Advanced Thymic CarcinomaPhase 2NCT07824505
Lucitanib (AL3810) in Patients With Advanced Thymic Carcinoma After Chemotherapy
A Phase 2 study testing lucitanib 15 mg QD and lucitanib 10 mg QD in people with Advanced Thymic Carcinoma, run by Haihe Biopharma Co., Ltd. at 16 sites in China.
Trial summary
Indication: Patients with advanced recurrent or metastatic thymic carcinoma. Phase IIa (China only):Approximately 6 patients. Phase IIb (China only):Approximately 54 patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Thymic Carcinoma
- What is being tested?
- lucitanib 15 mg QD and lucitanib 10 mg QD
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 16 sitesChina
- Study dates
- 16 Aug 2018to 6 Sep 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients eligible for enrollment in this study must meet all of the following criteria:
- Be able to understand and voluntarily sign the written informed consent form (ICF);
- Be male or female, aged 18 to 75 years;
- Have histologically or cytologically confirmed advanced solid tumors for which standard treatment has failed (defined as disease progression during or after treatment or intolerance to treatment-related toxicities), or for which no effective standard treatment is available, or patients who are unwilling to receive standard treatment (applicable to patients in the Phase IIa study);
- Have histologically or cytologically confirmed advanced, recurrent, or metastatic thymic carcinoma that is unresectable and not amenable to curative radiotherapy, and have failed at least one line of chemotherapy (applicable to patients in the Phase IIb study);
- Definition of treatment failure: Disease progression during or after first-line systemic chemotherapy (which may include platinum- or taxane-based chemotherapy) or intolerance to treatment-related toxicities, with radiographic or clinical evidence confirming disease progression.
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- For neoadjuvant/adjuvant therapy (chemotherapy or chemoradiotherapy), disease progression occurring during treatment or within 6 months after discontinuation of treatment will be considered failure of first-line treatment.
- Have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. If a lesion that has previously received local treatment (e.g., radiotherapy, ablation, or vascular intervention) is the only measurable lesion, there must be clear radiographic evidence of disease progression in that lesion (applicable to patients in the Phase IIb study);
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤1 (applicable to patients in the Phase IIa study) or ≤2 (applicable to patients in the Phase IIb study);
- Have adequate bone marrow, hepatic, and renal function, without blood transfusion, blood product transfusion, granulocyte colony-stimulating factor (G-CSF), or other hematopoietic growth factor support within 2 weeks prior to the first dose:
- Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L;
- Hemoglobin ≥9 g/dL;
- Platelet count ≥90 × 10⁹/L;
- Serum total bilirubin ≤1.5 × the upper limit of normal (ULN);
- Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN (≤5 × ULN in patients with liver metastases);
- Creatinine clearance ≥50 mL/min, calculated using the Cockcroft-Gault formula (see Appendix 4);
- Urinary protein <1+. If urinary protein is ≥1+, the quantitative 24-hour urinary protein must be <1.0 g/24 h;
- International normalized ratio (INR) ≤1.5 and activated partial thromboplastin time (APTT) ≤1.5 × ULN;
- For females of childbearing potential, have a negative serum or urine pregnancy test within 7 days prior to the first dose. Male patients and female patients of childbearing potential must use adequate contraceptive measures from the time of signing the ICF until 6 months after the last dose of study drug;
- Have a body weight ≥40 kg;
- Have a life expectancy of ≥12 weeks, as judged by the investigator.
