Ensartinib in Combination With Bevacizumab in ALK-positive NSCLC Patients With TP53 Mutation (NCT05491811) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Ensartinib in Combination With Bevacizumab in ALK-positive NSCLC Patients With TP53 Mutation
China47 participantsStarted 2022-08-01
Plain-language summary
This is a prospective, single-arm, multicenter, phase II study to investigate the efficacy and safety of Ensartinib plus Bevacizumab in metastatic anaplastic lymphoma kinase (ALK)-rearranged Non-Small Cell Lung Cancer (NSCLC) with TP53 mutation.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Histologically or cytologically confirmed advanced (stage IIIB) or metastatic (stage IV) NSCLC;
* ALK positive with TP53 mutation was confirmed by tissue samples or blood in each center; TP53 mutation detection needs to be confirmed by NGS. ALK positive can be detected by NGS,IHC,RT-PCR and FISH;
* Age ≥ 18 years old;
* ALK-TKI-naive patients, and allowed to have received at most one line previous chemotherapy;
* ECOG Performance status (PS) score is 0-2;
* Karnofsky Performance Status of ≥70;
* Subjects with CNS metastases are only eligible if the CNS metastases are adequately treated with radiotherapy and/or surgery and subjects are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 1 week prior to randomization.
A.Patients receiving radiotherapy or radiosurgery with a dose exceeding 30 Gy will have 3 weeks for neurological stabilization before randomization.
B.This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
* Life expectancy of at least 12 weeks;
* Able to swallow oral drugs;
* It has certain organ system functions, defined as follows:
A. Absolute neutrophil count (ANC) ≥1.5 x 109/L B. Platelets ≥100 x 109/L C. hemoglobin ≥9 g per deciliter (≥90g per liter) note that blood transfusions are permitted to achieve the required hemoglobin level.
D. Total bilirubin ≤1.5 times upper limit of normal (ULN) E. In the absence of l…
What they're measuring
1
12-month Progression-free Survival (PFS) rate
Timeframe: The primary analysis of 12-month PFS rate based on investigator assessment will occur when PFS maturity is observed at approximately 12 months after the first patient begin study treatment