NCT04976647

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
156

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2022

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 26, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

January 18, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2023

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2024

Completed
Last Updated

May 6, 2022

Status Verified

May 1, 2022

Enrollment Period

1 year

First QC Date

July 20, 2021

Last Update Submit

May 5, 2022

Conditions

Squamous Non-small-cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (3)

  • Adverse Events (AE)

    Up to 5 years

  • Duration of Response (DOR) per RECIST 1.1 assessed by IRRC

    Up to 5 years

  • Overall Survival (OS)

    Up to 5 years

Study Arms (3)

A arm: HLX10+chemo

ACTIVE COMPARATOR

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.

Drug: HLX10+chemo

B arm: HLX10+HLX07+chemo

EXPERIMENTAL

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

Drug: HLX10+HLX07+chemo

C arm: HLX10+HLX07

EXPERIMENTAL

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

Drug: HLX10+HLX07

Interventions

HLX10+chemoDRUG

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

A arm: HLX10+chemo
HLX10+HLX07+chemoDRUG

HLX07 1500mg IV q3w; 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
HLX10+HLX07DRUG

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

C arm: HLX10+HLX07

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

RECRUITING

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2021

First Posted

July 26, 2021

Study Start

January 18, 2022

Primary Completion

January 30, 2023

Study Completion

October 30, 2024

Last Updated

May 6, 2022

Record last verified: 2022-05

Locations

CN(1)