months | Intent to Treat (ITT) Pembrolizumab: Participants included in the ITT population who were stratified with the intent to receive pembrolizumab in the event of the control-arm assignment. Participants censored: TRT A: 80, TRT B: 34. | Months | MEDIAN |
| PRIMARY | PFS by BICR (With or Without Pembrolizumab) | Baseline to Progressive Disease or Death from Any Cause Up to 31 Months | ITT Population: All randomized participants, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants were analyzed according to the treatment arm they were assigned to regardless of what actual treatment they received. Participants censored: TRT A: 98, TRT B:45. | Months | MEDIAN |
| SECONDARY | Percentage of Participant With Disease Control Rate (DCR) by BICR (With Pembrolizumab) | Baseline to Progressive Disease or Death from Any Cause Up to 31 Months | ITT Pembrolizumab: Participants included in the ITT population who were stratified with the intent to receive pembrolizumab in the event of the control-arm assignment. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participant With DCR by BICR (With or Without Pembrolizumab) | Baseline to Progressive Disease or Death from Any Cause Up to 31 Months | ITT Population: All randomized participants, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants were analyzed according to the treatment arm they were assigned to regardless of what actual treatment they received. | Percentage of Participants | NUMBER |
| SECONDARY | PFS2 (With Pembrolizumab) | Baseline to Second Disease Progression or Death from Any Cause Up to 38 Months | ITT Pembrolizumab: Participants included in the ITT population who were stratified with the intent to receive pembrolizumab in the event of the control-arm assignment. Participants censored: TRT A: 103; TRT B: 62 | Months | MEDIAN |
| SECONDARY | PFS2 (With or Without Pembrolizumab) | Baseline to Second Disease Progression or Death from Any Cause Up to 38 Months | ITT Population: All randomized participants, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants were analyzed according to the treatment arm they were assigned to regardless of what actual treatment they received. Participants censored: TRT A: 126; TRT B: 77 | Months | MEDIAN |
| SECONDARY | Overall Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR) by BICR (With Pembrolizumab) | Baseline through Disease Progression or Death Up to 31 Months | ITT Pembrolizumab: Participants included in the ITT population who were stratified with the intent to receive pembrolizumab in the event of the control-arm assignment. | Percentage of participants | NUMBER |
| SECONDARY | ORR: Percentage of Participants With CR or PR by BICR (With or Without Pembrolizumab) | Baseline through Disease Progression or Death Up to 31 Months | ITT Population: All randomized participants, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants were analyzed according to the treatment arm they were assigned to regardless of what actual treatment they received. | Percentage of Participants | NUMBER |
| SECONDARY | Duration of Response (DoR) by BICR (With Pembrolizumab) | Date of CR or PR to Date of Disease Progression or Death Due to Any Cause Up to 31 Months | ITT Pembrolizumab: Participants included in the ITT population who were stratified with the intent to receive pembrolizumab in the event of the control-arm assignment. Participants censored: TRT A:74; TRT B: 25. | Months | MEDIAN |
| SECONDARY | DOR by BICR (With or Without Pembrolizumab) | Date of CR or PR to Date of Disease Progression or Death Due to Any Cause Up to 31 Months | ITT Population: All randomized participants, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants were analyzed according to the treatment arm they were assigned to regardless of what actual treatment they received. Participants censored: TRT A: 90; TRT B: 33. | Months | MEDIAN |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 outcomesResults by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) (With Pembrolizumab) | Selpercatinib (TRT A) | 24.84 | 95% Confidence Interval 16.89 to NA | Months | |
| Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) (With Pembrolizumab) | Pemetrexed and Platinum With Pembrolizumab (TRT B) | 11.17 | 95% Confidence Interval 8.77 to 16.76 | Months | |
