The purpose of this project is to evaluate progression-free survival (PFS) of D-1553 Tablet versus Docetaxel Injection in subjects with prior standard therapy failure kirsten rat sarcoma viral oncogene (KRAS) G12C mutation positive locally advanced or metastatic non small cell lung cancer (NSCLC), progression-free survival (PFS) as assessed by the Independent Review Committee (IRC) based on RECIST 1.1 was used as the primary endpoint.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
522
D-1553 is a KRAS inhibitor.
Docetaxel, is an anti-tumor drug, significantly reduces the number of free tubules by promoting tubule polymerization into stable microtubules and inhibiting their depolymerization.
Anhui Province Hospital
Hefei, Anhui, China
NOT_YET_RECRUITINGCancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGXuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGBeijing Cancer Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGProgression-free survival (PFS)
Time from subject randomization (first treatment) to first disease progression or death from any cause, whichever occurred first, was assessed by an independent Review Committee (IRC) per Response evaluation criteria in solid tumors (RECIST) 1.1.
Time frame: Baseline up to 3 years
Overall survival (OS)
From randomization to the time of death from any cause.
Time frame: Baseline up to 3 years
Objective mitigation rate (ORR)
According to RECIST 1.1 criteria, proportion of patients with confirmed tumor volume reduction to pre-specified values and maintained minimum requirements , namely the proportion of patients with complete response (CR) and partial response (PR).
Time frame: Baseline up to 3 years
Duration of Response (DOR)
From the time of tumor first evaluated as complete or partial response to the time of first disease progression or death from various causes.
Time frame: Baseline up to 3 years
Disease control rate (DCR)
According to RECIST 1.1 criteria, proportion of patients with confirmed tumor volume reduction to pre-specified values and maintained minimum requirements , namely the proportion of patients with CR, PR and stable disease (SD).
Time frame: Baseline up to 3 years
Time to response (TTR)
Time from patient randomization (first treatment) to first response per RECIST 1.1 criteria
Time frame: Baseline up to 3 years
Patient-reported outcome (PRO)
Reports of their health status directly from patients
Time frame: Baseline up to 3 years
Abnormal laboratory test indicators
The occurrence of laboratory test indicators exceed the normal range
Time frame: From the subject signed the informed consent form to 30 days after the last dose
Adverse event rate
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs)
Time frame: From the subject signed the informed consent form to 30 days after the last dose
Time to Maximum Plasma Concentration (Tmax)
Time to maximum plasma concentration after dosing
Time frame: Pre-dose and 2 hours after D1553 administration on Day 1 of cycle 1 and cycle 3. Each cycle is 21 days.
Half life (t1/2)
Time required for plasma concentrations to drop by half
Time frame: Pre-dose and 2 hours after D1553 administration on Day 1 of cycle 1 and cycle 3. Each cycle is 21 days.
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Peking University Third Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGBeijing Chest Hospital,Capital Medical University
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGThe Fifth medical center of Chinese PLA General Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGThe Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
NOT_YET_RECRUITINGChongqing Cancer Hospital
Chongqing, Chongqing Municipality, China
NOT_YET_RECRUITINGThe Southwest hospital of AMU
Chongqing, Chongqing Municipality, China
NOT_YET_RECRUITING...and 76 more locations