Concurrent Chemoradiotherapy Combination With Anlotinib for Limited-stage Small Cell Lung Cancer

NCT04882033 | Unknown Phase 1

• 1 other identifier: ALTER-L039
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the tolerability and toxicity of different dose of anlotinib combination with concurrent chemoradiotherapy in the treatment of limited-stage SCLC patients.

Conditions

Small Cell Lung Cancer Limited Stage

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerance Dose (MTD) is the dose of treatment in the cohort where there are 2 cases of DLT reported.

  Dose Limiting Toxicity (DLT) is referred to grade 3 non-hematological toxicity or grade 4 hematological toxicity according to NCI CTCAE 4.03 criteria

  From enrollment to completion of study. Estimated about 18months

Secondary Outcomes (4)

• PFS（Progress free survival）

  each 42 days up to intolerance the toxicity or PD (up to 24 months)

• OS（Overall Survival）

  From enrollment until death (up to 24 months)

• ORR（Objective Response Rate）

  each 42 days up to intolerance the toxicity or PD (up to 24 months)

• DCR（Disease Control Rate）

  each 42 days up to intolerance the toxicity or PD (up to 24 months)

Study Arms (1)

Concurrent chemoradiotherapy plus anlotinib

EXPERIMENTAL

Concurrent chemoradiotherapy plus anlotinib for 4-6 cycles This study will include a sequential evaluation of 3 subjects per dose group. Low-dose groups: anlotinib 8mg per day with concurrent chemoradiotherapy. Middle-dose groups: anlotinib 10mg per day with concurrent chemoradiotherapy. High-dose groups: anlotinib 12mg per day with concurrent chemoradiotherapy.

Drug: Concurrent chemoradiotherapy plus anlotinib

Interventions

Concurrent chemoradiotherapy plus anlotinib DRUG

Anlotinib: for cycle 1-6. P.O; QD; from days 1 to 14 in a 21-day cycle. 8mg in low-dose groups (3 subjects). 10mg in middle-dose groups (3 subjects). 12mg in high-dose groups (3 subjects). Chemotherapy: For cycle 1/4/5/6. Etoposide 100mg/m2, d1-3, q3w; Cisplatin 25mg/m2 d1-3, q3w. For cycle 2/3. Etoposide 50mg/m2, d1-3, q4w; Cisplatin 25mg/m2 d1-3, q4w. Radiotherapy: For cycle 2/3.Thoracic radiotherapy dose will be 2.0Gy per day, given 5 days a week, to cumulative dose of 60～66Gy.

Concurrent chemoradiotherapy plus anlotinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients voluntarily participate in this study, signed informed consent.
• Patients aged between 18 -75 years; According to the eighth edition of AJCC and the standard of the VALG two-stage staging method, the patient is confirmed by histology or cytology as limited-stage SCLC (stage I-III, any T, any N, M0) and cannot be operated on.
• Patients with ECOG PS Scoring: 0\~1 point
• Patients with concurrent chemoradiotherapy must comply with relevant regulations.
• PCI is given according to the judgment of the investigator.
• Patients with normal organ function, the following criteria are met: (1) blood routine examination criteria (without blood transfusion in 14 days) : a) hemoglobin (HB) ≥90g/L; b) absolute neutrophil count (ANC) ≥1.5×10e9/L; c) platelet (PLT) ≥80×10e9/L; (2) biochemical tests meet the following criteria: a) total bilirubin (TBIL) ≤1.5 times of upper limit of normal (ULN); b) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 ULN, if liver metastasis occurred, ALT and AST ≤5 ULN; c) serum creatinine (Cr) ≤1.5 ULN or creatinine clearance (CCr) ≥60mL/min.
• For women of child-bearing age, the pregnancy test results (serum or urine) within 1 week before enrolment must be negative. They will take appropriate methods for contraception during the study until the 6 months post the last administration of study drug. For men (previous surgical sterilization accepted), will take appropriate methods for contraception during the study until the 6 months post the last administration of study drug.

You may not qualify if:

• Small cell and non-small cell mixed lung cancer
• Extensive stage small cell lung cancer
• Central lung tumors that imaging shows tumor lesions invade local large blood vessels; or with significant pulmonary cavum or necrotizing
• Less than 4 weeks from the last clinical trial or participating in other clinical studies.
• History:
• \) Brain metastasis or spinal cord compression 2) Other active malignancies that require simultaneous treatment. 3) History of immunodeficiency, including HIV-positive or other acquired, congenital immunodeficiency disease, or history of organ transplantation.
• \) History of mental drug abuse and cannot be cured or have mental disorders 6. Patients with any severe and/or uncontrolled disease, including:
• blood pressure control is not ideal (systolic blood pressure ≥ 150 mmHg, diastolic blood pressure ≥ 100 mmHg);
• Significant cardiac disease as defined as: grade I or greater myocardial infarction, unstable arrhythmia (including corrected QT interval (QTc ) period between male or greater 450 ms, female or greater 470 ms); New York Heart Association (NYHA) grade II or greater heart dysfunction , or Echocardiography reveal left ventricular ejection fraction (LVEF) less than 50%
• Decompensated diabetes or other remedies for high-dose glucocorticoid therapy.
• Exacerbation of chronic obstructive pulmonary disease (COPD) or other serious respiratory diseases that require hospitalization
• Active or uncontrollable serious infection (≥CTC AE Level 2 infection);
• Uncontrolled pleural effusion, pericardial effusion and abdominal effusion requiring repeated drainage.
• Urine routine test protein≥++, and confirmed 24 hours urine protein\>1.0 g; 7. Imaging shows that the tumor has been violated around important vascular or the researchers determine the tumor is likely to invade important blood vessels caused by fatal bleeding during the follow-up.
• \. Patients who received a major surgical treatment or severe trauma, the effects of surgery or trauma have been eliminated in less than 2 weeks before being enrolled 9. Patients with clinically significant hemoptysis occurred within 3 months prior to enrollment (greater than 1/2 teaspoon of bright red blood). History of clinically relevant major bleeding event (e.g. gastrointestinal hemorrhage, hemorrhagic acne, bleeding gastric ulcer, occult blood test ≥ ++, or vasculitis, etc.) 10. Patients who have arterial/venous thromboembolism events within 6 months before being enrolled, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

MeSH Terms

Interventions

Chemoradiotherapy; anlotinib

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Central Study Contacts

Xiyan Nan, Doctor

CONTACT

+86 18811796429; 18811796429@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2021
• First Posted: May 11, 2021
• Study Start: May 7, 2021
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2023
• Last Updated: May 11, 2021

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available within 6 months of study completion
• Access Criteria: Data access requests will be reviewed by an external indepentent Review Panel. Requesdtors will be required to sign a Data Access Agreement.

Locations

CN (1)