Ensartinib in Combination With Bevacizumab in ALK-positive NSCLC Patients With TP53 Mutation

Sponsor
Sun Yat-sen University
Study ID
NCT05491811
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ensartinib — DRUG
    Participants will receive Ensartinib 225 mg oral once daily from baseline until disease progression, unacceptable toxicity, withdrawal of consent or death.
  • Bevacizumab — DRUG
    Participants will receive 7.5 mg/kg intravenous on Day 1 of 21 day cycles (every 3 weeks) from baseline until disease progression, unacceptable toxicity, withdrawal of consent or death.

Study Details

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.

Key Dates

First listed
Aug 8, 2022
Start date
Aug 1, 2022
Status verified
Apr 2026
Primary completion
Aug 31, 2024
Completion
Dec 31, 2026

Study Design

Enrollment
47 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ensartinib and Bevacizumab
    Ensartinib 225 mg oral once daily with Bevacizumab 7.5mg/kg intravenous every 3 weeks

Primary Outcome Measure

12-month Progression-free Survival (PFS) rate [ Time Frame: 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 ]

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