Anlotinib Plus Platinum-etoposide in First-line of Extensive-stage Small-cell Lung Cancer

NCT04675697 | Unknown Phase 2

• 1 other identifier: 2019010023
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Anlotinib is a novel multi-target tyrosine kinase inhibitor (TKI) for tumor angiogenesis and tumor cell proliferation. The efficacy of Anlotinib as a third-line or beyond therapy for SCLC was confirmed in the ALTER1202 trial. The aim of this trial was to investigate the prognostic value of Anlotinib plus platinum-etoposide in first-line treatment of extensive-stage SCLC patients.

Conditions

Extensive-stage Small-cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• PFS

  progression-free survival

  up to 1 year

• ORR

  objective response rate (ORR, CR+PR)

  up to 1 year

Secondary Outcomes (3)

• OS

  From randomization until death (up to 15 months)

• DCR

  At the end of every 2 cycles (each cycle is 21 days)，through treatment，up to 1 year

• DoR

  At the end of every 2 cycles (each cycle is 21 days)，through treatment，up to 1 year

Study Arms (1)

Anlotinib+EP

EXPERIMENTAL

Drug: Platinum-etoposide+Anlotinib

Interventions

Platinum-etoposide+Anlotinib DRUG

Platinum-etoposide regiment consisted of etoposide 100mg/m2, d1\~3 of 21-day cycle, with investigators' choice of either cisplatin (75-80mg/m2, Q3W) or carboplatin (AUC=5\~6, Q3W). Anlotinib treated of 12mg Qd from day 1 to 14 of a 21-day cycle. Eligible patients received anlotinib plus platinum-etoposide for 4\~6 cycles, and followed by maintenance therapy with Anlotinib. The efficacy was evaluated every 6 weeks (2 cycles) through treatment.

Anlotinib+EP

Eligibility Criteria

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

You may qualify if:

• Aged 18 to 70 years old;
• Rated as grade 0 to 2 in ECOG whole-body status (PS), or grade 3 to 4 if induced by SCLC;
• Of the expected survival no less than 3 months;
• With extensive-stage SLCL diagnosed pathologically (according to the VALG staging standard introduced by the Veterans Administration Lung Study Group), and having a measurable lesion (a tumor lesion of ≥ 10mm in long diameter in CT scanning, or a lymph node lesion of ≥ 15mm in short diameter in CT scanning, which had not received radiotherapy, cryotherapy or other local therapies, according to the RECIST1.1 standard);
• Having not received chemotherapy or immunotherapy;
• Patients included should also have normal major organ functions, that is, their organs should meet the following criteria:
• Blood routine examination criteria: ANC ≥ 1.5 × 109/L, PLT ≥ 100 × 109/L and Hb≥100g/L (no blood transfusion or blood products in 14 days, and no G-CSF or other hematopoietic stimulant corrections).
• Biochemical examination criteria: TBIL \< 1.5 × ULN, ALT, AST and ALP \< 2.5 × ULN, BUN and Cr ≤ 1 × ULN, or endogenous creatinine clearance rate ≥ 50ml/min.
• Subjects should voluntarily participate in the study, sign the Informed Consent, and be well compliant and cooperative in follow-up visits.

You may not qualify if:

• Having mixed small cell carcinoma and non-small cell carcinoma;
• Having active central nervous system (CNS) metastases and/or cancerous meningitis or found to have active central nervous system (CNS) metastases and/or cancerous meningitis in examinations during the screening stage. Patients can be included in the study as long as they: (1) Have asymptomatic brain metastases (without progressive central nervous system symptoms induced by brain metastases, requiring no corticosteroids, and having the lesion size ≤ 1.5cm), provided that they should undergo regular brain imaging examinations for the diseased site; (2) Have been treated and are in stable status, have no imaging evidence for new or enlarged brain metastases at least 2 weeks after brain metastasis treatment, and have discontinued steroids or anticonvulsants at least 14 days before the therapy of the study starts.
• Patients whose imaging findings showed invaded central great vessels or obvious pulmonary cavity or necrotizing tumor should be excluded.
• Patients with hypertension who are taking two or more antihypertensive drugs should be excluded.
• Patients having the following should be excluded: Cardiovascular diseases: Myocardial ischemia or myocardial infarction or grade II or above, uncontrolled arrhythmias, new functions of grade III to IV, or cardiac ejection fraction \< 50%;
• Abnormal coagulation function (INR \> 1.5 or prothrombin time (PT) \> ULN+4 seconds, or APTT \> 1.5ULN), prone to bleeding or receiving thrombolytic or anticoagulant therapy;
• With known hereditary or acquired bleeding and thrombosis tendency;
• Having a wound or fracture that has cannot be healed for a long time;
• Subject to factors that significantly affect the absorption of oral medication;
• Having the urine routine result suggest urine protein ≥++, or confirmed the 24-hour urine protein amount ≥ 1.0g;
• With serous membrane effusion that is with clinical symptoms and requires symptomatic treatment;
• With active infections that require antimicrobial treatment;
• Having a history of psychotropic drug abuse and unable to quit or with a mental disorder;
• Previously or currently having other incurable malignancies;
• Pregnant or lactating women who are fertile but are unwilling or unable to take effective contraception measures should be excluded.

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead
• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: collaborator

Study Sites (1)

Xiangya Hospital Central South University

Changsha, Hunan, 410000, China

RECRUITING

Related Publications (1)

• Deng P, Hu C, Chen C, Cao L, Gu Q, An J, Qin L, Li M, He B, Jiang J, Yang H. Anlotinib plus platinum-etoposide as a first-line treatment for extensive-stage small cell lung cancer: A single-arm trial. Cancer Med. 2022 Oct;11(19):3563-3571. doi: 10.1002/cam4.4736. Epub 2022 May 8.

  PMID: 35526266 DERIVED

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Huaping S Yang, M.D

  Xiangya Hospital of Central South University

  STUDY DIRECTOR

Central Study Contacts

Huaping S Yang, M.D

CONTACT

+8613973129956; lyhuaping@aliyun.com

Pengbo Deng, M.D

CONTACT

+8613574888840; 12859155@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: December 2, 2020
• First Posted: December 19, 2020
• Study Start: January 24, 2019
• Primary Completion: December 31, 2020
• Study Completion: January 31, 2021
• Last Updated: December 19, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (1)