A Randomized, Double-blind, Placebo Controlled Phase III Study to Investigate Efficacy and Safety of HLX10 + Chemotherapy (Carboplatin- Etoposide) in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Sponsor

Shanghai Henlius Biotech (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04063163

Collaborator

(none)

567

Enrollment

Location

Arms

39.4

Anticipated Duration (Months)

14.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a randomized, double-blind, multicenter, phase III clinical study to compare the clinical efficacy and safety of HLX10+ Chemotherapy vs placebo+Chemotherapy in Previously Untreated Patients with Extensive Stage Small Cell Lung Cancer.

Eligible subjects in this study will be randomized to Arm A or Arm B at 2:1 ratio as follows:

Arm A (HLX10 arm): HLX10 + chemotherapy (Carboplatin-Etoposide) ; Arm B (placebo arm):

Placebo + chemotherapy (Carboplatin-Etoposide); The three stratification factors for randomization include: PD-L1 expression level (negative, positive, not available), Brain metastasis (yes versus no), Age (≥ 65 years versus < 65 years)

Condition or Disease	Intervention/Treatment	Phase
Extensive Stage Small Cell Lung Cancer	Drug: HLX10 Drug: carboplatin and etoposide Drug: placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

567 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-Blind, Multicenter, Phase III Study to Compare Clinical Efficacy and Safety of HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) in Combination With Chemotherapy (Carboplatin-Etoposide) in Previously Untreated Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Actual Study Start Date :

Sep 12, 2019

Anticipated Primary Completion Date :

Dec 23, 2022

Anticipated Study Completion Date :

Dec 23, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A HLX 10+chemotherapy (Carboplatin-Etoposide)	Drug: HLX10 HLX10 is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc. Drug: carboplatin and etoposide chemotherapeutics
Placebo Comparator: B Placebo+chemotherapy (Carboplatin-Etoposide)	Drug: carboplatin and etoposide chemotherapeutics Drug: placebo placebo

Arm

Intervention/Treatment

Experimental: A

HLX 10+chemotherapy (Carboplatin-Etoposide)

Drug: HLX10

HLX10 is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc.

Drug: carboplatin and etoposide

chemotherapeutics

Placebo Comparator: B

Placebo+chemotherapy (Carboplatin-Etoposide)

Drug: carboplatin and etoposide

chemotherapeutics

Drug: placebo

placebo

Outcome Measures

Primary Outcome Measures

OS [A period from randomization through death regardless of causality (approximately up to 24 months).]
Overall survival (OS)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Histologically or cytologically diagnosed with ES-SCLC (according to the Veterans Administration Lung Study Group staging system).
No prior systemic therapy for ES-SCLC
Major organs are functioning well
Participant must keep contraception

Exclusion Criteria:

Histologically or cytologically confirmed mixed SCLC.
Known history of severe allergy to any monoclonal antibody.
Known hypersensitivity to carboplatin or etoposide.
Pregnant or breastfeeding females.
Patients with a known history of psychotropic drug abuse or drug addiction.
Patients who have other factors that could lead to the early termination of this study based on the investigator's judgment.