Trial · NCT07911449
Osimertinib Plus Stereotactic Radiosurgery/Radiotherapy for EGFR-Mutant Non-Small Cell Lung Cancer With Symptomatic Brain Metastases
NCT07911449, Phase 2, Recruiting, Cho Ray Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Osimertinib Plus Stereotactic Radiosurgery/Radiotherapy for EGFR-Mutant Non-Small Cell Lung Cancer With Symptomatic Brain Metastases. Trials, record NCT07911449. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07911449
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Osimertinib Plus Stereotactic Radiosurgery/Radiotherapy for EGFR-Mutant Non-Small Cell Lung Cancer With Symptomatic Brain Metastases
- NCT number
- NCT07911449
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 41 participants, estimated
- Lead sponsor
- Cho Ray Hospital
- Conditions
- Non-Small Cell Lung Cancer, Brain Metastases From Non-small Cell Lung Cancer (NSCLC), EGFR Activating Mutation
- Interventions
- Osimertinib, Stereotactic Radiosurgery
- First posted
- 2026-11-02
- Last updated
- 2026-11-12
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Intracranial objective response rate (iORR) | Assessed every 12 weeks from the first day of SRS/SRT, up to 12 months | Percentage of participants with a best intracranial response of complete response (iCR) or partial response (iPR) according to RANO-BM on contrast-enhanced brain MRI (contrast-enhanced CT if MRI is not feasible). iCR: disappearance of all intracranial target and non-target lesions, no new lesions, no corticosteroids, clinically stable or improved. iPR: at least 30% decrease in the sum of longest diameters of target lesions (10 mm or larger) versus baseline, no new lesions, stable or decreased corticosteroids, clinically stable or improved. |
| Primary | Intracranial disease control rate (iDCR) | Assessed every 12 weeks from the first day of SRS/SRT, up to 12 months | Proportion of participants with a best intracranial response of iCR, iPR or stable disease (iSD) according to RANO-BM. |
| Secondary | Intracranial progression-free survival (iPFS) | From the first day of SRS/SRT until the date of first documented intracranial progression (RANO-BM) or death from any cause, whichever came first, assessed every 12 weeks up to 36 months | Time in months from the first day of SRS/SRT to first documented intracranial progression according to RANO-BM or death from any cause, whichever occurs first. Participants without an event are censored at the date of the last adequate brain imaging assessment. Median estimated by the Kaplan-Meier method. |
| Secondary | Intracranial Progression-Free Survival Rate at 6 Months | 6 months after the first day of SRS/SRT | Percentage of participants alive and free of intracranial progression according to RANO-BM at 6 months after the first day of SRS/SRT, estimated by the Kaplan-Meier method. |
| Secondary | Intracranial Progression-Free Survival Rate at 12 Months | 12 months after the first day of SRS/SRT | Percentage of participants alive and free of intracranial progression according to RANO-BM at 12 months after the first day of SRS/SRT, estimated by the Kaplan-Meier method. |
| Secondary | Progression-free survival (PFS) | From the first day of SRS/SRT until the date of first documented progression at any site (RANO-BM or RECIST 1.1) or death from any cause, whichever came first, assessed every 12 weeks up to 36 months | Time in months from the first day of SRS/SRT to first documented progression at any site (intracranial according to RANO-BM or extracranial according to RECIST 1.1) or death from any cause, whichever occurs first. Participants without an event are censored at the date of the last adequate assessment. Median estimated by the Kaplan-Meier method. |
| Secondary | Progression-Free Survival Rate at 12 Months | 12 months after the first day of SRS/SRT | Percentage of participants alive and free of progression at any site (RANO-BM or RECIST 1.1) at 12 months after the first day of SRS/SRT, estimated by the Kaplan-Meier method. |
| Secondary | Change From Baseline in EORTC QLQ-C30 Global Health Status/Quality of Life Score at t0 and t3 | Baseline (within [7] days before the first radiotherapy fraction), t0 (at completion of radiotherapy), and t3 ([3] months after completion of radiotherapy) | Global health status/QoL is measured with the EORTC QLQ-C30 version 3.0 (items 29 and 30, 7-point scale). Raw scores are linearly transformed to a 0-100 scale according to the EORTC Scoring Manual; higher scores indicate better quality of life. Change from baseline is reported at t0 and t3. A change of \>= 10 points is considered clinically meaningful. |
| Secondary | Change From Baseline in EORTC QLQ-C30 Functional Scale Scores at t0 and t3 | Baseline (within [7] days before the first radiotherapy fraction), t0 (at completion of radiotherapy), and t3 ([3] months after completion of radiotherapy) | Five functional scales of the EORTC QLQ-C30 version 3.0: physical, role, emotional, cognitive and social functioning. Each scale is scored 0-100 according to the EORTC Scoring Manual; higher scores indicate better functioning. A scale score is calculated if at least half of its items are answered. Each scale is reported separately as change from baseline at t0 and t3. |
| Secondary | Change From Baseline in EORTC QLQ-C30 Symptom Scale and Single-Item Scores at t0 and t3 | Baseline (within [7] days before the first radiotherapy fraction), t0 (at completion of radiotherapy), and t3 ([3] months after completion of radiotherapy) | Three symptom scales (fatigue, nausea and vomiting, pain) and six single items (dyspnoea, insomnia, appetite loss, constipation, diarrhoea, financial difficulties) of the EORTC QLQ-C30 version 3.0. Each is scored 0-100 according to the EORTC Scoring Manual; higher scores indicate a greater symptom burden. Each scale/item is reported separately as change from baseline at t0 and t3. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes0
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.
Papers4
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/NCT07911449
GET https://conductscience.org/api/trials/v1/NCT07911449/registered