Lung Cancer
Conditions
Brief summary
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.
Detailed description
A Phase II, Single-arm, Multi-centre Study of Durvalumab as Sequential Therapy in Patients with Locally Advanced, Unresectable Non-Small Cell Lung Cancer (Stage III) Who Have Not Progressed Following Rh-Endostatin combined with reduced-dose CCRT(50 Gy) Therapy (Relief)
Interventions
Continuous intravenous infusion of endostar (Simcere Pharma- ceutical, Nanjing, China) was made over 120 h before the begin- ning of radiotherapy, and then repeated every two weeks. The dose was 7.5 mg/m2/24 h 120 h, 14 days/cycle. ECG monitoring was performed during the first delivery of endostar.
RADIATIONThoracic irradiation of 50 Gy with 3DCRT or IMRT
Concurrent thoracic chemoradiotherapy with reduced irradiation dose of 50 Gy will be given to patients with unresectable stage III NSCLC who can not tolerate irradiation dose to 60 Gy.
Sponsors
Wuhan University
Shanghai Chest Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival | up to approximately 3 years | 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). |
| adverse events (AE) | 5 years from patient enrollment | Number of participants with adverse events as assessed by CTCAE v5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | up to 5 years from patient enrollment | OS was defined as the time from the date of randomization until death due to any cause. OS was calculated using the Kaplan-Meier technique. |
| Objective Response Rate | Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter up to 3 three years | ORR was defined as the percentage of patients with at least one visit response of Complete Response (CR) or Partial Response (PR) per RECIST 1.1 for target lesions: CR: Disappearance of all target lesions; PR: \>=30% decrease in the sum of the longest diameter of target lesions; OR = CR + PR. |
Outcome results
None listed