Monoclonal Antibodies
MORAb-202 for Non-Small Cell Lung Cancer
Local Institution - 0031, Seville, Spain
MORAb-202Phase 2RecruitingResearch Sponsored by Bristol-Myers SquibbEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upup to 2 years
Awards & highlights
No Placebo-Only Group
Study Summary
This trial studies the safety and effectiveness of a drug for metastatic lung cancer patients who have been previously treated.
Eligible Conditions
- Non-Small Cell Lung Cancer
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%
Thrombocytopenia
30%
Vomiting
30%
Cough
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%
Oropharyngeal pain
11%
Myalgia
11%
Anxiety
11%
Dysgeusia
11%
Pruritus
11%
Oedema peripheral
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%
Vision blurred
5%
Alanine aminotransferase increased
5%
Epistaxis
5%
Hypertension
5%
Small intestinal obstruction
5%
Hypertriglyceridaemia
5%
Hyperglycaemia
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%
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%
Large intestinal obstruction
1%
Chest pain
1%
Hip fracture
1%
Pulmonary oedema
1%
Acute kidney injury
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
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
Find a site
Who is running the clinical trial?
Eisai Inc.Industry Sponsor
512 Previous Clinical Trials
151,974 Total Patients Enrolled
Bristol-Myers SquibbLead Sponsor
2,576 Previous Clinical Trials
4,033,775 Total Patients Enrolled
Media Library
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research being conducted at many different hospitals in Canada?
"The trial is based in Virginia Cancer Specialists, PC Fairfax (Fairfax, VA), Mid-Florida Cancer Center (Sanford, FL), Mayo Clinic- Rochester (Rochester, MN) as well as 6 other locations."
Answered by AI
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