The Study of Tusamitamab Ravtansine (IBI126) Combined With Sintilimab and Tusamitamab Ravtansine (IBI126) Combined With Sintilimab Plus Platinum-based Chemotherapy and Pemetrexed in Subjects With CEACAM5 Positive Expression Advanced/Metastatic Non-squamous Non-small-cell Lung Cancer (NSQ NSCLC)
- Conditions
- Non-squamous Non-small-cell Lung Cancer
- Interventions
- Drug: Tusamitamab ravtansine+SintilimabDrug: Tusamitamab ravtansine+Sintilimab+Carboplatin or Cisplatin+PemetrexedDrug: Sintilimab+Carboplatin or Cisplatin+Pemetrexed
- Registration Number
- NCT05849246
- Lead Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Brief Summary
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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 4
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description tusamitamab ravtansine + sintilimab Tusamitamab ravtansine+Sintilimab Sintilimab dose will be administered intravenously prior to intravenous administration of tusamitamab ravtansine dose every 3 weeks. Tusamitamab ravtansine + Sintilimab + carboplatin/ cisplatin + pemetrexed Tusamitamab ravtansine+Sintilimab+Carboplatin or Cisplatin+Pemetrexed Sintilimab dose will be administered intravenously prior to intravenous adminstration of tusamitamab ravtansine dose every 3 weeks. Pemetrexed will be infused over 10 minutes after tusamitamab ravtansine infusion on Day 1 and then Q3W. Carboplatin / cisplatin will be infused over 15 to 60 minutes immediately after pemetrexed infusion on Day 1 and Q3W for the first 4 cycles. Sintilimab + carboplatin/ cisplatin + pemetrexed Sintilimab+Carboplatin or Cisplatin+Pemetrexed Pemetrexed will be infused over 10 minutes after Sintilimab infusion on Day 1 and then Q3W. Carboplatin/ cisplatin will be infused over 15 to 60 minutes immediately after pemetrexed infusion on Day 1 and Q3W for the first 4 cycles.
- Primary Outcome Measures
Name Time Method Overall Response Rate (ORR) per RECIST 1.1 by investigators. 3 years ORR is defined as proportion of participants who have a confirmed complete
- Secondary Outcome Measures
Name Time Method Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and laboratory abnormalities 3 years TEAEs, SAEs and laboratory abnormalities according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).
Pharmacokinetic concentrations of tusamitamab ravtansine (IBI126) 3 years Duration of Response (DoR) 3 years DoR is defined the time when subject reaches complete or partial response for the first time to the progression of the disease.
Progression-free Survival (PFS) 3 years Time to Response (TTR) 3 years Disease Control Rate (DCR) 3 years
Trial Locations
- Locations (1)
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital🇨🇳Hangzhou, Zhejiang, China