Who cannot join
- Patients who meet any of the following criteria will be excluded from the study:
- Have unresolved toxicities related to previous anticancer treatment that have not recovered to ≤Grade 1 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), except for alopecia and ≤Grade 2 peripheral neuropathy due to oxaliplatin;
- Have had other malignancies within the past 5 years, except for adequately controlled basal cell carcinoma of the skin or carcinoma in situ of the cervix;
- Have central nervous system (CNS) metastases requiring clinical intervention or tumor-related epilepsy. Patients with previously treated and stable CNS metastases for ≥3 months without the need for corticosteroids or antiepileptic drugs, as well as patients with asymptomatic CNS metastases, may be enrolled;
- Have received systemic anticancer therapy within 2 weeks prior to the first dose, including chemotherapy, molecularly targeted therapy, immunotherapy, biological therapy, hormone therapy, or traditional Chinese medicine for anticancer treatment (according to the indications specified in the relevant traditional Chinese medicine package insert). Patients who have completed a 2-week washout period may be eligible for enrollment;
- Have received definitive radiotherapy within 4 weeks prior to the first dose (including radiotherapy involving >25% of the bone marrow), or local palliative radiotherapy for bone metastases within 2 weeks prior to the first dose;
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- Have previously received treatment with a vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor or programmed cell death protein 1/programmed death-ligand 1 (PD-1/PD-L1) inhibitor;
- Have clinically uncontrolled serous effusion, such as pleural effusion that cannot be adequately controlled by drainage or other interventions;
- Have any of the following cardiovascular conditions:
- Congestive heart failure of New York Heart Association (NYHA) functional class ≥II;
- Serious cardiac arrhythmia requiring pharmacological treatment;
- Acute myocardial infarction, severe or unstable angina pectoris, or coronary or peripheral arterial bypass surgery within 6 months prior to the first dose;
- Left ventricular ejection fraction (LVEF) <50%;
- Corrected QT interval (QTc) >450 ms in males or >470 ms in females, or risk factors for torsades de pointes, such as clinically significant hypokalemia as judged by the investigator, a family history of long QT syndrome, or a family history of inherited arrhythmias (e.g., Wolff-Parkinson-White syndrome);
- Uncontrolled hypertension, defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg despite standardized antihypertensive treatment;
- Have experienced an arterial/venous thrombotic or embolic event within 6 months prior to the first dose, such as stroke (including transient ischemic attack), deep vein thrombosis, or pulmonary embolism;
- Have known human immunodeficiency virus (HIV) infection, active hepatitis B, or active hepatitis C. Active hepatitis B is defined as hepatitis B surface antigen (HBsAg) positivity with HBV DNA ≥10³ copies/mL or ≥200 IU/mL. Active hepatitis C is defined as positive hepatitis C virus (HCV) antibody and positive HCV RNA by polymerase chain reaction (PCR);
- Have an active bacterial, fungal, or viral infection requiring systemic treatment within 1 week prior to the first dose;
- Have received a strong cytochrome P450 (CYP) 2C8 and/or CYP3A4 inhibitor or a strong CYP3A4 inducer within 1 week or 5 half-lives of the drug, whichever is longer, prior to the first dose, or require continued treatment with any of these medications during the study;
- Be unable to discontinue medications that may cause QTc prolongation or torsades de pointes (e.g., antiarrhythmic drugs) during the study;
- Have experienced a bleeding event of ≥Grade 3 according to CTCAE within 4 weeks prior to the first dose or have a bleeding tendency. Patients with active duodenal ulcers, ulcerative colitis, intestinal obstruction, or other conditions considered by the investigator to potentially cause gastrointestinal bleeding or perforation are also excluded. Patients with a history of intestinal perforation or intestinal fistula that has not completely healed are also excluded;
- Have multiple factors that may affect the absorption, distribution, metabolism, or elimination of oral study drug, such as inability to swallow medication, frequent vomiting, or chronic diarrhea;
- Have any clinically significant systemic disease requiring treatment, as judged by the investigator, including but not limited to autoimmune diseases (except those requiring inhaled or topical treatment), thyroid disorders (patients with stable thyroid function on hormone replacement therapy may be enrolled), interstitial lung disease of ≥Grade 2 according to CTCAE, organ transplantation, or a history of psychiatric drug abuse, alcohol abuse, or illicit drug use;
- Have poorly healing wounds, severe ulcers, or fractures; or have undergone major surgery (in China, major surgery is defined as Grade 3 or Grade 4 surgery according to the Administrative Measures for the Clinical Application of Medical Technologies, effective May 1, 2009) or experienced significant traumatic injury within 28 days prior to the first dose of study drug;
- Have a known or suspected hypersensitivity to the study drug and/or any of its excipients;
- Be pregnant or breastfeeding;
- Be receiving treatment in another interventional clinical trial within 4 weeks prior to the first dose. Patients participating in a non-interventional clinical trial (e.g., an epidemiological study) may be eligible for enrollment. Patients who have entered the survival follow-up period of an interventional clinical trial may also be eligible for enrollment;
- Have any other disease or medical condition that, in the investigator's judgment, is unstable or may affect patient safety or compliance with the study.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
China16 sites
Beijing Cancer Hospital
Beijing
Peking University People's Hospital
Beijing
Xuanwu Hospital Capital Medicine University
Beijing
Hunan Cancer Hospital
Changsha
Fujian Medicine University Union Hospital
Fuzhou
Sun Yat-sen University Cancer Center
Guangzhou
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou
Zhejiang Cancer Hospital
Hangzhou
Fudan University Shanghai Cancer Center
Shanghai
Shanghai Chest Hospital
Shanghai
ShangHai Pulmonary Hospital
Shanghai
China Shenyang The Tenth People's Hospital
Shenyang
Tianjin Cancer Hospital
Tianjin
Tianjin Medicine University General Hospital
Tianjin
Tangdu Hospital Fourth Military Medical University
Xi'an
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Clinical Study of Lucitanib (AL3810) in Patients With Advanced Recurrent or Metastatic Thymic Carcinoma Who Have Failed at Least First-line Chemotherapy
Indication: Patients with advanced recurrent or metastatic thymic carcinoma. Phase IIa (China only):Approximately 6 patients. Phase IIb (China only):Approximately 54 patients.
