Patient case: 57-year-old male with lung adenocarcinoma; genetic feature: KRAS (G12V), high tumor mutational burden

Clinical trial: Bevacizumab After Chemoradiotherapy For Locally Advanced Lung Adenocarcinoma

Summary: This prospective phase II study is to determine the efficacy and safety of bevacizumab maintenance therapy after concurrent chemoradiotherapy in locally advanced lung adenocarcinoma

Detailed description: This prospective phase II study is to determine the efficacy and safety of bevacizumab maintenance therapy after concurrent chemoradiotherapy in locally advanced lung adenocarcinoma.
  All patients received 4 cycles of weekly docetaxel (25mg/㎡) and nedaplatin (25mg/㎡)(DP), each of 1 day's duration, combined with split-course thoracic radiotherapy, with one-month break.Bevacizumab maintenance therapy starts 1-2 months later after the chemotherapy.The recommended dose for intravenous infusion is 15mg/kg body weight, and the drug is given every 3 weeks for 6 courses. Toxicities will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0.

Eligibility: Inclusion Criteria:
  -  Pathologic confirmation of lung adenocarcinoma
  -  Patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  -  Unresectable, refusing surgery or after R2 surgery ,confirmed by PET-CT or chest and abdominal CT, craniocerebral MRI, and ECT.
  -  After radiotherapy and chemotherapy, the tumor is in partial remission, complete remission or stable.
  -  1-2 months after chemoradiotherapy ends.
  -  Organ and bone marrow functions were normal within the first 30 days of enrollment, including: • AST, ALT≤ 2.5*ULN or ≤5*ULN (with liver metastasis); • TBil ≤ 1.5 ULN • neutrophils absolute value ≥500 cells/mm3 • creatinine clearance ≥45 mL/min ;• platelets≥50,000 cells/mm3.
  -  CB6 within normal limits
  -  Patients and their family signed the informed consents
  Exclusion Criteria:
  -  Lung squamous carcinoma.
  -  The tumor has completely approached, encircled, or invaded the intravascular space of the great vessels (e.g., the pulmonary artery or the superior vena cava).
  -  The tumor was associated with a cavity over 2cm in diameter.
  -  Bleeding tendency or coagulation disorder.
  -  Patients with hemoptysis (1/2 teaspoon blood/day) within 1 month.
  -  Full-dose anticoagulation therapy was used within the past 1 month.
  -  Severe vascular disease occurred within 6 months.
  -  Gastrointestinal fistula, perforation or abdominal abscess occurred within 6 months.
  -  Hypertensive crisis, hypertensive encephalopathy, symptomatic heart failure (New York class II or above), active cerebrovascular disease or cardiovascular disease occurred within 6 months.
  -  Uncontrolled hypertension (systolic > 150mmHg and/or diastolic > 100mmHg).
  -  Major surgery within 28 days or minor surgery or needle biopsy within 48 hours.
  -  Urine protein 3-4+, or 24h urine protein quantitative >1g.
  -  Degree 3 esophagitis after chemoradiotherapy has not recovered.
  -  Elderly patients (age 75 years).
  -  The investigator does not consider the participant to be eligible for this study.

Relevance to patient case: not relevant