A Phase III Study to Investigate Efficacy and Safety of HLX10 + Chemotherapy in Patients With ES-SCLC

Shanghai Henlius Biotech585 enrolled

Overview

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)

After screening, subjects meeting the inclusion criteria and none of the exclusion criteria will be enrolled. Included subjects will be treated with HLX10 or placebo in combination with chemotherapy once every 3 weeks, until disease progression, death, intolerable toxicity, withdrawal of informed consent, or occurrence of other reasons specified in the protocol (whichever occurs first).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

585

Conditions

Extensive Stage Small Cell Lung Cancer

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (5)

Institute for Personalized Medicine

Tbilisi, Georgia

Wojew. Wielospecjalistyczne Centrum Onkologii i Traumatologi

Lodz, Poland

Arkhangelsk Clinical Oncology Dispensary

Arkhangelsk, Russia

Medipol Mega Hospital

Istanbul, Turkey (Türkiye)

Komunalnyi zaklad Miska bahato

Dnipropetrovsk, Ukraine

Outcomes

Primary Outcomes

Overall survival (OS)

Time frame: The period from randomization through death regardless of causality (up to approximately 56 months)

Secondary Outcomes

Progression Free Survival (PFS) Assessed by IRRC According to RECIST 1.1

PFS is defined as a period from randomization initiation to the first documentation of PD or death regardless of causality (whichever occurs first).

Time frame: From randomization initiation to the first documentation of PD or death regardless of causality, whichever occurs first (up to approximately 56 months).

Objective Response Rate

The ORR is defined as the proportion of subjects with a best overall response of CR or PR, according to RECIST 1.1. The best overall response will be defined as the best response across all time points in the order of CR, PR, SD, PD, and not NE.

Time frame: From baseline until PR or CR, whichever occurs first (up to approximately 56 months)

Duration of Response

DOR is defined as a period from the first documentation of response (CR or PR) through the first documentation of PD or death (whichever occurs first).

Time frame: From the first documentation of response (CR or PR) through the first documentation of PD or death, whichever occurs first (up to approximately 56 months).