Study of Anlotinib Plus Chemotherapy as the First-line Treatment in Patients With Advanced NSCLC

Chinese Academy of Medical Sciences & Peking Union Medical College logo

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase

Unknown
Phase 2
Phase 1

Conditions

Squamous Cell Carcinoma
Adenocarcinoma
NSCLC

Treatments

Drug: Anlotinib combined with paclitaxel and carboplatin, phase I
Drug: Anlotinib combined with pemetrexed and carboplatin, phase I
Drug: Anlotinib combined with pemetrexed and carboplatin, phase II
Drug: Anlotinib combined with paclitaxel and carboplatin, phase II

Study type

Interventional

Funder types

Other

Identifiers

NCT03636685
NCC201807006

Details and patient eligibility

About

Non-small cell lung cancer has the highest morbidity and mortality in China,and platinum-based chemotherapy is the standard first-line treatment for the wild-type NSCLC,however the overall survival still less than one year.Anlotinib is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR2、VEGFR3、PDGFRβ and c-Kit, which has strong effect of anti-angiogenesis.This study is aim to evaluate the efficacy and safety of the combination regimen of anlotinib plus platinum-based chemotherapy as first-line treatment for NSCLC.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age:18~70 years;
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 -2
  • Subjects with histologically or cytologically confirmed locally advanced or advanced NSCLC
  • EGFR\ALK\ROS1 wildtype or unknown,or patients with EGFR\ALK\ROS1 mutations but refuse to receive corresponding inhibitors' treatment
  • No indications for radiation therapy
  • Previously chemotherapy naive or postoperative adjuvant chemotherapy ended more than 1 year
  • Subjects with at least one measurable lesion as defined by RECIST (version 1.1),which is confirmed by computed tomography (CT) scan or MRI

Exclusion criteria

  • Small Cell Lung Cancer
  • central lung squamous carcinoma along with cavum, or non-small cell lung cancer along with hemoptysis (>50ml/day)
  • Within 30 days before enrollment, the patient had used any chemotherapy drugs in the previous treatment regimen or clinical study; Or, within 14 days before the first administration of the study therapy, the patient has used any targeted anticancer drugs in the previous treatment regimen or clinical study; Or stop other experimental drugs or cancer drugs for less than five half-life of the drug
  • Previous use of anti-angiogenic drugs (such as anlotinib, apatinib, bevacizumab, endostar, etc.)
  • have got non remissive toxic reactions derived from previous therapies, which is over level 1 in CTC AE (4.0), alopecia NOT included
  • Spinal cord compression or symptomatic and untreated brain metastases (asymptomatic, stable, no need for steroid treatment for 4 weeks before study start)
  • with kinds of factors which affect oral medicine (e.g. failing to swallow, gastrointestinal tract getting resected, chronic diarrhea and ileus)
  • Previous histories include: interstitial pneumonia, drug-induced interstitial pneumonia, radiation pneumonia requiring steroid treatment, and clinically proven active interstitial pneumonia
  • get arterial/venous thrombosis within 6 months, such as cerebrovascular accidents (including temporary ischemic stoke), prevenous thrombosis, and pulmonary embolism
  • Have suffered from hemorrhagic disease or coagulation dysfunction
  • diagnosed with disease which will severely endanger the security of patients or influence the completion of this research

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Non-squamous cell lung cancer
Experimental group
Description:
Anlotinib combined with pemetrexed and carboplatin, phase I Anlotinib combined with pemetrexed and carboplatin, phase II
Treatment:
Drug: Anlotinib combined with pemetrexed and carboplatin, phase II
Drug: Anlotinib combined with pemetrexed and carboplatin, phase I
Squamous cell lung cancer
Experimental group
Description:
Anlotinib combined with paclitaxel and carboplatin, phase I Anlotinib combined with paclitaxel and carboplatin, phase II
Treatment:
Drug: Anlotinib combined with paclitaxel and carboplatin, phase II
Drug: Anlotinib combined with paclitaxel and carboplatin, phase I

Trial contacts and locations

0

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Central trial contact

Zhaoyuan Shi; Yuankai Shi, MD

Data sourced from clinicaltrials.gov

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