Trials / Not Yet Recruiting
Not Yet RecruitingNCT05891080
Neoadjuvant Therapy With Toripalimab and JS004 Combined With Platinum-based Doublet Chemotherapy for Resectable or Potentially Resectable Stage III Non-small Cell Lung Cancer: A Randomised Controlled, Open-label, Phase 2 Trial
- Status
- Not Yet Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 124 (estimated)
- Sponsor
- Shanghai Pulmonary Hospital, Shanghai, China · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
For stage III non-small cell lung cancer (NSCLC), neoadjuvant chemotherapy plus PD-1 antibody is recommended. However, most patients could not achieve complete pathological response (CPR). New immunotherapeutic strategy is needed to achieve higher CPR rate. JS004 is a new antibody targeting B and T lymphocyte attenuator (BTLA) which restrains the function of immune cells and leads to immune escape of tumor cells. The combination of PD-1 antibody and BTLA antibody has shown good therapeutic effect in solid tumors. This trial aims to investigate the efficacy and safety of the therapeutic regimen of toripalimab and JS004 plus chemotherapy in stage III NSCLC.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Toripalimab | Specified dose on specified days. |
| DRUG | JS004 | Specified dose on specified days. |
| DRUG | Pemetrexed | Specified dose on specified days. |
| DRUG | Nab-paclitaxel | Specified dose on specified days. |
| DRUG | Carboplatin | Specified dose on specified days. |
| PROCEDURE | Surgery | Patients with resectable tumor after neoadjuvant therapy will be treated with surgery. |
Timeline
- Start date
- 2023-07-01
- Primary completion
- 2025-07-01
- Completion
- 2030-07-01
- First posted
- 2023-06-06
- Last updated
- 2023-06-06
Source: ClinicalTrials.gov record NCT05891080. Inclusion in this directory is not an endorsement.