Trial · NCT05566041
A Phase 3, Controlled, Open-label, Global Randomized Study of RRx-001 With a Platinum Doublet or a Platinum Doublet in Small Cell Lung Cancer
NCT05566041, Phase 3, Unknown, EpicentRx, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase 3, Controlled, Open-label, Global Randomized Study of RRx-001 With a Platinum Doublet or a Platinum Doublet in Small Cell Lung Cancer. Trials, record NCT05566041. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05566041
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 3, Controlled, Open-label, Global Randomized Study of RRx-001 With a Platinum Doublet or a Platinum Doublet in Small Cell Lung Cancer
- NCT number
- NCT05566041
- Status
- Unknown
- Phases
- Phase 3
- Enrollment
- 292 participants, estimated
- Lead sponsor
- EpicentRx, Inc.
- Conditions
- Carcinoma, Small Cell Lung
- Interventions
- RRx-001 + eLOOP Device, Cisplatin/carboplatin plus etoposide
- First posted
- 2022-10-04
- Last updated
- 2024-10-31
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) and Overall Survival (OS) | Estimated up to 12 Months | To compare the co-primary efficacy endpoints comprising progression free survival (PFS) and overall survival (OS). PFS is defined as the time from randomization until disease progression or all-cause mortality between the two arms. Disease progression is assessed by the blinded independent central review (BICR) via RECIST 1.1, and is the basis for the principal definition of PFS. OS is defined as the time from randomization to all-cause mortality |
| Secondary | Overall Response Rate (ORR) | Estimated up to 12 Months | To compare overall response rate (ORR, as assessed by the BICR via RECIST 1.1), between the two arms Duration of response will also be characterized and compared between the two arms |
| Other | Disease Control Rate (DCR) | Estimated up to 12 Months | To compare the disease control rate (DCR) defined as the sum of complete responses (CR) + partial responses (PR) + stable disease (SD) between the two arms |
| Other | Relative Dose Intensities (RDIs) | Estimated up to 12 Months | To compare the relative dose intensities (RDIs) of etoposide/platinum expressed as the dose delivered divided by the dose intensity of the standard regimen the last time the patient received platinum etoposide between the two arms as a proxy for improved tolerability |
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.
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/NCT05566041
GET https://conductscience.org/api/trials/v1/NCT05566041/registered