Trials / Unknown
UnknownNCT04108013
A Study of SHR-1210 in Combination With Carboplatin+Paclitaxel-albumin in Subjects With Resectable NSCLC
A Randomized,Controlled,Open-label,Prospective,Single-center Study to Investigate the Neoadjuvant Therapy of SHR-1210 in Combination With Carboplatin and Paclitaxel-albumin in Combination With Carboplatin and Paclitaxel in Resectable NSCLC
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 38 (estimated)
- Sponsor
- Xuanwu Hospital, Beijing · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This study is a randomized, controlled, open-label, prospective, single-center phase II clinical study. Target population is patients with stage II and IIIA resectable non-small cell lung cancer who had not received systemic chemotherapy. Study objective is to evaluate the major pathologic response of SHR-1210 + carboplatin + paclitaxel-albumin in subjects with resectable non-small cell lung cancer. SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody.
Detailed description
In this study, eligible subject will be randomized into study arm or control arm to accept study treatment. Subjects who randomized into control will have the opportunity to receive the treatment of carboplatin + paclitaxel-albumin therapy after confirmed disease progression. Treatment cycles of chemotherapy will be 2.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SHR-1210 | In the experimental group, 200mg SHR-1210 was given in the first day of each cycle, Carboplatin was given in the first day of each cycle, Paclitaxel-albumin was given in the first and eighth day of each cycle, with intravenous drip. |
| DRUG | Carboplatin and Paclitaxel-albumin | In the control group, Carboplatin was given in the first day of each cycle, Paclitaxel-albumin was given in the first and eighth day of each cycle, with intravenous drip. |
Timeline
- Start date
- 2019-10-08
- Primary completion
- 2021-07-31
- Completion
- 2021-07-31
- First posted
- 2019-09-27
- Last updated
- 2019-09-27
Source: ClinicalTrials.gov record NCT04108013. Inclusion in this directory is not an endorsement.