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)
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| ClinicalTrials.gov Identifier: NCT04063163 |
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Recruitment Status : Unknown
Verified March 2022 by Shanghai Henlius Biotech.
Recruitment status was: Active, not recruiting
First Posted : August 21, 2019
Last Update Posted : September 30, 2022
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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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 585 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 : | September 12, 2019 |
| Actual Primary Completion Date : | October 22, 2021 |
| Estimated Study Completion Date : | December 2022 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: A
HLX 10+chemotherapy (Carboplatin-Etoposide)
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Drug: HLX10
HLX10 is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc. Drug: carboplatin and etoposide chemotherapeutics |
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Placebo Comparator: B
Placebo+chemotherapy (Carboplatin-Etoposide)
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Drug: carboplatin and etoposide
chemotherapeutics Drug: placebo placebo |
- OS [ Time Frame: A period from randomization through death regardless of causality (approximately up to 24 months). ]Overall survival (OS)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04063163
| China | |
| ShanghaiHenliusBiotech | |
| Shanghai, China | |
| Georgia | |
| Institute for Personalized Medicine | |
| Tbilisi, Georgia | |
| Poland | |
| Wojew. Wielospecjalistyczne Centrum Onkologii i Traumatologi | |
| Lodz, Poland | |
| Russian Federation | |
| Arkhangelsk Clinical Oncology Dispensary | |
| Arkhangelsk, Russian Federation | |
| Turkey | |
| Medipol Mega Hospital | |
| Istanbul, Turkey | |
| Ukraine | |
| Komunalnyi zaklad Miska bahato | |
| Dnipropetrovsk, Ukraine | |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Shanghai Henlius Biotech |
| ClinicalTrials.gov Identifier: | NCT04063163 |
| Other Study ID Numbers: |
HLX10-005-SCLC301 |
| First Posted: | August 21, 2019 Key Record Dates |
| Last Update Posted: | September 30, 2022 |
| Last Verified: | March 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Extensive Stage Small Cell Lung Cancer Anti-PD-1 Monoclonal Antibody |
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Lung Neoplasms Small Cell Lung Carcinoma Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic |
Bronchial Neoplasms Carboplatin Etoposide Antineoplastic Agents Antineoplastic Agents, Phytogenic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |