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
This trial does not accept healthy volunteersQualifiers
≥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
Design model
Single group
Treatments tested in this trial
Anlotinib
DrugFor patients treated with conventional Intensity-Modulated Radiation Therapy (IMRT), the median prescribed dose was 60 Gy/30 fractions (range: 50.0-70.0 Gy, in 25-35 fractions) (median BED10 72 Gy, range: 60-84 Gy) to the planning target volume (PTV). As for patients with IMRT-based simultaneously integrated boost (SIB), the median prescribed dose was 59.92 Gy/28 fractions (range: 50.0-70.0 Gy, in 25-33 fractions) (median BED10 72.74 Gy, range: 60-84 Gy) to the planning gross tumor volume (PGTV), and 50.4 Gy/28 fractions (range: 45-59.4 Gy, in 25-33 fractions) (median BED10 59.47 Gy, range: 53.1-70.1 Gy) to the PTV. It should be noted that the PTV in the SIB group contains the PGTV. Anlotinib was administered orally concurrently with the first day of radiotherapy, at a dose of 12 mg for a maximum of three cycles. Each cycle was defined as 2 weeks on-treatment followed by 1 week off-treatment. If intolerance occurs, the dose may be reduced to 8-10 mg/day or stopped.
Treatment groups
44 Participants
are divided into 1 treatment groupGroup A: Radiotherapy plus AnlotinibExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
2-year progression-free survival (PFS)
Time frame
From the first day of radiotherapy to the occurrence of objective tumor progression or death due to any cause, whichever occurs first, assessed up to 60 monthsSecondary outcomes
1
Overall Survival(OS)
Time frame
From the first day of radiotherapy to the occurrence of death due to any cause, assessed up to 60 months2
Local regional recurrence (LR)
Time frame
From the first day of radiotherapy to the occurrence of clinical and/or biopsy-proven recurrence within the bronchial stump, ipsilateral hilum, mediastinum, or supraclavicular, whichever occurs first, assessed up to 60 months3
Distant metastasis (DM)
Time frame
From the first day of radiotherapy to the occurrence of any evidence of metastatic disease beyond the locoregional regions previously mentioned, assessed up to 60 months4
Acute toxicity
Time frame
From the first day of radiotherapy and up to the 3-month post-radiotherapy follow-up visitSponsors and contacts
Click on the lead sponsor to view all of their trials.
JIANYANG WANG
Lead sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor institution
Source ClinicalTrials.gov