Trial · NCT04005144
Brigatinib and Binimetinib in Treating Patients With Stage IIIB-IV ALK or ROS1-Rearranged Non-small Cell Lung Cancer
NCT04005144, Phase 1, Terminated, University of California, San Francisco
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Brigatinib and Binimetinib in Treating Patients With Stage IIIB-IV ALK or ROS1-Rearranged Non-small Cell Lung Cancer. Trials, record NCT04005144. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04005144
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Brigatinib and Binimetinib in Treating Patients With Stage IIIB-IV ALK or ROS1-Rearranged Non-small Cell Lung Cancer
- NCT number
- NCT04005144
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 3 participants, actual
- Lead sponsor
- University of California, San Francisco
- Conditions
ALK Gene Rearrangement, Lung Non-Small Cell Carcinoma, Progressive Disease, ROS1 Gene Rearrangement, Stage IIIB Lung Cancer, Stage IIIC Lung Cancer, Stage IV Lung Cancer, Stage IVA Lung Cancer, Stage IVB Lung Cancer
- Interventions
- Binimetinib, Brigatinib
- First posted
- 2019-07-02
- Last updated
- 2022-10-17
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recommended Phase 2 Dose | Up to 12 months | Evaluating the number and frequency of adverse events as determined by the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version (v)5.0 by investigator's assessment will be used to determine the recommended phase 2 dose for future studies. |
| Primary | Number of Participants with Dose Limiting Toxicities | Up to 28 days | A dose limiting toxicity (DLT) is generally defined as a grade 3 or higher, treatment-related adverse event that is attributable to the study treatment during the first 28 days of therapy (Cycle 1). The dose limiting toxicity will be based on the tolerability observed during cycle 1 of treatment/observation. Adverse events will be assessed by the investigators using NCI-CTCAE v5.0. |
| Primary | Number of Total Treatment-Emergent Adverse Events (AEs) | From treatment initiation through study completion, an average of 1 year | Treatment Emergent AEs will be defined by the NCI CTCAE v5.0 as AEs newly occuring after the patient has begun study treatment. |
| Primary | Number of Treatment-Emergent Adverse Events by Grade | From treatment initiation through study completion, an average of 1 year | Severity grade will be defined by the NCI CTCAE v5.0. |
| Primary | Number of Grade 3 or Greater Treatment-Emergent Adverse Events by CTCAE v5.0 | From treatment initiation through study completion, an average of 1 year | Severity grade will be defined by the NCI CTCAE v5.0. |
| Primary | Number of Serious Treatment-Emergent Adverse Events by CTCAE v5.0 | From treatment initiation through study completion, an average of 1 year | Severity grade will be defined by the NCI CTCAE v5.0. |
| Primary | Number of Treatment-Emergent Adverse Events with an Outcome of Death by CTCAE v5.0 | From treatment initiation through study completion, an average of 1 year | Severity grade will be defined by the NCI CTCAE v5.0. |
| Primary | Number of Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment | From treatment initiation through study completion, an average of 1 year | Severity grade will be defined by the NCI CTCAE v5.0. |
| Primary | Number of Treatment-Emergent Adverse Events Resulting in Interruption, Reduction, or Delay of study treatment | From treatment initiation through study completion, an average of 1 year | Severity grade will be defined by the NCI CTCAE v5.0. |
| Secondary | Objective Response Rate (ORR) Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | From treatment initiation through study completion, an average of 1 year | RECIST v1.1 will be used to determine the overall response rate defined as participants with a complete response (CR) or a partial response (PR). Point estimate and 95% exact binomial confidence interval (CI) will be obtained for ORR. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT04005144
GET https://conductscience.org/api/trials/v1/NCT04005144/registered