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Anlotinib Plus Immune Checkpoint Inhibitors for Lung Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE2/PHASE3

Anlotinib Plus Immune Checkpoint Inhibitors for Lung Cancer

Anlotinib With or Without Immune Checkpoint Inhibitors in Standard Chemo-immunotherapy Failed Advanced Non-small Cell Lung Cancer

NCT04322617•Hunan Province Tumor Hospital

View on ClinicalTrials.gov

Summary

This study aims to explore the efficacy of Anlotinib with or without Immune Checkpoint Inhibitor in Standard Chemo-immunotherapy Failed Advanced NSCLC.

Detailed Description

This study aims to explore the efficacy of Anlotinib with or without Immune Checkpoint Inhibitor in Standard Chemo-immunotherapy Failed Advanced NSCLC. The primary endpoint was PFS.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form.
•2. Age ≥ 18 years.
•3. Histopathology or cytology confirmed lung cancer
•4. Failed from first line Chemo-immunotherapy.
•5. ECOG 0-1.
•6. Predicted survival ≥ 12 weeks.
•7. Adequate bone marrow hematopoiesis and organ function
•8. Presence of measurable lesions according to RECIST 1.1.
•9. Subjects with stable brain metastases may be included in the study.

Exclusion Criteria

•1. Subjects who have received any of the following treatments must be excluded:
•* Treatment with molecules such as EGFR, VEGFR antibodies within 4 weeks prior to the first dose of study drug.
•* Have received radiation within 14 days prior to the first dose or have not recovered from radiation-related toxicity. Chest and extra-brain palliative radiotherapy, stereotactic radiosurgery, and stereotactic body radiotherapy may be performed 7 days prior to the first dose.
•* Ongoing (or inability to discontinue) possibly potent CYP1A2, CYP3A inhibitor (1 week), or inducer (2 weeks) drug therapy or herbal supplements within 1-2 weeks prior to the first dose.
•2. Presence of spinal cord compression or meningeal metastasis.
•3. History of other malignant tumors within 2 years.
•4. Adverse events (except alopecia of any degree) of CTCAE \> grade 1 due to prior treatment (e.g., adjuvant chemotherapy, radiotherapy, etc.) prior to the first dose.
•5. History of stroke or intracranial hemorrhage within 6 months prior to the first dose.
•6. The presence of any severe or poorly controlled systemic disease, including poorly controlled hypertension and active bleeding in the judgment of the investigator.
•7. Subjects with persistent or active infection, including but not limited to hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV) and COVID-19 infection.
+7 more criteria

Locations (1)

Yongchang Zhang

Changsha, Hunan, China

Key Dates

Start Date

March 24, 2020

Primary Completion Date

March 24, 2028

Completion Date

March 24, 2029

Last Updated

June 4, 2024

Enrollment

1,200

ESTIMATED participants

Conditions

Non-small Cell Lung Cancer

Interventions

Anlotinib plus the same Immune Checkpoint Inhibitors.

DRUG

Anlotinib plus the new Immune Checkpoint Inhibitors.

DRUG

Anlotinib

DRUG

Contacts

Yongchang Zhang, MD

CONTACT

+8613873123436 zhangyongchang@csu.edu.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 4, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Anlotinib Plus Immune Checkpoint Inhibitors for Lung Cancer

Inclusion Criteria

Exclusion Criteria

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