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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 below
Select...
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 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

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 more
Other 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 • NCT00982111
57%
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%
Dyspepsia
5%
Productive cough
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
1,540 Previous Clinical Trials
567,873 Total Patients Enrolled
Jonsson Comprehensive Cancer CenterLead Sponsor
359 Previous Clinical Trials
26,006 Total Patients Enrolled
Eli Lilly and CompanyIndustry Sponsor
2,618 Previous Clinical Trials
3,201,534 Total Patients Enrolled

Media Library

Necitumumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04285671 — Phase 1 & 2
Lung Cancer Research Study Groups: Treatment (necitumumab, trastuzumab, osimertinib)
Lung Cancer Clinical Trial 2023: Necitumumab Highlights & Side Effects. Trial Name: NCT04285671 — Phase 1 & 2
Necitumumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04285671 — Phase 1 & 2

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
~4 spots leftby Dec 2024