Small Cell Lung Cancer Extensive StagePhase 1/2NCT04659785
A Study of Fluzoparib Combined With Apatinib as Second-Line Treatment of Patients With Extensive Stage Small Cell Lung Cancer（FA-ES-SCLC）
A Phase 1/2 study testing Fluzoparib and Apatinib in people with Small Cell Lung Cancer Extensive Stage, run by Tianjin Medical University Second Hospital at 1 site in China.
Trial summary
This open-label, dose finding phase Ib trial studies the tolerability and the best dose of fluzoparib in combination with apatinib and to see how well these two drugs work together as second-line treatment of patients with extensive stage small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Small Cell Lung Cancer Extensive Stage
- What is being tested?
- Fluzoparib and Apatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2020to 31 Dec 2022
- Phase
- Phase 1/2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Extensive Stage Small Cell Lung Cancer diagnosed by pathology (histology or cytology) (according to WHO classification in 2015);
- Failure of first-line treatment；
- Age 18-70 years old;
- ≤21 days before the first study drug, CT or MRI scan, at least one target lesion without previous radiotherapy as defined by Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1);
- PS score: 0-2; the expected survival time ≥ 12 weeks;
- No anti-angiogenesis drugs or PARP inhibitors have been used in previous treatments;
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- All acute toxic reactions caused by previous anti-tumor treatments or surgical operations were relieved before the screening period 0-1 grade (according to NCI CTCAE 5.0 judgment) or to the level specified by the inclusion/exclusion criteria (hair loss and other researchers believe that the subjects are not Except for toxicity that poses a safety risk);
- No blood transfusion or blood products, no correction with G-CSF and other hematopoietic stimulating factors within 14 days before the first administration. First research before investigating drugs, laboratory test values meet the following conditions:
- Blood routine: white blood cell count (WBC) ≥3.0 × 109/L; absolute neutrophil count (ANC) ≥1.5 × 109/L; Platelet (PLT) ≥100 × 109/L; Hemoglobin content (HGB) ≥9.0 g/dL;
- Liver function: Aspartate aminotransferase (AST) ≤2.5 x ULN in subjects without liver metastasis, alanine liver aminotransferase (ALT) ≤2.5 x ULN; ALT and AST in subjects with liver metastases <5 x ULN; Serum total bilirubin (TBIL) ≤1.5 x ULN (except Gilbert syndrome total bilirubin <3.0 mg/dL); Albumin (ALB) ≥3 g/dL;
- Renal function: serum creatinine ≤1.5 x ULN or creatinine clearance CrCl≥40 mL/minute;
- Coagulation function: International normalized ratio (INR) ≤ 1.5, activated partial thromboplastin time (APTT) ≤ 1.5 x ULN;
- Others: Lipase ≤ 1.5 x ULN, if lipase> 1.5 x ULN but no clinical or imaging confirmed pancreatitis can be included; amylase ≤ 1.5 x ULN, if amylase> 1.5 x ULN but no clinical or imaging confirmed pancreatitis can be included in the group. Alkaline phosphatase (ALP)≤2.5ULN, subjects with bone metastases, ALP≤5ULN;
- Non-surgically sterilized female subjects of childbearing age must have a negative serum HCG test within 3 days before the first medication, and non-lactating period. Male subjects and females of childbearing age must start the first study drug to after the last study drug 6 contraception within months;
- Subjects voluntarily join the study, with good compliance, with safety and survival follow-up.
