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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial studies the safety and effectiveness of a drug for metastatic lung cancer patients who have been previously treated.
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.Check my eligibility
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.See study design
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 belowSelect...
I am fully active or can carry out light work.
Select...
My lung cancer is confirmed to be advanced and has spread.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Therapeutic procedure
Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 per investigator assessment
Secondary outcome measures
Disease Control Rate (DCR) by RECIST 1.1 per investigator assessment
Duration of Response (DoR) by RECIST 1.1 per investigator assessment
Number of deaths
+6 moreSide effects data
From 2020 Phase 2 trial • 332 Patients • NCT0228995067%
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
9%
Gastrooesophageal reflux disease
9%
Dyspepsia
9%
Musculoskeletal pain
9%
Dehydration
8%
Palmar-plantar erythrodysaesthesia syndrome
8%
Dysuria
8%
Paraesthesia
7%
Nasal congestion
7%
Sinusitis
7%
Aspartate aminotransferase increased
6%
Malaise
6%
Abdominal discomfort
6%
Erythema
6%
Dry mouth
6%
Influenza
6%
Abdominal distension
6%
Musculoskeletal chest pain
6%
Muscle spasms
6%
Influenza like illness
6%
Vertigo
5%
Hyperglycaemia
5%
Vision blurred
5%
Alanine aminotransferase increased
5%
Epistaxis
5%
Hypertension
5%
Small intestinal obstruction
5%
Hypertriglyceridaemia
4%
Chills
4%
Bone pain
4%
Febrile neutropenia
4%
Cystitis
4%
Neck pain
4%
Intestinal obstruction
4%
Depression
3%
Dry skin
3%
Nail discolouration
3%
Drug hypersensitivity
3%
Peripheral swelling
3%
Hot flush
2%
Ear pain
2%
Flank pain
2%
Muscular weakness
1%
Acute kidney injury
1%
Large intestinal obstruction
1%
Strangulated umbilical hernia
1%
Interstitial lung disease
1%
Pulmonary embolism
1%
Petechiae
1%
Bile duct obstruction
1%
Pneumonia
1%
Carbon monoxide diffusing capacity decreased
1%
Bacteraemia
1%
Pneumonitis
1%
Bile duct stone
1%
Chest pain
1%
Hip fracture
1%
Pulmonary oedema
1%
Pancytopenia
1%
Tracheitis
1%
Non-cardiac chest pain
1%
Clostridium difficile colitis
1%
Restrictive pulmonary disease
1%
Infusion related reaction
1%
Confusional state
1%
Hyperkalaemia
1%
Respiratory failure
1%
Hemiparesis
1%
Ischaemic stroke
1%
Hypertensive crisis
1%
Arthritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Farletuzumab 5 mg/kg + Carboplatin/Paclitaxel or Carboplatin/PLD
Placebo + Carboplatin/Paclitaxel or Carboplatin/PLD
Trial Design
1Treatment groups
Experimental Treatment
Group I: MORAb-202Experimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Eisai Inc.Industry Sponsor
515 Previous Clinical Trials
153,932 Total Patients Enrolled
Bristol-Myers SquibbLead Sponsor
2,639 Previous Clinical Trials
4,128,982 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My lung cancer is not adenocarcinoma but another type.I regularly need fluid drained from my body due to swelling.I am fully active or can carry out light work.The doctor can measure the disease using a specific method called RECIST 1.1.I had a pneumonectomy or lung surgery more than a year ago.I had chest radiation over 6 months ago.My lung cancer is confirmed to be advanced and has spread.
Research Study Groups:
This trial has the following groups:- Group 1: MORAb-202
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there a high chance of harmful side effects from MORAb-202 Dose 1?
"MORAb-202 Dose 1 falls into the category of a Phase 2 trial, so there is some evidence that it is safe but none yet to support its efficacy. Consequently, our team gave it a safety score of 2."
Answered by AI
Are there still places available for people who want to participate in this trial?
"This particular clinical trial, as indicated on clinicaltrials.gov, is not presently looking for new participants. The listing was created on October 14th 2022 and last edited on October 24th of the same year. There are, however, 2148 other trials that are recruiting patients."
Answered by AI
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