Anlotinib Plus Immune Checkpoint Inhibitors for Lung Cancer (ATHENA)

Hunan Province Tumor Hospital

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: Anlotinib plus the new Immune Checkpoint Inhibitors.; Drug: Anlotinib plus the same Immune Checkpoint Inhibitors.; Drug: Anlotinib

Study type: Interventional

Funder types: Other

Identifiers

NCT04322617

20200113

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,200 participants in 3 patient groups

Cohort A: Anlotinib with the same Immune Checkpoint Inhibitors.

Experimental group

Description:

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

Treatment:

Drug: Anlotinib plus the same Immune Checkpoint Inhibitors.

Cohort B: Anlotinib with the new Immune Checkpoint Inhibitors.

Experimental group

Description:

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

Treatment:

Drug: Anlotinib plus the new Immune Checkpoint Inhibitors.

Cohort C: Anlotinib Monotherapy.

Experimental group

Description:

Anlotinib Monotherapy.

Treatment:

Drug: Anlotinib