Tusamitamab ravtansine in NSQ NSCLC participants with negative or moderate CEACAM5 expression tumors and high circulating CEA

JRCT ID: jRCT2011220001

Registered date:12/04/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Non-squamous non-small cell lung cancer
• Date of first enrollment: 11/09/2023
• Target sample size: 38
• Countries of recruitment: Spain,Japan,Belgium,Japan,France,Japan,Italy,Japan,Turkey,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

Drug: Tusamitamab ravtansine (SAR408701)
Pharmaceutical Form: Concentrate for solution, Route of Administration: Intravenous infusion

Outcome(s)

Primary Outcome

1. Objective Response Rate (ORR) [ Time Frame: Baseline up to approximately 9 months after last patient treated ]
Objective Response Rate (ORR), defined as the proportion of participants who have a confirmed complete response (CR) or partial response (PR) as best overall response (BOR) per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1

Secondary Outcome

1. Incidence of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and laboratory abnormalities [ Time Frame: Baseline up to approximately 90 days after the last study treatment administration ]
Incidence of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and laboratory abnormalities according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0

2. Progression-free survival (PFS) [ Time Frame: Baseline up to approximately 9 months after last patient treated ]
PFS defined as the time from the date of first tusamitamab ravtansine administration to the date of the first documented disease progression or death due to any cause, whichever comes first.

3. Disease control rate (DCR) [ Time Frame: Baseline up to approximately 9 months after last patient treated ]
DCR defined as the percentage of participants who have achieved confirmed CR or PR, or stable disease as BOR per RECIST v1.1

4. Duration of response (DOR) [ Time Frame: Baseline up to approximately 9 months after last patient treated ]
DOR, defined as the time from first documented evidence of CR or PR until progressive disease (PD) determined per RECIST v1.1 or death from any cause, whichever occurs first.

5. Incidence of participants with anti-therapeutic antibodies (ATAs) against tusamitamab ravtansine [ Time Frame: Baseline up to approximately 30 days after the last study treatment administration ]

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Histologically or cytologically proven diagnosis of NSQ NSCLC metastatic disease at study entry; progression after platinum-based chemotherapy and immune checkpoint inhibitor.
- Participants with moderate or negative CEACAM5 expression as demonstrated prospectively by central laboratory via immune histochemistry (IHC) and high circulating CEA levels (>=100 ng/mL). Moderate CEACAM5 expression is defined as intensity >= 2 + in >= 1% and <50 % of tumor cells. Negative CEACAM5 expression is defined as intensity of 1 + whatever the percentage of stained tumor cells or <1% of tumor cells.
- At least one measurable lesion by RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Women of childbearing potential or male patient with women of childbearing potential who agree to use highly effective method of birth control.

Exclude criteria

- Patients with untreated brain metastases or history of leptomeningeal disease.
- History within the last 3 years of an invasive malignancy other than the one treated in this study, with the exception of resected/ablated basal or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix, or other local tumors considered cured by local treatment.
- History of known uncontrolled infection with human immunodeficiency virus (HIV), or unresolved viral hepatitis
- Significant concomitant illness that could impair the participation in the study or interpretation of the results or any major surgery with 3 weeks prior treatment administration
- Nonresolution of any prior treatment-related toxicity to <Grade 2 according to NCI CTCAE v5.0, with the exception of alopecia, vitiligo, or active thyroiditis controlled with hormone replacement therapy.
- Previous history of and/or unresolved corneal disorders. The use of contact lenses is not permitted.
- Prior treatment with maytansinoid derivatives (DM1 or DM4 antibody drug conjugate) or any drug targeting CEACAM5.
- Concurrent treatment with any other anticancer therapy
- Poor bone marrow, liver or kidney functions.

Related Information

• Primary Sponsor: Tanaka Tomoyuki
• Secondary ID(s): NCT05245071,2021-004423-32