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

Stopped early · Phase 2

Conditions studied: Non-squamous Non-small-cell Lung Cancer (NSQ NSCLC)

In brief

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 combination with pembrolizumab and platinum-based chemotherapy with or without pemetrexed to be tested in the expansion part of the study in the NSQ NSCLC population * Expansion part (including participants treated at the recommended dose for expansion \[RDE\] from the Safety Run-in part): to assess the antitumor activity of several dose levels (DLs; if applicable) of tusamitamab ravtansine in combination with pembrolizumab and of several DLs of tusamitamab ravtansine in combination with pembrolizumab, platinum-based chemotherapy, and pemetrexed in the NSQ NSCLC population Secondary Objectives: * To assess the safety and tolerability of several DLs (if applicable) of tusamitamab ravtansine in combination with pembrolizumab and of 1 DL of tusamitamab ravtansine in combination with pembrolizumab and platinum-based chemotherapy, and of several DLs of tusamitamab ravtansine in combination with pembrolizumab, and platinum-based chemotherapy with pemetrexed in the NSQ NSCLC population * To assess the antitumor activity of several DLs (if applicable) of tusamitamab ravtansine in combination with pembrolizumab and of 1 DL of tusamitamab ravtansine in combination with pembrolizumab and platinum-based chemotherapy, and of several DLs of tusamitamab ravtansine in combination with pembrolizumab, platinum-based chemotherapy, and pemetrexed in the NSQ NSCLC population * To assess the durability of the response to treatment with several DLs (if applicable) of tusamitamab ravtansine in combination with pembrolizumab and of 1 DL of tusamitamab ravtansine in combination with pembrolizumab and platinum-based chemotherapy, and of several DLs of tusamitamab ravtansine in combination with pembrolizumab and platinum-based chemotherapy, and pemetrexed in the NSQ NSCLC population * To assess the antitumor activity of tusamitamab ravtansine in combination with pembrolizumab and platinum-based chemotherapy in the NSQ NSCLC population * To assess the pharmacokinetics (PK) of tusamitamab ravtansine, pembrolizumab, pemetrexed, cisplatin, and carboplatin, each when given in combination as a doublet (tusamitamab ravtansine + pembrolizumab) or a triplet (tusamitamab ravtansine + pembrolizumab + platinum-based chemotherapy) or a quadruplet (tusamitamab ravtansine + pembrolizumab + platinum-based chemotherapy + pemetrexed) * To assess the immunogenicity of tusamitamab ravtansine in combination with pembrolizumab and tusamitamab ravtansine in combination with pembrolizumab and platinum based chemotherapy with or without pemetrexed

Key facts

Study ID

NCT04524689

Run by

Sanofi

People needed

57

Starts

2020-10-26

Expected to finish

2024-12-24

Last updated by the study team

2025-10-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• KU Medical Center_Investigational Site Number :8400002 — Westwood, Kansas, United States
• Centro Avancado de Oncologia CECAN - Liga Contra o Cancer Site Number : 0760004 — Natal, Rio Grande do Norte, Brazil
• Centro de Investigacion y Desarrollo Oncologico (CIDO) Hochstetter 599 of. 602-603-1001, Temuco_Investigational Site Number :1520005 — Temuco, La Araucanía, Chile
• ONCOCENTRO APYS Av. La Marina 1702, 2do piso, Viña del Mar_Investigational Site Number :1520003 — Viña del Mar, Valparaiso, Chile
• Orlandi Oncologia General Salvo 159, Providencia_Investigational Site Number :1520002 — Santiago, Chile
• ICEGCLINIC Avenida Serafín Zamora 190 Torre B, piso 4. La Florida_Investigational Site Number :1520006 — Santiago, Chile
• Fakultní nemocnice Olomouc Onkologická klinika I.P. Pavlova 6_Site Number :2030001 — Olomouc, Czechia
• Nemocnice AGEL Ostrava - Vitkovice Plicní oddělení Zalužanského 2214/35_Site Number :2030002 — Ostrava - Vitkovice, Czechia
• Institut Sainte-Catherine 250 Chemin de Baigne-Pieds_Investigational Site Number :2500005 — Avignon, France
• CHRU BREST 5 Avenue Foch_Investigational Site Number :2500003 — Brest, France
• Centre François Magendie Hôpital du Haut Lévèque Av.de Magellan_Investigational Site Number :2500001 — Pessac, France
• Pôle régional de Cancérologie 2 rue de la Milèterie BP 577_Investigational Site Number :2500004 — Poitiers, France
• Országos Onkológiai Intézet Ráth György u. 7_Investigational Site Number :3480002 — Budapest, Hungary
• Veszprém Megyei Tüdőgyógyintézet 049/2 Hrsz_Investigational Site Number :3480004 — Farkasgyepü, Hungary
• Investigational Site Number : 3760001 — Ramat Gan, Israel
• Investigational Site Number : 3760002 — Tel Aviv, Israel
• Investigational Site Number : 7240005 — A Coruña, A Coruña [La Coruña], Spain
• Investigational Site Number : 7240006 — Badalona, Catalunya [Cataluña], Spain
• Investigational Site Number : 7240007 — Oviedo, Principality of Asturias, Spain
• Investigational Site Number : 7240002 — Las Palmas, Spain
• Investigational Site Number : 7240004 — Madrid, Spain
• Investigational Site Number : 7240001 — Madrid, Spain

Full record on ClinicalTrials.gov

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