This study will evaluate the efficacy, safety, pharmacokinetics and immunogenicity of RC148 injection as a single agent or in combination for the treatment of locally advanced or metastatic non-small cell lung cancer
Primary objective: to evaluate the efficacy of RC148 injection as monotherapy or combination therapy in patients locally advanced or metastatic non-small cell lung cancer;
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
121
RC148; Carboplatin; Paclitaxel; pemetrexed
RC148 Monotherapy
Beijing Tiantan Hospital of Capital Medical University
Beijing, Beijing Municipality, China
Objective Response Rate (ORR)
Tumor assessment will be performed until radiographic disease progression, initiation of new anticancer therapy, withdrawal of consent, death, loss to follow-up, or other end of study criterion is met, whichever is earlier.
Time frame: 24 months
Disease Control Rate (DCR)
Tumor assessment will be performed until radiographic disease progression, initiation of new anticancer therapy, withdrawal of consent, death, loss to follow-up, or other end of study criterion is met, whichever is earlier.
Time frame: 24 months
Duration of Response (DOR)
Tumor assessment will be performed until radiographic disease progression, initiation of new anticancer therapy, withdrawal of consent, death, loss to follow-up, or other end of study criterion is met, whichever is earlier.
Time frame: 24 months
Progression-free survival (PFS)
Tumor assessment will be performed until radiographic disease progression, initiation of new anticancer therapy, withdrawal of consent, death, loss to follow-up, or other end of study criterion is met, whichever is earlier.
Time frame: 24 months
Overall survival (OS)
Tumor assessment will be performed until radiographic disease progression, initiation of new anticancer therapy, withdrawal of consent, death, loss to follow-up, or other end of study criterion is met, whichever is earlier.
Time frame: 24 months
Number of participants with adverse events (AEs)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
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Peking University Cancer Hospital
Beijing, Beijing Municipality, China
Shunde Hospital of Southern Medical University
Foshan, Guangdong, China
The First People's Hospital of Shunde
Foshan, Guangdong, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
The First affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Jiangmen Central Hospital
Jiangmen, Guangdong, China
The Second Affiliated Hospital of Guilin Medical College
Gulin, Guangxi, China
Affiliated Cancer Hospital of Guangxi Medical University
Nanning, Guangxi, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
...and 14 more locations
Time frame: 24 months
Incidence of RC148 anti-drug antibody (ADA)
Serum samples will be collected from participants for ADA analysis of RC148. The blood sampling time points and time windows are described in protocol
Time frame: 24 months
Maximum observed concentration (Cmax) of RC148
Serum concentrations of RC148 in individual subjects at different time points after RC148 administration
Time frame: 24 months