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

NCT ID: NCT04976647

Last Updated: 2022-05-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-18
• Study Completion Date: 2024-10-30

Brief 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.

Conditions

Squamous Non-small-cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A arm: HLX10+chemo

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.

Group Type: ACTIVE_COMPARATOR

HLX10+chemo

Intervention Type: DRUG

HLX10 300mg IV Q3W; carboplaitin (AUC5 or 6) IV Q3W + nab-paclitaxel (260mg/m2) IV Q3W for 4-6 circle

B arm: HLX10+HLX07+chemo

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

Group Type: EXPERIMENTAL

HLX10+HLX07+chemo

Intervention Type: DRUG

HLX07 1500mg IV q3w; HLX10 300mg IV Q3W; carboplaitin (AUC5 or 6) IV Q3W + nab-paclitaxel (260mg/m2) IV Q3W for 4-6 circle

C arm: HLX10+HLX07

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

Group Type: EXPERIMENTAL

HLX10+HLX07

Intervention Type: DRUG

HLX07 1500mg IV q3w; HLX10 300mg IV Q3W;

Interventions

HLX10+chemo

HLX10 300mg IV Q3W; carboplaitin (AUC5 or 6) IV Q3W + nab-paclitaxel (260mg/m2) IV Q3W for 4-6 circle

Intervention Type: DRUG

HLX10+HLX07+chemo

HLX07 1500mg IV q3w; HLX10 300mg IV Q3W; carboplaitin (AUC5 or 6) IV Q3W + nab-paclitaxel (260mg/m2) IV Q3W for 4-6 circle

Intervention Type: DRUG

HLX10+HLX07

HLX07 1500mg IV q3w; HLX10 300mg IV Q3W;

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Henlius Biotech

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Wu yilong, phD

Role: primary

syylwu@live.cn

(8620)83827812-51486

Other Identifiers

HLX10HLX07-sqNSCLC-201

Identifier Type: -

Identifier Source: org_study_id