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.

← Back to Search

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

Must not have

Patients with untreated brain metastases or history of leptomeningeal disease

Concurrent treatment with any other anticancer therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to approximately 90 days after the last study treatment administration

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a medication called tusamitamab ravtansine for patients with a specific type of lung cancer. The medication targets cancer cells and delivers a substance that helps to destroy them. The trial aims to see if this treatment is safe and effective for these patients.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have brain metastases that haven't been treated or a history of leptomeningeal disease.

Select...

I am not currently receiving any other cancer treatments.

Select...

I have not been treated with drugs targeting CEACAM5 or maytansinoid derivatives.

Select...

I have had eye problems related to my cornea and I don't wear contact lenses.

Select...

I do not have uncontrolled HIV or unresolved hepatitis.

Select...

My bone marrow, liver, or kidney functions are not good.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to approximately 90 days after the last study treatment administration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to approximately 90 days after the last study treatment administration

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to approximately 90 days after the last study treatment administration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response Rate (ORR)

Secondary study objectives

Disease control rate (DCR)

Duration of response (DOR)

Incidence of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and laboratory abnormalities

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 9Eligibility 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.