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Toripalimab and JS004 Combined With Platinum-based Chemotherapy for Relapsed and Extensive-stage Small Cell Lung Cancer

StatusCompleted
PhasePhase 2
Started
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Record History

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  1. Completed without a posted recruiting period Show 5 more changesShow less
    • Primary completion date changed from estimate of Sep 1, 2030 to Aug 29, 2026
    • Start date changed from estimate of Nov 1, 2024 to Nov 18, 2024
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints: details revised at 3 of 5 entries
    • Site details revised
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06648200
Lead Sponsor Shanghai Pulmonary Hospital, Shanghai, China
Conditions
(from sponsor)		 Small Cell Lung Cancer Extensive Stage, Small Cell Lung Cancer Recurrent
Related terms Recurrence, Small Cell Lung Carcinoma
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov