Trial · NCT04632758
Study Comparing WX-0593 to Crizotinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients
NCT04632758, Phase 3, Unknown, Qilu Pharmaceutical Co., Ltd.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study Comparing WX-0593 to Crizotinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients. Trials, record NCT04632758. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04632758
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Comparing WX-0593 to Crizotinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients
- NCT number
- NCT04632758
- Status
- Unknown
- Phases
- Phase 3
- Enrollment
- 292 participants, actual
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- WX-0593 Tablets, crizotinib
- First posted
- 2020-11-17
- Last updated
- 2023-11-24
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) | from randomization until firstly recorded disease progression or death (whichever occurs earlier), or to the date that the last patients observed for 12 months | PFS as assessed by independent radiology review based on RECIST v. 1.1 criteria |
| Secondary | Progression-free survival (PFS) | from randomization until firstly recorded disease progression or death (whichever occurs earlier), or to the date that the last patients observed for 12 months | PFS based on investigator assessment |
| Secondary | OS | from randomization until death due to any cause, withdraws informed consent, is lost to follow-up or refuses phone visits, or study completion（up to 2.5 years） | Overall survival (OS) |
| Secondary | Confirmed Objective Response Rate (ORR) Assessed By independent radiology review | From fist administration to the date that the last patients observed for 12 months | ORR is defined the percentage of the participants who have achieved complete response (CR) or partial response (PR) per independent radiology review using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 after the initiation of study treatment. |
| Secondary | Confirmed Objective Response Rate (ORR) Assessed By Investigators | From fist administration to the date that the last patients observed for 12 months | ORR is defined the percentage of the participants who have achieved complete response (CR) or partial response (PR) per Investigators using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 after the initiation of study treatment. |
| Secondary | Time to Response (TTR) Assessed By independent radiology | From fist administration to the date that the last patients observed for 12 months | Assessed from date of the first dose until the date of progression per independent radiology review |
| Secondary | Time to Response (TTR) Assessed By Investigators | From fist administration to the date that the last patients observed for 12 months | Assessed from date of the first dose until the date of progression per investigator. |
| Secondary | Duration of response (DOR) Assessed By independent radiology | From fist administration to the date that the last patients observed for 12 months | The DOR is defined as the time from the date of the first response CR/PR (whichever is first recorded) to the date on which progressive disease (PD) is first noted or date of death. |
| Secondary | Duration of response (DOR) Assessed By Investigators | From fist administration to the date that the last patients observed for 12 months | The DOR is defined as the time from the date of the first response CR/PR (whichever is first recorded) to the date on which progressive disease (PD) is first noted or date of death. |
| Secondary | CNS response rate based on independent radiology review | From fist administration to the date that the last patients observed for 12 months | CNS response rate based on independent radiology review |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 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 |
|---|---|
| 38280448 | 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/NCT04632758
GET https://conductscience.org/api/trials/v1/NCT04632758/registered