Randomized, Open Label Phase 3 study of SAR408701 versus Docetaxel in Previously Treated metastatic Non-Squamous Non-Small Cell Lung Cancer patients with CEACAM5 positive tumors
- Conditions
- metastatic lung cancerMetastatic non-squamous non-small cell lung cancer10027476
- Registration Number
- NL-OMON54679
- Lead Sponsor
- Sanofi BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 19
• At least 18 years of age or above (or countries 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 progression after platinum-based chemotherapy and immune
checkpoint inhibitor.
• Participants with carcinoembryonic antigen-related cell adhesion molecule
(CEACAM) 5 expression of >=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 effective contraceptive methods during
and for at least 7 months after the last dose of study intervention.
• A male participant who agrees to use effective contraception methods during
and for at least 6 months after the last dose of study intervention.
• Patients with untreated brain metastases and history of leptomeningeal
disease. if previously treated brain metastases no documentation of
non-progressive disease in brain within 4 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 < grade 2
according to NCI CTCAE V5.0, 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Progression free survival<br /><br>- Overal survival</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Objective response rate will be defined as the proportion of participants who<br /><br>have a complete response (CR) or partial response (PR), as best<br /><br>overall response derived from Overall Response (OR) determined by the IRC per<br /><br>RECIST 1.1<br /><br>- Health related quality of life by means of questionnaires EORTC QLQ-LC13 and<br /><br>EORTC QLQ C-30<br /><br>- Incidence of TEAEs and SAEs and laboratory abnormalities according to NCI<br /><br>CTCAE V5<br /><br>- Duration of response (DOR) is defined as the time from first documented<br /><br>evidence of CR or PR until progressive disease (PD) determined per RECIST 1.1<br /><br>or death from any cause</p><br>