Comparing Crizotinib and standard chemotherapy for advanced lung cancer

Crizotinb or Standard Chemotherapy in Met Exon 14 Skipping Advanced Non-small Cell Lung Cancer

This study tests whether Crizotinib works better than standard chemotherapy for people with advanced lung cancer that has a specific genetic change.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (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: NCT04322578 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness and safety of Crizotinib compared to standard chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) that has a specific genetic alteration known as MET exon 14 skipping. Participants will be monitored for clinical outcomes and survival data will be collected for comprehensive analysis. The trial aims to determine which treatment provides better results for this specific patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with confirmed MET exon 14 skipping advanced non-small cell lung cancer and no prior systemic treatment.

Not a fit: Patients who have previously received systemic therapy for their advanced lung cancer or those with certain recent treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients with advanced NSCLC with MET exon 14 skipping.

How similar studies have performed: Other studies have shown promising results with targeted therapies in similar patient populations, 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 and recorded local progression or metastatic non-small cell lung cancer without systemic treatment.
4. MET exon 14 skippign confirmed by an accredited local laboratory.
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 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; non-small cell lung cancer; Crizotinb; Chemotherapy