Status:
TERMINATED
Tusamitamab Ravtansine (SAR408701) in Combination With Pembrolizumab and Tusamitamab Ravtansine (SAR408701) in Combination With Pembrolizumab and Platinum-based Chemotherapy With or Without Pemetrexed in Patients With NSQ NSCLC
Lead Sponsor:
Sanofi
Conditions:
Non-squamous Non-small-cell Lung Cancer (NSQ NSCLC)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Primary Objective: * Safety run-in part: to assess the tolerability and to determine the recommended doses of tusamitamab ravtansine in combination with pembrolizumab and tusamitamab ravtansine in co...
Detailed Description
The expected duration of study intervention for participants may vary, based on disease progression date; median expected duration of study per participant is estimated at 10 months (up to 1 month for...
Eligibility Criteria
Inclusion
- Inclusion criteria :
- Histologically- or cytologically-confirmed diagnosis of advanced or metastatic NSQ NSCLC with no EGFR sensitizing mutation or BRAF mutation or ALK/ROS alterations.
- No prior systemic chemotherapy for the treatment of the participant's advanced or metastatic disease (treatment with chemotherapy and/or radiation as part of neoadjuvant/adjuvant therapy is allowed as long as completed at least 6 months prior to diagnosis of advanced or metastatic disease).
- Expression of CEACAM5 as demonstrated prospectively by a centrally assessed Immunohistochemistry (IHC) assay of ≥2+ in intensity involving at least 1% of the tumor cell population in archival tumor sample (or if not available fresh biopsy sample).
- Measurable disease based on RECIST 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
- Life expectancy of at least 3 months
- Exclusion criteria:
- Medical condition requiring concomitant administration of a medication with a strong CYP3A inhibitor.
- Uncontrolled brain metastases and history of leptomeningeal disease.
- Significant concomitant illness, including any severe medical condition that, in the opinion of the investigator or Sponsor, 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.
- History of known acquired immunodeficiency syndrome (AIDS) related illnesses or known HIV disease requiring antiretroviral treatment, or active hepatitis A, B, or C infection.
- History of active autoimmune disease that has required systemic treatment in the past 2 years.
- History of allogeneic tissue/solid organ transplantation.
- Active infection requiring IV systemic therapy within 2 weeks prior to randomization or active tuberculosis.
- Interstitial lung disease or history of pneumonitis that has required oral or IV steroids
- Non-resolution 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.
- Unresolved corneal disorder or any previous corneal disorder considered by an ophthalmologist to predict higher risk of drug-induced keratopathy. The use of contact lenses is not permitted.
- Symptomatic herpes zoster within 3 months prior to screening.
- Significant allergies to humanized monoclonal antibodies.
- Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A \[IgA\] dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).
- Concurrent treatment with any other anticancer therapy.
- Have received prior chemotherapy treatment for advanced/metastatic NSCLC.
- The patient is a candidate for a curative treatment with either surgical resection and/or chemoradiation
- Washout period before the first administration of study intervention of less than 3 weeks or less than 5 times the half-life, whichever is shorter, for any investigational treatment).
- Any prior therapy targeting CEACAM5.
- Any prior treatment with any other anti-PD-1, or PD-L1 or programmed death ligand 2 (PD-L2), anti-CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4.
- Any prior maytansinoid treatment (DM1 or DM4 ADC).
- Is receiving systemic steroid therapy ≤3 days prior to the first dose of study therapy or receiving any other form of immunosuppressive medication. Daily steroid replacement therapy or any corticosteroid premedication if applicable are allowed.
- Any radiation therapy to lung \>30 Gy within 6 months of first study intervention administration.
- Has received or will receive a live vaccine within 30 days prior to the first study intervention administration.
- Any major surgery within the preceding 3 weeks of the first study intervention administration.
- Prior/concurrent clinical study experience
- Current participation in any other clinical study involving an investigational study treatment or any other type of medical research.
- Poor organ function
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
October 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 24 2024
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT04524689
Start Date
October 26 2020
End Date
December 24 2024
Last Update
October 29 2025
Active Locations (22)
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1
KU Medical Center_Investigational Site Number :8400002
Westwood, Kansas, United States, 66205
2
Centro Avancado de Oncologia CECAN - Liga Contra o Cancer Site Number : 0760004
Natal, Rio Grande do Norte, Brazil, 59062-000
3
Centro de Investigacion y Desarrollo Oncologico (CIDO) Hochstetter 599 of. 602-603-1001, Temuco_Investigational Site Number :1520005
Temuco, La Araucanía, Chile, 4780000
4
ONCOCENTRO APYS Av. La Marina 1702, 2do piso, Viña del Mar_Investigational Site Number :1520003
Viña del Mar, Región de Valparaíso, Chile, 2520598