Who cannot join
- Active brain metastases or meningeal metastases with clinical symptoms. Subjects with treated brain metastases need to meet the following conditions to be tested considered into the group:
- It is confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) that the lesion is stable since the end of treatment≥4 weeks;
- No need to receive systemic corticosteroids (>10mg/day prednisone or equivalent dose) treatment;
- The third space effusion with clinical symptoms, such as pericardial effusion, pleural effusion and effusion that cannot be controlled by pumping or other treatments ascites;
- People with symptoms of cough, hemoptysis, bloody sputum within 1 month before the first medication;
- Minor surgery (including catheterization) was performed within 48 hours before the first study drug;
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- Other anti-tumor drugs are currently being used within 4 weeks after the last systemic cytotoxic drug treatment or radiotherapy drug treatment;
- Currently or recently (within 30 days before enrollment) using another investigational drug or participating in another clinical study;
- Other malignant tumors (fully treated cervical carcinoma in situ or skin squamous cell carcinoma, or controlled skin except for basal cell carcinoma);
- Have previously received PARP inhibitors or small molecule inhibitors targeting vascular endothelial cell growth factor receptor (VEGFR) agent treatment;
- Patients with hypertension who cannot be reduced to the normal range after treatment with antihypertensive drugs (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg);
- There are clinical symptoms or diseases of the heart that are not well controlled, such as: I. Heart failure above NYHA 2; II. Instability Stereotyped angina; III. Myocardial infarction occurred within 1 year; IV. clinically significant supraventricular or ventricular arrhythmia needs treatment or intervention; V QTc>470ms;
- Abnormal coagulation function (INR>1.5 or prothrombin time (PT)>ULN+4 seconds or APTT>1.5 ULN), with have a bleeding tendency or are receiving thrombolysis or anticoagulation therapy;
- Have significant clinically significant bleeding symptoms or have a clear bleeding tendency within 3 months before signing the ICF (Information Consent Form), such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood++ and above, or suffering from vasculitis;
- Arterial/venous thrombotic events, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc;
- Have the following medical history within 24 weeks before signing the ICF: peptic ulcer, gastrointestinal perforation, corrosive esophagitis or gastritis, inflammation enteropathy or diverticulitis, abdominal fistula, tracheo-esophageal fistula, or intra-abdominal abscess;
- Major surgery or severe traumatic injury, fracture or ulcer occurred within 4 weeks before treatment;
- There are factors that significantly affect the absorption of oral drugs, such as inability to swallow, chronic diarrhea, and intestinal obstruction;
- Urine routine test indicates urine protein ≥ ++, or confirmed 24-hour urine protein ≥ 1.0 g;
- The investigator judges other situations that may affect the conduct of clinical research and the judgment of research results;
- Patients with a clear history of allergies may be potentially allergic or intolerant to Apatinib and Fluzoparib;
- Human immunodeficiency virus (HIV) infection, active hepatitis B (hepatitis B surface antigen positive and HBV DNA ≥ 500 IU/ml), hepatitis C (hepatitis C antibody is positive and HCV-RNA is higher than the detection limit of the analytical method);
- According to the judgment of the investigator, there is an accompanying disease (such as poorly controlled hypertension, severe diabetes, neurological or mental illness, etc.) that seriously endangers the safety of the subject, may confuse the research results, or affects the subject to complete the study Any other situation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Second Hospital
Tianjin, Tianjin Municipality, 300211
Haitao Wang, +86-022-88326791, peterrock2000@126.com
Li Zang, +86-15202259910, 15202259910@163.com
About this study
Official title: A Single-Arm,Single-Center, Phase Ib/II Clinical Study of Fluzoparib (SHR-3162) Combined With Apatinib as Second-Line Treatment of Patients With Extensive Stage Small Cell Lung Cancer（SCLC）
This open-label, dose finding phase Ib trial studies the tolerability and the best dose of fluzoparib in combination with apatinib and to see how well these two drugs work together as second-line treatment of patients with extensive stage small cell lung cancer. The safety and efficacy of fluzoparib in combination with apatinib will be explored. Both dose escalation and dose expansion parts are included in this study.
Read the detailed description
The degree of malignancy of small cell lung cancer is extremely high. About 60% to 70% of patients are diagnosed as extensive. The median survival time of the disease is only 9 to 10 months, and the 2-year survival rate is less than 10%. Fluzoparib is an oral potent, selective poly-ADP ribose polymerase-1 (PARP-1) and PARP-2 inhibitor. Apatinib is an oral selective vascular endothelial growth factor receptor (VEGFR) inhibitor.This open-label, dose finding phase Ib trial studies the tolerability and the best dose of fluzoparib in combination with apatinib as second-line treatment of patients with extensive stage small cell lung cancer. The safety and efficacy of fluzoparib in combination with apatinib will be explored.
