Evaluate efficacy and safety of SHR-1701 in combination with bevacizumab and chemotherapy in advanced or metastatic non-squamous non-small-cell lung cancer with EGFR mutation after failure of TKIs
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
561
SHR-1701 + Pemetrexed Disodium + cisplatin/carboplatin + bevacizumab
Placebo + SHR-1701 + Pemetrexed Disodium+ cisplatin/carboplatin
Placebo 1 + Placebo 2 +Pemetrexed Disodium + cisplatin/carboplatin
Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and immune-related adverse events (irAEs) as per NCI-CTC AE 5.0 (Stage I)
Time frame: 2 years
BIRC-assessed progression-free survival (PFS) as per RECIST v1.1(Stage II)
Time frame: 2 years
Progression free survival (PFS)(Stage I)
Time frame: 2 years
Objective response rate (ORR)(Stage I)
Time frame: 2 years
Disease control rate (DCR) (Stage I)
Time frame: 2 years
Duration of response (DOR) (Stage I)
Time frame: 2 years
Overall survival (OS) (Stage I)
Time frame: 2 years
Progression free survival (PFS)(Stage II)
Time frame: 2 years
Objective response rate (ORR)(Stage II)
Time frame: 2 years
Disease control rate (DCR)(Stage II)
Time frame: 2 years
Duration of response (DOR) (Stage II)
Time frame: 2 years
Overall survival (OS) (Stage II)
Time frame: 2 years
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Incidence and severity of adverse events (AEs), serious adverse events (Stage II)
Time frame: 2 years
(SAEs), and immune-related adverse events (irAEs) as per NCI-CTC AE 5.0(Stage II)
Time frame: 2 years