SAR408701 in Combination With Pembrolizumab and Pembrolizumab Alone in Patients With Non-squamous Non-small Cell Lung Cancer (NSQ NSCLC)

  • STATUS
    Recruiting
  • End date
    Dec 16, 2022
  • participants needed
    54
  • sponsor
    Sanofi
Updated on 16 November 2020
Investigator
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Summary

Primary Objectives:

  • Part 1 (safety run-in): To assess the tolerability and to confirm the recommended dose of SAR408701 in combination with pembrolizumab in the NSQ NSCLC population
  • Part 2: To assess the antitumor activity of SAR408701 in combination with pembrolizumab and pembrolizumab single agent in the NSQ NSCLC population

Secondary Objective:

  • To assess the safety and tolerability of SAR408701 in combination with pembrolizumab and pembrolizumab single agent
  • To assess the durability of the response to treatment with SAR408701 in combination with pembrolizumab and pembrolizumab single agent
  • To assess the efficacy on progression-free survival (PFS) of SAR408701 in combination with pembrolizumab and pembrolizumab single agent
  • To assess the pharmacokinetics (PK) of SAR408701 and pembrolizumab when given in combination, and of pembrolizumab when given as a single agent
  • To assess the immunogenicity of SAR408701 when given in combination with pembrolizumab

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 11 months (up to 1 month for screening, a median of 6 months for treatment, and a median of 4 months for end-of-treatment assessments and safety follow-up visit).

Details
Treatment Pembrolizumab, SAR408701
Clinical Study IdentifierNCT04524689
SponsorSanofi
Last Modified on16 November 2020

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Eligibility

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Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Non-squamous Non-small-cell Lung Cancer (NSQ NSCLC)?
Do you have any of these conditions: Do you have Non-squamous Non-small-cell Lung Cancer (NSQ NSCLC)??
Do you have any of these conditions: Do you have Non-squamous Non-small-cell Lung Cancer (NSQ NSCLC)??
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 50% of the tumor cell population in archival tumor sample (or if not available fresh biopsy sample)
PD-L1 positive tumor (TPS 1%) as determined locally by an approved test
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
Untreated 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 longer, 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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