The primary objectives of this study are to assess if SAR408701 has a better progression free survival and general overall survival compared to docetaxel, and main secondary endpoints are objective response rate, time to deterioration on health…
ID
Source
Brief title
Condition
- Metastases
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Progression free survival
- Overal survival
Secondary outcome
- 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 derived from Overall Response (OR) determined by the IRC per
RECIST 1.1
- Health related quality of life by means of questionnaires EORTC QLQ-LC13 and
EORTC QLQ C-30
- Incidence of TEAEs and SAEs and laboratory abnormalities according to NCI
CTCAE V5
- Duration of response (DOR) is defined as the time from first documented
evidence of CR or PR until progressive disease (PD) determined per RECIST 1.1
or death from any cause
Background summary
A protein called CEACAM5 is expressed at the surface of some types of cancer
including lung cancer. SAR408701 consists of a drug component called DM4. DM4
is linked to an antibody; this is a protein in the blood that protects the body
against bacteria and viruses. It can recognize abnormal cells and binds to the
surface of these cells. The antibody component of SAR408701 binds to the
CEACAM5 antigen expressed at the surface of the tumor cell. Then SAR408701
enters the tumor cells and the drug DM4 kills the cell.
Study objective
The primary objectives of this study are to assess if SAR408701 has a better
progression free survival and general overall survival compared to docetaxel,
and main secondary endpoints are objective response rate, time to deterioration
on health related quality of life, safety and duration of response. Also only
for SAR408701 arm, pharmokinetics and development of antibody to SAR408701 will
be analyzed.
The crossover phase only has tertiary endpoints: to assess the safety and
objective response rate of crossover SAR408701 treatment after documented
disease progression on docetaxel treatment
Study design
Phase 3, randomized, open label, parallel.
Intervention
SAR408701, intravenous infusion, once every two weeks.
Docetaxel, intravenous infusion, once every three weeks.
Cross-over treatment after docetaxel (optional): SAR408701, intravenous
infusion, once every 2 weeks.
Study burden and risks
Burden and risks are related to the blood sampling, CT or MRI scan (radation
burden), biopsy and possible side effects of the study medication.
Paasheuvelweg 25
Amsterdam 1105 BP
NL
Paasheuvelweg 25
Amsterdam 1105 BP
NL
Listed location countries
Age
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 6 months after the last dose of study intervention.
Exclusion criteria
• 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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | 2019-001273-81 |
| EudraCT | EUCTR2019-001273-81-NL |
| CCMO | NL71128.100.19 |