Staging IV NSCLC Clinical Trial
Official title:
Efficacy and Safety of Rh-endostatin（Endostar）Combined With Platinum-based Doublet Chemotherapy and Pembrolizumab as First Line Therapy in Patients With Advanced or Metastatic Non-small-cell Lung Cancer
The aim of this study was to investigate that efficacy and safety of rh-endostatin（Endostar）combined with platinum-based doublet chemotherapy and Pembrolizumab as first line therapy in patients with advanced or metastatic non-small-cell lung cancer.
The study design is a single arm. The subjects are 186, including Squamous and Non-Squamous
NSCLC. Squamous NSCLC receives rh-endostatin at a dose of 15mg/m2 for 5 days and 200 mg of
pembrolizumab at day 1 in each cycle, repeating every 3 weeks till to PD or unacceptable
toxicities. all the patients with squamous NSCLC also receive carboplatin (5U/AUC) or
cisplatin ( 75mg/m2) and [nab]-paclitaxel (100mg/m2) for the first 4 cycles. For non-squamous
NSCLC, rh-endostatin at a dose of 15mg/m2 for 5 days, 200 mg of pembrolizumab at day 1 and
pemetrexed (500mg/m2,d1) are given in each cycle, repeating every 3 weeks till to PD or
unacceptable toxicities. Non-squamous NSCLC also receive carboplatin (5U/AUC) or cisplatin (
75mg/m2) and pemetrexed (500mg/m2,d1) for the first 4 cycles. The radiographic evaluation
will be taken place at baseline, 6 and 12 weeks after treatment and every 9 weeks thereafter
based on Recist 1.1, till to PD or unacceptable toxicities. After that, survival follow-up is
going on every 3 months till to the death. The safety evaluation is based on CTCAE 4.0. In
addition to the above, the examination of ct DNA and PD-L1 for tumor sample and peripheral
blood is taken at the baseline, and also examination of ct DNA and PD-L1 for peripheral blood
at week 6 and 12 of treatment and at the time of PD.
Primary endpoint: .PFS Secondary endpoints:OS,ORR,DCR and safety
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