Concurrent Chemoradiotherapy Combination With Anlotinib for Unresectable Stage III NSCLC Patients：An Exploratory Single-Arm Phase II Clinical Trail
Overview
- Phase
- Phase 2
- Intervention
- Anlotinib
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Sponsor
- Shandong Cancer Hospital and Institute
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- PFS
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this study is to determine whether concurrent chemoradiotherapy combination with Anlotinib is safe, effective in the treatment of unresectable stage III NSCLC patients.
Detailed Description
The purpose of this study is to determine whether concurrent chemoradiotherapy combination with Anlotinib is safe, effective in the treatment of unresectable stage III NSCLC patients, whether this regimen can improve PFS.
Investigators
Jinming Yu
Chief Physician
Shandong Cancer Hospital and Institute
Eligibility Criteria
Inclusion Criteria
- •Patients voluntarily participate in this study, signed informed consent.
- •Patients pathologically diagnosed as locally advanced (IIIB / IV) unresectable non-small cell lung cancer, with measurable lesions; IIIa3 patient: Multiple stations lymph node metastasis detected by mediastinoscope, other lymph node biopsy or PET-CT; IIIa4 patient: Bulky or stable multiple stations N2 lymph node metastasis (Bulky lymph node: short diameter \> 2cm in spiral CT imaging, especially the extranodal invasion); and IIIb patient; T3/4 patient with several ipsilateral or contralateral satellite nodules metastasis will be excluded.
- •Detection of genotypes by providing detectable specimens (tissue) prior to enrollment: patients with negative EGFR mutation, or ALK rearrangement test results.
- •Patients aged between 18 -75 years; with ECOG PS Scoring: 0\~1 point; with expected survival time\>3 months.
- •Patients with normal organ function within 7 days prior to treatment, the following criteria are met:
- •a) blood routine examination criteria (without blood transfusion in 14 days) : i) hemoglobin (HB) ≥100g/L; ii) white blood cell (WBC)≥ 3.0×10e9/L, absolute neutrophil count (ANC) ≥1.5×10e9/L; iii) platelet (PLT) ≥100×10e9/L; b) biochemical tests meet the following criteria: i) total bilirubin (TBIL) ≤1.5 times of upper limit of normal (ULN); ii) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 ULN, if liver metastasis occurred, ALT and AST ≤5 ULN; iii) serum creatinine (Cr) ≤1.5 ULN or creatinine clearance (CCr) ≥60mL/min;
- •Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥50% lower limit of normal (LLN);
- •Lung function evaluation: forced expiratory volume in first second (FEVI)≥1.45L/s.
- •Exclusion Criteria(Patient meet any criteria as following will be excluded):
- •Patients who had previously used anlotinib hydrochloride capsules;
Exclusion Criteria
- Not provided
Arms & Interventions
Concurrent Chemoradiotherapy+Anlotinib
1. Radiotherapy: Thoracic radiotherapy dose will be 2.0Gy per day, given 5 days a week, to cumulative dose of 60～66Gy. If radiotherapy and chemotherapy are conducted in the same day, chemotherapy should be priority to radiotherapy. 2. Chemotherapy: Platinum based dual drug regime determined by researcher.After finishing concurrent chemoradiotherapy, there is no need of maintenance chemotherapy. 3. Anlotinib: Combined with 12mg/d QD Anlotinib on the first, second weeks and fourth, fifth weeks of radiotherapy, that is on the day1\~14, day22\~36. 4. Maintenance therapy: One month after finishing concurrent chemoradiotherapy, 12mg/d QD Anlotinib can be administrated, each cycle is defined as 2 weeks on-treatment followed by 1 week off-treatment. The treatment can continue until disease progression or treatment intolerance, but should not exceed 24 months. 5. During the course of study, it's not allowed to receive other anti-tumor therapy.
Intervention: Anlotinib
Concurrent Chemoradiotherapy+Anlotinib
1. Radiotherapy: Thoracic radiotherapy dose will be 2.0Gy per day, given 5 days a week, to cumulative dose of 60～66Gy. If radiotherapy and chemotherapy are conducted in the same day, chemotherapy should be priority to radiotherapy. 2. Chemotherapy: Platinum based dual drug regime determined by researcher.After finishing concurrent chemoradiotherapy, there is no need of maintenance chemotherapy. 3. Anlotinib: Combined with 12mg/d QD Anlotinib on the first, second weeks and fourth, fifth weeks of radiotherapy, that is on the day1\~14, day22\~36. 4. Maintenance therapy: One month after finishing concurrent chemoradiotherapy, 12mg/d QD Anlotinib can be administrated, each cycle is defined as 2 weeks on-treatment followed by 1 week off-treatment. The treatment can continue until disease progression or treatment intolerance, but should not exceed 24 months. 5. During the course of study, it's not allowed to receive other anti-tumor therapy.
Intervention: Concurrent Chemoradiotherapy
Outcomes
Primary Outcomes
PFS
Time Frame: 2 years
Progression Free Survival
Secondary Outcomes
- OS(2 years)
- ORR(2 years)
- DCR(2 years)