A Study of Sequential Anlotinib Followed by EP Regimen Plus Concurrent Radiotherapy for Unresectable Stage III Non-small Cell Lung Cancer

NCT04111913 | Unknown Phase 2

• 1 other identifier: ALTER-L028
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Anlotibib (AL3818) is a kind of innovative medicines approved by State Food and Drug Administration（SFDA:2011L00661） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd. Anlotinib is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR2、VEGFR3、PDGFRβ and c-Kit. It has the obvious resistance to new angiogenesis. The trial is to evaluate the efficacy and safety of sequential anlotinib followed by EP regimen plus concurrent radiotherapy for unresectable stage III non-small cell lung cancer(NSCLC).

Conditions

Unresectable Stage III Non-small Cell Lung Cancer

Keywords

anlotinib

Outcome Measures

Primary Outcomes (1)

• Progress-free survival (PFS)

  Progression-Free Survival (PFS) as Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1)

  Approximately 12 months.

Secondary Outcomes (4)

• The recurrence rate in 12-month

  12 months.

• The recurrence rate in 24-month

  12 months.

• The disease control rate in 6-month

  6 months.

• The disease control rate in 12-month

  12 months.

Study Arms (1)

anlotinib and chemoradiotherapy

EXPERIMENTAL

anlotinib: 12 mg, po, qd, on day1-14 of a 21 days cycle; anlotinib will be administrated to 2 cycles for induction before the 2 cycles of chemoradiation and anlotinib will be administrated up to 1year or disease progression for maintenance treatment. EP regimen: cisplatin 50mg/m2, d1, 8, 29, 36; etoposide 50mg/m2, d1\~5, d29\~33. Radiotherapy program: 2 Gy / time / d, 5 d / week;PTV radiotherapy 60\~66Gy/30\~33 times/6\~7 weeks.

Drug: Anlotinib Hydrochloride

Interventions

Anlotinib Hydrochloride DRUG

anlotinib once daily on days 1-14 of 21days cycle.

anlotinib and chemoradiotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated informed consent. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.
• ≥ 18 and ≤ 70 years of age within male and female.
• Histologically confirmed，locally advanced NSCLC of stage IIIA/IIIB.
• Unresectable stage IIIA and stage IIIB with pathological evidence of the following images or lymph nodes:
• Multiple metastases of the mediastinal lymph nodes are transferred into a massive mass or multiple sites (IIIA: T1-3N2 or IIIB: T4N2)
• Contralateral hilar, mediastinal lymph nodes, or the same, contralateral scalene or supraclavicular lymph node metastasis (IIIB: T1-4N3)
• The lesion invades the heart, aorta and esophagus (IIIB: T4N0-1)
• Life expectancy of more than 3 months.
• Eastern Cooperative Oncology Group(ECOG)performance scale 0-1.
• Weight loss ≤5% in the last 3 months since enrollment.
• Good lung function (predicted FEV1 ≥1 liter), no history of bronchial pneumonia, tracheobronchial disease and upper respiratory tract bleeding.
• None previous chemotherapy or targeted therapy.
• Adequate hepatic, renal, heart, and hematologic functions (Absolute Neutrophil Count(ANC) ≥ 1.5×109/L, Platelet (PLT) ≥ 100×109/L, Hemoglobin(HB) ≥ 90 g/L, total bilirubin within 1.5×the upper limit of normal(ULN), and serum transaminase≤2.5×the Upper Limit Of Normal(ULN), serum creatine ≤ 1.25 x Upper Limit Of Normal(ULN), creatinine clearance rate ≥ 45ml/min.
• 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.

You may not qualify if:

• small cell lung cancer (including small cell and non-small cell mixed lung cancer).
• Radiologically documented evidence of tumor lesions from large vessels ≤ 5mm or major blood vessel invasion or encasement by cancer; Obvious cavity or necrosis formed in the tumor.
• History and complication:
• Less than 4 weeks from the last clinical trial or participating in other clinical studies.
• Other active malignancies that require simultaneous treatment.
• History of malignancy except cured basal cell skin cancer, or carcinoma in situ of the cervix, or superficial bladder cancer.
• Patients with previous anti-tumor treatment-related adverse reactions (excluding hair loss) did not return to NCI-CTCAE ≤ 1 level.
• Coagulation disfunction（INR\>1.5 or PT\>Upper Limit Of Normal(ULN)+4s or Activated Partial Thromboplastin Time (APTT) \>1.5 Upper Limit Of Normal(ULN)）, hemorrhagic tendency or receiving the therapy of thrombolysis or anticoagulation.
• Renal insufficiency. Urine protein≥++, and 24h urine protein quantitation≥1.0g.
• Patients had major surgery or severe trauma before enrollment. The effects of surgery or trauma have been eliminated for less than 14 days.
• Severe acute or chronic infection requiring systemic treatment.
• Patients who 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%.
• Peripheral neuropathy with ≥CTCAE 2 degrees currently present, except for trauma.
• Respiratory syndrome (≥CTC AE grade 2 dyspnea).
• Symptomatic serous effusion requiring treatment .(including hydrothorax, ascites, hydropericardium)

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead
• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: collaborator

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

RECRUITING

Central Study Contacts

Dehua Wu

CONTACT

020-61642136; 331576705@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2019
• First Posted: October 1, 2019
• Study Start: October 1, 2019
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2022
• Last Updated: October 1, 2019

Record last verified: 2019-08

Locations

CN (1)