Lung Cancer Clinical Trial

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 (CARMEN-LC05)

Summary

Primary Objective:

•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 in the NSQ NSCLC population

Secondary Objectives:

To assess the safety and tolerability of tusamitamab ravtansine in combination with pembrolizumab and tusamitamab ravtansine in combination with pembrolizumab and platinum-based chemotherapy with or without pemetrexed
To assess the antitumor activity of tusamitamab ravtansine in combination with pembrolizumab and tusamitamab ravtansine in combination with pembrolizumab, and platinum-based chemotherapy, with or without pemetrexed 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 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

View Full Description

Full Description

The expected duration of the study intervention for participants may vary based on progression date; median expected duration of study per participant is estimated 10 months (up to 1 month for screening, a median of 6 months for treatment, and a median of 3 months for end-of-treatment assessments and safety follow-up visit).

View Eligibility Criteria

Eligibility Criteria

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
Capable of giving signed informed consent

Exclusion criteria:

Medical condition requiring concomitant administration of a medication with a narrow therapeutic window and metabolized by CYP450 or a strong CTP3A 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.

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

120

Study ID:

NCT04524689

Recruitment Status:

Recruiting

Sponsor:

Sanofi

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There are 27 Locations for this study

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KU Medical Center_Investigational Site Number :8400002
Westwood Kansas, 66205, United States More Info
Ashley Vallandingham
Contact
913-588-0512
[email protected]
Chao Huang
Principal Investigator
Renovatio Clinical_Investigational Site Number :8400004
The Woodlands Texas, 77380, United States More Info
Nessrine Benchaita
Contact
832-703-9168
[email protected]
Maya Fleyhan
Contact
713-703-6347
[email protected]
Jonathan Lu
Principal Investigator
Virginia Cancer Specialists_Investigational Site Number :8400001
Fairfax Virginia, 22031, United States More Info
Carrie Friedman
Contact
703-636-1473
[email protected]
Alexander Spira
Principal Investigator
Centro de Investigacion y Desarrollo Oncologico (CIDO) Hochstetter 599 of. 602-603-1001, Temuco_Investigational Site Number :1520005
Temuco La Araucanía, 47800, Chile More Info
Felipe Rey
Contact
56452657374
[email protected]
Nicolás Salazar
Contact
56452657374
[email protected]
Felipe Rey, MD
Principal Investigator
ONCOCENTRO APYS Av. La Marina 1702, 2do piso, Viña del Mar_Investigational Site Number :1520003
Viña del Mar Valparaíso, 25205, Chile More Info
Alejandro Acevedo
Contact
56 323320850
[email protected]
Valentina Vargas
Contact
56 323320850
[email protected]
Alejandro Acevedo, MD
Principal Investigator
Orlandi Oncologia General Salvo 159, Providencia_Investigational Site Number :1520002
Santiago , 75007, Chile More Info
Francisco Orlandi
Contact
56 2 24339699
[email protected]
Alessandra Mafucci
Contact
56 2 24339699
[email protected]
Francisco Orlandi, MD
Principal Investigator
ICEGCLINIC Avenida Serafín Zamora 190 Torre B, piso 4. La Florida_Investigational Site Number :1520006
Santiago , 82414, Chile More Info
Paola Celedon
Contact
56 2 32100060
[email protected]
Yordelis Morales
Contact
56 2 32100060
[email protected]
Paola Celedon, MD
Principal Investigator
Fakultní nemocnice Olomouc Onkologická klinika I.P. Pavlova 6_Site Number :2030001
Olomouc , 77900, Czechia
Nemocnice AGEL Ostrava - Vitkovice Plicní oddělení Zalužanského 2214/35_Site Number :2030002
Ostrava - Vitkovice , 70384, Czechia More Info
Jaromír Roubec
Contact
00420 595 633 400
[email protected]
Zuzana Gerlochová
Contact
00420 595 633 412
[email protected]
Jaromír Roubec, MD
Principal Investigator
Institut Sainte-Catherine 250 Chemin de Baigne-Pieds_Investigational Site Number :2500005
Avignon , 84918, France More Info
Magali Ravoire
Principal Investigator
CHRU BREST 5 Avenue Foch_Investigational Site Number :2500003
Brest , 29200, France More Info
Gilles Robinet
Principal Investigator
Centre François Magendie Hôpital du Haut Lévèque Av.de Magellan_Investigational Site Number :2500001
Pessac , 33600, France More Info
Rémi Veillon
Principal Investigator
Pôle régional de Cancérologie 2 rue de la Milèterie BP 577_Investigational Site Number :2500004
Poitiers Cedex , 86021, France More Info
Nicolas Isambert
Contact
+33 (0)5 49 44 45 48
[email protected]
Nicolas Isambert
Principal Investigator
Investigational Site Number :3480003
Budapest , 1083, Hungary
Országos Onkológiai Intézet Ráth György u. 7_Investigational Site Number :3480002
Budapest , 1122, Hungary More Info
Fanni FARNER
Contact
36 20 999 7488
[email protected]
Tünde NAGY, MD
Principal Investigator
Veszprém Megyei Tüdőgyógyintézet 049/2 Hrsz_Investigational Site Number :3480004
Farkasgyepü , 8582, Hungary More Info
Szilvia VAJCS
Contact
36 20 431 4184
[email protected]
Balázs MEDGYASSZAY, MD
Principal Investigator
Investigational Site Number :3480005
Kaposvár , 7400, Hungary
Investigational Site Number :3480006
Kecskemét , 6000, Hungary
SzSzBMK, Jósa András Oktatókórház Sóstói út 62_Investigational Site Number :3480007
Nyíregyháza , 4400, Hungary More Info
Beatrix FEKETE
Contact
36 20 225 0757
[email protected]
Péter SZABÓ, MD
Principal Investigator
Investigational Site Number :3760004
Jerusalem , 91031, Israel
Investigational Site Number :3760001
Ramat Gan , 52656, Israel
Investigational Site Number :3760002
Tel Aviv , 64239, Israel
Investigational Site Number :7240003
Valencia Valenciana, Comunidad, 46010, Spain
Investigational Site Number :7240005
La Coruña , 15006, Spain
Investigational Site Number :7240002
Las Palmas , 35016, Spain
Investigational Site Number :7240004
Madrid , 28040, Spain
Investigational Site Number :7240001
Madrid , 28041, Spain

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

120

Study ID:

NCT04524689

Recruitment Status:

Recruiting

Sponsor:


Sanofi

How clear is this clinincal trial information?

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