What is the mechanism of action of this treatment?

The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include chemotherapy, immunotherapy, targeted therapy, and antibody-drug conjugates (ADCs). Chemotherapy works by killing rapidly dividing cells, including cancer cells. Immunotherapy enhances the body's immune system to recognize and attack cancer cells. Targeted therapy blocks specific molecules involved in cancer cell growth and survival. ADCs, like MORAb-202, combine a monoclonal antibody that targets a specific tumor-associated antigen with a cytotoxic agent, allowing for precise delivery of the drug to cancer cells while sparing normal cells. These mechanisms are important for NSCLC patients as they enable personalized treatment approaches, potentially improving outcomes and minimizing side effects.

What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include antibody-drug conjugates like MORAb-202, chemotherapy, and immunotherapy. The side effects of antibody-drug conjugates can include neutropenia, peripheral neuropathy, and fatigue. Chemotherapy often results in neutropenia, febrile neutropenia, and hypertension, as well as gastrointestinal issues like nausea and vomiting. Immunotherapy, such as pembrolizumab and atezolizumab, can cause immune-related adverse events including pneumonitis, colitis, hepatitis, and endocrinopathies. Patients may also experience rash, pruritus, and fatigue. It is important to discuss these potential side effects with a healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

FDA-approved treatments for Non-Small Cell Lung Cancer (NSCLC) include several antibody-drug conjugates (ADCs) and targeted therapies. One notable ADC is fam-trastuzumab deruxtecan, approved for patients with HER2-mutant NSCLC. Additionally, immunotherapy combinations such as pembrolizumab with chemotherapy have been approved for advanced NSCLC without driver mutations. While specific ADCs targeting folate receptor alpha like MORAb-202 are not mentioned, the approval of other ADCs and targeted therapies highlights the evolving landscape of NSCLC treatment.

What other types of research exist?

Promising alternatives to MORAb-202 for NSCLC patients include: 1) Brentuximab vedotin, an ADC targeting CD30, which has shown high response rates in CD30-positive lymphomas and may have potential in NSCLC with CD30 expression. 2) EGFr-reactive monoclonal antibodies conjugated with Vinca derivatives, which have demonstrated complete tumor regression in xenograft models and warrant further investigation in clinical settings. 3) Pembrolizumab plus cetuximab, a combination therapy being investigated for treatment-refractory metastatic head and neck cancer, which may offer benefits for NSCLC patients with similar molecular profiles.

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Monoclonal Antibodies

MORAb-202 for Non-Small Cell Lung Cancer

Phase 2

Recruiting

Research Sponsored by Bristol-Myers Squibb

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1

Histologically or cytologically documented metastatic NSCLC AC (as defined by the 8th International Association for the Study of Lung Cancer Classification)

Must not have

Significant third-space fluid retention (eg, ascites or pleural effusion) that requires repeated drainage

NSCLC histologies other than AC (ie, squamous cell carcinoma, large cell carcinoma)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new medicine called MORAb-202 to see if it is safe and effective for patients with a type of lung cancer that has spread and who have already tried other treatments.

Who is the study for?

This trial is for people with a specific lung cancer type called metastatic NSCLC adenocarcinoma, who have already been treated before. Participants should be able to perform daily activities with ease or with slight limitations (ECOG PS of 0 or 1) and must have measurable signs of the disease according to certain medical criteria.

What is being tested?

The study is testing MORAb-202's safety and how well it works in patients with advanced lung cancer that has spread. The main goal is to see if this treatment can shrink the cancer in those who've had previous treatments.

What are the potential side effects?

While not explicitly listed, side effects may include typical reactions to new cancer drugs such as nausea, fatigue, allergic responses, potential organ inflammation, and changes in blood counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

Select...

My lung cancer is confirmed to be advanced and has spread.

Exclusion Criteria

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

Select...

I regularly need fluid drained from my body due to swelling.

Select...

My lung cancer is not adenocarcinoma but another type.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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: MORAb-202Experimental Treatment1 Intervention

0 / 4Eligibility 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

The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include chemotherapy, immunotherapy, targeted therapy, and antibody-drug conjugates (ADCs). Chemotherapy works by killing rapidly dividing cells, including cancer cells. Immunotherapy enhances the body's immune system to recognize and attack cancer cells. Targeted therapy blocks specific molecules involved in cancer cell growth and survival. ADCs, like MORAb-202, combine a monoclonal antibody that targets a specific tumor-associated antigen with a cytotoxic agent, allowing for precise delivery of the drug to cancer cells while sparing normal cells. These mechanisms are important for NSCLC patients as they enable personalized treatment approaches, potentially improving outcomes and minimizing side effects.