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Monoclonal Antibodies

Tusamitamab Ravtansine for Non-Small Cell Lung Cancer (CARMEN-LC06 Trial)

Phase 2
Waitlist Available
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to approximately 30 days after the last study treatment administration
Awards & highlights

CARMEN-LC06 Trial Summary

This trial will evaluate how safe and effective a new treatment is for NSQ NSCLC with negative/moderate CEACAM5 expression and high CEA. 38 participants will receive the treatment and be monitored for effects.

Who is the study for?
This trial is for adults with a type of lung cancer called NSQ NSCLC who have already tried platinum-based chemotherapy and immune checkpoint inhibitors. They must have tumors with specific protein levels (CEACAM5) and high CEA in their blood, be relatively healthy, able to use birth control, and not have had certain treatments or unresolved health issues.Check my eligibility
What is being tested?
The study tests Tusamitamab ravtansine given every two weeks as the only treatment until the disease worsens, side effects become too much, a new cancer therapy starts, or if decided by the patient or doctor. The focus is on its effectiveness, safety profile, and how it moves through the body.See study design
What are the potential side effects?
Specific side effects are not listed but may include typical reactions to monoclonal antibody therapies such as infusion-related reactions, fatigue, nausea. Safety will be closely monitored due to potential adverse events leading to stopping treatment.

CARMEN-LC06 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My non-squamous NSCLC has worsened after treatments including platinum-based chemotherapy and immunotherapy.
Select...
My tumor shows moderate or no CEACAM5 and my CEA levels are high.
Select...
I am fully active or can carry out light work.

CARMEN-LC06 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to approximately 30 days after the last study treatment administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to approximately 30 days after the last study treatment administration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate (ORR)
Secondary outcome measures
Disease control rate (DCR)
Duration of response (DOR)
Incidence of participants with anti-therapeutic antibodies (ATAs) against tusamitamab ravtansine
+2 more

Side effects data

From 2015 Phase 3 trial • 602 Patients • NCT01419197
18%
Thrombocytopenia
17%
Nausea
17%
Headache
16%
Decreased appetite
16%
Asthenia
15%
Pyrexia
14%
Aspartate aminotransferase increased
13%
Epistaxis
13%
Cough
11%
Fatigue
11%
Vomiting
11%
Diarrhoea
10%
Paraesthesia
10%
Abdominal pain
10%
Dry mouth
10%
Urinary tract infection
9%
Insomnia
9%
Upper respiratory tract infection
7%
Blood alkaline phosphatase increased
7%
Musculoskeletal pain
7%
Neuropathy peripheral
7%
Anaemia
7%
Constipation
7%
Mucosal inflammation
7%
Alanine aminotransferase increased
7%
Arthralgia
7%
Abdominal pain upper
6%
Myalgia
6%
Back pain
6%
Nasopharyngitis
6%
Dizziness
6%
Dyspnoea
6%
Hypokalaemia
5%
Blood bilirubin increased
5%
Hyperglycaemia
5%
Neutropenia
5%
Lacrimation increased
5%
Pain
5%
Sinusitis
1%
Pulmonary embolism
1%
Pneumonia
1%
Hypersensitivity
1%
Upper gastrointestinal haemorrhage
1%
Tumour necrosis
1%
Abscess
1%
Hepatotoxicity
1%
Lymphoedema
1%
Epilepsy
1%
Upper limb fracture
1%
Muscular weakness
1%
Hemiplegia
1%
Cellulitis
1%
Seizure
1%
Abdominal infection
1%
Biliary tract infection
1%
Toxicity to various agents
1%
Pulmonary Fibrosis
1%
Lung infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab Emtansine - Post TPC Treatment Switch
Trastuzumab Emtansine
Treatment of Physician's Choice (TPC)

CARMEN-LC06 Trial Design

1Treatment groups
Experimental Treatment
Group I: Tusamitamab ravtansineExperimental Treatment1 Intervention
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).

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,163 Previous Clinical Trials
3,512,458 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
857 Previous Clinical Trials
2,019,277 Total Patients Enrolled

Media Library

Tusamitamab ravtansine (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05245071 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: Tusamitamab ravtansine
Non-Small Cell Lung Cancer Clinical Trial 2023: Tusamitamab ravtansine Highlights & Side Effects. Trial Name: NCT05245071 — Phase 2
Tusamitamab ravtansine (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05245071 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is admission still open for the current trial taking place?

"Clinicaltrials.gov reveals that this research project, first published on June 3rd 2022, is currently enrolling patients into its program. There has been a recent update to the trial posted on March 13th 2023."

Answered by AI

Has Tusamitamab ravtansine obtained regulatory clearance for commercial distribution?

"The safety of Tusamitamab ravtansine has been appraised at a 2 out of 3, taking into account the Phase 2 trial results which indicate some data in support of its security but no information around efficacy."

Answered by AI

What is the aggregate count of participants enrolled in this research program?

"Affirmative, the data on clinicaltrials.gov attests to this trial's ongoing recruitment, which began on June 3rd 2022 and was recently revised on March 13th 2023. Approximately 38 individuals need to be enlisted at 25 different healthcare facilities."

Answered by AI

In what capacity are healthcare facilities participating in this research?

"This medical research is being conducted from 25 separate sites, comprising of Investigational Site Number:2500008 located in Saint-mande, Emilia-Romagna; Investigational Site Number :7920004 situated in Istanbul, Milano; and lastly, the third location at Investigational Site Number :3800003 found in Ravenna, Barcelona [Barcelona]."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Tusamitamab Ravtansine in NSQ NSCLC Participants With Negative or Moderate CEACAM5 Expression Tumors and High Circulating CEA
2022. "Tusamitamab Ravtansine in NSQ NSCLC Participants With Negative or Moderate CEACAM5 Expression Tumors and High Circulating CEA". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05245071.
~8 spots leftby Apr 2025
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