Extensive Small Cell Lung Cancer Clinical Trial
Official title:
A Phase II Clinical Study of Cadonilimab(PD-1/CTLA-4 Bi-Specific Antibody) in Treatment-naïve or Relapsed Extensive Small Cell Lung Cancer
Small cell lung cancer (SCLC) accounts for 15% of lung cancer cases and is an aggressive cancer characterized by rapid growth, early metastasis, and a poor prognosis. Approximately 75% of SCLC patients present with extensive-stage disease at the time of diagnosis, which is classically defined as a disease that cannot be encompassed by a single radiation field. Before the era of immunotherapy, the standard first-line therapy for ES-SCLC was platinum-based chemotherapy with etoposide; Once complete remission (CR) or partial remission (PR) was achieved after chemotherapy, consolidative thoracic radiation was recommended. Despite this standard treatment, the median overall survival (OS) of ES-SCLC is about 8-11 months, which has not changed for about 40 years. Combining concurrent radiotherapy of the thorax and immunochemotherapy may have a synergistic effect. Besides, for patients with recurrent SCLC, topotecan remains the only approved second-line treatment, and the outcomes are poor. With the most recent approval of EP plus a programmed death ligand 1(PD-L1) inhibitor, there are now more therapeutic options for managing ES-SCLC.The best second-line therapy after combination of chemo-immunotherapy is not well defined, as many second-line therapies were studied only after use of EP. However, second-line treatment options for patients with relapsed ES-SCLC are limited and include reintroduction of EP (with or without an immunotherapy), lurbinectedin, and topotecan. Therefore, we designed this trial to explore the efficacy and safety of cadonilimab as second-line therapy for ES-SCLC. We present a safety profile and a final analysis of ORR. In this single-center phase 2 trial, Cohort_1 patients with no history of previous systemic treatment for ES-SCLC received cadonilimab with EC/EP for two cycles (induction phase), then, those who did not progress received concurrent palliative RT and two cycles of cadonilimab with EC/EP (combination phase). Afterward they received cadonilimab every 3 weeks for a maximum of 2 years after study enrolment (maintenance phase). Cohort_2 patients with recurrent SCLC and after at most one systemic treatment received cadonilimab plus vorolanib, until disease progression or unacceptable toxicity. The primary endpoints was objective response rate (ORR); the second endpoints were progression-free survival (PFS), disease control rate (DCR), overall survival (OS) and treatment-emergent adverse event (TEAE) .
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
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Adebelizumab Combined With Chemotherapy and Radiotherapy Treat ES-SCLC
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Phase 2 | |
| Not yet recruiting |
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A Study of TQB2450 or Placebo Combined With Anlotinib, Etoposide and Carboplatin Versus Etoposide and Carboplatin in Subjects With Extensive Small Cell Lung Cancer (ETER701)
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Phase 3 |