Read the detailed description
This study consists of two parts: a Phase IIa study and a Phase IIb study. Phase IIa study: A single-arm, open-label study to evaluate the safety and tolerability of Lucitanib administered at 15 mg once daily for three consecutive weeks followed by one week off treatment in patients with advanced solid tumors who have failed standard therapy, have no effective treatment options, or are unwilling to receive standard therapy.
Phase IIb study: A randomized, double-blind, placebo-controlled, multicenter study to evaluate Lucitanib in patients with advanced, recurrent, or metastatic thymic carcinoma who have failed at least first-line chemotherapy and are not eligible for surgical resection or definitive radiotherapy.
- Conditions
- Advanced Thymic Carcinoma
- Being tested
- lucitanib 15 mg QD, lucitanib 10 mg QD, placebo QD
- Keywords
- Lucitanib, AL3810, Advanced recurrent or metastatic thymic carcinoma, Tyrosine kinase inhibitor
- Medical subject headings
- Thymoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lucitanib 15 mg QDDrug
Also called AL3810
Phase IIa: The investigational product will be orally administrated when fasting at dose level of lucitanib 15 mg, QD, 3 weeks on and 1 week off
lucitanib 10 mg QDDrug
Also called AL3810
Phase IIb: The investigational product will be orally administrated when fasting at dose level of lucitanib 10 mg QD
placebo QDDrug
Phase IIb: The investigational product will be orally administrated when fasting at dose level of Placebo QD
| Study group | Role | What they receive |
|---|---|---|
| IIa: lucitanib 15 mg,QD | Experimental | Phase IIa: lucitanib 15 mg, QD, 3 weeks on and 1 week off. Receives: Drug: lucitanib 15 mg QD |
| IIb: lucitanib 10 mg, QD | Experimental | Phase IIb: lucitanib 10 mg, QD Receives: Drug: lucitanib 10 mg QD |
| IIb: placebo, QD | Placebo comparator | Phase IIb: placebo, QD Receives: Drug: placebo QD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase IIa:Safety and Tolerability
The safety and tolerability of lucitanib will be evaluated based on the incidence, type, severity, and outcome of adverse events (AEs) and treatment-emergent adverse events (TEAEs), including dose-limiting toxicities (DLTs) and other adverse events occurring during the treatment period. Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.03.
Measured: From first dose through 28 days after the last dose
Phase IIb:Progression-free survival (PFS) by independent review committee
Progression-free survival is defined as the time from the date of randomization to the date of disease progression or death from any cause, whichever occurs first, as assessed by independent review committee according to RECIST Version 1.1.
Measured: Up to approximately 24 months
Secondary outcomes (17)
Phase IIa: Progression-free survival (PFS) by investigator
Progression-free survival is defined as the time from the date of first dose of lucitanib to the date of disease progression or death from any cause, whichever occurs first, as assessed by the investigator according to RECIST Version 1.1
Measured: Up to approximately 24 months
Phase IIa: Objective response rate (ORR)
Objective response rate is defined as the proportion of participants with a best overall response of complete response (CR) or partial response (PR), as assessed by the investigator according to RECIST Version 1.1.
Measured: Up to approximately 24 months
Phase IIa: Disease Control Rate (DCR)
Disease control rate is defined as the proportion of participants with a best overall response of complete response (CR), partial response (PR), or stable disease (SD), as assessed by the investigator according to RECIST Version 1.1.
Measured: Up to approximately 24 months
Phase IIb: Progression-free survival (PFS) by investigator assessment
Progression-free survival is defined as the time from the date of randomization to the date of disease progression or death from any cause, whichever occurs first, as assessed by the investigator according to RECIST Version 1.1.
Measured: Up to approximately 24 months
Phase IIb: 6-month progression-free survival rate
The 6-month progression-free survival rate is defined as the proportion of participants who remain alive and free of disease progression at 6 months after randomization, as assessed according to RECIST Version 1.1.
