A Study of HLX07 + HLX10 With or Without Chemotherapy Versus HLX10 With Chemotherapy in First Line sqNSCLC

Henlius Pharmaceuticals

Status and phase

Enrolling

Phase 2

Conditions

Squamous Non-small-cell Lung Cancer

Treatments

Drug: HLX10+HLX07+chemo

Drug: HLX10+chemo

Drug: HLX10+HLX07

Study type

Interventional

Funder types

Industry

Identifiers

NCT04976647

HLX10HLX07-sqNSCLC-201

Details and patient eligibility

About

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.

Enrollment

156 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

156 participants in 3 patient groups

A arm: HLX10+chemo

Active Comparator group

Description:

Participants receive 300mg HLX10 IV every 3 weeks (Q3W) in combination with carboplaitin (AUC5 or 6) IV Q3W and nab-paclitaxel (260mg/m2) IV Q3W for 4-6 circle.

Treatment:

Drug: HLX10+chemo

B arm: HLX10+HLX07+chemo

Experimental group

Description:

Participants receive 300mg HLX10 IV Q3W plus 1500mg HLX07 IV Q3W with chemo.

Treatment:

Drug: HLX10+HLX07+chemo

C arm: HLX10+HLX07

Experimental group

Description:

Participants receive 300mg HLX10 IV Q3W plus 1500mg HLX07 IV Q3W.