- Conditions
- Small Cell Lung Cancer Extensive Stage
- Being tested
- Fluzoparib, Apatinib
- Keywords
- Fluzoparib, Apatinib, Small Cell Lung Cancer
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluzoparibDrug
Also called SHR3162, HS10160
Take Fluzoparib orally（either at 50,100mg bid）until disease progression or appearance of unbearable toxicity
ApatinibDrug
Also called Apatinib mesylate
Take apatinib orally (either at 375mg、500mg、750mg qd）until disease progression or appearance of unbearable toxicity
| Study group | Role | What they receive |
|---|---|---|
| Fluzoparib + Apatinib | Experimental | Fluzoparib and apatinib will be administered continuously and orally in combination, 28 days per cycle, until disease progression or unacceptable toxicity. Receives: Drug: Fluzoparib; Drug: Apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase Ⅰb: Determination of Recommended Phase II dose (RP2D) of Escalating Dose of Fluzoparib with Apatinib
The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for the dose expansion arms, based on safety, tolerability and efficacy data collected during the dose escalation portion of the study
Measured: Up to 28 days after the first dose of Fluzoparib and Apatinib combination therapy
PhaseⅠb: Incidence of Adverse Events [safety and tolerability]
Adverse events defined according to Common Terminology for Adverse Events (CTCAE) v5.0
Measured: From screening up to 28 days after end of treatment
Phase Ⅱ: Objective Response Rate(ORR) as Assessed by the Investigator according to RECIST v1.1
Objective Response Rate(Complete response + Partial response (CR+PR)), determined using RECIST v1.1 criteria, defined as best overall response (complete or partial response) across all assessment time points.
Measured: up to approximately 2 Years
Secondary outcomes (5)
Progression Free Survival（PFS）
Progression Free Survival, defined as first assessment of disease progression or death, whichever is earlier.
Measured: Up to approximately 2 Years
Overall survival（OS）
Overall survival is the time from intervention to death due to any reason or lost of follow-up
Measured: Up to approximately 2 Years
Duration of Response（DoR）
Duration of Response, determined using RECIST v1.1 criteria.
Measured: Up to approximately 2 Years
Adverse Event Rate（AER）
Adverse events defined according to Common Terminology for Adverse Events (CTCAE) v5.0
Measured: Up to approximately 2 Years
Biomarker Detection
Evaluation of TP53 gene status through next-generation sequencing technology
Measured: Up to approximately 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start1 Jul 2020
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung Cancer Extensive StageStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Second Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Haitao Wang, Principal investigator, Tianjin Medical University Second Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04659785
- Sponsor's protocol ID
- ES-SCLC-2nd-IIT-SHR3162-APA
- Status last verified
- Dec 2020
- First submitted
- 2 Dec 2020
- Last updated
- 9 Dec 2020
- 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 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm,Single-Center, Phase Ib/II Clinical Study of Fluzoparib (SHR-3162) Combined With Apatinib as Second-Line Treatment of Patients With Extensive Stage Small Cell Lung Cancer（SCLC）
- ClinicalTrials.gov ID
- NCT04659785
- Acronym / sponsor ID
- ES-SCLC-2nd-IIT-SHR3162-APA
- Conditions
- Small Cell Lung Cancer Extensive Stage
- Keywords
- Fluzoparib, Apatinib, Small Cell Lung Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Tianjin Medical University Second HospitalUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 9 Dec 2020 (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 open-label, dose finding phase Ib trial studies the tolerability and the best dose of fluzoparib in combination with apatinib and to see how well these two drugs work together as second-line treatment of patients with extensive stage small cell lung cancer. The safety and efficacy of fluzoparib in combination with apatinib will be explored. Both dose escalation and dose expansion parts are included in this study.
