Trial · NCT05204628
A Study to Evaluate and Compare the Efficacy and Safety of XZP-3621 Versus Crizotinib
NCT05204628, Phase 3, Unknown, Xuanzhu Biopharmaceutical Co., Ltd.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate and Compare the Efficacy and Safety of XZP-3621 Versus Crizotinib. Trials, record NCT05204628. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05204628
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate and Compare the Efficacy and Safety of XZP-3621 Versus Crizotinib
- NCT number
- NCT05204628
- Status
- Unknown
- Phases
- Phase 3
- Enrollment
- 238 participants, estimated
- Lead sponsor
- Xuanzhu Biopharmaceutical Co., Ltd.
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- XZP-3621, Crizotinib
- First posted
- 2022-01-24
- Last updated
- 2022-01-24
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) | From the date of randomization to the date of the first documented disease progression or death, whichever occurred first (up to overall period of approximately 30 months) | PFS was defined as the time (in months) from randomization to the first documentation of disease progression, as determined by investigators using Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 or to death from any cause, whichever occurred first. |
| Secondary | Progression-Free Survival (PFS) | From the date of randomization to the date of the first documented disease progression or death, whichever occurred first (up to overall period of approximately 30 months). | PFS was defined as the time (in months) from randomization to the first documentation of disease progression, as Determined by Blind Independent Central Review(BICR)Using RECISTv1.1., or to death from any cause, whichever occurred first. |
| Secondary | Overall Survival (OS) | From randomization until death (up to approximately 30 months). | OS defined as time from date of randomization to date of death due to any cause, as Determined by the investigator and Blind Independent Central Review (BICR) Using RECISTv1.1 |
| Secondary | Overall Response Rate (ORR) | From randomization until death (up to approximately 30 months) | ORR defined as the proportion of patients with a best overall response defined as Complete Response (CR) or Partial Response (PR) as evaluated by Blinded Independent Central Review (BICR) and by investigator assessment per RECIST 1.1 |
| Secondary | Duration of Response (DOR) | From randomization until death (up to approximately 30 months) | DOR defined as the time from date of first documented CR or PR to date of first documented disease progression or death due to any cause |
| Secondary | Disease Control Rate (DCR) | Baseline, Week 8, thereafter every 8 weeks until disease progression, death or withdrawal from the study (up to overall period of approximately 30 months) | DCR defined as the proportion of patients with best overall response of CR, PR, or Stable Disease (SD) |
| Secondary | Intracranial Objective Response Rate (IC-ORR) | Baseline, Week 8, thereafter every 8 weeks until disease progression, death or withdrawal from the study (up to overall period of approximately 30 months) | IC-ORR as Determined by BICR and investigator Using Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) |
| Secondary | Intracranial Duration of Response (IC-DoR) | Baseline, Week 8, thereafter every 8 weeks until disease progression, death or withdrawal from the study (up to overall period of approximately 30 months) | IC-ORR as Determined by BICR and investigator Using Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) |
| Secondary | Area Under the Plasma Concentration-time Curve (AUC) of XZP-3621 and Its Metabolite | Pre-dose (within 1 hour before XZP-3621), 4 hours post-dose at first dosing day and Week 4; Pre-dose (within 1 hour) at Week 8,12,16 (up to 4 months) | AUC was collected for both XZP-3621 and its major metabolite, and was based on their concentrations in plasma over time. |
| Secondary | Maximum Plasma Concentration Observed (Cmax) of XZP-3621 and Its Metabolite | Pre-dose (within 1 hour before XZP-3621), 4 hours post-dose at first dosing day and Week 4; Pre-dose (within 1 hour) at Week 8,12,16 (up to 4 months) | Cmax was collected for both XZP-3621 and its major metabolite, and was based on their concentrations in plasma over time. |
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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 43011476 | 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/NCT05204628
GET https://conductscience.org/api/trials/v1/NCT05204628/registered