Non-small cell lung cancer metastatic MedDRA version: 21.1 Level: PT Classification code 10059515 Term: Non-small cell lung cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Code: SAR408701
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Not available
Current Sponsor code: SAR408701
Other descriptive name: SAR408701
Concentration un
Sponsors
sanofi-aventis recherche & développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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 4 months after the last dose of study intervention. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 433 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 217
Exclusion criteria
Exclusion 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Study is designed with two primary endpoints that will be analyzed on randomized participants at the time of the cutoff date for each given analysis (progressive free survival [PFS] and overall survival [OS]) Study success is defined either on PFS or OS The primary objective is to determine whether SAR408701 improves the progression free survival (PFS) when compared to docetaxel in participants with metastatic non-squamous NSCLC expressing CEACAM5 =2+ in intensity in at least 50% of the tumor cell population and previously treated with standard-of-care platinum-based chemotherapy and an immune checkpoint inhibitor (ICI) The primary objective is to determine whether SAR408701 improves the overall survival (OS) when compared with docetaxel in participants with metastatic non-squamous NSCLC expressing CEACAM5 =2+ in intensity in at least 50% of the tumor cell population and previously treated with standard-of-care platinum-based chemotherapy and an immune checkpoint inhibitor;Secondary Objective: • To compare the objective response rate (ORR) of SAR408701 with docetaxel • To compare the health related quality of life (HRQOL) of SAR408701 with docetaxel • To evaluate the safety of SAR408701 compared to docetaxel • To assess the duration of response (DOR) of SAR408701 compared to docetaxel;Primary end point(s): 1- Progression free survival (PFS) : 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) : OS will be defined as the time of randomization to the date of death due to any cause.;Timepoint(s) of evaluation of this end point: 1- Baseline to up to approximately 15 months 2- Baseline up to approximately 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1- Objective response rate (ORR) : Objective response rate will be defined as the proportion of participants who have a complete response (CR) or partial response (PR), as best overall response 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 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: TTD in physical function as determined by EORTC QLQ C30 4- Health related quality of life (HRQOL) - role function: 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): Incidence of TEAEs and SAEs and laboratory abnormalities according to NCI CTCAE V5 6- Duration of response (DOR) : 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;Timepoint(s) of evaluation of this end point: 1- Baseline up to approximately 2 years 2-3-4- Baseline up to median 12 months 5- Baseline up to end of study (approximately 2 years) 6- Baseline up to approximately 2 years | — |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, China, France, Germany, Greece, Hungary, Israel, Italy, Japan, Korea, Republic of, Lithuania, Mexico, Netherlands, Poland, Portugal, Romania, Russian Federation, Spain, Turkey, Ukraine, United States
Contacts
Public ContactUnidad de Estudios Clínicos
sanofi-aventis, s.a.
Outcome results
None listed