Clinical trial NCT05132218: Ensatinib in alK-positive Patients Undergoing Initial Treatment for Advanced Non-small Cell Lung Cancer
Official title: Prospective Exploratory Real World Study of Ensatinib in alK-positive Patients Undergoing Initial Treatment for Advanced Non-small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ALK Positive
NSCLC Stage IIIB
NSCLC Stage IV
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
Collaborators: name: Betta Pharmaceuticals Co., Ltd.
First posted: 2021-11-24
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Single arm real world study of non-small cell lung cancer; stage IIIB or stage IV ALK positive NSCLC；

Brief summary: The experimental design is exploratory, single-arm, multi-center, real-world research.

Ensatinib 225mg qd A prospective and exploratory real-world study of Ensatinib for ALK-positive advanced non-small cell lung cancer patients Test purposes Exploring the real world, Ensatinib is effective for the newly treated ALK+ advanced NSCLC

1. Efficacy and safety;
2. The relationship between molecular mechanism and curative effect;
3. Ensatinib resistance mechanism;

Detailed description: Enrolled patients:

1. stage IIIB or stage IV NSCLC
2. Each center confirmed ALK+ by tissue samples (Abbott FISH, VENTANA ALK D5F3, NGS method confirmation);
3. Without any ALK-TKI treatment; Study endpoint

Primary endpoint:

According to the RECIST1.1 standard, the progression-free survival (PFS) assessed by the investigator;

Secondary endpoint:

According to the RECIST1.1 standard, the objective response rate (ORR) evaluated by the investigator; the time to treatment failure (TTF); according to the RECIST1.1 standard, the ORR and PFS of patients with different ALK fusion subtypes evaluated by the investigator; total Lifetime (OS); safety;

Exploratory endpoint:

The correlation between the biomarkers in blood or/and tissue samples and the efficacy of Ensatinib; the resistance mechanism of Ensatinib;

The sample size is determined:

The plan is to analyze 60-80 patients with EML4-ALK fusion v1 and v3 subtypes. Based on the proportion of patients with both subtypes in ALK-positive patients, the proportion is about 40%. Based on the 20% dropout rate, the plan is to include ALK without distinction. 180 patients with fusion subtype; statistical methods:

Eligibility criteria: Inclusion Criteria:

1. stage IIIB or stage IV NSCLC by histology or cytology;
2. All centers confirmed ALK positive by tissue samples (Abbott FISH, VENTANA ALK D5F3, NGS method confirmation);
3. Without any ALK-TKI treatment;
4. Voluntarily and capable of following the trial and follow-up procedures;
5. Able to understand the nature of the trial, and be able to complete the signing of a written informed consent form.

Exclusion Criteria:

* 1. Pereceived any ALK-TKI treatment ; 2. Received any chemotherapy within 4 weeks, or underwent major surgery or radiotherapy within the last 14 days; 3. The investigator believes that the patient is not suitable for Ensatinib treatment.

Had a stem cell or organ transplant. 4. Having serious cardiovascular disease, including but not limited to: 5.Sino - QTcF interval ≥450 ms or other significant ECG abnormalities. According to the study, researchers either ruled that hypertension was poorly controlled (systolic blood pressure \>160 mmHg or diastolic blood pressure \>100mmHg).

6. Dysphagia, active gastrointestinal disease, or other disease that significantly affects drug absorption, distribution, metabolism, and excretion.

7. Previous history of interstitial lung disease, drug-induced interstitial lung disease, radioactive pneumonia requiring steroid treatment, or any indication of clinically active interstitial lung disease.

Primary outcomes:
measure: progression-free survival
timeFrame: 2021.09.27-2024.12.30
Secondary outcomes:
measure: overall survival
timeFrame: 2021.09.27-2024.12.30
measure: Time-to-TreatmentFailure
timeFrame: 2021.09.27-2024.12.30
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
References: