Anlotinib Plus Immune Checkpoint Inhibitors for Lung Cancer

NCT04322617 | Recruiting Phase 2

• 1 other identifier: 20200113
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Non-small Cell Lung Cancer

Keywords

Anlotinib, Immune Checkpoint Inhibitor, NSCLC

Outcome Measures

Primary Outcomes (1)

• Progression free survival time (PFS)

  Progression free survival time define as first dose to first documented disease progression assessed by investigator or death due to any cause.

  Time from first subject dose to study completion, or up to 36 month.

Secondary Outcomes (2)

• Objective Response Rate (ORR)

  Time from first subject dose to study completion, or up to 36 month.

• Overall survival (OS)

  Time from first subject dose to study completion, or up to 36 month.

Study Arms (3)

Cohort A: Anlotinib with the same Immune Checkpoint Inhibitors.

EXPERIMENTAL

Anlotinib plus Immune Checkpoint Inhibitors which has been used in first line treatment.

Drug: Anlotinib plus the same Immune Checkpoint Inhibitors.

Cohort B: Anlotinib with the new Immune Checkpoint Inhibitors.

EXPERIMENTAL

Anlotinib plus Immune Checkpoint Inhibitors which has not been used in first line treatment.

Drug: Anlotinib plus the new Immune Checkpoint Inhibitors.

Cohort C: Anlotinib Monotherapy.

EXPERIMENTAL

Anlotinib Monotherapy.

Drug: Anlotinib

Interventions

Anlotinib plus the same Immune Checkpoint Inhibitors. DRUG

Anlotinib, 8mg po qd, D1-D14 every 21days.

Also known as: Pembrolizumab, Sintilimab etc. have been used in the previous treatment.

Cohort A: Anlotinib with the same Immune Checkpoint Inhibitors.

Anlotinib plus the new Immune Checkpoint Inhibitors. DRUG

Anlotinib, 8mg po qd, D1-D14 every 21days.

Also known as: Pembrolizumab, Sintilimab etc. have not been used in the previous treatment.

Cohort B: Anlotinib with the new Immune Checkpoint Inhibitors.

Anlotinib DRUG

Anlotinib, 8mg po qd, D1-D14 every 21days.

Also known as: Anlotinib monotherapy.

Cohort C: Anlotinib Monotherapy.

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.
• Presence of spinal cord compression or meningeal metastasis.
• History of other malignant tumors within 2 years.
• 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.
• History of stroke or intracranial hemorrhage within 6 months prior to the first dose.
• The presence of any severe or poorly controlled systemic disease, including poorly controlled hypertension and active bleeding in the judgment of the investigator.
• 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.
• Heart-related diseases or abnormalities
• Past history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy or interstitial lung disease with active clinical symptoms, immune pneumonia caused by immunotherapy.
• Refractory nausea and vomiting, chronic gastrointestinal disease, difficulty swallowing drugs, or inability to adequately absorb sunvozertinib or anlotinib due to previous bowel resection.
• Live vaccine was given 2 weeks before the first medication.
• Women who are breastfeeding or pregnant.

Sponsors & Collaborators

• Hunan Province Tumor Hospital: lead

Study Sites (1)

Yongchang Zhang

Changsha, Hunan, 410013, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

anlotinib; pembrolizumab

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

• Yongchang Zhang, MD

  Hunan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yongchang Zhang, MD

CONTACT

+8613873123436; zhangyongchang@csu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Director of Clinical Trial Center

Study Record Dates

• First Submitted: March 24, 2020
• First Posted: March 26, 2020
• Study Start: March 24, 2020
• Primary Completion (Estimated): March 24, 2028
• Study Completion (Estimated): March 24, 2029
• Last Updated: June 4, 2024

Record last verified: 2024-06

Locations

CN (1)