A Randomized, Open-Label, Multicenter, Phase II Study of HLX07 (Anti-EGFR Antibody) In Combination With HLX10 (Anti-PD-1 Antibody) With or Without Chemotherapy Versus HLX10 With Chemotherapy in First Line Recurrent or Metastatic Squamous Non-Small C

• Status: Not yet recruiting
• Trial end date: 2023-10-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the clinical efficacy and safety of HLX07 In Combination with HLX10 with or without Chemotherapy versus HLX10 with Chemotherapy in First Line Recurrent or Metastatic Squamous Non-Small Cell Lung Cancer.This study consists of three periods, screening period (28 days), treatment period and follow-up period (including safety follow-up, survival follow-up).Subjects can be enrolled into this study only if they meet inclusion criteria and do not meet exclusion criteria.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Henlius Biotech

Criteria

Inclusion Criteria:

• Histologically confirmed diagnosis of previously untreated, Recurrent or Metastatic Squamous Non-Small Cell Lung Cancer

• EGFR immunohistochemistry (IHC) H score ≥200 assessed by central lab

• Has measurable disease as defined by RECIST 1.1 as determined by the IRRC

• Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale

• Has a life expectancy of greater than 12 weeks

• Has adequate organ function

Exclusion Criteria:

• Histologically non-squamous NSCLC must be exclused. For non-small-cell histology, if has squamous components be allowed

• Has history of such as PD-1/PD-L1、EGFR、 CTLA4 targeted therapy

• EGFR sensitivity mutation or ALK or ROS1 gene rearrangement need to be excluded

• Has had other active malignancies within 5 years or at the same time

• Has uncontrolled pleural effusion、pericardial effusion or ascites