Measured: 6 months after randomization
Phase IIb: Objective response rate (ORR)
Objective response rate is defined as the proportion of participants with a best overall response of complete response (CR) or partial response (PR), according to RECIST Version 1.1.
Measured: Up to approximately 24 months
Phase IIb: Disease control rate (DCR)
Disease control rate is defined as the proportion of participants with a best overall response of complete response (CR), partial response (PR), or stable disease (SD), according to RECIST Version 1.1.
Measured: Up to approximately 24 months
Phase IIb: Duration of response (DoR)
Duration of response is defined as the time from the date of first documented complete response or partial response to the date of disease progression or death from any cause, whichever occurs first, as assessed according to RECIST Version 1.1.
Measured: From the date of first documented response until disease progression or death, assessed up to approximately 24 months
Phase IIb: Overall survival (OS)
Overall survival is defined as the time from the date of randomization to the date of death from any cause.
Measured: From the date of randomization until death from any cause, assessed up to approximately 48 months
Phase IIb: Safety and tolerability
The safety and tolerability of lucitanib will be evaluated based on the incidence, type, severity, and outcome of adverse events (AEs) and treatment-emergent adverse events (TEAEs) occurring during the treatment period and safety follow-up. Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.03.
Measured: From first dose through 28 days after the last dose
Phase IIa:Area Under the Concentration-Time Curve from Time Zero to the Last Measurable Concentration (AUClast)
AUClast of lucitanib in plasma will be evaluated based on plasma concentrations of lucitanib collected pre-dose and at 30 min, 1, 2, 3, 4, 8, and 12 hours post-dose.
Measured: Day 1 and Day 15
Phase IIa:Area Under the Concentration-Time Curve over 24 Hours (AUC24)
AUC24 of lucitanib in plasma will be evaluated based on plasma concentrations of lucitanib collected pre-dose and at 30 min, 1, 2, 3, 4, 8, and 12 hours post-dose.
Measured: Day 1 and Day 15
Phase IIa:Maximum Observed Concentration (Cmax)
Maximum observed plasma concentration (Cmax) of lucitanib will be evaluated based on plasma concentrations collected pre-dose and at 30 min, 1, 2, 3, 4, 8, and 12 hours post-dose.
Measured: Day 1 and Day 15
Phase IIa:Minimum Observed Concentration (Cmin)
Minimum observed plasma concentration (Cmin) of lucitanib will be evaluated based on plasma concentrations collected pre-dose and at 30 min, 1, 2, 3, 4, 8, and 12 hours post-dose.
Measured: Day 1 and Day 15
Phase IIa:Accumulation Ratio (Racc)
Accumulation ratio (Racc) of lucitanib will be evaluated based on plasma concentrations on Day 1 and Day 15.
Measured: Day 15
Phase IIa:Terminal Half-Life (t1/2)
Terminal half-life (t1/2) of lucitanib will be evaluated based on plasma concentrations collected following dosing.
Measured: Day 1 and Day 15
Phase IIa:Clearance (CL)
Clearance (CL) of lucitanib will be evaluated based on plasma concentrations collected following dosing.
Measured: Day 1 and Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start16 Aug 2018
- Primary completion6 Sep 2021
- Study completion6 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Thymic CarcinomaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haihe Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Huiming Cai, MD, Study director, Haihe Biopharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07824505
- Sponsor's protocol ID
- AL3810-202
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Clinical Study of Lucitanib (AL3810) in Patients With Advanced Recurrent or Metastatic Thymic Carcinoma Who Have Failed at Least First-line Chemotherapy
- ClinicalTrials.gov ID
- NCT07824505
- Acronym / sponsor ID
- AL3810-202
- Conditions
- Advanced Thymic Carcinoma
- Keywords
- Lucitanib, AL3810, Advanced recurrent or metastatic thymic carcinoma, Tyrosine kinase inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Haihe Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Aug 2018 (actual)
- Primary completion
- 6 Sep 2021 (actual)
- Study completion
- 6 Sep 2021 (actual)
- First posted
- 17 Sep 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.
Indication: Patients with advanced recurrent or metastatic thymic carcinoma. Phase IIa (China only):Approximately 6 patients. Phase IIb (China only):Approximately 54 patients.
Detailed description
This study consists of two parts: a Phase IIa study and a Phase IIb study. Phase IIa study: A single-arm, open-label study to evaluate the safety and tolerability of Lucitanib administered at 15 mg once daily for three consecutive weeks followed by one week off treatment in patients with advanced solid tumors who have failed standard therapy, have no effective treatment options, or are unwilling to receive standard therapy.
