Trials / Not Yet Recruiting
Not Yet RecruitingNCT06648200
Toripalimab and JS004 Combined With Platinum-based Chemotherapy for Relapsed and Extensive-stage Small Cell Lung Cancer
Toripalimab and JS004 Combined With Platinum-based Chemotherapy for Relapsed and Extensive-stage Small Cell Lung Cancer: a Single-center, Randomized Trial
- Status
- Not Yet Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- Shanghai Pulmonary Hospital, Shanghai, China · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
For extensive-stage small cell lung cancer (SCLC), platinum-chemotherapy (cisplatin or carboplatin) combined with etoposide as the first-line treatment is recommended. However, the recurrence rate is extremely high after the initial first-line treatment. For those who relapse or progress within more than six minths after the end of the-first-line treatment, chose the current guideline recommendation trearment plan has the poor prognosis. A new immunotherapeutic strategy is needed to achieve better anti-tumor effects. JS004 is a new antibody targeting B and T lymphocyte attenuator (BTLA), which restrains immune cells; function and leads to immune escape of tumor cells. The combination of PD-1 and BTLA antibodies has shown a good therapeutic effect in solid tumors. This trial aims to investigate the efficacy and safety of the therapeutic regimen of toripalimab and JS004 combined with platinum-based doublet chemotherapy in extensive-stage SCLC or relapsed within more than six months after radical treatment SCLC.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | JS004 | Specified dose on specified days. |
| DRUG | Toripalimab | Specified dose on specified days. |
| DRUG | Etoposide | Specified dose on specified days. |
| DRUG | Platinum | Specified dose on specified days. |
Timeline
- Start date
- 2024-11-01
- Primary completion
- 2030-09-01
- Completion
- 2030-09-01
- First posted
- 2024-10-18
- Last updated
- 2024-10-18
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06648200. Inclusion in this directory is not an endorsement.