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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
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 collected for full analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A: Target Therapy Group. | Experimental | Patients with MET exon 14 skipping will be treated with First line crizotinib or savolitinib and other MET TKIs. |
|
| Cohort B: Chemotherapy or Chemotherapy plus immune checkpoint inhibitor | Experimental | Patients with MET exon 14 skipping will be treated with chemotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crizotinib | Drug | Crizotinib 250mg po bid. Savolitinib 300mg po, qd. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | PFS defines as first dose to first documented disease progression assessed by investigator or death due to any cause | Time from first subject dose to study completion, or up to 36 month |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | To assess overall survival, define as first dose to the death of the subject due to any cause | Time from first subject dose to study completion, or up to 36 month |
| Objective Response Rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
Prior systemic therapy for locally advanced or metastatic disease.
Subjects who have received any of the following treatments must be excluded:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongchang Zhang, MD | Contact | +8613873123436 | +861383123436 | zhangyongchang@csu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yongchang Zhang, MD | Hunan Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yongchang Zhang | Recruiting | Changsha | Hunan | 410013 | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D000077547 | Crizotinib |
| C000593259 | 1-(1-(imidazo(1,2-a)pyridin-6-yl)ethyl)-6-(1-methyl-1H-pyrazol-4-yl)-1H-(1,2,3)triazolo(4,5-b)pyrazine |
| D000068437 | Pemetrexed |
| D000082082 | Immune Checkpoint Inhibitors |
| D016190 | Carboplatin |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000631 | Aminopyridines |
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| Pemetrexed | Drug | Pemetrexed, 500mg/m2, ivgtt erery 21day. |
|
|
To assess Chemotherapy and TKIs overall response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator, define as the proportion of subjects who have a complete response (CR) or a partial response (PR)
| Time from first subject dose to study completion, or up to 36 month |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011725 |
| Pyridines |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000074322 | Antineoplastic Agents, Immunological |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |