Anlotinib Plus Immune Checkpoint Inhibitors for Lung Cancer

NCT ID: NCT04322617

Last Updated: 2024-06-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 1200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-24
• Study Completion Date: 2029-03-24

Brief 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.

Conditions

Non-small Cell Lung Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort A: Anlotinib with the same Immune Checkpoint Inhibitors.

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

Group Type: EXPERIMENTAL

Anlotinib plus the same Immune Checkpoint Inhibitors.

Intervention Type: DRUG

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

Cohort B: Anlotinib with the new Immune Checkpoint Inhibitors.

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

Group Type: EXPERIMENTAL

Anlotinib plus the new Immune Checkpoint Inhibitors.

Intervention Type: DRUG

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

Cohort C: Anlotinib Monotherapy.

Anlotinib Monotherapy.

Group Type: EXPERIMENTAL

Anlotinib

Intervention Type: DRUG

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

Interventions

Anlotinib plus the same Immune Checkpoint Inhibitors.

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

Intervention Type: DRUG

Anlotinib plus the new Immune Checkpoint Inhibitors.

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

Intervention Type: DRUG

Anlotinib

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

Intervention Type: DRUG

Other Intervention Names

Pembrolizumab, Sintilimab etc. have been used in the previous treatment.; Pembrolizumab, Sintilimab etc. have not been used in the previous treatment.; Anlotinib monotherapy.

Eligibility Criteria

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.

8. Heart-related diseases or abnormalities

9. 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.

10. Refractory nausea and vomiting, chronic gastrointestinal disease, difficulty swallowing drugs, or inability to adequately absorb sunvozertinib or anlotinib due to previous bowel resection.

11. Live vaccine was given 2 weeks before the first medication.

12. Women who are breastfeeding or pregnant.

13. Hypersensitivity to the test drug and the ingredients.

14. Other conditions assessed by the investigator to be unsuitable for participation in the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hunan Province Tumor Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yongchang Zhang

Professor, Director of Clinical Trial Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yongchang Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

Hunan Cancer Hospital

Locations

Yongchang Zhang

Changsha, Hunan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yongchang Zhang, MD

Role: CONTACT

zhangyongchang@csu.edu.cn

+8613873123436 ext. +861383123436

Facility Contacts

Yongchang Zhang, MD

Role: primary

zhangyongchang@csu.edu.cn

+8613873123436 ext. +8613873123436

Other Identifiers

20200113

Identifier Type: -

Identifier Source: org_study_id