Study of Apatinib as Third-line and Later Therapy in Patients With Small Cell Lung Cancer (SCLC)

NCT ID: NCT02995187

Last Updated: 2017-09-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2018-09-30

Brief Summary

This is a Single-center, Open-label, Single-arm,Non-randomized exploratory clinical trial evaluating the efficacy and safety of Apatinib for third-line and later treatment of patients with small cell lung cancer.

Detailed Description

Although fist-line therapy with Cisplatin and etoposide(EP)or Carboplatin and etoposide(CE)and second-line therapy with topotecan has been given, patients with extensive small cell lung cancer(ED-SCLC) still relapse and 2-year survival is less than 10%. There is no standard treatment recommendation for this group of patients who failed to second-line therapy and had good performance status. Apatinib has been approved as a second-line treatment for advanced gastric cancer. Several phase III clinical studies of non small cell lung cancer, liver cancer, colorectal cancer and other tumors also showed apatinib has less toxic side effects and better patient tolerance. However, the clinical application of apatinib in small cell lung cancer is still lack of evidence-based medicine. And this clinical trial is designed to prospectively investigate the efficacy and safety of apatinib in recurrent SCLC patients in our center.

Conditions

Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Apatinib Mesylate tablet

Patients received oral apatinib 500 mg in tablet once daily, a treatment cycle was defined as 28 days (4 weeks).

Group Type: EXPERIMENTAL

Apatinib Mesylate tablet

Intervention Type: DRUG

Apatinib 500 mg in tablet once daily

Interventions

Apatinib Mesylate tablet

Apatinib 500 mg in tablet once daily

Intervention Type: DRUG

Other Intervention Names

Apatinib

Eligibility Criteria

Inclusion Criteria

1. 18 years to 75 years;

2. Had a histologically or cytologically confirmed diagnosis of SCLC;

3. Had received at least 2 lines chemotherapy regimen and must include basis of the platinum regimen after which disease diagnosed;

4. Have not received VEGFR-TKI;

5. Had a life expectancy of at least 3 months;

6. Had an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2;

7. Had a disease status that was measurable or evaluable as defined by Response Evaluation Criteria in Solid Tumors (RECIST, version1.1), larger than 10 mm in diameter by spiral CT scan;

8. Adequate hepatic, renal, heart, and hematologic functions (hemoglobin ≥90g/L, platelets ≥ 80×10^9/L, neutrophils ≥ 1.5×10^9/L, total bilirubin within 1.5×the upper limit of normal(ULN), and b) ALT and AST≤2.5×the ULN (If liver metastases, serum transaminase≤5×the ULN), serum creatine ≤ 1.25 x ULN, creatinine clearance rate > 45ml/min;

9. For women of child-bearing age, the pregnancy test results (serum or urine) within 7 days before enrolment must be negative. They will take appropriate methods for contraception during the study until the 8th week post the last administration of study drug. For men (previous surgical sterilization accepted), will take appropriate methods for contraception during the study until the 8th week post the last administration of study drug;

10. Signed and dated informed consent.Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.

Exclusion Criteria

1. Patients with non-small cell lung cancer;

2. Imaging (CT or MRI) results indicate that the existence of central tumors locally invading the large vessel could be detected, or apparent pulmonary cavity or necrotizing tumors;

3. Patients with clinical symptoms of brain metastases or meningeal metastasis;

4. Patients with poor-controlled arterial hypertension (systolic pressure ≥ 140 mmHg and/or diastolic pressure ≥ 90 mm Hg) despite standard medical management;

5. Suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias (including QT interval male ≥ 450 ms, female ≥ 470 ms). Grade III-IV cardiac insufficiency according to New York Heart Association (NYHA) criteria or echocardiography check: left ventricular ejection fraction (LVEF)<50%;

6. Coagulant function abnormality (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT ULN > 1.5), with bleeding tendency or is treated with thrombolysis and anticoagulation;

7. Patients whose routine urine tests indicate that urine protein ≥ ++ or verifies that the 24-h urine protein quantitation ≥ 1.0 g;

8. Patients who received major surgical operations or experienced severe traumatic injuries, bone fracture, or ulcers within 4 weeks before screening;

9. Patients who had obvious hemoptysis within 2 months before screening, or experienced daily hemoptysis with a volume more than half a tea spoon (2.5ml) or above; Patients who experienced bleeding symptoms of clinical significance , or with confirmed bleeding tendency such as hemorrhage of digestive tract, hemorrhagic gastric ulcer, baseline occult blood in stool ++ and above, or vasculitis, etc;

10. Patients who manifested arterial/venous thrombus events, e.g.cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism, etc., within 12 months before screening;

11. Allergic to any ingredients of Apatinib;

12. Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Yutao Liu

Associate Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yutao Liu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Locations

Chinese Academy of Medical Sciences

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Yutao Liu, M.D.

Role: CONTACT

13911901165@139.com

+8613911901165

Facility Contacts

Yutao Liu, MD

Role: primary

13911901165@139.com

References

Liu Y, Hu X, Jiang J, Yang L, Zhou S, Liu P, Li J, Wang Y, Hao X, Shi Y. A Prospective Study of Apatinib in Patients with Extensive-Stage Small Cell Lung Cancer After Failure of Two or More Lines of Chemotherapy. Oncologist. 2020 May;25(5):e833-e842. doi: 10.1634/theoncologist.2019-0391. Epub 2020 Apr 6.

Reference Type: DERIVED

PMID: 32250517 (View on PubMed)

Other Identifiers

CH-L-061

Identifier Type: -

Identifier Source: org_study_id