Study of Anlotinib Plus Chemoradiotherapy in Patients With Locally Advanced NSCLC
Status:
Unknown status
Trial end date:
2021-05-17
Target enrollment:
Participant gender:
Summary
Lung cancer is the most common cancer, accounting for 20% of cancer-related deaths worldwide.
In 2015, an estimated 610,200 patients (22 per cent of cancer-related deaths) died of lung
cancer. Non-small cell lung cancer ((NSCLC)) accounts for 80% to 85% of lung cancer. Most
patients are locally advanced or metastatic diseases at the time of diagnosis. Some IIIA
tumors are considered resectable, but many IIIA (with larger N2) and IIIB (T4, any NM0, any
TN3M0) are not considered suitable for surgery. Since the 1990s, simultaneous radiotherapy
and chemotherapy ((CHRT)) has become the cornerstone of (NSCLC) in locally advanced non-small
cell lung cancer (NSCLC). At present, there is no clinical evidence of survival benefits of
synchronous radiotherapy plus TKI targeted therapy for unresectable stage Ⅲ A and stage Ⅲ B
non-small cell lung cancer. However, a HELPER STUDY study was conducted to evaluate the
efficacy and safety of continuous intravenous infusion combined with EP regimen plus
concurrent radiotherapy in the treatment of unresectable stage Ⅲ NSCLC. The median survival
time was 34.7 months and the 3-year survival rate was 47.7%. Anlotinib capsule is a small
molecule multi-target tyrosine kinase inhibitor. This is a single group partitioned,
multicenter, exploratory clinical study to observe and evaluate the safety and tolerance of
anlotinib hydrochloride combined with cisplatin plus etoposide or pemetrexed in the treatment
of locally advanced NSCLC patients. To determine the maximum tolerable dose of (MTD) and / or
stage II clinical recommended dose (RP2D) and evaluate its preliminary efficacy. In the first
stage of this study, 12 patients with locally advanced NSCLC were divided into 3 experimental
groups. After taking three different doses of anlotinib combined with platinum simultaneous
radiotherapy, the dose limited toxicity was observed, and the maximum tolerable dose was
determined in the second stage. 78 patients were enrolled according to RP2D, and the indexes
such as ORR were evaluated. To evaluate the safety and efficacy of anlotinib combined with
platinum-containing simultaneous radiotherapy in the treatment of locally advanced NSCLC.
Anlotinib (D1-14, d22-36, followed by a 21-day cycle, taking medicine for 2 weeks, stopping
for 1 week).
Group 1: 8mg po qd, Group 2: 10mg po qd, Group 3: 12mg po qd;
Combined chemotherapy:
Cisplatin + etoposide Or PC: carboplatin AUC2, paclitaxel 45-50 mg 2 per week; Cisplatin +
pemetrexed (non-squamous cell carcinoma). Simultaneous radiotherapy: 3D-CRT or IMRT external
radiotherapy (60-66 Gy, 2.0 Gy / day).
The curative effect was evaluated after 6 weeks of simultaneous radiotherapy and chemotherapy
combined with alotinib, and then the efficacy of alotinib or chemotherapy was maintained
until PD.
Main outcome measures:
Phase I main outcome measures: maximum tolerated dose (MTD), dose limited toxic (DLT).
Main indicators of II: objective remission rate (ORR). Secondary indicators: disease control
rate (DCR), progression-free survival (PFS)
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Second Affiliated Hospital of Xi'an Jiaotong University
Collaborators:
First Affiliated Hospital Xi'an Jiaotong University Shaanxi Provincial Cancer Hospital Shaanxi Provincial People's Hospital Tang-Du Hospital Xijing Hospital