The objective of this study is to assess the similarity between QL1101 and Avastin® respectively combined with chemotherapy in terms of efficacy and safety in patients with non-squamous non-small cell lung cancer. The study intends to include first-line patients with non-squamous non-small cell lung cancer, and uses QL1101 combined with basic chemotherapy CP (paclitaxel + carboplatin). The regimen is consistent with the usage and dosage of Avastin® at home and abroad indicated for the treatment of non-squamous non-small cell lung cancer.
The study is a randomized, double-blind, positive drug-controlled, multi-center Phase III study. It is planned to enroll 512 treatment-naïve patients with non-squamous non-small cell lung cancer (NSCLC). Subjects are randomized into the QL1101 combined with paclitaxel/carboplatin or Avastin® combined with paclitaxel/carboplatin treatment group by a ratio of 1:1, and stratified by age (≥65 years, \<65 years), sex (male, female) and EGFR subtype (sensitive mutation type, wild type).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
535
targeted vascular endothelial growth factor (VEGF) monoclonal antibodies
targeted vascular endothelial growth factor (VEGF) monoclonal antibodies
175 mg/m2, IV (in the vein) following investigational product on day 1 of each 21 day cycle. Number of cycles 4-6.
AUC 5 IV, (in the vein) following paclitaxel on day 1 of each 21 day cycle. Number of cycles: 4-6.
Shanghai Chest hospital
Shanghai, China
Tianjin Chest hospital
Tianjin, China
Objective response rate
The actual endpoint is best response seen during the study
Time frame: 18 weeks
Disease control rate
DOR is defined as the time from the first tumor evaluation as CR or PR to the first evaluation as PD or death
Time frame: 3 months, 6 months, 9 months, 1 year
Overall survival (OS)
OS is defined as the time from randomization and grouping to patient death due to various causes. For patients who are lost to follow-up, the date when they were contacted for the last time will be used as the cut off time.
Time frame: 18 months after enrollment and randomization of the last case
Progression-free survival (PFS)
PFS is defined as the time from randomization and grouping to PD or death.
Time frame: 18 months after enrollment and randomization of the last case
Treatment-emergent adverse events
Assessment following therapy with either QL1101 or avastin
Time frame: 18 weeks
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