Clinical trial · Interventional
SHR-1316 Combined With Chemotherapy and Chest Radiotherapy in ES-SCLC
SHR-1316 Plus Chemotherapy and Sequential Thoracic Radiotherapy as First-line Therapy for Extensive-stage Small-Cell Lung Cancer (ES-SCLC): a Phase II Trial
NCT04562337CI-TRIAL-00078493unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is a one arm, open, single center phase II study. The main purpose of this study was to evaluate the tolerance and preliminary efficacy of SHR1316 combined with chest radiotherapy after induction therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Extensive-stage Small Cell Lung Cancer | Lung Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| Radiation therapy | Radiation | — | UNRESOLVED |
| SHR1316 | Drug | Adebrelimab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SHR1316+Chemotherapy +Radiotherapy
- description
- Paiticipant receive SHR-1316 、Chemotherapy and Radiotherapy
- interventionNames
- Drug: SHR1316
- Drug: Carboplatin
- Drug: Etoposide
- Radiation: Radiation therapy
- Drug: Cisplatin
Primary outcomes (1)
- measure
- overall survival (OS)
- timeFrame
- Up to approximately 36 months
Secondary outcomes (7)
- measure
- progression-free survival (PFS)
- timeFrame
- Up to approximately 36 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed diagnosis of Extensive small cell lung cancer * Eastern Cooperative Oncology Group performance status (PS) of 0 to 1 * 18 to 75 years old * The function of vital organs meets the following requirements. WBC ≥ 3.0 × 10\^9/L, ANC≥1.5×10\^9/L, PLT≥100×10\^9/L, Hb≥9g/dL, ALT and AST ≤2.5 times ULN, TBIL ≤1.5 x ULN, CREA ≤1.5 times ULN or CCr≥50mL/min. INR≤1.5 x ULN, APTT ≤1.5 x ULN * have not received first-line systemic therapy or immunosuppressive therapy for es-sclc * The estimated survival period is more than 8 weeks * With measurable lesion defined by the RECIST v1.1: Previously irradiated lesions may only be considered as measurable disease if disease progression has been unequivocally documented at that site since radiation and the previously irradiated lesion is not the only site of disease; * Signed written informed consent prior to study entry Exclusion Criteria: * Active or untreated CNS metastases * Leptomeningeal diseases * Uncontrolled or symptomatic hypercalcemia * Active, known or suspected autoimmune diseases * have received any T cell co stimulation or immune checkpoint therapy * Corticosteroids (\> 10 mg / day prednisone or equivalent) or other immunosuppressants were used within 14 days before the first dose of study drug. * Subjects had active infections. * Failing to properly control the clinical symptoms or disease of the heart * Patients who have previously received allogeneic bone marrow transplantation or solid organ transplantation * Known to be allergic to the study drug or excipients, known to have a serious allergic reaction to any kind of monoclonal antibody; have a history of hypersensitivity to cisplatin or etoposide * According to the researcher's judgment, there are other factors that may lead to the termination of the study
References
Publications (1)
- DERIVEDChen D, Zou B, Li B, Gao A, Huang W, Shao Q, Meng X, Zhang P, Tang X, Hu X, Zhang Y, Guo J, Zhao C, Yuan J, Li Q, Zhu C, Yu J, Wang L. Adebrelimab plus chemotherapy and sequential thoracic radiotherapy as first-line therapy for extensive-stage small-cell lung cancer (ES-SCLC): a phase II trial. EClinicalMedicine. 2024 Aug 21;75:102795. doi: 10.1016/j.eclinm.2024.102795. eCollection 2024 Sep. PMID 39252865