Detailed description
The degree of malignancy of small cell lung cancer is extremely high. About 60% to 70% of patients are diagnosed as extensive. The median survival time of the disease is only 9 to 10 months, and the 2-year survival rate is less than 10%. Fluzoparib is an oral potent, selective poly-ADP ribose polymerase-1 (PARP-1) and PARP-2 inhibitor. Apatinib is an oral selective vascular endothelial growth factor receptor (VEGFR) inhibitor.This open-label, dose finding phase Ib trial studies the tolerability and the best dose of fluzoparib in combination with apatinib as second-line treatment of patients with extensive stage small cell lung cancer. The safety and efficacy of fluzoparib in combination with apatinib will be explored.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fluzoparib + Apatinib | Experimental | Drug: Fluzoparib, Drug: ApatinibFluzoparib and apatinib will be administered continuously and orally in combination, 28 days per cycle, until disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients with Extensive Stage Small Cell Lung Cancer diagnosed by pathology (histology or cytology) (according to WHO classification in 2015);
- Failure of first-line treatment；
- Age 18-70 years old;
- ≤21 days before the first study drug, CT or MRI scan, at least one target lesion without previous radiotherapy as defined by Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1);
- PS score: 0-2; the expected survival time ≥ 12 weeks;
Key exclusion criteria (23 listed)
- Active brain metastases or meningeal metastases with clinical symptoms. Subjects with treated brain metastases need to meet the following conditions to be tested considered into the group:
- The third space effusion with clinical symptoms, such as pericardial effusion, pleural effusion and effusion that cannot be controlled by pumping or other treatments ascites;
- People with symptoms of cough, hemoptysis, bloody sputum within 1 month before the first medication;
- Minor surgery (including catheterization) was performed within 48 hours before the first study drug;
- Other anti-tumor drugs are currently being used within 4 weeks after the last systemic cytotoxic drug treatment or radiotherapy drug treatment;
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 |
|---|---|---|
| FluzoparibAlso: SHR3162, HS10160Take Fluzoparib orally（either at 50,100mg bid）until disease progression or appearance of unbearable toxicity | Drug | Fluzoparib + Apatinib |
| ApatinibAlso: Apatinib mesylateTake apatinib orally (either at 375mg、500mg、750mg qd）until disease progression or appearance of unbearable toxicity | Drug | Fluzoparib + Apatinib |
Primary outcome
Phase Ⅰb: Determination of Recommended Phase II dose (RP2D) of Escalating Dose of Fluzoparib with Apatinib
Time frame: Up to 28 days after the first dose of Fluzoparib and Apatinib combination therapy
The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for the dose expansion arms, based on safety, tolerability and efficacy data collected during the dose escalation portion of the study
PhaseⅠb: Incidence of Adverse Events [safety and tolerability]
Time frame: From screening up to 28 days after end of treatment
Adverse events defined according to Common Terminology for Adverse Events (CTCAE) v5.0
Phase Ⅱ: Objective Response Rate(ORR) as Assessed by the Investigator according to RECIST v1.1
Time frame: up to approximately 2 Years
Objective Response Rate(Complete response + Partial response (CR+PR)), determined using RECIST v1.1 criteria, defined as best overall response (complete or partial response) across all assessment time points.
5 secondary outcomes
Progression Free Survival（PFS）
Time frame: Up to approximately 2 Years
Overall survival（OS）
Time frame: Up to approximately 2 Years
Duration of Response（DoR）
Time frame: Up to approximately 2 Years
Adverse Event Rate（AER）
Time frame: Up to approximately 2 Years
Biomarker Detection
Time frame: Up to approximately 2 Years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2020.
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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.
Haitao Wang principal investigator
Tianjin Medical University Second Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Fluzoparib and Apatinib in people with Small Cell Lung Cancer Extensive Stage, run by Tianjin Medical University Second Hospital at 1 site 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 15 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 9 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Haitao Wang, MD (+86-022-88326791, peterrock2000@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase Ⅰb: Determination of Recommended Phase II dose (RP2D) of Escalating Dose of Fluzoparib with Apatinib (time frame: Up to 28 days after the first dose of Fluzoparib and Apatinib combination therapy). The study lists 3 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 9 Dec 2020.