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Monoclonal Antibodies
Necitumumab + Trastuzumab + Osimertinib for Lung Cancer
Phase 1 & 2
Recruiting
Led By Jonathan W Goldman
Research Sponsored by Jonsson Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Progressed on osimertinib. Osimertinib must have been included as the last systemic therapy prior to trial enrollment. This excludes patients who received osimertinib in combination with other EGFR-tyrosine kinase inhibitor (TKI) or anti-human epidermal growth factor receptor (anti-HER) therapy
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study Summary
This trial is testing the side effects and best dose of trastuzumab and necitumumab given with osimertinib, to treat patients with stage IV EGFR-mutated non-small cell lung cancer that is resistant to osimertinib and has not responded to previous treatment.
Who is the study for?
This trial is for adults with stage IV non-small cell lung cancer that has an EGFR mutation and hasn't improved after osimertinib treatment. Participants must be in good physical condition, not planning to conceive, able to take oral medication, and meet specific blood and organ function criteria.Check my eligibility
What is being tested?
The study tests the combination of trastuzumab and necitumumab with osimertinib against advanced lung cancer resistant to previous treatments. It aims to find the best dose while assessing how well this combo works compared to osimertinib alone.See study design
What are the potential side effects?
Possible side effects include immune reactions due to monoclonal antibodies (trastuzumab, necitumumab), such as infusion-related symptoms, allergic responses; plus effects from osimertinib like diarrhea, rash, dry skin, nail changes or mouth sores.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My last treatment was osimertinib, and my cancer progressed after it.
Select...
I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Therapeutic procedure
Incidence of adverse events (Phase Ib)
Objective response rate (ORR) (Phase II)
Secondary outcome measures
Duration of response (DoR) (Phase II)
Overall survival (OS) (Phase II)
Patient reported outcomes (PROs)
+2 moreOther outcome measures
Mutant allele fraction in circulating tumor deoxyribonucleic acid (DNA) (ctDNA)
Potential biomarkers associated with response from liquid biopsies
Quality of life data questionnaire
Side effects data
From 2020 Phase 3 trial • 633 Patients • NCT0098211157%
Nausea
41%
Rash
36%
Anorexia
35%
Vomiting
30%
Constipation
30%
Diarrhoea
30%
Neutropenia
29%
Asthenia
29%
Fatigue
25%
Hypomagnesaemia
24%
Anaemia
18%
Cough
16%
Mucosal inflammation
15%
Dyspnoea
15%
Leukopenia
15%
Pyrexia
14%
Dry skin
14%
Dermatitis acneiform
13%
Oedema peripheral
13%
Weight decreased
13%
Dizziness
11%
Back pain
10%
Hypocalcaemia
10%
Pruritus
10%
Conjunctivitis
10%
Stomatitis
10%
Headache
10%
Alopecia
9%
Abdominal pain upper
9%
Paronychia
9%
Rash generalised
8%
Non-small cell lung cancer
8%
Hyponatraemia
7%
Hypokalaemia
7%
Epistaxis
7%
Haemoptysis
7%
Thrombocytopenia
7%
Blood creatinine increased
7%
Dysgeusia
6%
Fluid retention
6%
Abdominal pain
6%
Oral candidiasis
6%
Urinary tract infection
6%
Musculoskeletal pain
6%
Pain in extremity
6%
Depression
6%
Insomnia
6%
Hypertension
5%
Lymphopenia
5%
Productive cough
5%
Dyspepsia
5%
Hirsutism
5%
Hyperglycaemia
5%
Pneumonia
5%
Tinnitus
5%
Paraesthesia
4%
Pulmonary embolism
4%
Non-cardiac chest pain
2%
General physical health deterioration
2%
Convulsion
2%
Metastases to central nervous system
2%
Medication error
2%
Respiratory failure
2%
Deep vein thrombosis
1%
Peripheral ischaemia
1%
Multi-organ failure
1%
Peripheral embolism
1%
Pericardial effusion
1%
Sepsis
1%
Subclavian vein thrombosis
1%
Atrial fibrillation
1%
Atrial flutter
1%
Cardiac failure
1%
Cardiac tamponade
1%
Musculoskeletal chest pain
1%
Death
1%
Device related infection
1%
Infection
1%
Lung infection
1%
Neutropenic sepsis
1%
Incorrect dose administered
1%
Dehydration
1%
Ischaemic stroke
1%
Syncope
1%
Renal failure
1%
Renal failure acute
1%
Lacrimation increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Necitumumab+Pemetrexed+Cisplatin
Pemetrexed+Cisplatin
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (necitumumab, trastuzumab, osimertinib)Experimental Treatment5 Interventions
Patients receive necitumumab IV over 60 minutes and trastuzumab IV over 30-90 minutes on days 1 and 15. Patients also receive osimertinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab
2014
Completed Phase 4
~5190
Necitumumab
2013
Completed Phase 3
~1390
Osimertinib
2017
Completed Phase 4
~1010
Find a Location
Who is running the clinical trial?
Genentech, Inc.Industry Sponsor
1,541 Previous Clinical Trials
568,117 Total Patients Enrolled
Jonsson Comprehensive Cancer CenterLead Sponsor
360 Previous Clinical Trials
27,686 Total Patients Enrolled
Eli Lilly and CompanyIndustry Sponsor
2,619 Previous Clinical Trials
3,206,573 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant and agree to use two effective birth control methods.My blood counts, kidney, liver functions, and heart are within normal ranges.I am fully active or can carry out light work.I will use a condom with partners who are pregnant or can become pregnant.I do not have brain metastases, serious health issues, or recent other cancers.I haven't recently used specific cancer treatments or experimental drugs targeting EGFR/HER.My lung cancer is stage IV with specific EGFR mutations.My last treatment was osimertinib, and my cancer progressed after it.I do not have allergies to the treatment, heart disease, uncontrolled heart failure, or recent heart attacks.You currently have an infection, are pregnant, breastfeeding, or plan to have a baby during the trial.You have had a blood clot in an artery or vein within the past 3 months, or you have recently received a yellow fever vaccine.I don't have ongoing side effects from past treatments or small cell lung cancer.You have a disease that can be measured using specific guidelines.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (necitumumab, trastuzumab, osimertinib)
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 the research team currently seeking participants for this experiment?
"Affirmative. According to the records on clinicaltrials.gov, this research project is presently seeking participants; it was originally posted in January 29th 2021 and last modified February 28th 2022. At present, 26 people must be recruited from a single site for enrollment into the trial."
Answered by AI
To what extent is the population participating in this trial being observed?
"Affirmative. Clinicaltrials.gov reveals that this research, first shared on the 29th of January 2021 is actively recruiting patients. 26 individuals are required for enrolment at a single site location."
Answered by AI
To what ailment is Necitumumab regularly prescribed?
"Necitumumab is primarily utilized to combat breast cancer, although its efficacy can also be seen in treating neoplasms, countering high recurrence risk, and as a first line of defense."
Answered by AI
Has Necitumumab ever been investigated in previous scientific investigations?
"Currently, there are 292 studies actively investigating Necitumumab. 67 of these trials have reached the third phase while the majority of sites conducting research on this drug is set in Seattle, Washington with 17877 other locations running tests as well."
Answered by AI
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