ALK-Positive or ROS1-Positive Locally Advanced or Metastatic Non-Small Cell Lung CancerPhase 1NCT07912268
Study of SIM0518 in Participants With ALK-Positive or ROS1-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
A Phase 1 study testing SIM0518, SIM0518+Bupropion and SIM0518+Midazolam in people with ALK-Positive or ROS1-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 8 sites in China.
Trial summary
This is a multicenter, open-label, Phase I study designed to evaluate the safety, tolerability, efficacy, and pharmacokinetic /pharmacodynamic characteristics of SIM0518 in trial participants with ALK-positive or ROS1-positive locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ALK-Positive or ROS1-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
- What is being tested?
- SIM0518, SIM0518+Bupropion and SIM0518+Midazolam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 8 sitesChina
- Study dates
- 1 Nov 2026to 1 Jun 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must meet all of the following inclusion criteria:
- Voluntary participation and signing of informed consent.
- Age ≥ 18 years, male or female.
- Histologically and/or cytologically confirmed stage IIIB-IV non-curatively treatable (surgery, radiotherapy) Non-Small Cell Lung Cancer.
- It was confirmed that trial participants carried ALK or ROS1 rearrangements from previous local test reports, in which testing was performed using kits approved by regulatory authorities.
- Part 1:
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- a: Heavily pretreated advanced.
- b: Presence of at least one measurable or evaluable tumor lesion per Response Evaluation Criteria in Solid Tumors, version 1.1.
- （RECIST 1.1. ）Participants enrolled in the backfill phase must have measurable disease. Lesions previously irradiated cannot be considered target lesions unless the lesion progresses significantly.
- Part 2 of 3:
- a: Cohort 1, Cohort 2, Cohort 4, and Cohort 5: disease progression or intolerance during/after treatment with at least one ALK inhibitor or a ROS1 inhibitor, with no more than 3 ALK/ROS1 inhibitors; and progression or intolerance after a maximum of one-line chemotherapy regimen.
- Cohort 3: has not received ALK inhibitor therapy and has progressed or is intolerant after up to one chemotherapy regimen.
- b. Presence of at least one measurable lesion per RECIST 1.1; lesions previously irradiated cannot be considered target lesions unless the lesion progresses significantly.
- Eastern Cooperative Oncology Group Performance Status(ECOG) score 0 or 1.
- Expected survival ≥ 12 weeks.
- Adequate organ and bone marrow function.
- Trial participants must confirm at screening that archival formalin-fixed paraffin-embedded (FFPE) tumor tissue samples obtained within 3 years of signing the informed consent form or fresh biopsy samples collected prior to the first dose for retrospective testing of the ALK/ROS1 gene are available.
- -Women of childbearing potential must have a negative blood pregnancy test within 3 days prior to the first dose. Female trial participants of childbearing potential or male trial participants with female partners of childbearing potential are required to use effective methods of contraception from signing the informed consent form until 180 days after the last dose of study drug and refrain from donating sperm/eggs.
Who cannot join
- Target disease to be excluded
- NSCLC trial participants have driver gene mutations other than ALK/ROS1 that have corresponding marketed targeted agents, such as EGFR sensitivity mutations, HER2 mutations, KRASG12C mutations, BRAFV600 mutations, RET fusions, MET14 exon skipping mutations, MET amplifications, NTRK fusions.
- Trial participants had symptomatic Central Nervous System metastases (CNS) metastases within 2 weeks prior to the first dose of study treatment, or CNS metastases requiring CNS-directed local therapy (e.g., radiotherapy or surgery) or corticosteroid therapy.
- The trial participant had spinal cord compression (due to tumor) unless the trial participant achieved good pain control by treatment and neurological function fully recovered within 4 weeks prior to the first dose.
- Medical Status and Prior/Concomitant Diseases
- History of other active malignancies within the past 3 years with the following exceptions: adequately treated basal cell carcinoma or squamous cell skin cancer, carcinoma in situ of the breast or carcinoma in situ of the cervix, low-risk prostate cancer (Gleason score ≤ 6) under surveillance without any treatment intervention plan (e.g., surgery, radiotherapy, or castration therapy), and other concomitant malignancies assessed by the investigator in consultation with the sponsor as low risk of recurrence.
