Back to resultsTusamitamab Ravtansine in NSQ NSCLC Participants With Negative or Moderate CEACAM5 Expression Tumors and High Circulating CEA (CARMEN-LC06)
Primary Purpose
Non-squamous Non-small Cell Lung Cancer
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Tusamitamab ravtansine
Sponsored by
About this trial
This is an interventional treatment trial for Non-squamous Non-small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Histologically or cytologically proven diagnosis of NSQ NSCLC metastatic disease at study entry; progression after platinum-based chemotherapy and immune checkpoint inhibitor.
- Participants with moderate or negative CEACAM5 expression as demonstrated prospectively by central laboratory via immune histochemistry (ICH) and high circulating CEA levels (≥100 ng/mL). Moderate CEACAM5 expression is defined as intensity ≥ 2 + in ≥ 1% and <50 % of tumor cells. Negative CEACAM5 expression is defined as intensity of 1 + whatever the percentage of stained tumor cells or <1% of tumor cells.
- At least one measurable lesion by RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Women of childbearing potential or male patient with women of childbearing potential who agree to use highly effective method of birth control.
Exclusion Criteria:
- Patients with untreated brain metastases or history of leptomeningeal disease.
- 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 uncontrolled infection with human immunodeficiency virus (HIV), or unresolved viral hepatitis
- Significant concomitant illness that could impair the participation in the study or interpretation of the results or any major surgery with 3 weeks prior treatment administration
- Nonresolution 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.
- Previous history of and/or unresolved corneal disorders. The use of contact lenses is not permitted.
- Prior treatment with maytansinoid derivatives (DM1 or DM4 antibody drug conjugate) or any drug targeting CEACAM5.
- Concurrent treatment with any other anticancer therapy
- Poor bone marrow, liver or kidney functions.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
Sites / Locations
- Renovatio Clinical-Site Number:8400003Recruiting
- Investigational Site Number :0560003Recruiting
- Investigational Site Number :0560001Recruiting
- Investigational Site Number :0560002Recruiting
- Investigational Site Number :2500003Recruiting
- Investigational Site Number :2500001Recruiting
- Investigational Site Number :2500007Recruiting
- Investigational Site Number :2500006Recruiting
- Investigational Site Number :2500002Recruiting
- Investigational Site Number :2500008Recruiting
- Investigational Site Number :3800003Recruiting
- Investigational Site Number :3800001Recruiting
- Investigational Site Number :3800002Recruiting
- Investigational Site Number :3920002Recruiting
- Investigational Site Number :3920001Recruiting
- Investigational Site Number :3920003Recruiting
- Investigational Site Number :7240004Recruiting
- Investigational Site Number :7240006Recruiting
- Investigational Site Number :7240001Recruiting
- Investigational Site Number :7240002Recruiting
- Investigational Site Number :7240008Recruiting
- Investigational Site Number :7240003Recruiting
- Investigational Site Number :7240005Recruiting
- Investigational Site Number :7240007Recruiting
- Investigational Site Number :7920002Recruiting
- Investigational Site Number :7920005Recruiting
- Investigational Site Number :7920003Recruiting
- Investigational Site Number :7920004Recruiting
- Investigational Site Number :7920001Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tusamitamab ravtansine
Arm Description
Tusamitamab ravtansine dose will be administered on Day 1 via IV infusion and repeated once every 2 weeks. The duration of 1 cycle will be 14 days (1 administration of tusamitamab ravtansine per cycle).
Outcomes
Primary Outcome Measures
Objective Response Rate (ORR)
Objective Response Rate (ORR), defined as the proportion of participants who have a confirmed complete response (CR) or partial response (PR) as best overall response (BOR) per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
Secondary Outcome Measures
Incidence of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and laboratory abnormalities
Incidence of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and laboratory abnormalities according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Progression-free survival (PFS)
PFS defined as the time from the date of first tusamitamab ravtansine administration to the date of the first documented disease progression or death due to any cause, whichever comes first.
Disease control rate (DCR)
DCR defined as the percentage of participants who have achieved confirmed CR or PR, or stable disease as BOR per RECIST v1.1
Duration of response (DOR)
DOR, defined as the time from first documented evidence of CR or PR until progressive disease (PD) determined per RECIST v1.1 or death from any cause, whichever occurs first
Incidence of participants with anti-therapeutic antibodies (ATAs) against tusamitamab ravtansine
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05245071
Brief Title
Tusamitamab Ravtansine in NSQ NSCLC Participants With Negative or Moderate CEACAM5 Expression Tumors and High Circulating CEA
Acronym
CARMEN-LC06
Official Title
Open-label, Phase 2 Study, Evaluating the Efficacy and Safety of Tusamitamab Ravtansine in Non-squamous Non-small-cell Lung Cancer (NSQ NSCLC) Participants With Negative or Moderate CEACAM5 Expression Tumors and High Circulating CEA
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 3, 2022 (Actual)
Primary Completion Date
December 2, 2024 (Anticipated)
Study Completion Date
December 2, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is an open label single group, Phase 2, 1-arm study for treatment to evaluate efficacy, safety, and Pharmacokinetic (PK) of tusamitamab ravtansine in nonsquamous non-small-cell-lung-cancer (NSQ NSCLC) participants with negative or moderate CEACAM5 expression tumors and high circulating carcinoembryonic antigen (CEA).
