Trial · NCT04772235
Phase I Study of Repotrectinib and Osimertinib in NSCLC Patients
NCT04772235, Phase 1, Unknown, Instituto Oncológico Dr Rosell
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase I Study of Repotrectinib and Osimertinib in NSCLC Patients. Trials, record NCT04772235. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04772235
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase I Study of Repotrectinib and Osimertinib in NSCLC Patients
- NCT number
- NCT04772235
- Status
- Unknown
- Phases
- Phase 1
- Enrollment
- 32 participants, estimated
- Lead sponsor
- Instituto Oncológico Dr Rosell
- Conditions
- Nsclc
- Interventions
- Repotrectinib, Osimertinib
- First posted
- 2021-02-26
- Last updated
- 2024-04-03
- Other registries' IDs
- eudract:2020-005151-20
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Adverse events (AEs) | Throughout the study period. Approximately 48 months | Number of patients experiencing AEs, both non treatment related and treatment related, classified by severity and graded according to the NCI CTCAE v5.0 |
| Primary | Incidence of Dose limiting toxicities (DLTs) | During the treatment cycle 1, 21 days | Number of patients experiencing AEs that have been predefined as DLTs: Toxicities resulting in an excessive number of missed doses, Hematologic, renal, hepatic toxicities grade ≥ 3; during the DLT observation period (Cycle 1, 21 days). Only patients in the Part A (dose escalation) of the study. |
| Secondary | Objective response rate (ORR) | Throughout the study period. Approximately 48 months | The ORR will be defined as the proportion of patients with complete response (CR) or partial response (PR). A confirmed response is a response that persists on a repeat-imaging performed at least 4 weeks after initial documentation of the response. Patients with a confirmed objective response (CR or PR) will be referred to as responders. Non-responders will include patients without a confirmed objective response, stable disease (SD), not evaluable (NE), or progression disease (PD). Blinded independent central review (BICR)-confirmed ORR will serve as the secondary (optional) analysis. |
| Secondary | Complete response rate (CR) | Throughout the study period. Approximately 48 months | Number of patients that achieve a confirmed complete response according to RECIST 1.1 criteria. (PR). A confirmed response is a response that persists on a repeat-imaging performed at least 4 weeks after initial documentation of the response. |
| Secondary | Partial response rate (PR) | Throughout the study period. Approximately 48 months | Number of patients that achieve a confirmed partial response according to RECIST 1.1 criteria. (PR). A confirmed response is a response that persists on a repeat-imaging performed at least 4 weeks after initial documentation of the response. |
| Secondary | Clinical Benefit Rate (CBR) | Throughout the study period. Approximately 48 months | The CBR will be defined as the proportion of patients with CR, PR, or stable disease. Stable disease refers to a condition where the tumor is neither increasing nor decreasing in extent or severity for at least 6 weeks after the first dose of repotrectinib, per RECIST, v1.1. The CBR and its 95% CI will be estimated using Clopper-Pearson exact confidence interval (CI). |
| Secondary | Duration of Response (DoR) | Throughout the study period. Approximately 48 months | The DOR will be defined from the first date of objective response (either CR or PR) to the first documentation of radiographically-confirmed disease progression, per RECIST v1.1 guideline and will be censored by the last tumor assessment date for patients without radiologically-confirmed disease progression. The DOR will be calculated only for patients with a confirmed, objective tumor response (PR or CR). |
| Secondary | Progression free survival (PFS) | Throughout the study period. Approximately 48 months | Progression-free survival (PFS) will be defined as the time from the first dose of repotrectinib to the first radiographically-confirmed case of disease progression or to death due to any cause, whichever occurs first. Investigator assessment will serve as the primary efficacy for radiographically-confirmed PFS. BICR-confirmed PFS will serve as the secondary (optional) analysis |
| Secondary | Overall survival (OS) | Throughout the study period. Approximately 48 months | Overall survival (OS) will be defined as the time from first dose of repotrectinib to the date of death, or lost to follow up, whichever occurs first. |
| Secondary | Intracranial Objective Response Rate (IC-ORR) | Throughout the study period. Approximately 48 months | IC-ORR is defined as the proportion of patients with intracranial target lesions that are measurable at Baseline who achieve a PR or CR, per RECIST, v.1.1. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 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/NCT04772235
GET https://conductscience.org/api/trials/v1/NCT04772235/registered