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- Gastrointestinal disorders affecting drug administration/absorption: including dysphagia/inability to swallow the drug; major gastrointestinal surgery (e.g., bowel resection with clinically significant sequelae, total gastrectomy, etc.) affecting absorption; chronic diarrhea, symptomatic diverticulosis; subjects with active or persistent gastrointestinal bleeding, active peptic ulcer requiring treatment, or malabsorption syndrome within 180 days prior to signing the informed consent form; intestinal obstruction or other gastrointestinal disease that, in the opinion of the investigator, is not suitable for enrollment within 90 days prior to signing the informed consent form.
- Any psychiatric or cognitive disorder that may limit their understanding and execution of informed consent.
- Uncontrollable or pleural effusion, pericardial effusion, or ascites requiring drainage or medical intervention within 4 weeks prior to the first dose of study treatment.
- Trial participants with any active infection requiring systemic treatment by intravenous infusion within 2 weeks prior to start of study treatment.
- History of pneumonitis or interstitial lung disease requiring oral or intravenous steroids. Current interstitial lung disease or pneumonitis or suspected interstitial lung disease or pneumonitis at screening that cannot be screened by imaging.
- Trial participants had a history of active tuberculosis infection within 1 year; trial participants with a history of active tuberculosis, unless judged by the investigator to have no evidence of active tuberculosis for more than 1 year prior to the first dose of study treatment.
- Known human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS).
- Active or chronic hepatitis B (HBsAg or HBcAb positive and HBV DNA ≥ 2000 IU/mL or ≥ 10,000 copies/mL) or hepatitis C (HCV antibody positive and HCV RNA ≥ ULN) infection; trial participants who are HBsAg positive or HBV-DNA positive at screening should receive antiviral therapy during the study in accordance with local practice.
- History of clinically significant cardiovascular disease.
- QTcF interval (corrected by Fridericia' s formula) > 450 milliseconds by electrocardiogram, hereditary long QT syndrome.
- Uncontrolled hyperglycemia, acute onset of cholelithiasis, or participants with susceptibility characteristics for acute pancreatitis as judged by the investigator within 28 days prior to the first dose.
- History of allogeneic organ transplantation or graft-versus-host disease.
- Known allergy to study drug or any excipients.
- Prior/concomitant therapy
- Prior four-generation ALK inhibitors or ALK molecular gels.
- Has not recovered from an AE due to prior anti-tumor therapy.
- Currently participating in or participating in studies of other investigational drugs or investigational devices within 4 weeks prior to the first dose of SIM0518.
- Major surgery within 4 weeks prior to the first dose of study treatment.
- The following medications were administered before the first dose of study treatment:
- Administration of strong or moderate CytochromeP450 3A4 (CYP3A4)inhibitors and/or strong CytochromeP450 2C8(CYP2C8) inhibitors ≤ 7 days or 5 half-lives (whichever is longer) prior to the first dose of study treatment;
- Administration of strong or moderate CYP3A4 inducers ≤ 14 days or 5 half-lives (whichever is longer) prior to the first dose of study treatment;
- Administer medications known to be at risk for torsades de pointes (TdP) ≤ 14 days or 5 half-lives, whichever is longer, prior to the first dose of study treatment;
- Medications that may prolong the QT interval ≤ 14 days prior to the first dose of study treatment (TdP risk is uncertain);
- Proton pump inhibitors (PPIs) or H2 blockers were administered ≤ 7 days before the first dose of study treatment;
- Received the following anti-tumor therapies prior to the first dose of study treatment:
- Received anti-tumor antibody or Antibody-Drug Conjugate(ADC) therapy (whichever is shorter) within 4 weeks or 5 half-lives (whichever is shorter) before the first dose of study treatment.
- Cytotoxic therapy, anti-tumor targeted small molecules (e.g. tyrosine kinase inhibitors) within 2 weeks prior to the first dose of study treatment.
- Traditional Chinese medicine/traditional Chinese medicine preparations with anti-tumor indications within 2 weeks prior to the first dose of study treatment.
- Traditional Chinese medicine/traditional Chinese medicine preparations (except topical medication) within 7 days prior to the first dose of study treatment.
- Radiotherapy (except whole brain radiotherapy, which requires 4 weeks) within 2 weeks prior to the first dose of study treatment.
- Use of any live vaccines within 4 weeks prior to the first dose of study treatment.
- Trial participants are pregnant or breastfeeding, or are expected to become pregnant or have children during the planned study.
