Clinical trial · Interventional
Bevacizumab After Chemoradiotherapy For Locally Advanced Lung Adenocarcinoma
A Single-armed Phase Ⅱ Study of Bevacizumab Maintenance Therapy After Chemoradiotherapy for Locally Advanced Lung Adenocarcinoma
NCT03904563CI-TRIAL-00064454completedPhase 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)
This prospective phase II study is to determine the efficacy and safety of bevacizumab maintenance therapy after concurrent chemoradiotherapy in locally advanced lung adenocarcinoma
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 Adenocarcinoma | Lung Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| chest radiation | Radiation | — | UNRESOLVED |
| concurrent chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bevacizumab
- description
- All patients received four 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.Then every patients are treated with Bevacizumab 1-2 months later.The recommended dose for intravenous infusion is 15mg/kg body weight, which is given every 3 weeks for up to 1 year.
- interventionNames
- Drug: Bevacizumab
- Radiation: chest radiation
- Drug: concurrent chemotherapy
Primary outcomes (2)
- measure
- Progression-free survival
- timeFrame
- 3-year
- description
- Progression-free survival in patients
- measure
- rate of grade≥2 radiation pneumonia(NCI-CTC4.0)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (13)
- BACKGROUNDTorre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4. PMID 25651787
- BACKGROUNDBradley JD, Paulus R, Komaki R, Masters G, Blumenschein G, Schild S, Bogart J, Hu C, Forster K, Magliocco A, Kavadi V, Garces YI, Narayan S, Iyengar P, Robinson C, Wynn RB, Koprowski C, Meng J, Beitler J, Gaur R, Curran W Jr, Choy H. Standard-dose versus high-dose conformal radiotherapy with concurrent and consolidation carboplatin plus paclitaxel with or without cetuximab for patients with stage IIIA or IIIB non-small-cell lung cancer (RTOG 0617): a randomised, two-by-two factorial phase 3 study. Lancet Oncol. 2015 Feb;16(2):187-99. doi: 10.1016/S1470-2045(14)71207-0. Epub 2015 Jan 16. PMID 25601342
- BACKGROUNDChun SG, Hu C, Choy H, Komaki RU, Timmerman RD, Schild SE, Bogart JA, Dobelbower MC, Bosch W, Galvin JM, Kavadi VS, Narayan S, Iyengar P, Robinson CG, Wynn RB, Raben A, Augspurger ME, MacRae RM, Paulus R, Bradley JD. Impact of Intensity-Modulated Radiation Therapy Technique for Locally Advanced Non-Small-Cell Lung Cancer: A Secondary Analysis of the NRG Oncology RTOG 0617 Randomized Clinical Trial. J Clin Oncol. 2017 Jan;35(1):56-62. doi: 10.1200/JCO.2016.69.1378. Epub 2016 Oct 31. PMID 28034064
- BACKGROUNDAntonia SJ, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Yokoi T, Chiappori A, Lee KH, de Wit M, Cho BC, Bourhaba M, Quantin X, Tokito T, Mekhail T, Planchard D, Kim YC, Karapetis CS, Hiret S, Ostoros G, Kubota K, Gray JE, Paz-Ares L, de Castro Carpeno J, Wadsworth C, Melillo G, Jiang H, Huang Y, Dennis PA, Ozguroglu M; PACIFIC Investigators. Durvalumab after Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer. N Engl J Med. 2017 Nov 16;377(20):1919-1929. doi: 10.1056/NEJMoa1709937. Epub 2017 Sep 8. PMID 28885881
- BACKGROUNDAhn JS, Ahn YC, Kim JH, Lee CG, Cho EK, Lee KC, Chen M, Kim DW, Kim HK, Min YJ, Kang JH, Choi JH, Kim SW, Zhu G, Wu YL, Kim SR, Lee KH, Song HS, Choi YL, Sun JM, Jung SH, Ahn MJ, Park K. Multinational Randomized Phase III Trial With or Without Consolidation Chemotherapy Using Docetaxel and Cisplatin After Concurrent Chemoradiation in Inoperable Stage III Non-Small-Cell Lung Cancer: KCSG-LU05-04. J Clin Oncol. 2015 Aug 20;33(24):2660-6. doi: 10.1200/JCO.2014.60.0130. Epub 2015 Jul 6.