Clinical trial · Interventional
A Trial of SHR-1316 Maintenance Therapy for Limited Stage Small Cell Lung Cancer
A Trial of SHR-1316 Maintenance Therapy for Limited Stage Small Cell Lung Cancer Without Progression After First Line Concurrent Chemoradiotherapy Treatment
NCT04647357CI-TRIAL-00048536unknownPhase 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)
SHR-1316 as Maintenance therapy for limited stage small cell lung cancer without progression after first line platinum based concurrent chemoradiotherapy
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 |
|---|---|---|---|
| Limited-stage Small Cell Lung Cancer, LS-SCLC | Lung Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SHR-1316 | Drug | Adebrelimab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SHR-1316
- interventionNames
- Drug: SHR-1316
Primary outcomes (1)
- measure
- PFS
- timeFrame
- Up to approximately 24 months
- description
- progression-free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. The age is 18-75 years old (including both ends), regardless of gender; 2. Histologically confirmed limited stage small cell lung cancer ; 3. ECOG PS 0 \~ 1; 4. Patients received at least 2 cycles of platinum based chemotherapy and radiotherapy, and completed within 1 to 42 days before the first medication. 5. The last chemotherapy must be finished before or at the same time of radiotherapy. 6. The disease did not progress after concurrent chemoradiotherapy; 7. The expected survival time was more than 3 months; 8. Pulmonary function: FEV1 \> 70%; Exclusion Criteria: 1. The subjects volunteered to participate in the study, signed the informed consent form, had good compliance and cooperated with the follow-up. 2. Mixed SCLC or NSCLC confirmed by histology; 3. Locally advanced small cell lung cancer receiving sequential chemoradiotherapy; 4. Have received anti-tumor therapy of systemic immune checkpoint inhibitors for SCLC; 5. Extensive SCLC; 6. Operable SCLC (clinical stage T1-2N0, except for those who are contraindicated or refuse surgery); 7. Interstitial pneumonia 8. History of active, known or suspected autoimmune diseases and autoimmune diseases, including but not limited to myasthenia gravis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, etc. 9. HIV, active Hepatitis B or Hepatitis C infection
References
Publications (0)
Data not yet available
No reference posted for this study.