A Clinical Study on the Efficacy and Safety of the Combination of Limertinib and Bevacizumab Versus Limertinib as First-line Treatment for NSCLC.

Sponsor
Shanghai Chest Hospital
Study ID
NCT06982924
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • EGFR Mutation Positive Advanced Non Small Cell Lung Cancer
  • PD-L1 Positive

Eligibility Criteria

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

Interventions

  • Limertinib+bevacizumab — DRUG
    The advanced or metastatic non-small cell lung cancer patients with EGFR mutation and high PD-L1 expression will receive the combination of Limertinib with bevacizuma in first-line treatment
  • Limertinib — DRUG
    The advanced or metastatic non-small cell lung cancer patients with EGFR mutation and high PD-L1 expression will receive Limertinib in first-line treatment

Study Details

A prospective, controlled Phase II clinical study on the efficacy and safety of the combination of limertinib and bevacizumab versus limertinib monotherapy as first - line treatment for locally advanced or recurrent metastatic non - squamous NSCLC with EGFR mutations and high PD-L1 expression.

Key Dates

First listed
May 21, 2025
Start date
Jun 30, 2025
Status verified
May 2025
Primary completion
Dec 30, 2026
Completion
Dec 30, 2028

Study Design

Enrollment
136 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental group
  • Placebo Comparator: Control Group

Primary Outcome Measure

PFS [ Time Frame: About 2 years ]

Central Contacts