Suspended

Anlotinib and Platinum-etoposide Treatment for Extensive-stage Small-cell Lung Cancer

What is being tested

Platinum-etoposide+Anlotinib

Drug

Who is being recruted

Bronchial Neoplasms+7

+ Carcinoma, Bronchogenic

+ Lung Diseases

From 18 to 70 Years

+32 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2

Interventional

Study Start: January 2019

See protocol details

Summary

Principal SponsorXiangya Hospital of Central South University

Study ContactHuaping S Yang, M.DMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: January 24, 2019

Actual date on which the first participant was enrolled.

This clinical trial is about testing the safety and effectiveness of a combination treatment for extensive-stage small-cell lung cancer. The treatment combines Anlotinib with Platinum-etoposide, and is given to patients who have not received any prior systematic chemotherapy or immunity checkpoint inhibitors therapy. The trial is specifically for adults aged 18-70 years with a confirmed diagnosis of extensive-stage small-cell lung cancer, who have not received previous systemic treatment for their condition and have an expected survival time of at least 3 months. The goal of this study is to find a new treatment option that could potentially improve the care and outcomes for patients with this type of lung cancer. During the trial, participants receive the combination treatment according to a specific schedule. The study measures the results by looking at two main outcomes: the objective response rate (ORR) and progression-free survival (PFS). The objective response rate refers to the proportion of patients who show a significant reduction in tumor size, while progression-free survival measures the length of time during and after the treatment that a patient lives with the disease but it does not get worse.

Official TitleAnlotinib Plus Platinum-etoposide in First-line Treatment of Extensive-stage Small-cell Lung Cancer: a Single-arm Phase II Trial

NCT04675697

Principal SponsorXiangya Hospital of Central South University

Study ContactHuaping S Yang, M.DMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

36 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchial NeoplasmsCarcinoma, BronchogenicLung DiseasesLung NeoplasmsNeoplasmsNeoplasms by SiteRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsSmall Cell Lung Carcinoma

Criteria

9 inclusion criteria required to participate

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)

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23 exclusion criteria prevent from participating

Having participated in other clinical trials on anti-tumor drugs 4 weeks before the inclusion

Previously or currently having other incurable malignancies

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

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Xiangya Hospital Central South University

Changsha, ChinaOpen Xiangya Hospital Central South University in Google Maps

SuspendedOne Study Center