Primary objective: ·To assess the antitumor activity of tusamitamab ravtansine in combination with sintilimab and tusamitamab ravtansine in combination with sintilimab, platinum-based chemotherapy and pemetrexed in the NSQ NSCLC population. Secondary objectives: To assess the safety and tolerability of tusamitamab ravtansine in combination with sintilimab and tusamitamab ravtansine in combination with sintilimab, platinum-based chemotherapy and pemetrexed in the NSQ NSCLC population. To assess the pharmacokinetic (PK) characteristic of tusamitamab ravtansine in combination with sintilimab and tusamitamab ravtansine in combination with sintilimab, platinum-based chemotherapy and pemetrexed in the NSQ NSCLC population.
The expected duration of the study intervention for participants may vary based on progression date; median expected duration of study per participant is estimated 10 months (up to 1 month for screening, a median of 6 months for treatment, and a median of 3 months for end-of-treatment assessments and safety follow-up visit).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
4
Pharmaceutical form: Concentrate for solution for infusion Route of administration: Intravenous. Other Name: Tusamitamab ravtansine. Other Name: Tyvyt®
Pharmaceutical form: Concentrate for solution for infusion Route of administration: Intravenous
Pharmaceutical form:Concentrate for solution for infusion Route of administration: Intravenous. Other Name: Tusamitamab ravtansine. Other Name: Tyvyt®
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Overall Response Rate (ORR) per RECIST 1.1 by investigators.
ORR is defined as proportion of participants who have a confirmed complete
Time frame: 3 years
Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and laboratory abnormalities
TEAEs, SAEs and laboratory abnormalities according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).
Time frame: 3 years
Pharmacokinetic concentrations of tusamitamab ravtansine (IBI126)
Time frame: 3 years
Duration of Response (DoR)
DoR is defined the time when subject reaches complete or partial response for the first time to the progression of the disease.
Time frame: 3 years
Progression-free Survival (PFS)
Time frame: 3 years
Time to Response (TTR)
Time frame: 3 years
Disease Control Rate (DCR)
Time frame: 3 years
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