To assess the efficacy and safety of D-0316 versus Icotinib, a standard of care epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI), in patients with locally advanced or Metastatic Non Small Cell Lung Cancer (NSCLC).
Name: D-0316 Capsule
Name: Icotinib Hydrochloride Tablets
Description: PFS is defined as the time from randomization until the date of objective disease progression or death by any cause, whichever occurs first. The primary endpoint of PFS was based on independent review committee (IRC) assessment.
Measure: Median Progression Free Survival (PFS) assessed by IRC Time: From randomization to objective disease progression or death, whichever came first, assessed up to 20 monthsDescription: PFS is defined as the time from randomization until the date of objective disease progression or death by any cause, whichever occurs first.
Measure: Median Progression Free Survival (PFS) assessed by Investigator Time: From randomization to objective disease progression or death, whichever came first, assessed up to 20 monthsDescription: ORR is defined as the percentage (%) of participants with measurable disease with a best overall response of complete response (CR) or partial response (PR). ORR was based on investigator and IRC assessment.
Measure: Objective Response Rate (ORR) Time: At baseline and every 6 weeks (±4 days) until disease progression, up to 20 monthsDescription: DoR is defined as the time from the date of first documented response (CR or PR) until the date of documented progression or death in the absence of disease progression. DoR was based on both Investigator and IRC assessment.
Measure: Duration of Response (DoR) Time: At baseline and every 6 weeks (±4 days) until disease progression, up to 20 monthsDescription: DCR is defined as the percentage (%) of participants who had a best overall response (BOR) of CR, PR or Stable disease (SD) ≥6 weeks prior to any progressive disease (PD) event, assessed by investigator and IRC.
Measure: Disease Control Rate (DCR) Time: At baseline and every 6 weeks (±4 days) until disease progression, up to 20 monthsDescription: OS is defined as the time from randomization until the date of death due to any cause.
Measure: Overall Survival (OS) Time: From randomization to date of death from any cause, whichever came first, up to 36 monthsDescription: iORR is calculated as the ORR (CR+PR) of lesions in the brain for patients who have measurable disease in the brain at baseline. iORR was based on both Investigator and IRC assessment.
Measure: Intracranial ORR (iORR) Time: At baseline and every 6 weeks (±4 days) until disease progression, up to 20 monthsDescription: iPFS is defined as time from randomization to intracranial disease progression or death due to any causes, assessed by investigator and IRC.
Measure: Intracranial PFS (iPFS) Time: From randomization to objective intracranial disease progression or death, whichever came first, up to 20 monthsDescription: AE is defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study medication, whether or not considered related to the study medication. AEs are summarized by type, incidence, severity and relationship to study medication.
Measure: Adverse event (AE) Time: At baseline and every 3 weeks (±4 days) for the first 6 weeks, and then every 6 weeks (±4 days) until objective disease progression or meet other withdrawal criteria, up to 36 monthsDescription: The FACT-L questionnaire consists of several major aspects of life (Physical, social/family, emotional, and functional well-being) as well as lung cancer subscale (symptoms, cognitive function, regret of smoking). Scores for item ranging from 0 (not at all) to 4 (very much).
Measure: Change From Baseline Scores on the functional assessment of cancer therapy - Lung (FACT-L) quality of life questionnaire Time: At baseline and every 6 weeks (±4 days) until disease progression, up to 20 monthsAllocation: Randomized
Parallel Assignment
There is one SNP
- The tumour tissues harbour one of the two common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations, assessed by central laboratory. --- L858R ---