A Phase 2 interventional study of Rh-endostatin in Staging IV NSCLC, sponsored by Guangzhou Institute of Respiratory Disease. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-02-07.
Sponsored by Guangzhou Institute of Respiratory Disease · Phase 2, Interventional, and Treatment
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
Guangzhou Institute of Respiratory Disease is the lead sponsor of 96 studies on the registry; 17 are open to participants now.
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Exclusion Criteria:
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 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.
Drug: Rh-endostatin
Squamous NSCLC: Rh-endostatin+Pembrolizumab+carboplatin or cisplatin +\[nab\]-paclitaxel during the treatment. Rh-endostatin+Pembrolizumab during the maintenance period. Non-squamous NSCLC: Rh-endostatin+Pembrolizumab+carboplatin or cisplatin +pemetrexed during the treatment. Rh-endostatin+Pembrolizumab + pemetrexed during the maintenance period.
Also known as: Pembrolizumab, carboplatin, cisplatin, pemetrexed, [nab]-paclitaxel
PFS
from the enrolment to PD or death
Time frame: 6-10 months
OS
from the enrolment to death
Time frame: 14-18 months
Plan to share: No
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This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Guangzhou Institute of Respiratory Disease