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NSCLC SCLCAnlotinib's Efficacy and Safety in Later-Line Treatment of Driver Gene-Negative Advanced Metastatic Non-Small Cell Lung Cancer and Extensive-Stage Small Cell Lung Cancer

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Study Aim

This study aims to observe the safety and effectiveness of Anlotinib as a later-line treatment for advanced metastatic non-small cell lung cancer and extensive-stage small cell lung cancer in individuals without driver gene mutations, focusing on progression-free survival.

What is being collected

Data Collection

Collected from past medical records and data - Retrospective
Who is being recruted

Bronchial Neoplasms+7

+ Carcinoma, Bronchogenic

+ Carcinoma, Non-Small-Cell Lung

Over 18 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: February 2026
See protocol details

Summary

Principal SponsorHenan Cancer Hospital
Study ContactQiming Wang
Last updated: February 11, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2026

Actual date on which the first participant was enrolled.

This study focuses on understanding the benefits of a drug called anlotinib for patients with advanced stages of non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) that have not responded to previous treatments. Anlotinib is a multi-targeted anti-angiogenic tyrosine kinase inhibitor, which means it works by blocking the growth of new blood vessels that cancer cells need to grow and multiply. It has shown promise in treating advanced soft tissue sarcoma and is approved in China for second-line or later treatment. However, there is limited information on its effectiveness in treating NSCLC and SCLC after the disease has progressed following initial treatment. This study aims to fill this gap and potentially improve care for these patients. The study is retrospective and observational, meaning it looks back at data from patients who have already received anlotinib treatment. It seeks to evaluate the efficacy and safety of anlotinib, either as a standalone treatment or in combination with other therapies, in later-line treatment of NSCLC and SCLC. The primary outcome measured is Progression-Free Survival (PFS), which is the length of time during and after the treatment that a patient lives with the disease but it does not get worse.

Official TitleMulticenter, Retrospective, Real World Study of Anlotinib in Cross-line Treatment of NSCLC and SCLC
Principal SponsorHenan Cancer Hospital
Study ContactQiming Wang
Last updated: February 11, 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

350 patients to be enrolled

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

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

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.

Over 18 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, BronchogenicCarcinoma, Non-Small-Cell LungLung DiseasesLung NeoplasmsNeoplasmsNeoplasms by SiteRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic Neoplasms

Criteria

3 inclusion criteria required to participate
Patients must be diagnosed with advanced metastatic non-small cell lung cancer (including squamous cell carcinoma, adenocarcinoma, etc.) or extensive-stage small cell lung cancer during the period from October 1, 2018 to April 30, 2025.

Patients clinically documented as having driver gene-negative advanced metastatic non-small cell lung cancer or extensive-stage small cell lung cancer, who were treated with anlotinib during the treatment period and continued using anlotinib after disease progression (with at least 4 months of continuous medication records in the medical records), or other immune or chemotherapy drugs.

Patients who underwent at least one imaging examination within 90 days before reapplication of anlotinib or other immune or chemotherapy drugs after progression during anlotinib treatment, and subsequently had at least two imaging examinations.

5 exclusion criteria prevent from participating
Patients who received other TKI-class anti-angiogenic drugs (including but not limited to bevacizumab, recombinant human endostatin, pazopanib, regorafenib, cabozantinib, sunitinib, sorafenib, apatinib, axitinib, lenvatinib, fruquintinib, vandetanib, cediranib, nintedanib, pralsetinib, selpercatinib, alectinib, ponatinib) before the first application of anlotinib treatment.

Patients who received other anti-angiogenic drugs (including but not limited to bevacizumab, recombinant human endostatin, pazopanib, regorafenib, cabozantinib, sunitinib, sorafenib, apatinib, axitinib, lenvatinib, fruquintinib, vandetanib, cediranib, nintedanib, pralsetinib, selpercatinib, alectinib, ponatinib) after progression.

Patients who underwent surgical treatment during anlotinib therapy.

Patients with driver gene positivity.

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Study Plan

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

Study Objectives

Primary 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.
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