- Other circumstances considered unsuitable for inclusion by the investigator
- Additional Exclusion Criteria for Trial Participants in Part 3 (Drug Interaction Studies)
- (Part 3 Cohort 4 only) Study participants are expected to use any CYP3A4 inhibitor or inducer within ≤ 7 days (for 3A4 inhibitors) or ≤ 14 days (for 3A4 inducers) or 5 half-lives (whichever is longer) prior to the first dose of midazolam (as CYP3A4 probe substrate) until completion of the Drug-Drug Interaction(DDI)assessment on Cycle2Day2;
- (Part 3 Cohort 5 only) Study participants are expected to use inhibitors and inducers of any specific metabolic enzyme/transporter (CYP2B6, CYP2C8, CYP2C9, P-gp, and BCRP) within ≤ 7 days (inhibitor) or ≤ 14 days (inducer) or 5 half-lives (whichever is longer) prior to the first dose of the specific probe substrate to be used by trial participants until the completion of the DDI assessment on Cycle2Day2; .
- (Part 3 only) Trial participants with contraindications to the administration of the drug according to the current labeling of probe substrates (midazolam, bupropion, repaglinide, tolbutamide, fexofenadine, rosuvastatin) to be used in the cohort in which the trial participant is participating;
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
China8 sites
Jilin Provincial Cancer Hospital
Changchun, Jilin, 130012
Haifeng Liu
Hunan Cancer Hospital
Changsha, Hunan, 410013
Lin Wu
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
Zhangzhou Huang
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
Fang Liu
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 220006
Mengzhi Wan
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200120
Caicun Zhou
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
Shengxiang Ren
Taizhou Enze Medical Center (Group), Enze Hospital
Taizhou, Zhejiang, 318050
Dongqing Lu
About this study
Official title: A Phase I, First-In-Human, Open-Label, Multicenter Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0518 in Participants With ALK-Positive or ROS1-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
This is a multicenter, open-label, Phase I study designed to evaluate the safety, tolerability, efficacy, and pharmacokinetic /pharmacodynamic characteristics of SIM0518 in trial participants with ALK-positive or ROS1-positive locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC). The study starts with a dose escalation part (Part 1), followed by a dose expansion part (Part 2). A Drug-Drug Interaction (DDI) study (Part 3) may be conducted after the Recommended Dose of SIM0518 is determined.
- Being tested
- SIM0518, SIM0518+Bupropion, SIM0518+Midazolam, SIM0518+Repaglinide, SIM0518+Tolbutamide
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIM0518Drug
SIM0518 is an oral, next-generation, highly selective ALK/ROS1 dual inhibitor.
SIM0518+BupropionDrug
SIM0518 is an oral, next-generation, highly selective ALK/ROS1 dual inhibitor. Bupropion is a sensitive probe substrate for cytochrome P2B6 SIM0518+Repaglinide
SIM0518+MidazolamDrug
SIM0518 is an oral, next-generation, highly selective ALK/ROS1 dual inhibitor.
Midazolam is a sensitive substrate of cytochrome P450 3A4/3A5
SIM0518+RepaglinideDrug
SIM0518 is an oral, next-generation, highly selective ALK/ROS1 dual inhibitor. Repaglinide is a sensitive probe substrate for Cytochrome P450 2C8 (CYP2C8)
SIM0518+TolbutamideDrug
SIM0518 is an oral, next-generation, highly selective ALK/ROS1 dual inhibitor. Tolbutamide is a probe substrate for Cytochrome P450 2C9 (CYP2C9)
SIM0518+FexofenadineDrug
SIM0518 is an oral, next-generation, highly selective ALK/ROS1 dual inhibitor. Fexofenadine is a sensitive probe substrate for P-glycoprotein (P-gp).
