SAR408701 in Combination With Ramucirumab in Pre-treated Patients With Non Squamous Non-small Cell Lung Cancer (NSQ NSCLC)

  • STATUS
    Recruiting
  • End date
    Feb 16, 2022
  • participants needed
    36
  • sponsor
    Sanofi
Updated on 16 April 2021
cancer
measurable disease
platinum-based chemotherapy
squamous non-small cell lung cancer

Summary

Primary Objectives:

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

Secondary Objectives:

  • To assess the safety and tolerability of SAR408701 in combination with ramucirumab
  • To assess the durability of the response to treatment with SAR408701 in combination with ramucirumab
  • To assess efficacy of SAR408701 in combination with ramucirumab on progression free survival
  • To assess the pharmacokinetic (PK) profile of SAR408701 and ramucirumab when given in combination
  • To assess the immunogenicity of SAR408701 when given in combination with ramucirumab

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
Condition Non Small Cell Lung Cancer Metastatic
Treatment Ramucirumab, SAR408701
Clinical Study IdentifierNCT04394624
SponsorSanofi
Last Modified on16 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Non Small Cell Lung Cancer Metastatic?
Do you have any of these conditions: Do you have Non Small Cell Lung Cancer Metastatic??
Do you have any of these conditions: Do you have Non Small Cell Lung Cancer Metastatic??
Do you have any of these conditions: Do you have Non Small Cell Lung Cancer Metastatic??
Do you have any of these conditions: Do you have Non Small Cell Lung Cancer Metastatic??
Do you have any of these conditions: Do you have Non Small Cell Lung Cancer Metastatic??
Do you have any of these conditions: Do you have Non Small Cell Lung Cancer Metastatic??
Do you have any of these conditions: Do you have Non Small Cell Lung Cancer Metastatic??
Do you have any of these conditions: Do you have Non Small Cell Lung Cancer Metastatic??
Do you have any of these conditions: Do you have Non Small Cell Lung Cancer Metastatic??
Do you have any of these conditions: Do you have Non Small Cell Lung Cancer Metastatic??
Do you have any of these conditions: Do you have Non Small Cell Lung Cancer Metastatic??
Do you have any of these conditions: Do you have Non Small Cell Lung Cancer Metastatic??
Do you have any of these conditions: Do you have Non Small Cell Lung Cancer Metastatic??
Metastatic disease progression fulfilling both of the following 2 criteria
Having progressive disease during or after platinum-based chemotherapy (at least 2 cycles). Maintenance therapy following platinum-based chemotherapy is not considered as a separate regimen. Adjuvant/neoadjuvant treatment for a patient who had a relapse with metastatic disease during or within 6 months of completing treatment will be considered as first-line treatment
AND
Participants with carcinoembryonic antigen-related cell adhesion molecule (CEACAM) 5 expression of 2+ in archival tumor sample (or if not available, fresh biopsy sample) involving at least 50 % of the tumor cell population as demonstrated prospectively by central laboratory via immune histochemistry (IHC)
\. Having progressive disease during or after 1 immune checkpoint inhibitor
At least one measurable lesion by RECIST v1.1
(anti-PD1/PD-L1); this could be given as monotherapy or in combination with
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
platinum-based chemotherapy (whatever the order)
A female participant who agrees to use effective contraceptive methods during and for at least 7 months after the last dose of study intervention
A male participant who agrees to use effective contraception methods during and for at least 4 months after the last dose of study intervention
Signed informed consent

Exclusion Criteria

Participants are excluded from the study if any of the following criteria
apply
Patients with untreated brain metastases and history of leptomeningeal disease
Significant concomitant illnesses that 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
Non-resolution of any prior treatment related toxicity to < grade 2 according to NCI CTCAE V5.0, except for alopecia, vitiligo and active thyroiditis controlled with hormonal replacement therapy
History of known acquired immunodeficiency syndrome (AIDS) related illnesses or known HIV disease requiring antiretroviral treatment, or unresolved viral hepatitis
Previous history of and/or unresolved corneal disorders. The use of contact lenses is not permitted
Radiographic evidence of major airway or blood vessel invasion or intratumor cavitation
History of uncontrolled hereditary or acquired thrombotic disorder or history of aneurism
Major surgery within 28 days prior to Day 1/first IMP infusion,. Postoperative bleeding complications or wound complications from a surgical procedure performed in the last 2 months
History of gross hemoptysis within 2 months before the first administration of study intervention
Any arterial thrombotic event within 6 months before the first administration of study intervention
Uncontrolled arterial hypertension (systolic 150 mmHg or diastolic 90 mmHg) despite standard medical management
Clinically relevant congestive heart failure (CHF; NYHA II-IV, or LVEF less than 50%) or symptomatic or poorly controlled cardiac arrhythmia
Serious or nonhealing wound, skin ulcer, or bone fracture within 28 days before the first administration of study intervention
Gastrointestinal (GI) perforation and/or fistulae within 6 months prior to first administration of study intervention
Significant bleeding disorders, vasculitis, or Grade 3-4 gastrointestinal (GI) bleeding within 3 months before the first administration of study intervention
Bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection Crohn's disease, ulcerative colitis, or chronic diarrhea
Medical condition requiring concomitant administration of a medication with a narrow therapeutic window and metabolized by CYP450 or a strong CYP3A inhibitor
Concurrent treatment with any other anticancer therapy
No more than 1-line previous chemotherapy in metastatic setting
Prior treatment with ramucirumab or docetaxel
Prior therapy targeting CEACAM5 or maytansinoid treatment (DM1 or DM4 antibody-drug conjugate)
Contraindication to use of corticosteroid premedication
Current therapeutic anticoagulation with warfarin, low-molecular-weight heparin, or similar agents. Patients receiving prophylactic, low-dose anticoagulation therapy are eligible
Previous enrollment in this study, current participation in any other clinical study involving an investigational study treatment, or any other type of medical research
Poor bone marrow, liver or kidney functions
Urine dipstick or routine analysis indicating proteinuria of 2+ or higher, unless a 24 hour urine collection demonstrates <1000 mg of protein
Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study.Most important exclusion criteria for potential participants
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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