Clinical trial · Interventional
Rh-Endostatin Combined With CCRT(50 Gy) Followed by Durvalumab Maintenance for the Treatment of Specific Phase III NSCLC
Rh-Endostatin Combined With Low-dose CCRT(50 Gy) Followed by Durvalumab Maintenance for the Treatment of Specific Phase III NSCLC Who Can Not Tolerate 60 Gy Irradiation
NCT04613284CI-TRIAL-00048051RELIEFunknownPhase 4ClinicalTrials.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)
A Study to Assess the Effects of Durvalumab following Rh-Endostatin combined with reduced-dose CCRT(50 Gy) in Patients with Stage III Unresectable Non-Small Cell Lung Cancer who can not tolerate 60 Gy irradiation.
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 |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Recombinant human endostatin (Endostar) | Drug | — | UNRESOLVED |
| Thoracic irradiation of 50 Gy with 3DCRT or IMRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Endostar combined Radiation
- interventionNames
- Drug: Recombinant human endostatin (Endostar)
- Radiation: Thoracic irradiation of 50 Gy with 3DCRT or IMRT
Primary outcomes (2)
- measure
- Progression Free Survival
- timeFrame
- up to approximately 3 years
- description
- PFS was defined as the time from randomization until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression).
- measure
- adverse events (AE)
- timeFrame
- 5 years from patient enrollment
- description
- Number of participants with adverse events as assessed by CTCAE v5.0
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Age at 18-75 years. * Documented evidence of NSCLC (locally advanced, unresectable, Stage III) * Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) * Eastern Cooperative Oncology Group performance status score (ECOG PS) of 0 to 1. * Estimated life expectancy of more than 12 weeks. Exclusion Criteria: * Prior exposure to any anti-PD-1 or anti-PD-L1 antibody. * Active or prior autoimmune disease or history of immunodeficiency. * Evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis B, C and HIV. * Evidence of uncontrolled illness such as symptomatic congestive heart failure, uncontrolled hypertension or unstable angina pectoris. * Any unresolved toxicity CTCAE \>Grade 2 from the prior chemoradiation therapy. * Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).
References
Publications (0)
Data not yet available
No reference posted for this study.