Combining Anlotinib with Immune Checkpoint Inhibitors for Lung Cancer Treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Yongchang Zhang
  Changsha, Hunan, China Recruiting

Study contacts

• Principal investigator: Yongchang Zhang, MD — Hunan Cancer Hospital
• Study coordinator: Yongchang Zhang, MD
• Email: zhangyongchang@csu.edu.cn
• Phone: +8613873123436

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Anlotinib after surgery for non-pCR non-small cell lung cancer

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• Combining TQB2450 injection with Anlotinib and chemotherapy for advanced lung cancer

  This study is testing if adding a new injection called TQB2450 to Anlotinib and chemotherapy can help people with advanced lung cancer who haven't responded to earlier treatments.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.