Crizotinb or Standard Chemotherapy in Met Exon 14 Skipping Advanced NSCLC

NCT04322578 | Recruiting Phase 2

• 1 other identifier: 20203017
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Non-small Cell Lung Cancer

Keywords

non-small cell lung cancer; Crizotinb; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Overall survival (OS)

  Time from first subject dose to study completion, or up to 36 month

• Objective Response Rate (ORR)

  Time from first subject dose to study completion, or up to 36 month

Study Arms (2)

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.

Drug: Crizotinib

Cohort B: Chemotherapy or Chemotherapy plus immune checkpoint inhibitor

EXPERIMENTAL

Patients with MET exon 14 skipping will be treated with chemotherapy.

Drug: Pemetrexed

Interventions

Crizotinib DRUG

Crizotinib 250mg po bid. Savolitinib 300mg po, qd.

Also known as: Savolitinib

Cohort A: Target Therapy Group.

Pemetrexed DRUG

Pemetrexed, 500mg/m2, ivgtt erery 21day.

Also known as: immune checkpoint inhibitors, Carboplatin, Bevacizumab

Cohort B: Chemotherapy or Chemotherapy plus immune checkpoint inhibitor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hunan Province Tumor Hospital: lead

Study Sites (1)

Yongchang Zhang

Changsha, Hunan, 410013, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Crizotinib; 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; Pemetrexed; Immune Checkpoint Inhibitors; Carboplatin; Bevacizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Aminopyridines; Pyridines; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses; Coordination Complexes; Organic Chemicals; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Study Officials

• Yongchang Zhang, MD

  Hunan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yongchang Zhang, MD

CONTACT

+8613873123436; zhangyongchang@csu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: March 24, 2020
• First Posted: March 26, 2020
• Study Start: March 24, 2020
• Primary Completion: March 24, 2025
• Study Completion: March 24, 2026
• Last Updated: June 4, 2024

Record last verified: 2024-06

Locations

CN (1)