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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- STATUS
- Recruiting
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- End date
- Dec 23, 2022
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- participants needed
- 567
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- sponsor
- Shanghai Henlius Biotech
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)
Details
| Condition | Extensive Stage Small Cell Lung Cancer |
|---|---|
| Treatment | Placebo, HLX10, carboplatin and etoposide |
| Clinical Study Identifier | NCT04063163 |
| Sponsor | Shanghai Henlius Biotech |
| Last Modified on | 17 February 2022 |
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