Status:
RECRUITING
Crizotinb or Standard Chemotherapy in Met Exon 14 Skipping Advanced NSCLC
Lead Sponsor:
Hunan Province Tumor Hospital
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study aims to explore the efficacy and safety of Crizotinb or Standard Chemotherapy in Met exon 14 skipping Advanced Non-small Cell Lung Cancer
Detailed Description
This study aims to explore the efficacy and safety of Crizotinb or Standard Chemotherapy in Met exon 14 skipping Advanced Non-small Cell Lung Cancer . All the clinical and survival data will be collec...
Eligibility Criteria
Inclusion
- Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form.
- Age ≥ 18 years.
- Histopathology or cytology confirmed and recorded local progression or metastatic non-small cell lung cancer without systemic treatment.
- MET exon 14 skippign confirmed by an accredited local laboratory.
- ECOG 0 - 1.
- Predicted survival ≥ 12 weeks.
- Adequate bone marrow hematopoiesis and organ function
- Presence of measurable lesions according to RECIST 1.1.
- Subjects with stable brain metastases may be included in the study.
Exclusion
- Prior systemic therapy for locally advanced or metastatic disease.
- 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.
- Presence of spinal cord compression or meningeal metastasis.
- History of other malignant tumors within 2 years.
- 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.
- History of stroke or intracranial hemorrhage within 6 months prior to the first dose.
- The presence of any severe or poorly controlled systemic disease, including poorly controlled hypertension and active bleeding in the judgment of the investigator.
- 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.
- Heart-related diseases or abnormalities
- 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.
- Refractory nausea and vomiting, chronic gastrointestinal disease, difficulty swallowing drugs, or inability to adequately absorb sunvozertinib or anlotinib due to previous bowel resection.
- Live vaccine was given 2 weeks before the first medication.
- Women who are breastfeeding or pregnant.
- Hypersensitivity to the test drug and the ingredients.
- Other conditions assessed by the investigator to be unsuitable for participation in the study.
Key Trial Info
Start Date :
March 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 24 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04322578
Start Date
March 24 2020
End Date
March 24 2026
Last Update
June 4 2024
Active Locations (1)
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1
Yongchang Zhang
Changsha, Hunan, China, 410013