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

Squamous Non-small-cell Lung Cancer Clinical Trial

Official title:

A Randomized, Open-Label, Multicenter, Phase II Study of HLX07 (Anti-EGFR Antibody) +HLX10 (Anti-PD-1 Antibody) With or Without Chemotherapy Versus HLX10 With Chemotherapy in First Line sqNSCLC

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04976647
• Other study ID #: HLX10HLX07-sqNSCLC-201
• Status: Recruiting
• Phase: Phase 2
• Start date: January 18, 2022
• Est. completion date: October 30, 2024

Study information

• Verified date: May 2022
• Source: Shanghai Henlius Biotech
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 156
• Est. completion date: October 30, 2024
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Squamous Non-small-cell Lung Cancer

Intervention

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

Locations

Country	Name	City	State
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Henlius Biotech

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR) per RECIST 1.1 assessed by IRRC	ORR is defined as the percentage of participants who have a Complete Response ([CR], disappearance of all evidence of disease) or Partial Response ([PR], regression of measurable disease and no new sites) per RECIST 1.1 as assessed by IRRC. ORR will be determined for each treatment arm.	Up to 5 years
Primary	Progression Free Survival (PFS) per RECIST 1.1 assessed by IRRC(Independent Radiology Review Committee)	PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 as assessed by IRRC or death due to any cause, whichever occurs first. PFS will be determined for each treatment arm	Up to 5 years
Secondary	Adverse Events (AE)	An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who experience an AE will be reported for each treatment arm.	Up to 5 years
Secondary	Duration of Response (DOR) per RECIST 1.1 assessed by IRRC	For participants who demonstrate CR or PR, DOR is defined as the time from first response (CR or PR) to subsequent disease progression or death from any cause, whichever occurs first. DOR will be determined for each treatment arm	Up to 5 years
Secondary	Overall Survival (OS)	OS is defined as the time from randomization to death due to any cause. OS will be determined for each treatment arm.	Up to 5 years