Phase IIb study: A randomized, double-blind, placebo-controlled, multicenter study to evaluate Lucitanib in patients with advanced, recurrent, or metastatic thymic carcinoma who have failed at least first-line chemotherapy and are not eligible for surgical resection or definitive radiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IIa: lucitanib 15 mg,QD | Experimental | Drug: lucitanib 15 mg QDPhase IIa: lucitanib 15 mg, QD, 3 weeks on and 1 week off. |
| IIb: lucitanib 10 mg, QD | Experimental | Drug: lucitanib 10 mg QDPhase IIb: lucitanib 10 mg, QD |
| IIb: placebo, QD | Placebo comparator | Drug: placebo QDPhase IIb: placebo, QD |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Patients eligible for enrollment in this study must meet all of the following criteria:
Key exclusion criteria (28 listed)
- Patients who meet any of the following criteria will be excluded from the study:
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 |
|---|---|---|
| lucitanib 15 mg QDAlso: AL3810Phase IIa: The investigational product will be orally administrated when fasting at dose level of lucitanib 15 mg, QD, 3 weeks on and 1 week off | Drug | IIa: lucitanib 15 mg,QD |
| lucitanib 10 mg QDAlso: AL3810Phase IIb: The investigational product will be orally administrated when fasting at dose level of lucitanib 10 mg QD | Drug | IIb: lucitanib 10 mg, QD |
| placebo QDPhase IIb: The investigational product will be orally administrated when fasting at dose level of Placebo QD | Drug | IIb: placebo, QD |
Primary outcome
Phase IIa:Safety and Tolerability
Time frame: From first dose through 28 days after the last dose
The safety and tolerability of lucitanib will be evaluated based on the incidence, type, severity, and outcome of adverse events (AEs) and treatment-emergent adverse events (TEAEs), including dose-limiting toxicities (DLTs) and other adverse events occurring during the treatment period. Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.03.
Phase IIb:Progression-free survival (PFS) by independent review committee
Time frame: Up to approximately 24 months
Progression-free survival is defined as the time from the date of randomization to the date of disease progression or death from any cause, whichever occurs first, as assessed by independent review committee according to RECIST Version 1.1.
17 secondary outcomes
Phase IIa: Progression-free survival (PFS) by investigator
Time frame: Up to approximately 24 months
Phase IIa: Objective response rate (ORR)
Time frame: Up to approximately 24 months
Phase IIa: Disease Control Rate (DCR)
Time frame: Up to approximately 24 months
Phase IIb: Progression-free survival (PFS) by investigator assessment
Time frame: Up to approximately 24 months
Phase IIb: 6-month progression-free survival rate
Time frame: 6 months after randomization
Phase IIb: Objective response rate (ORR)
Time frame: Up to approximately 24 months
Phase IIb: Disease control rate (DCR)
Time frame: Up to approximately 24 months
Phase IIb: Duration of response (DoR)
Time frame: From the date of first documented response until disease progression or death, assessed up to approximately 24 months
Phase IIb: Overall survival (OS)
Time frame: From the date of randomization until death from any cause, assessed up to approximately 48 months
Phase IIb: Safety and tolerability
Time frame: From first dose through 28 days after the last dose
Phase IIa:Area Under the Concentration-Time Curve from Time Zero to the Last Measurable Concentration (AUClast)
Time frame: Day 1 and Day 15
Phase IIa:Area Under the Concentration-Time Curve over 24 Hours (AUC24)
Time frame: Day 1 and Day 15
Phase IIa:Maximum Observed Concentration (Cmax)
Time frame: Day 1 and Day 15
Phase IIa:Minimum Observed Concentration (Cmin)
Time frame: Day 1 and Day 15
Phase IIa:Accumulation Ratio (Racc)
Time frame: Day 15
Phase IIa:Terminal Half-Life (t1/2)
Time frame: Day 1 and Day 15
Phase IIa:Clearance (CL)
Time frame: Day 1 and Day 15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Huiming Cai, MD study director
Haihe Biopharma
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing lucitanib 15 mg QD and lucitanib 10 mg QD in people with Advanced Thymic Carcinoma, run by Haihe Biopharma Co., Ltd. at 16 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 21 inclusion and 28 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: finished, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase IIa:Safety and Tolerability (time frame: From first dose through 28 days after the last dose). The study lists 2 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 17 Sep 2026.