Trial · NCT04819100
A Study of Selpercatinib After Surgery or Radiation in Participants With Non-Small Cell Lung Cancer (NSCLC)
NCT04819100, Phase 3, Active not recruiting, Eli Lilly and Company
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Selpercatinib After Surgery or Radiation in Participants With Non-Small Cell Lung Cancer (NSCLC). Trials, record NCT04819100. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04819100
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Selpercatinib After Surgery or Radiation in Participants With Non-Small Cell Lung Cancer (NSCLC)
- NCT number
- NCT04819100
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 152 participants, estimated
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Interventions
- Selpercatinib, Placebo
- First posted
- 2021-03-26
- Last updated
- 2026-03-04
- Other registries' IDs
- eudract:2020-005191-35
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event-Free Survival (EFS) | Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years) | EFS by Investigator Assessment in the Primary Analysis Population |
| Secondary | EFS | Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years) | EFS by investigator assessment in the overall population |
| Secondary | Overall Survival (OS) | Randomization to death from any cause (estimated as up to 9 years)] | OS |
| Secondary | EFS | Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years)] | EFS by blinded independent central review (BICR) |
| Secondary | Time to Distant Disease Recurrence in the Central Nervous System (CNS) | Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years) | Time to distant disease recurrence in the CNS by investigator assessment and BICR |
| Secondary | Progression Free Survival on the Next Line of Treatment (PFS2) | Randomization to disease progression on the next line of treatment or death from any cause (estimated as up to 9 years) | PFS2 by investigator assessment |
| Secondary | Positive Predictive Value (PPV) of Rearranged during Transfection (RET) Tests from Investigator-Identified Laboratories with Respect to the Lilly-Designated RET Test | Baseline | PPV of RET Tests from Investigator-Identified Laboratories with Respect to the Lilly-Designated RET Test |
| Secondary | Mean Change from Baseline over Time in NSCLC Symptoms | Baseline to treatment discontinuation (estimated as up to 3 years) | NSCLC symptoms will be measured using the 7-item NSCLC Symptom Assessment Questionnaire (NSCLC-SAQ). The NSCLC-SAQ measures the severity/frequency of the following core symptoms: Cough, pain, dyspnea, fatigue, and appetite. Raw scores range from 0 to 4 and the total score ranges from 0-20. Higher scores represent worse symptoms. |
| Secondary | Mean Change from Baseline over Time in Physical Function | Baseline to treatment discontinuation (estimated as up to 3 years) | Physical function will be measured by the 5 physical function items in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) (also known as the EORTC IL 19 questionnaire). Raw scores range from 0-20. Higher scores indicate worst function. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers2
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/NCT04819100
GET https://conductscience.org/api/trials/v1/NCT04819100/registered