Participants who will be enrolled, will receive tusamitamab ravtansine as monotherapy every two weeks (Q2W) until disease progression, unacceptable adverse event (AE), initiation of a new anticancer therapy, or the participant's or investigator's decision to stop the treatment, whichever comes first. A total of approximately 38 participants are planned to be treated.
Detailed Description
40 weeks (up to 4 weeks for screening, a median of 24 weeks for treatment, and a median of 12 weeks for end of treatment assessments and the safety follow-up visit).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-squamous Non-small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tusamitamab ravtansine
Arm Type
Experimental
Arm Description
Tusamitamab ravtansine dose will be administered on Day 1 via IV infusion and repeated once every 2 weeks. The duration of 1 cycle will be 14 days (1 administration of tusamitamab ravtansine per cycle).
Intervention Type
Drug
Intervention Name(s)
Tusamitamab ravtansine
Other Intervention Name(s)
SAR408701
Intervention Description
Pharmaceutical Form: Concentrate for solution Route of Administration: Intravenous infusion
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
Objective Response Rate (ORR), defined as the proportion of participants who have a confirmed complete response (CR) or partial response (PR) as best overall response (BOR) per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
Time Frame
Baseline up to approximately 9 months after last patient treated
Secondary Outcome Measure Information:
Title
Incidence of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and laboratory abnormalities
Description
Incidence of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and laboratory abnormalities according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time Frame
Baseline up to approximately 90 days after the last study treatment administration
Title
Progression-free survival (PFS)
Description
PFS defined as the time from the date of first tusamitamab ravtansine administration to the date of the first documented disease progression or death due to any cause, whichever comes first.
Time Frame
Baseline up to approximately 9 months after last patient treated
Title
Disease control rate (DCR)
Description
DCR defined as the percentage of participants who have achieved confirmed CR or PR, or stable disease as BOR per RECIST v1.1
Time Frame
Baseline up to approximately 9 months after last patient treated
Title
Duration of response (DOR)
Description
DOR, defined as the time from first documented evidence of CR or PR until progressive disease (PD) determined per RECIST v1.1 or death from any cause, whichever occurs first
Time Frame
Baseline up to approximately 9 months after last patient treated
Title
Incidence of participants with anti-therapeutic antibodies (ATAs) against tusamitamab ravtansine
Time Frame
Baseline up to approximately 30 days after the last study treatment administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically proven diagnosis of NSQ NSCLC metastatic disease at study entry; progression after platinum-based chemotherapy and immune checkpoint inhibitor.
Participants with moderate or negative CEACAM5 expression as demonstrated prospectively by central laboratory via immune histochemistry (ICH) and high circulating CEA levels (≥100 ng/mL). Moderate CEACAM5 expression is defined as intensity ≥ 2 + in ≥ 1% and <50 % of tumor cells. Negative CEACAM5 expression is defined as intensity of 1 + whatever the percentage of stained tumor cells or <1% of tumor cells.
At least one measurable lesion by RECIST v1.1
Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
Women of childbearing potential or male patient with women of childbearing potential who agree to use highly effective method of birth control.
Exclusion Criteria:
Patients with untreated brain metastases or history of leptomeningeal disease.
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 uncontrolled infection with human immunodeficiency virus (HIV), or unresolved viral hepatitis
Significant concomitant illness that could impair the participation in the study or interpretation of the results or any major surgery with 3 weeks prior treatment administration
Nonresolution 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.
Previous history of and/or unresolved corneal disorders. The use of contact lenses is not permitted.
Prior treatment with maytansinoid derivatives (DM1 or DM4 antibody drug conjugate) or any drug targeting CEACAM5.
Concurrent treatment with any other anticancer therapy
Poor bone marrow, liver or kidney functions.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Trial Transparency email recommended (Toll free number for US & Canada)
Phone
800-633-1610
Ext
option 6
Email
Contact-US@sanofi.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Renovatio Clinical-Site Number:8400003
City
El Paso
State/Province
Texas
ZIP/Postal Code
79915
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0560003
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0560001
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0560002
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2500003
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2500001
City
Creteil
ZIP/Postal Code
94010
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2500007
City
Marseille
ZIP/Postal Code
13015
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2500006
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2500002
City
RENNES Cedex 09
ZIP/Postal Code
35033
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2500008
City
Saint-mande
ZIP/Postal Code
94160
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3800003
City
Ravenna
State/Province
Emilia-Romagna
ZIP/Postal Code
48121
Country
Italy
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3800001
City
Rozzano
State/Province
Lombardia
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3800002
City
Milano
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920002
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
460-0001
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920001
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
003-0804
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920003
City
Sunto-gun
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240004
City
Barcelona
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
08028
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240006
City
Barcelona
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240001
City
Hospitalet de Llobregat
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240002
City
Madrid
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240008
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240003
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240005
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240007
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7920002
City
Adana
ZIP/Postal Code
01120
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7920005
City
Ankara
ZIP/Postal Code
1111
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7920003
City
Istanbul
ZIP/Postal Code
34300
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7920004
City
Istanbul
ZIP/Postal Code
34722
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7920001
City
Malatya
Country
Turkey
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Learn more about this trial
Tusamitamab Ravtansine in NSQ NSCLC Participants With Negative or Moderate CEACAM5 Expression Tumors and High Circulating CEA
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