Trial · NCT02954523
Dasatinib and Osimertinib (AZD9291) in Advanced Non-Small Cell Lung Cancer With EGFR Mutations
NCT02954523, Phase 1, Phase 2, Terminated, Chul Kim; results first posted 2024-07-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Dasatinib and Osimertinib (AZD9291) in Advanced Non-Small Cell Lung Cancer With EGFR Mutations. Trials, record NCT02954523. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02954523
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dasatinib and Osimertinib (AZD9291) in Advanced Non-Small Cell Lung Cancer With EGFR Mutations
- NCT number
- NCT02954523
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 10 participants, actual
- Lead sponsor
- Chul Kim
- Conditions
- EGFR Gene Mutation, Nonsmall Cell Lung Cancer
- Interventions
- Dasatinib, Osimertinib
- First posted
- 2016-11-03
- Last updated
- 2024-07-05
- Results first posted
- 2024-07-05
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase I : Number of Patients With Drug-related Adverse Events as Assessed by CTCAEv4.0 | Cycle 1 (28 day cycle) | Number of patients with drug related adverse events (Dose Limiting Toxicities) on dasatinib when given in combination with osimertinib |
| Primary | Phase II : Number of Patients That do Not Progress According to RECIST v1.1 | 9 months | The rate of patients non-responding (progressive disease or stable disease lasting 4 months or less) to the combination of osimertinib and dasatinib |
| Secondary | Number of Patients With Treatment-related Adverse Events in the Phase II Study | 18 months | Number of patients with treatment-related adverse events in the phase II study, who are treated at the same dose that has been selected based on the phase I part |
| Secondary | Concentration of Osimertinib in Blood (Cmax) | 0 hour, 4 hours post dose | To describe the concentration of osimertinib when administered with dasatinib. Blood is obtained from patients before each cycle and 4 hours after start of the first 2 cycles. |
| Secondary | Progression-free Survival | 3 years | Determination of the time between the start of the experimental treatment and progression of the tumor |
| Secondary | Overall Survival | 47 months | From the date of start of the experimental treatment until the date of death from any cause, whichever came first, assessed up to 47 months. |
| Secondary | Duration of Response | 3 years | Determination of the duration of the response to the treatment, calculated from start of treatment in case of partial response and from the declaration of complete response in case of complete response. The end of the response will be when the tumor progresses |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase I : Number of Patients With Drug-related Adverse Events as Assessed by CTCAEv4.0 | Cycle 1 (28 day cycle) | participants | NUMBER | |
| PRIMARY | Phase II : Number of Patients That do Not Progress According to RECIST v1.1 | 9 months | Study close to accrual early. No participants enrolled in phase II. | ||
| SECONDARY | Number of Patients With Treatment-related Adverse Events in the Phase II Study | 18 months | Study close to accrual early. No participants enrolled in phase II. | ||
| SECONDARY | Concentration of Osimertinib in Blood (Cmax) | 0 hour, 4 hours post dose | Study Terminated early due to lack of enrollment. | nM/mL | MEAN |
| SECONDARY | Progression-free Survival | 3 years | months | MEDIAN | |
| SECONDARY | Overall Survival | 47 months | months | MEDIAN | |
| SECONDARY | Duration of Response | 3 years | months | MEDIAN |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase I : Number of Patients With Drug-related Adverse Events as Assessed by CTCAEv4.0 | Phase I- Dasatinib Dose Level 2 | 0 | participants | ||
