X-396 (Ensartinib) Capsules in ALK-Positive NSCLC Patients With Brain Metastases

NCT04415320 | Unknown Phase 2

• 1 other identifier: BTP-42324-IIT
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

To assess efficacy and safety of oral X-396 (Ensartinib) capsule in Chinese ALK-positive NSCLC patients with brain metastases, eligible patients will be enrolled with objective responses being primary outcome measures.

Conditions

Lung Cancer, Nonsmall Cell; Brain Metastases

Keywords

NSCLC, Brain metastases, ALK mutations, X-396 (Ensartinib)

Outcome Measures

Primary Outcomes (1)

• Intracranial objective response rate (iORR) based on investigator assessment according to RNAO-BM.

  iORR per RANO-BM calculated as the proportion of patients with a best intracranial overall response defined as complete response (CR) or partial response (PR), based on investigator assessment.

  12 weeks

Secondary Outcomes (14)

• Disease control rate based on intracranial response (iDCR) according to RANO-BM.

  12 weeks

• Progression-free survival based on intracranial response (iPFS) according to RANO-BM

  36 months

• Time to progression based on intracranial response (iTTP) according to RANO-BM.

  36 months

• Duration of response based on intracranial response (iDOR) according to RANO-BM.

  36 months

• Intracranial objective response rate (iORR) based on intracranial response according to RECIST 1.1.

  12 weeks

Study Arms (1)

X-396(Ensartinib) Capsule

EXPERIMENTAL

Drug: X-396(Ensartinib)

Interventions

X-396(Ensartinib) DRUG

All consented, enrolled, eligible patients receive X-396 capsules, 225mg once daily.

X-396(Ensartinib) Capsule

Eligibility Criteria

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

You may qualify if:

• Female or male, 18 years of age or older
• Histologically or cytologically confirmed locally advance or recurrent/metastatic NSCLC that was positive for ALK mutations.
• Contrast-enhanced MRI or CT confirmed parenchymal brain metastases with at least one measurable lesion (according to RANO and RECIST 1.1), which was not previously treated with radiotherapy.
• At most once treated with chemotherapy, which must have been completed at least 4 weeks before the initiation of study treatment. Any adverse events related to previous chemotherapy treatment have disappeared.
• A Karnofsky Performance Status score of at least 60.
• An expected survival time of at least 12 weeks.
• Adequate organ functions.
• Drug related toxicities has been relieved to grade 1 (based on NCI CTCAE v4.03), except for hair loss.
• Being willing and able to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.
• Signed and dated informed consent.

You may not qualify if:

• Currently under treatment of other systemic anti-cancer therapies.
• Evidence of active malignancy within last 5 years.
• Patients who participated in other clinical trials within last 4 weeks before the initiation of study treatment.
• Patients who received surgery or immunotherapy within last 4 weeks before the initiation of study treatment.
• Patients who need to receive drugs which are potent CYP3A4 inhibitors or inducers within last 2 weeks before the initiation of study treatment and during the study.
• Patients who previously received organ transplantation or stem cell transplantation.
• Patients with clinically significant cardiovascular diseases.
• Patients with active gastrointestinal diseases or other conditions that will interfere significantly with the absorption, distribution, metabolism or excretion of study medication.
• Patients with interstitial lung disease history or signs of active interstitial lung disease.
• Patients with known allergy or delayed hypersensitivity reaction to study drug or its excipients.
• Pregnant and lactating women.
• Patients with other illness or medical conditions potentially interfering with the study treatment.

Sponsors & Collaborators

• Betta Pharmaceuticals Co., Ltd.: lead
• Fudan University: collaborator

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Brain Neoplasms

Interventions

ensartinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Jianhua Chang

CONTACT

8613916619284; changjianhua@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: June 4, 2020
• Study Start: March 21, 2019
• Primary Completion: December 1, 2020
• Study Completion: June 1, 2021
• Last Updated: June 4, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)