SAR408701 versus docetaxel in previously treated, carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) positive metastatic non-squamous non-small-cell lung cancer patients

JRCT ID: jRCT2080225013

Registered date:10/01/2020

Basic Information

• Recruitment status: completed
• Health condition(s) or Problem(s) studied: Non-small cell lung cancer metastatic
• Date of first enrollment: 06/03/2020
• Target sample size: 450
• Countries of recruitment: Argentina,Australia,Belgium,Brazil,Bulgaria,Canada,Chile,China,France,Germany,Greece,Hungary,India,Israel,Italy,Republic of Korea,Lithuania,Mexico,Netherlands,Poland,Portugal,Romania,Russian Federation,Singapore,Spain,Turkey,United Kingdom,United States,Japan
• Study type: Interventional

Intervention(s)

SAR408701 (tusamitamab ravtansine) arm:
- Drug: Tusamitamab ravtansine (SAR408701)
- - Pharmaceutical form: Concentrate for solution for intravenous infusion, Route of administration: intravenous (IV) infusion

Docetaxel arm:
- Drug: Docetaxel
- - Pharmaceutical form: Concentrate for solution for intravenous infusion, Route of administration: IV infusion

Outcome(s)

Primary Outcome

1. Progression free survival (PFS)
[Time Frame for evaluation: Baseline to up to approximately 15 months]
PFS will be defined as the time from randomization to the date of the first documented disease progression or death of any cause, whichever comes first.
2. Overall Survival (OS)
[Time Frame for evaluation: Baseline up to approximately 2 years]
OS will be defined as the time of randomization to the date of death due to any cause.

Secondary Outcome

1. Objective response rate (ORR)
[Time Frame for evaluation: Baseline up to approximately 2 years]
ORR will be defined as the proportion of participants who have a complete response (CR) or partial response (PR), as best overall response derived from Overall Response (OR) determined by the Independent Radiology Review Committee (IRC) per Response Evaluation Criteria in Solid Tumor (RECIST) 1.1
2. Health related quality of life (HRQOL) - disease related symptoms
[Time Frame for evaluation: Baseline up to median 12 months]
Time to deterioration (TTD) in disease related symptoms as determined by European Organization for Research and Treatment for Cancer (EORTC)- Quality of life Questionnaire (QLQ)-Lung Cancer (LC)13
3. Health related quality of life (HRQOL) - physical function
[Time Frame for evaluation: Baseline up to median 12 months]
TTD in physical function as determined by EORTC QLQ C30
4. Health related quality of life (HRQOL) - role function
[Time Frame for evaluation: Baseline up to median 12 months]
TTD in role function as determined by EORTC QLQ C30
5. Number of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
[Time Frame for evaluation: Baseline up to end of study (approximately 2 years)]
Incidence of TEAEs and SAEs and laboratory abnormalities according to NCI CTCAE V5
6. Duration of response (DOR)
[Time Frame for evaluation: Baseline up to approximately 2 years]
Duration of response (DOR) is defined as the time from first documented evidence of complete response (CR) or partial response (PR) until progressive disease (PD) determined per RECIST 1.1 or death from any cause, whichever occurs first.

Key inclusion & exclusion criteria

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

Include criteria

- At least 18 years of age or above (or country's legal age of maturity if above 18 years) and signed the informed consent.
- Histologically or cytologically proven diagnosis of non-squamous NSCLC with metastatic disease at study entry; progression after platinum-based chemotherapy and immune checkpoint inhibitor.
- Participants with carcinoembryonic antigen-related cell adhesion molecule (CEACAM) 5 expression of greater than or equal to 2+ in archival tumor sample (or if not available, fresh biopsy sample) involving at least 50 % of the tumor cell population as demonstrated prospectively by central laboratory via immune histochemistry (IHC).
- At least one measurable lesion by RECIST v1.1 as determined by local site investigator /radiologist assessment.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- A female participant who agrees to use highly effective contraceptive methods during and for at least 7 months after the last dose of study intervention.
- A male participant who agrees to use highly effective contraception methods during and for at least 6 months after the last dose of study intervention.

Exclude criteria

Participants are excluded from the study if any of the following criteria apply:
- Patients with untreated brain metastases and history of leptomeningeal disease. if previously treated brain metastases no documentation of non-progressive disease in brain by imaging performed at least 4 weeks after CNS directed treatment and at least 2 weeks prior to the first dose of study intervention.
- Significant concomitant illnesses, including all severe medical conditions that would impair the patient's participation in the study or interpretation of the results.
- 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.
- Non-resolution of any prior treatment related toxicity to less than grade 2 according toNational Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version (V) 5.0, except for alopecia, vitiligo and active thyroiditis controlled with hormonal replacement therapy
- History of known acquired immunodeficiency syndrome (AIDS) related illnesses or known HIV disease requiring antiretroviral treatment, or unresolved viral hepatitis
- Previous history of and/or unresolved corneal disorders. The use of contact lenses is not permitted.
- Concurrent treatment with any other anticancer therapy.
- Prior treatment with docetaxel or maytansinoid derivatives (DM1 or DM4 antibody drug conjugate) or any drug targeting CEACAM5.
- Contraindication to use of corticosteroid premedication.
- Previous enrollment in this study and current participation in any other clinical study involving an investigational study treatment or any other type of medical research.
- Poor bone marrow, liver or kidney functions
- Hypersensitivity to any of the study interventions, or components thereof (EDTA), or drug (paclitaxel, polysorbate 80) or other allergy that, in the opinion of the Investigator, contraindicates participation in the study.

Related Information

• Primary Sponsor: Sanofi K.K.
• Secondary Sponsor: -
• Source(s) of Monetary Support: -
• Secondary ID(s): NCT04154956,2019-001273-81,JapicCTI-205105