| Phase I : Number of Patients With Drug-related Adverse Events as Assessed by CTCAEv4.0 | Phase 1- Dasatinib Dose Level 1 | 3 | participants | ||
| Phase I : Number of Patients With Drug-related Adverse Events as Assessed by CTCAEv4.0 | Phase 1- Dasatinib Dose Level -1 | 0 | participants | ||
| Concentration of Osimertinib in Blood (Cmax) | Phase I- Dose Level 1 | 211.5 | Full Range 166 to 314 | nM/mL | |
| Concentration of Osimertinib in Blood (Cmax) | Phase 1- Dose Level 2 | 355 | Full Range 345 to 365 | nM/mL | |
| Concentration of Osimertinib in Blood (Cmax) | Phase 1- Dose Level -1 | 107 | Full Range 107 to 107 | nM/mL | |
| Progression-free Survival | Phase I- Dose Level 1 | 24.7 | Full Range 3.7 to 31.3 | months | |
| Progression-free Survival | Phase I- Dose Level 2 | 10.1 | Full Range 4.5 to 16.7 | months | |
| Progression-free Survival | Phase I- Dose Level -1 | 10.5 | Full Range 10.5 to 10.5 | months | |
| Overall Survival | Dose Level 1 | 36.1 | Full Range 23.5 to 46.6 | months |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase IPhase I- Dasatinib Dose Level 2 | 3 | |
| Overall Study | STARTED | Phase 1- DasatinibDose Level 1 | 6 | |
| Overall Study | STARTED | Phase 1- DasatinibDose Level -1 | 1 | |
| Overall Study | COMPLETED | Phase IPhase I- Dasatinib Dose Level 2 | 3 | |
| Overall Study | COMPLETED | Phase 1- DasatinibDose Level 1 | 6 | |
| Overall Study | COMPLETED | Phase 1- DasatinibDose Level -1 | 1 | |
| Overall Study | NOT COMPLETED | Phase IPhase I- Dasatinib Dose Level 2 | 0 | |
| Overall Study | NOT COMPLETED | Phase 1- DasatinibDose Level 1 | 0 | |
| Overall Study | NOT COMPLETED | Phase 1- DasatinibDose Level -1 | 0 |
Source ClinicalTrials.gov
Adverse events324
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 | Abdominal distension | Gastrointestinal disorders | Phase I- Dose Level 1 | 0 | 6 | |
| other | Abdominal distension | Gastrointestinal disorders | Phase I- Dose Level 2 | 1 | 3 | 2 |
| other | Abdominal distension | Gastrointestinal disorders | Phase I- Dose Level -1 | 0 | 1 | |
| other | Acute kidney injury | Renal and urinary disorders | Phase I- Dose Level 1 | 1 | 6 | 1 |
| other | Acute kidney injury | Renal and urinary disorders | Phase I- Dose Level 2 | 0 | 3 | |
| other | Acute kidney injury | Renal and urinary disorders | Phase I- Dose Level -1 | 1 | 1 | 1 |
| other | Alanine aminotransferase increased | Investigations | Phase I- Dose Level 1 | 4 | 6 | 7 |
| other | Alanine aminotransferase increased | Investigations | Phase I- Dose Level 2 | 2 | 3 | 3 |
| other | Alanine aminotransferase increased | Investigations | Phase I- Dose Level -1 | 1 | 1 | 4 |
| other | Allergic reaction | Immune system disorders | Phase I- Dose Level 1 | 1 | 6 | 1 |
1 to 10 of 324Source ClinicalTrials.gov
See all 324 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase I- Dose Level 1 | 1 | 6 |
| Total, all-cause mortality | Phase I- Dose Level 2 | 2 | 3 |
| Total, all-cause mortality | Phase I- Dose Level -1 | 1 | 1 |
| Total, other adverse events | Phase I- Dose Level 1 | 6 | 6 |
| Total, other adverse events | Phase I- Dose Level 2 | 3 | 3 |
| Total, other adverse events | Phase I- Dose Level -1 | 1 | 1 |
| Total, serious adverse events | Phase I- Dose Level 1 | 4 | 6 |
| Total, serious adverse events | Phase I- Dose Level 2 | 2 | 3 |
| Total, serious adverse events | Phase I- Dose Level -1 | 0 | 1 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34568058 | DERIVED |
Source PubMed
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/NCT02954523
GET https://conductscience.org/api/trials/v1/NCT02954523/events?page=2