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

Side effects data

From 2020 Phase 2 trial • 332 Patients • NCT02289950

67%

Nausea

54%

Anaemia

49%

Fatigue

41%

Constipation

39%

Neutropenia

35%

Headache

34%

Diarrhoea

31%

Stomatitis

31%

Neutrophil count decreased

30%

Cough

30%

Thrombocytopenia

30%

Vomiting

28%

Abdominal pain

26%

Arthralgia

24%

White blood cell count decreased

23%

Asthenia

22%

Dyspnoea

20%

Decreased appetite

19%

Platelet count decreased

18%

Alopecia

17%

Rash

16%

Nasopharyngitis

16%

Upper respiratory tract infection

16%

Pyrexia

16%

Dizziness

16%

Hypokalaemia

16%

Peripheral sensory neuropathy

15%

Leukopenia

15%

Hypomagnesaemia

13%

Back pain

13%

Urinary tract infection

12%

Abdominal pain upper

12%

Pain in extremity

11%

Oedema peripheral

11%

Oropharyngeal pain

11%

Myalgia

11%

Anxiety

11%

Dysgeusia

11%

Pruritus

11%

Insomnia

Gastrooesophageal reflux disease

Dyspepsia

Musculoskeletal pain

Dehydration

Palmar-plantar erythrodysaesthesia syndrome

Dysuria

Paraesthesia

Nasal congestion

Sinusitis

Aspartate aminotransferase increased

Malaise

Abdominal discomfort

Erythema

Dry mouth

Influenza

Abdominal distension

Musculoskeletal chest pain

Muscle spasms

Influenza like illness

Vertigo

Hyperglycaemia

Vision blurred

Alanine aminotransferase increased

Epistaxis

Hypertension

Small intestinal obstruction

Hypertriglyceridaemia

Chills

Bone pain

Febrile neutropenia

Cystitis

Neck pain

Intestinal obstruction

Depression

Dry skin

Nail discolouration

Drug hypersensitivity

Peripheral swelling

Hot flush

Ear pain

Flank pain

Muscular weakness

Acute kidney injury

Large intestinal obstruction

Strangulated umbilical hernia

Interstitial lung disease

Pulmonary embolism

Petechiae

Bile duct obstruction

Pneumonia

Carbon monoxide diffusing capacity decreased

Bacteraemia

Pneumonitis

Bile duct stone

Chest pain

Hip fracture

Pulmonary oedema

Pancytopenia

Tracheitis

Non-cardiac chest pain

Clostridium difficile colitis

Restrictive pulmonary disease

Infusion related reaction

Confusional state

Hyperkalaemia

Respiratory failure

Hemiparesis

Ischaemic stroke

Hypertensive crisis

Arthritis

100%

80%

60%

40%

20%

Study treatment Arm

Farletuzumab 5 mg/kg + Carboplatin/Paclitaxel or Carboplatin/PLD

Placebo + Carboplatin/Paclitaxel or Carboplatin/PLD

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.