What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) that involve targeted therapies and cytotoxic agents, such as Tusamitamab Ravtansine, often have side effects including fatigue, nausea, increased liver function tests, and hematologic toxicities like neutropenia and thrombocytopenia. Additionally, these treatments can cause infusion reactions and specific organ toxicities depending on the target antigen.

What prior FDA approvals exist?

Several FDA-approved treatments for Non-Small Cell Lung Cancer (NSCLC) utilize targeted therapy and antibody-drug conjugates (ADCs) similar to Tusamitamab Ravtansine. For instance, fam-trastuzumab deruxtecan is an ADC approved for patients with HER2-mutant NSCLC, delivering a cytotoxic agent specifically to cancer cells expressing HER2. Additionally, pembrolizumab, an immune checkpoint inhibitor, is approved for NSCLC with PD-L1 expression. These treatments exemplify the trend towards personalized, targeted therapies in NSCLC, aiming to improve efficacy and reduce systemic toxicity.

What other types of research exist?

Promising novel alternatives to Tusamitamab Ravtansine for NSCLC patients include: 1) Selpercatinib, which has shown potent and durable antitumor activity in RET fusion-positive NSCLC. 2) Ceritinib, which has demonstrated significant radiologic response in ALK-rearranged lung adenocarcinoma. 3) Gefitinib, which has shown dramatic and prolonged response in EGFR-mutant NSCLC. These therapies target specific genetic mutations and have shown efficacy in clinical trials, making them viable options for treatment in 2024.

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Monoclonal Antibodies

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

Q: What is the mechanism of action of this treatment?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include targeted therapies and immunotherapies. Targeted therapies, like tyrosine kinase inhibitors (TKIs), block specific proteins that drive cancer growth, such as EGFR or ALK. Immunotherapies, such as PD-1/PD-L1 inhibitors, boost the immune system's ability to attack cancer cells. Tusamitamab Ravtansine, an antibody-drug conjugate, targets CEACAM5 to deliver a cytotoxic agent directly to cancer cells, reducing harm to normal cells. This targeted approach is significant for NSCLC patients as it offers personalized treatment options, potentially improving outcomes and reducing side effects compared to traditional chemotherapy.

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

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My non-squamous NSCLC has worsened after treatments including platinum-based chemotherapy and immunotherapy.

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My tumor shows moderate or no CEACAM5 and my CEA levels are high.

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I am fully active or can carry out light work.

CARMEN-LC06 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to approximately 30 days after the last study treatment administration

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%

Vomiting

11%

Fatigue

11%

Diarrhoea

10%

Paraesthesia

10%

Abdominal pain

10%

Dry mouth

10%

Urinary tract infection

Insomnia

Upper respiratory tract infection

Blood alkaline phosphatase increased

Musculoskeletal pain

Neuropathy peripheral

Anaemia

Constipation

Mucosal inflammation

Alanine aminotransferase increased

Arthralgia

Abdominal pain upper

Nasopharyngitis

Myalgia

Back pain

Dizziness

Dyspnoea

Hypokalaemia

Blood bilirubin increased

Hyperglycaemia

Neutropenia

Lacrimation increased

Pain

Sinusitis

Muscular weakness

Epilepsy

Pulmonary embolism

Pneumonia

Hypersensitivity

Upper gastrointestinal haemorrhage

Tumour necrosis

Abscess

Hepatotoxicity

Lymphoedema

Upper limb fracture

Hemiplegia

Cellulitis

Seizure

Abdominal infection

Biliary tract infection

Toxicity to various agents

Pulmonary Fibrosis

Lung infection

100%

80%

60%

40%

20%

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).

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include targeted therapies and immunotherapies. Targeted therapies, like tyrosine kinase inhibitors (TKIs), block specific proteins that drive cancer growth, such as EGFR or ALK. Immunotherapies, such as PD-1/PD-L1 inhibitors, boost the immune system's ability to attack cancer cells. Tusamitamab Ravtansine, an antibody-drug conjugate, targets CEACAM5 to deliver a cytotoxic agent directly to cancer cells, reducing harm to normal cells. This targeted approach is significant for NSCLC patients as it offers personalized treatment options, potentially improving outcomes and reducing side effects compared to traditional chemotherapy.

Emerging therapeutic agents for lung cancer.