Clinical trial NCT04063163: 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)
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Extensive Stage Small Cell Lung Cancer
Keywords: Extensive Stage
Small Cell Lung Cancer
Anti-PD-1 Monoclonal Antibody
Lead sponsor: Shanghai Henlius Biotech
Sponsor class: INDUSTRY
First posted: 2019-08-21
Enrollment: 585
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


Eligibility criteria: 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.

Primary outcomes:
measure: OS
timeFrame: A period from randomization through death regardless of causality (approximately up to 24 months).
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: ShanghaiHenliusBiotech
city: Tbilisi
country: Georgia
facility: Institute for Personalized Medicine
city: Lodz
country: Poland
facility: Wojew. Wielospecjalistyczne Centrum Onkologii i Traumatologi
city: Arkhangelsk
country: Russian Federation
facility: Arkhangelsk Clinical Oncology Dispensary
city: Istanbul
country: Turkey
facility: Medipol Mega Hospital
city: Dnipropetrovsk
country: Ukraine
facility: Komunalnyi zaklad Miska bahato
Study officials:
References:
citation: Cheng Y, Han L, Wu L, Chen J, Sun H, Wen G, Ji Y, Dvorkin M, Shi J, Pan Z, Shi J, Wang X, Bai Y, Melkadze T, Pan Y, Min X, Viguro M, Li X, Zhao Y, Yang J, Makharadze T, Arkania E, Kang W, Wang Q, Zhu J; ASTRUM-005 Study Group. Effect of First-Line Serplulimab vs Placebo Added to Chemotherapy on Survival in Patients With Extensive-Stage Small Cell Lung Cancer: The ASTRUM-005 Randomized Clinical Trial. JAMA. 2022 Sep 27;328(12):1223-1232. doi: 10.1001/jama.2022.16464.