Serplulimab Plus Bevacizumab and Chemotherapy for EGFR-mutant Metastatic NSCLC Patients After EGFR-TKI Treatment Failure

Conditions

• Non-Squamous Non-Small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• Serplulimab — DRUG
  300 mg，IV，Q3W
• Bevacizumab Biosimilar HLX04 — DRUG
  7.5 mg/kg，Q3W
• Pemetrexed — DRUG
  500 mg/m2，IV，Q3W
• Carboplatin — DRUG
  AUC=5，IV，Q3W

Study Details

The purpose of this study is to evaluate the efficacy and safety of Serplulimab Plus Bevacizumab and chemotherapy in TKI-resistant EGFR-mutated non-squamous NSCLC Chinese patients.

Key Dates

Start date

May 8, 2023

Status verified

Apr 2023

Primary completion

Aug 31, 2024

Completion

Jun 30, 2025

Study Design

Enrollment

46 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Serplulimab+Bevacizumab+Pemetrexed+Carboplatin
  Using Serplulimab in combination with bevacizumab, carboplatin and pemetrexed to treat patients with EGFR mutated, advanced non-small cell lung cancer (NSCLC) after failure of EGFR tyrosine kinase inhibitors.

Primary Outcome Measure

ORR(Overall Response Rate) [ Time Frame: From start of treatment to 12 months ]

Central Contacts

• zhen he
  +86 13523530961
  [email protected]

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