Radiotherapy Plus Anlotinib in LA-NSCLC Intolerable to cCRT
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJIANYANG WANG
About this trial
Concurrent chemoradiotherapy (cCRT) is the standard treatment for patients with negative epidermal growth factor receptor (EGFR)-mutated unresectable locally advanced non-small cell lung cancer (LA-NSCLC). However, parts of patients only receive sequential chemoradiotherapy (sCRT) due to various reasons. This phase II study aimed to improve the outcomes of patients receiving sCRT by combining anti-angiogenesis therapy (Anlotinib) during radiotherapy course.We hypothesize that the combination of radiotherapy with anlotinib could improve the 2-year PFS rate from 35% with sCRT to 50. The accrual target was 44 patients.
Eligibility criteria
Qualifiers
≥18 years old with no restrictions on sex;
Peripheral tumor, or central lung cancer with non-squamous tissue or a mixed tissue with less than 50% squamous carcinoma;
Eastern cooperative oncology group (ECOG) score ≤2 was required;
Received systemic chemotherapy or combined chemotherapy and immumitherapy for ≥ 4 weeks without progression;
Disqualifiers
currently receiving treatment for malignancies at other sites, except for curable non-melanoma skin cancer and cervical carcinoma in situ;
previous malignancy within five years;
thoracic radiotherapy history, hemoptysis, myocardial infarction or cerebrovascular accident within three months;
uncontrolled or active pulmonary inflammation;
Trial design
Treatments tested in this trial
- Anlotinib
Treatment groups
44 Participants
are divided into 1 treatment groupSponsors and collaborators
JIANYANG WANG
Lead sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor institution
Source ClinicalTrials.gov