Combination treatment for advanced lung cancer with specific mutations

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 phase II clinical study evaluates the effectiveness of sunvozertinib combined with anlotinib in patients with advanced non-small cell lung cancer (NSCLC) who have specific EGFR-sensitive mutations. The study is open-label and single-arm, meaning all participants will receive the same treatment without a control group. Approximately 52 patients will be treated until disease progression or intolerable side effects occur, with the primary goal of assessing progression-free survival. The trial is set to begin recruitment in mainland China in April 2024 and is expected to conclude in December 2027.

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 and recorded local progression or metastatic non-small cell lung cancer without systemic treatment.
4. EGFR-sensitive mutations confirmed by an accredited local laboratory, including exon 19 deletions, exon 21 L858R point mutations, and T790M mutations, combined with co-mutations, including but not limited to TP53, PIK3CA, catenin beta-1 (CTNB1), and retinoblastoma (RB1).
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. Prior systemic therapy for locally advanced or metastatic disease.
2. 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.
3. Presence of spinal cord compression or meningeal metastasis.
4. History of other malignant tumors within 2 years.
5. 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.
6. History of stroke or intracranial hemorrhage within 6 months prior to the first dose.
7. The presence of any severe or poorly controlled systemic disease, including poorly controlled hypertension and active bleeding in the judgment of the investigator.
8. 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.
9. Heart-related diseases or abnormalities
10. 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.
11. Refractory nausea and vomiting, chronic gastrointestinal disease, difficulty swallowing drugs, or inability to adequately absorb sunvozertinib or anlotinib due to previous bowel resection.
12. Live vaccine was given 2 weeks before the first medication.
13. Women who are breastfeeding or pregnant.
14. Hypersensitivity to the test drug and the ingredients.
15. Other conditions assessed by the investigator to be unsuitable for participation in the study.

Where it's running

• Hunan Cancer Hospital
  Changsha, Hunan, China Recruiting

Study contacts

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

Similar studies

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

• Combination treatment for advanced lung cancer with specific mutations

  This study is testing a new combination of two drugs for people with advanced lung cancer who have specific genetic mutations to see if it helps them live longer without their cancer getting worse.

  Recruiting Phase 2 Hunan Province Tumor Hospital · Changsha, Hunan · NCT06348927

• Sunvozertinib as follow-up treatment after surgery for early-stage NSCLC with EGFR exon 20 insertion or PACC mutations

  This trial tests whether taking sunvozertinib after complete surgery can lower the chance of cancer coming back in adults with stage IB–IIIA non-small cell lung cancer whose tumors have EGFR exon 20 insertion or PACC mutations.

  Recruiting at 4 sites Phase 3 Dizal Pharmaceuticals · Beijing and 48 other locations · NCT07182682

• Sunvozertinib for untreated advanced non-small cell lung cancer with uncommon EGFR mutations

  This will test whether the oral drug sunvozertinib can shrink tumors and be safe in adults with untreated advanced non‑small cell lung cancer who have uncommon EGFR mutations.

  Recruiting Phase 2 Fudan University · Shanghai · NCT07117890

• DZD6008 plus sunvozertinib for advanced EGFR‑mutant non‑small cell lung cancer

  This will test whether combining oral EGFR inhibitor DZD6008 with sunvozertinib is safe and helps shrink tumors in adults with advanced EGFR‑mutant non‑small cell lung cancer.

  Recruiting at 9 sites Phase 1/2 Dizal Pharmaceuticals · Beijing, Beijing Municipality and 13 other locations · NCT07079475

• Combining SRT and Anlotinib for treating brain metastases from lung cancer

  This study is testing if combining a targeted cancer drug called Anlotinib with a type of focused radiation therapy can help patients with non-small cell lung cancer who have limited brain metastases and haven't responded to other treatments.

  Recruiting The First People's Hospital of Lianyungang · Lianyungang, Jiangsu · NCT06476093

• Short-course radiation then tislelizumab plus anlotinib before and after surgery for stage II–IIIA lung cancer

  This study will try short-course radiotherapy followed by the immune drug tislelizumab and the targeted drug anlotinib given before and after surgery for people with stage II–IIIA non-small cell lung cancer.

  Recruiting Phase 2 Zhejiang Cancer Hospital · Hangzhou, Zhejiang · NCT06379087

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.