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Lung cancer drug combo trial halted early

NCT ID NCT04524689

Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new drug (tusamitamab ravtansine) combined with pembrolizumab and chemotherapy in 57 people with advanced non-squamous non-small-cell lung cancer that has a specific marker (CEACAM5). The goal was to see if the combination was safe and shrank tumors. The trial was terminated early, so results are limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

57 people

The number who actually took part.

Started

Oct 2020

Finished

Dec 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-squamous non-small-cell lung cancer (NSQ NSCLC)

Contacts and locations

Locations

  • CHRU BREST 5 Avenue Foch_Investigational Site Number :2500003

    Brest, 29200, France

  • Centre François Magendie Hôpital du Haut Lévèque Av.de Magellan_Investigational Site Number :2500001

    Pessac, 33600, France

  • Centro Avancado de Oncologia CECAN - Liga Contra o Cancer Site Number : 0760004

    Natal, Rio Grande do Norte, 59062-000, Brazil

  • Centro de Investigacion y Desarrollo Oncologico (CIDO) Hochstetter 599 of. 602-603-1001, Temuco_Investigational Site Number :1520005

    Temuco, La Araucanía, 4780000, Chile

  • Fakultní nemocnice Olomouc Onkologická klinika I.P. Pavlova 6_Site Number :2030001

    Olomouc, 77900, Czechia

  • ICEGCLINIC Avenida Serafín Zamora 190 Torre B, piso 4. La Florida_Investigational Site Number :1520006

    Santiago, 8241470, Chile

  • Institut Sainte-Catherine 250 Chemin de Baigne-Pieds_Investigational Site Number :2500005

    Avignon, 84918, France

  • Investigational Site Number : 3760001

    Ramat Gan, 5266202, Israel

  • Investigational Site Number : 3760002

    Tel Aviv, 64239, Israel

  • Investigational Site Number : 7240001

    Madrid, 28041, Spain

  • Investigational Site Number : 7240002

    Las Palmas, 35016, Spain

  • Investigational Site Number : 7240004

    Madrid, 28040, Spain

  • Investigational Site Number : 7240005

    A Coruña, A Coruña [La Coruña], 15006, Spain

  • Investigational Site Number : 7240006

    Badalona, Catalunya [Cataluña], 08916, Spain

  • Investigational Site Number : 7240007

    Oviedo, Principality of Asturias, 33011, Spain

  • KU Medical Center_Investigational Site Number :8400002

    Westwood, Kansas, 66205, United States

  • Nemocnice AGEL Ostrava - Vitkovice Plicní oddělení Zalužanského 2214/35_Site Number :2030002

    Ostrava - Vitkovice, 70384, Czechia

  • ONCOCENTRO APYS Av. La Marina 1702, 2do piso, Viña del Mar_Investigational Site Number :1520003

    Viña del Mar, Valparaiso, 2520598, Chile

  • Orlandi Oncologia General Salvo 159, Providencia_Investigational Site Number :1520002

    Santiago, 7500713, Chile

  • Országos Onkológiai Intézet Ráth György u. 7_Investigational Site Number :3480002

    Budapest, 1122, Hungary

  • Pôle régional de Cancérologie 2 rue de la Milèterie BP 577_Investigational Site Number :2500004

    Poitiers, 86021, France

  • Veszprém Megyei Tüdőgyógyintézet 049/2 Hrsz_Investigational Site Number :3480004

    Farkasgyepü, 8582, Hungary