SIM0518+ Rosuvastatin CalciumDrug
SIM0518 is an oral, next-generation, highly selective ALK/ROS1 dual inhibitor. Rosuvastatin is a probe substrate for Breast Cancer Resistance Protein (BCRP)
| Study group | Role | What they receive |
|---|---|---|
| SIM0518 | Experimental | SIM0518 Capsule, Use as specified in the Protocol Receives: Drug: SIM0518 |
| SIM0518+Midazolam | Experimental | SIM0518 Capsuleand Midazolam Oral Solution ，Use as Specified in the Protocol Receives: Drug: SIM0518+Midazolam |
| SIM0518+Bupropion | Experimental | SIM0518 Capsule and Bupropion Hydrochloride Tablets ，Use as Specified in the Protocol Receives: Drug: SIM0518+Bupropion |
| SIM0518+Repaglinide | Experimental | SIM0518 Capsuleand Repaglinide Tablets ,Use as Specified in the Protocol Receives: Drug: SIM0518+Repaglinide |
| SIM0518+Tolbutamide | Experimental | SIM0518 Capsule, and Tolbutamid Tablets,Use as Specified in the Protocol Receives: Drug: SIM0518+Tolbutamide |
| SIM0518+Fexofenadine | Experimental | SIM0518 Capsule and Fexofenadine Hydrochloride Tablets
,Use as Specified in the Protocol Receives: Drug: SIM0518+Fexofenadine |
| SIM0518+Rosuvastatin Tablets | Experimental | SIM0518 Capsule and Rosuvastatin Calcium Tablets ,Use as Specified in the Protocol Receives: Drug: SIM0518+ Rosuvastatin Calcium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity(DLT) (Dose escalation)
DLTs will be assessed during the dose-escalation phase and are defined as toxicities that meet pre-defined severity criteria.
Measured: During the first cycle treatment with SIM0518
Adverse event Rate
The occurrence of all adverse events (AEs), evaluated by Common Terminology Criteria for Adverse Events (CTCAE)6.0.
Measured: Up to approximately 24 months
Adverse event Severity
The Severity of all adverse events (AEs), evaluated by Common Terminology Criteria for Adverse Events（CTCAE）6.0.
Measured: Up to approximately 24 months
Serious Adverse Event Rate
The Occurrence of Serious Adverse Event Rate According to the Protocol
Measured: Up to approximately 24 months
Serious Adverse Event Severity
The Severitye of Serious Adverse Event Rate According to the Protocol
Measured: Up to approximately 24 months
Objective Response Rate (ORR)
ORR is the proportion of subjects with complete response（CR）or partial response(PR) assessed according to RECIST v1.1.
Measured: Up to approximately 24 months
Secondary outcomes (16)
Pharmacokinetics: The area under the curve (AUC)
The area under the curve (AUC) of serum concentration of SIM0518
Measured: Up to approximately 24 months
Pharmacokinetics:Peak concentration (Cmax)
Maximum observed concentration (Cmax) of SIM0518
Measured: Up to approximately 24 months
Pharmacokinetics: T1/2
Terminal half-life (T1/2)
Measured: Up to approximately 24 months
Pharmacokinetics: Tmax
Time to maximum concentration
Measured: Up to approximately 24 months
Pharmacokinetics: Ctrough
Minimum observed concentration (Cmax) of SIM0518
Measured: Up to approximately 24 months
Duration of Response (DOR)
DOR is the time from the date of first documented complete response (CR) or partial response (PR) to the earliest date of progressive disease (PD) or death from any cause, assessed according to Response Evaluation Criteria in Solid Tumors version 1.1.
Measured: Up to approximately 24 months
Disease Control Rate (DCR)
DCR is the proportion of participants with complete response (CR), partial response (PR) or stable disease (SD) assessed according to Response Evaluation Criteria in Solid Tumors version 1.1.
Measured: Up to approximately 24 months
Time To Response (TTR)
TTR is the time from the date of study treatment initiation to the date of first documented complete response (CR) or partial response (PR), assessed according to Response Evaluation Criteria in Solid Tumors version 1.1.
Measured: Up to approximately 24 months
Intracranial Objective Response Rate (IC-ORR)
IC-ORR is the proportion of participants with complete response (CR) or partial response (PR) for intracranial lesions assessed according to Response Evaluation Criteria in Solid Tumors version 1.1.
Measured: Up to approximately 24 months
Intracranial Disease Control Rate (IC-DCR)
IC-DCR is the proportion of participants with complete response (CR), partial response (PR) or stable disease (SD) for intracranial lesions assessed according to Response Evaluation Criteria in Solid Tumors version 1.1.
Measured: Up to approximately 24 months
Intracranial Duration of Response (IC-DOR)
IC-DOR is the time from the date of first documented complete response (CR) or partial response (PR) for intracranial lesions to the earliest date of intracranial progressive disease (PD) or death from any cause, assessed according to Response Evaluation Criteria in Solid Tumors version 1.1.
Measured: Up to approximately 24 months
Intracranial Time To Response (IC-TTR)
IC-TTR is the time from the date of study treatment initiation to the date of first documented complete response (CR) or partial response (PR) for intracranial lesions, assessed according to Response Evaluation Criteria in Solid Tumors version 1.1.
