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Keynatinib in Treated Patients With NSCLC and Brain Metastases | Clinical Trials | Clareo Health

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Keynatinib in Treated Patients With NSCLC and Brain Metastases

Study of Keynatinib in Patients With Advanced Non-small Cell Lung Cancer With Brain Metastasis or Progression of Brain Metastasis After Treatment With EGFR Inhibitor(s)

NCT04824079•Medolution Ltd.

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the safety and efficacy of Keynatinib capsules in patients with advanced non-small cell lung cancer (NSCLC) with brain metastasis or progression of brain metastasis after treatment with EGFR inhibitors. As well as, to evaluate the penetration rate of Keynatinib in the Blood-Brain Barrier (BBB) and its PK characteristics, and the relationship between exposure levels with efficacy and safety.

Detailed Description

This is a multicenter, non-randomized, open, single-arm, phase IIa trial investigating the security and effectiveness of Keynatinib in patients with advanced non-small cell lung cancer (NSCLC) with brain metastasis or progression of brain metastasis after treatment with EGFR inhibitors.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Unlimited gender, age ≥ 18 years；
•2. Histologically or cytologically documented locally advanced, metastatic NSCLC (including L858R and/or Exon19 del mutation positive). The EGFR mutation assessed by local laboratory/or central laboratory via tissue/cytology or in plasma;
•3. Subjects should have the following conditions: a. (Cohort 1) Progression on any of the first or second generation EGFR inhibitors (gefitinib, erlotinib, afatinib, etc.).B. (Cohort 2) Progression on any third generation EGFR inhibitor (oxitinib, etc.), prior or non-prior treatment with any first or second generation EGFR inhibitor;
•4. The peripheral lesions did not progress after EGFR inhibitor treatment, but the occurrence of brain metastasis or progression of brain metastasis was confirmed by magnetic resonance imaging (MRI);
•5. As determined by the investigator, no final surgical resection or radiotherapy is expected for all lesions;
•6. Stable condition for at least 2 weeks prior to study medication without any corticosteroid or anticonvulsant therapy;
•7. The status score of Eastern Cooperative Oncology Group (ECOG) is 0 to 1 points, and there was no deterioration during the first 2 weeks of enrollment;
•8. Estimated survival time \> 3 months；
•9. Sufficient bone marrow, liver, kidney and blood coagulation function；
•10. Subjects must be willing to use barrier contraception；
+1 more criteria

Exclusion Criteria

•1. Have previously received chemotherapy, immunotherapy or any other systemic antitumor therapies within 4 weeks before the first administration; Have previously received EGFR-TKI within 5× half-life before the first administration; Have received oral fluorouracil and other small-molecule targeted drugs (whichever is longer) within 2 weeks or 5× half-life before enrollment; Within 2 weeks before enrollment, subjects had received palliative radiotherapy for non-target lesions for symptom relief, and traditional Chinese medicine (including Chinese patent medicine) for tumor indication;
•2. Have received whole brain radiation therapy;
•3. Only leptomeningeal metastasis are present;
•4. Historical intracranial hemorrhage not related to the tumor;
•5. Major organ surgery (excluding needle biopsy) or significant trauma have been performed within 4 weeks prior to enrollment;
•6. The drug or food with strong inhibition or induction of cytochrome P450 (CYP) isoenzyme CYP3A4 could not be stopped. The drug or food with strong inhibition or induction of cytochrome P450 (CYP) isoenzyme CYP3A4 had been used within 7 days before enrollment;
•7. Any unresolved toxicities from prior therapy greater than CTCAE 5.0 grade 1 at the time of enrollment with the exception of alopecia;
•8. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the tablet or previous significant bowel resection that would preclude adequate absorption of Keynatinib;
•9. Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or CT scan at baseline revealed the presence of idiopathic pulmonary fibrosis; Uncontrolled large pleural effusion or pericardial effusion; Active tuberculosis;
•10. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses or active infection including hepatitis B, hepatitis C and HIV;
+4 more criteria

Locations (5)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Hunan Cancer Hospital

Changsha, Hunan, China

Shandong Cancer Hospital

Jinan, Shandong, China

Key Dates

Start Date

October 21, 2020

Primary Completion Date

December 10, 2024

Completion Date

December 10, 2024

Last Updated

January 22, 2025

Enrollment

ACTUAL participants

Conditions

Non-Small Cell Lung Cancer With EGFR MutationBrain Metastases

Interventions

Keynatinib

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Keynatinib in Treated Patients With NSCLC and Brain Metastases

Inclusion Criteria

Exclusion Criteria

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