Trials / Completed
CompletedNCT03134872
A Study of SHR-1210 in Combination With Pemetrexed and Carboplatin in Subjects With Non-squamous NSCLC
A Phase III, Randomized, Open-Label, Multi-center Study of SHR-1210(Anti-PD-1 Antibody) in Combination With Pemetrexed and Carboplatin as First Line Therapy in Subjects With Advanced/Metastatic Non-squamous Non-small Cell Lung Cancer
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 419 (actual)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody. This is a randomized,Phase III, multicenter ,open-label study designed to evaluate the safety and efficacy of SHR-1210 with carboplatin and pemetrexed versus carboplatin-pemetrexed in subjects who are chemotherapy naive and have Stage IIIB/IV non-squamous NSCLC. The primary hypothesis is that SHR-1210 combined with carboplatin and pemetrexed prolongs Progression Free Survival (PFS) in per RECIST 1.1 by blinded independent central review (ITT population and population was indicated by high PD-L1 expression) compared to carboplatin and pemetrexed treatment .
Detailed description
In this study, subjects will be randomly assigned to receive either carboplatin and pemetrexed for 4-6 cycles followed by pemetrexed maintenance until progression or unacceptable toxicity, OR receive SHR-1210 combined with carboplatin and pemetrexed chemotherapy for 4-6 cycles followed by pemetrexed maintenance with SHR-1210 until progression or unacceptable toxicity (SHR-1210 for a maximum of 2 years). Subjects assigned to the chemotherapy arm will have the opportunity to crossover to receive SHR-1210 monotherapy once they experience progression of disease (PD) defined by RECIST 1.1 and meet all the crossover criteria.
Conditions
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Lung Diseases
- Respiratory Tract Disease
- Neoplasms by Site
- Neoplasm, Bronchial
- Carcinoma, Bronchogenic
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | SHR-1210 | SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody. |
| DRUG | Carboplatin | Carboplatin |
| DRUG | Pemetrexed | Pemetrexed |
Timeline
- Start date
- 2017-05-12
- Primary completion
- 2019-07-27
- Completion
- 2019-08-29
- First posted
- 2017-05-01
- Last updated
- 2020-06-09
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03134872. Inclusion in this directory is not an endorsement.