Measured: Up to approximately 24 months
Intracranial Progression-Free Survival (IC-PFS)
IC-PFS is the time from the date of study treatment initiation to the earliest date of intracranial progressive disease (PD) or death from any cause, assessed according to Response Evaluation Criteria in Solid Tumors version 1.1.
Measured: Up to approximately 24 months
Objective Response Rate (ORR) (Part 1)
ORR is the proportion of participants with complete response (CR) or partial response (PR) assessed according to Response Evaluation Criteria in Solid Tumors version 1.1.
Measured: Up to approximately 24 months
Number of Participants with Abnormal Laboratory Values
This metric is defined as the number of participants with at least one laboratory value outside the predefined reference range during the specified observation period.
Measured: Up to approximately 24 months
Tolerability
Tolerability includes, but is not limited to, the proportion of trial participants with dose adjustments (interruption, reduction) or permanent treatment discontinuation due to adverse events (AE)
Measured: Up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALK-Positive or ROS1-Positive Locally Advanced or Metastatic Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Jiangsu Simcere Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Xiansheng Zaiming Technology Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Caicun Zhou, Principal investigator, Shanghai East Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07912268
- Sponsor's protocol ID
- SIM0518-101
- Status last verified
- Jul 2026
- First submitted
- 22 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, First-In-Human, Open-Label, Multicenter Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0518 in Participants With ALK-Positive or ROS1-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07912268
- Acronym / sponsor ID
- SIM0518-101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Xiansheng Zaiming Technology Co., Ltd.
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 3 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, open-label, Phase I study designed to evaluate the safety, tolerability, efficacy, and pharmacokinetic /pharmacodynamic characteristics of SIM0518 in trial participants with ALK-positive or ROS1-positive locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC). The study starts with a dose escalation part (Part 1), followed by a dose expansion part (Part 2). A Drug-Drug Interaction (DDI) study (Part 3) may be conducted after the Recommended Dose of SIM0518 is determined.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| SIM0518 | Experimental | Drug: SIM0518SIM0518 Capsule, Use as specified in the Protocol |
| SIM0518+Midazolam | Experimental | Drug: SIM0518+MidazolamSIM0518 Capsuleand Midazolam Oral Solution ，Use as Specified in the Protocol |
| SIM0518+Bupropion | Experimental | Drug: SIM0518+BupropionSIM0518 Capsule and Bupropion Hydrochloride Tablets ，Use as Specified in the Protocol |
| SIM0518+Repaglinide | Experimental | Drug: SIM0518+RepaglinideSIM0518 Capsuleand Repaglinide Tablets ,Use as Specified in the Protocol |
| SIM0518+Tolbutamide | Experimental | Drug: SIM0518+TolbutamideSIM0518 Capsule, and Tolbutamid Tablets,Use as Specified in the Protocol |
| SIM0518+Fexofenadine | Experimental | Drug: SIM0518+FexofenadineSIM0518 Capsule and Fexofenadine Hydrochloride Tablets ,Use as Specified in the Protocol |
| SIM0518+Rosuvastatin Tablets | Experimental | Drug: SIM0518+ Rosuvastatin CalciumSIM0518 Capsule and Rosuvastatin Calcium Tablets ,Use as Specified in the Protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Participants must meet all of the following inclusion criteria:
- Voluntary participation and signing of informed consent.
- Age ≥ 18 years, male or female.
- Histologically and/or cytologically confirmed stage IIIB-IV non-curatively treatable (surgery, radiotherapy) Non-Small Cell Lung Cancer.
- It was confirmed that trial participants carried ALK or ROS1 rearrangements from previous local test reports, in which testing was performed using kits approved by regulatory authorities.
Key exclusion criteria (43 listed)
- Target disease to be excluded
- NSCLC trial participants have driver gene mutations other than ALK/ROS1 that have corresponding marketed targeted agents, such as EGFR sensitivity mutations, HER2 mutations, KRASG12C mutations, BRAFV600 mutations, RET fusions, MET14 exon skipping mutations, MET amplifications, NTRK fusions.
- Trial participants had symptomatic Central Nervous System metastases (CNS) metastases within 2 weeks prior to the first dose of study treatment, or CNS metastases requiring CNS-directed local therapy (e.g., radiotherapy or surgery) or corticosteroid therapy.
- The trial participant had spinal cord compression (due to tumor) unless the trial participant achieved good pain control by treatment and neurological function fully recovered within 4 weeks prior to the first dose.
