Trial · NCT07912268
Study of SIM0518 in Participants With ALK-Positive or ROS1-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
NCT07912268, Phase 1, Not yet recruiting, Jiangsu Simcere Pharmaceutical Co., Ltd.
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Study of SIM0518 in Participants With ALK-Positive or ROS1-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer. Trials, record NCT07912268. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07912268
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of SIM0518 in Participants With ALK-Positive or ROS1-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
- NCT number
- NCT07912268
- Status
- Not yet recruiting
- Phases
- Phase 1
- Enrollment
- 270 participants, estimated
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Conditions
- ALK-Positive or ROS1-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
- Interventions
- SIM0518, SIM0518+Bupropion, SIM0518+Midazolam, SIM0518+Repaglinide, SIM0518+Tolbutamide, SIM0518+Fexofenadine, SIM0518+ Rosuvastatin Calcium
- First posted
- 2026-11-03
- Last updated
- 2026-11-03
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose-limiting toxicity(DLT) (Dose escalation) | During the first cycle treatment with SIM0518 | DLTs will be assessed during the dose-escalation phase and are defined as toxicities that meet pre-defined severity criteria. |
| Primary | Adverse event Rate | Up to approximately 24 months | The occurrence of all adverse events (AEs), evaluated by Common Terminology Criteria for Adverse Events (CTCAE)6.0. |
| Primary | Adverse event Severity | Up to approximately 24 months | The Severity of all adverse events (AEs), evaluated by Common Terminology Criteria for Adverse Events（CTCAE）6.0. |
| Primary | Serious Adverse Event Rate | Up to approximately 24 months | The Occurrence of Serious Adverse Event Rate According to the Protocol |
| Primary | Serious Adverse Event Severity | Up to approximately 24 months | The Severitye of Serious Adverse Event Rate According to the Protocol |
| Primary | Objective Response Rate (ORR) | Up to approximately 24 months | ORR is the proportion of subjects with complete response（CR）or partial response(PR) assessed according to RECIST v1.1. |
| Secondary | Pharmacokinetics: The area under the curve (AUC) | Up to approximately 24 months | The area under the curve (AUC) of serum concentration of SIM0518 |
| Secondary | Pharmacokinetics:Peak concentration (Cmax) | Up to approximately 24 months | Maximum observed concentration (Cmax) of SIM0518 |
| Secondary | Pharmacokinetics: T1/2 | Up to approximately 24 months | Terminal half-life (T1/2) |
| Secondary | Pharmacokinetics: Tmax | Up to approximately 24 months | Time to maximum concentration |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT07912268
GET https://conductscience.org/api/trials/v1/NCT07912268/registered?page=2