Combining Anlotinib with Immune Checkpoint Inhibitors for Lung Cancer Treatment

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

This study is testing whether combining a drug called Anlotinib with immune treatments can help people with advanced lung cancer who haven't responded to other therapies live longer without their cancer getting worse.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 1200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hunan Province Tumor Hospital (Academic / other)
• Drugs / interventions: sunvozertinib, anlotinib, chemotherapy, immunotherapy, radiation
• Locations: 1 site (Changsha, Hunan)
• Trial ID: NCT04322617 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of Anlotinib, both alone and in combination with Immune Checkpoint Inhibitors, in patients with advanced Non-small Cell Lung Cancer (NSCLC) who have not responded to standard chemo-immunotherapy. The primary goal is to evaluate progression-free survival (PFS) among participants. Eligible patients will be those aged 18 and older with confirmed lung cancer who have experienced treatment failure from first-line therapies. The study will assess various combinations of Anlotinib and immune therapies to determine the most effective approach.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with confirmed advanced NSCLC who have failed first-line chemo-immunotherapy.

Not a fit: Patients who have recently received certain targeted therapies or radiation treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new option for patients with advanced NSCLC who have limited treatment alternatives.

How similar studies have performed: Other studies have shown promise in combining targeted therapies with immune checkpoint inhibitors, suggesting potential for success in this approach.

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.

Where this trial is running

Changsha, Hunan

• Yongchang Zhang — Changsha, Hunan, China (Recruiting)

Study contacts

• Principal investigator: Yongchang Zhang, MD — Hunan Cancer Hospital
• Study coordinator: Yongchang Zhang, MD

Conditions Non-small Cell Lung Cancer; Anlotinib, Immune Checkpoint Inhibitor, NSCLC