- Medical Status and Prior/Concomitant Diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SIM0518SIM0518 is an oral, next-generation, highly selective ALK/ROS1 dual inhibitor. | Drug | SIM0518 |
| SIM0518+BupropionSIM0518 is an oral, next-generation, highly selective ALK/ROS1 dual inhibitor. Bupropion is a sensitive probe substrate for cytochrome P2B6 SIM0518+Repaglinide | Drug | SIM0518+Bupropion |
| SIM0518+MidazolamSIM0518 is an oral, next-generation, highly selective ALK/ROS1 dual inhibitor. Midazolam is a sensitive substrate of cytochrome P450 3A4/3A5 | Drug | SIM0518+Midazolam |
| SIM0518+RepaglinideSIM0518 is an oral, next-generation, highly selective ALK/ROS1 dual inhibitor. Repaglinide is a sensitive probe substrate for Cytochrome P450 2C8 (CYP2C8) | Drug | SIM0518+Repaglinide |
| SIM0518+TolbutamideSIM0518 is an oral, next-generation, highly selective ALK/ROS1 dual inhibitor. Tolbutamide is a probe substrate for Cytochrome P450 2C9 (CYP2C9) | Drug | SIM0518+Tolbutamide |
| SIM0518+FexofenadineSIM0518 is an oral, next-generation, highly selective ALK/ROS1 dual inhibitor. Fexofenadine is a sensitive probe substrate for P-glycoprotein (P-gp). | Drug | SIM0518+Fexofenadine |
| SIM0518+ Rosuvastatin CalciumSIM0518 is an oral, next-generation, highly selective ALK/ROS1 dual inhibitor. Rosuvastatin is a probe substrate for Breast Cancer Resistance Protein (BCRP) | Drug | SIM0518+Rosuvastatin Tablets |
Primary outcome
Dose-limiting toxicity(DLT) (Dose escalation)
Time frame: 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.
Adverse event Rate
Time frame: Up to approximately 24 months
The occurrence of all adverse events (AEs), evaluated by Common Terminology Criteria for Adverse Events (CTCAE)6.0.
Adverse event Severity
Time frame: Up to approximately 24 months
The Severity of all adverse events (AEs), evaluated by Common Terminology Criteria for Adverse Events（CTCAE）6.0.
Serious Adverse Event Rate
Time frame: Up to approximately 24 months
The Occurrence of Serious Adverse Event Rate According to the Protocol
Serious Adverse Event Severity
Time frame: Up to approximately 24 months
The Severitye of Serious Adverse Event Rate According to the Protocol
Objective Response Rate (ORR)
Time frame: 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.
16 secondary outcomes
Pharmacokinetics: The area under the curve (AUC)
Time frame: Up to approximately 24 months
Pharmacokinetics:Peak concentration (Cmax)
Time frame: Up to approximately 24 months
Pharmacokinetics: T1/2
Time frame: Up to approximately 24 months
Pharmacokinetics: Tmax
Time frame: Up to approximately 24 months
Pharmacokinetics: Ctrough
Time frame: Up to approximately 24 months
Duration of Response (DOR)
Time frame: Up to approximately 24 months
Disease Control Rate (DCR)
Time frame: Up to approximately 24 months
Time To Response (TTR)
Time frame: Up to approximately 24 months
Intracranial Objective Response Rate (IC-ORR)
Time frame: Up to approximately 24 months
Intracranial Disease Control Rate (IC-DCR)
Time frame: Up to approximately 24 months
Intracranial Duration of Response (IC-DOR)
Time frame: Up to approximately 24 months
Intracranial Time To Response (IC-TTR)
Time frame: Up to approximately 24 months
Intracranial Progression-Free Survival (IC-PFS)
Time frame: Up to approximately 24 months
Objective Response Rate (ORR) (Part 1)
Time frame: Up to approximately 24 months
Number of Participants with Abnormal Laboratory Values
Time frame: Up to approximately 24 months
Tolerability
Time frame: Up to approximately 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Caicun Zhou principal investigator
Shanghai East Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SIM0518, SIM0518+Bupropion and SIM0518+Midazolam in people with ALK-Positive or ROS1-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 8 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 43 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenwen Hu (+86 181 3649 7530, huwenwen1@zaiming.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity(DLT) (Dose escalation) (time frame: During the first cycle treatment with SIM0518). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.