| PFS by BICR (With or Without Pembrolizumab) | Selpercatinib (TRT A) | 24.84 | 95% Confidence Interval 17.31 to NA | Months | |
| PFS by BICR (With or Without Pembrolizumab) | Pemetrexed and Platinum With or Without Pembrolizumab (TRT B) | 11.17 | 95% Confidence Interval 8.77 to 16.76 | Months | |
| Percentage of Participant With Disease Control Rate (DCR) by BICR (With Pembrolizumab) | Selpercatinib (TRT A) | 89.1 | 95% Confidence Interval 82.5 to 93.9 | Percentage of Participants | |
| Percentage of Participant With Disease Control Rate (DCR) by BICR (With Pembrolizumab) | Pemetrexed and Platinum With Pembrolizumab (TRT B) | 84.3 | 95% Confidence Interval 74.7 to 91.4 | Percentage of Participants | |
| Percentage of Participant With DCR by BICR (With or Without Pembrolizumab) | Selpercatinib (TRT A) | 89.3 | 95% Confidence Interval 83.4 to 93.7 | Percentage of Participants | |
| Percentage of Participant With DCR by BICR (With or Without Pembrolizumab) | Pemetrexed and Platinum With or Without Pembrolizumab (TRT B) | 82.4 | 95% Confidence Interval 73.6 to 89.2 | Percentage of Participants | |
| PFS2 (With Pembrolizumab) | Selpercatinib (TRT A) | NA | 95% Confidence Interval NA to NA | Months | |
| PFS2 (With Pembrolizumab) | Pemetrexed and Platinum With Pembrolizumab (TRT B) | NA | 95% Confidence Interval NA to NA | Months |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Selpercatinib (TRT A) | 159 | |
| Overall Study | STARTED | Pemetrexed and Platinum With or Without Pembrolizumab (TRT B) | 102 | |
| Overall Study | Received at Least One Dose of Study Drug | Selpercatinib (TRT A) | 158 | |
| Overall Study | Received at Least One Dose of Study Drug | Pemetrexed and Platinum With or Without Pembrolizumab (TRT B) | 98 | |
| Overall Study | COMPLETED | Selpercatinib (TRT A) | 61 | |
| Overall Study | COMPLETED | Pemetrexed and Platinum With or Without Pembrolizumab (TRT B) | 70 | |
| Overall Study | NOT COMPLETED | Selpercatinib (TRT A) | 98 | |
| Overall Study | NOT COMPLETED | Pemetrexed and Platinum With or Without Pembrolizumab (TRT B) | 32 |
Source ClinicalTrials.gov
Adverse events318
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 (TRT A) | 18 | 158 | 35 |
| other | Anaemia | Blood and lymphatic system disorders | Carboplatin or Cisplatin+Pemetrexed+/-Pembrolizumab (TRT B) | 57 | 98 | 209 |
| other | Leukopenia | Blood and lymphatic system disorders | Selpercatinib (TRT A) | 11 | 158 | 22 |
| other | Leukopenia | Blood and lymphatic system disorders | Carboplatin or Cisplatin+Pemetrexed+/-Pembrolizumab (TRT B) | 8 | 98 | 37 |
| other | Neutropenia | Blood and lymphatic system disorders | Selpercatinib (TRT A) | 6 | 158 | 13 |
| other | Neutropenia | Blood and lymphatic system disorders | Carboplatin or Cisplatin+Pemetrexed+/-Pembrolizumab (TRT B) | 18 | 98 | 61 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Selpercatinib (TRT A) | 11 | 158 | 17 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Carboplatin or Cisplatin+Pemetrexed+/-Pembrolizumab (TRT B) | 10 | 98 | 20 |
| other | Hyperthyroidism | Endocrine disorders | Selpercatinib (TRT A) | 4 | 158 | 8 |
| other | Hyperthyroidism | Endocrine disorders | Carboplatin or Cisplatin+Pemetrexed+/-Pembrolizumab (TRT B) | 7 | 98 | 7 |
1 to 10 of 318Source ClinicalTrials.gov
See all 318 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Selpercatinib (TRT A) | 32 | 158 |
| Total, all-cause mortality | Carboplatin or Cisplatin+Pemetrexed+/-Pembrolizumab (TRT B) | 17 | 98 |
| Total, other adverse events | Selpercatinib (TRT A) | 156 | 158 |
| Total, other adverse events | Carboplatin or Cisplatin+Pemetrexed+/-Pembrolizumab (TRT B) | 97 | 98 |
| Total, serious adverse events | Selpercatinib (TRT A) | 55 | 158 |
| Total, serious adverse events | Carboplatin or Cisplatin+Pemetrexed+/-Pembrolizumab (TRT B) | 23 | 98 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Selpercatinib (TRT A) vs Carboplatin or Cisplatin+Pemetrexed+/-Pembrolizumab (TRT B): deaths from any cause | Trial comparisons |
| Selpercatinib (TRT A) vs Carboplatin or Cisplatin+Pemetrexed+/-Pembrolizumab (TRT B): serious adverse events | Trial comparisons |
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/NCT04194944
GET https://conductscience.org/api/trials/v1/NCT04194944/registered?page=2