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Monoclonal Antibodies

Osimertinib + Necitumumab for Lung Cancer

Phase 1
Waitlist Available
Led By Jonathan W Riess
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with stage IV or recurrent/metastatic histologically confirmed non-small cell lung cancer (NSCLC) with specific EGFR activating mutations
Adequate archival tissue from a biopsy performed after progression of disease on previous EGFR-TKI or willing to consent for a fresh tumor biopsy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights

Study Summary

This trial studies the side effects and best dose of necitumumab when given with osimertinib in treating patients with EGFR-mutant non-small cell lung cancer.

Who is the study for?
This trial is for adults over 18 with stage IV or recurrent non-small cell lung cancer (NSCLC) that has specific EGFR mutations and worsened after previous treatments. Participants must be able to swallow pills, have a life expectancy of more than 3 months, good organ function, and agree to use contraception. It's not for those with certain heart issues, uncontrolled illnesses, recent major surgery, interstitial lung disease history, pregnant/breastfeeding women, or HIV-positive patients on antiretrovirals.Check my eligibility
What is being tested?
The trial tests the combination of two drugs: Necitumumab (an immunotherapy drug) and Osimertinib (a drug blocking enzymes needed by cancer cells). The goal is to see if this combo is better at treating NSCLC compared to current methods. Patients will also undergo various scans and provide biospecimens to assess treatment effects.See study design
What are the potential side effects?
Possible side effects include immune system changes leading to inflammation in different body parts; reactions related to infusion; potential interference with normal growth of tumor cells which could affect other cellular processes; fatigue; digestive disturbances; blood-related issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lung cancer is stage IV or recurrent with specific EGFR mutations.
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I can provide tissue samples from after my cancer progressed on EGFR-TKI treatment.
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I have had previous treatments for my condition.
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I am 18 years old or older.
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I am fully active or can carry out light work.
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I can swallow pills.
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My blood, liver, and kidney functions are all within normal ranges.

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
Incidence of toxicity
Maximum tolerated dose (MTD) of necitumumab combined with osimertinib
Secondary outcome measures
Disease control rate (DCR) with combination osimertinib and necitumumab
Objective response rate (ORR) in patients treated at the recommended phase II dose
Progression-free survival (PFS)
Other outcome measures
Pharmacokinetic (PK) parameters of osimertinib in combination with necitumumab
Presence of biomarkers of response and resistance to previous EGFR-tyrosine kinase inhibitors

Side effects data

From 2020 Phase 3 trial • 633 Patients • NCT00982111
57%
Nausea
41%
Rash
36%
Anorexia
35%
Vomiting
30%
Diarrhoea
30%
Constipation
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%
Epistaxis
7%
Haemoptysis
7%
Thrombocytopenia
7%
Blood creatinine increased
7%
Hypokalaemia
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%
Hirsutism
5%
Productive cough
5%
Dyspepsia
5%
Hyperglycaemia
5%
Lymphopenia
5%
Pneumonia
5%
Tinnitus
5%
Paraesthesia
4%
Pulmonary embolism
4%
Non-cardiac chest pain
2%
Convulsion
2%
General physical health deterioration
2%
Metastases to central nervous system
2%
Medication error
2%
Respiratory failure
2%
Deep vein thrombosis
1%
Peripheral ischaemia
1%
Peripheral embolism
1%
Sepsis
1%
Pericardial effusion
1%
Multi-organ failure
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 (osimertinib, necitumumab)Experimental Treatment5 Interventions
Patients receive osimertinib PO QD on days 1-21 and necitumumab IV over 60 minutes on days 1 and 8. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI and blood sample collection throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1920
Computed Tomography
2017
Completed Phase 2
~2790
Necitumumab
2013
Completed Phase 3
~1390
Osimertinib
2017
Completed Phase 4
~1010

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,609 Previous Clinical Trials
40,915,508 Total Patients Enrolled
Jonathan W RiessPrincipal InvestigatorCity of Hope Comprehensive Cancer Center LAO
4 Previous Clinical Trials
196 Total Patients Enrolled

Media Library

Necitumumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02496663 — Phase 1
Lung Cancer Research Study Groups: Treatment (osimertinib, necitumumab)
Lung Cancer Clinical Trial 2023: Necitumumab Highlights & Side Effects. Trial Name: NCT02496663 — Phase 1
Necitumumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02496663 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open slots for this experiment?

"According to clinicaltrials.gov, this medical research is not presently recruiting any participants and has been inactive since July 1st 2022. Despite the lack of openings for this trial, there are currently 3760 other trials requiring enrollment from prospective patients."

Answered by AI

Is this an unprecedented clinical trial?

"Necitumumab has had a long research trajectory, beginning with the ICON Clinical Research-sponsored trial of 1093 participants in 2010. Since then, 102 active trials have been conducted across 1080 cities and 53 countries; 43 of these studies have since reached completion."

Answered by AI

Has Necitumumab been previously investigated in any research?

"Since its inception at ImClone Investigational Site in 2010, necitumumb has been a subject of 43 completed clinical trails. At present time, 102 trials are actively recruiting participants; with many locations being based out of Duarte, California."

Answered by AI

To what degree could Necitumumab endanger a patient's health?

"Since this is a Phase 1 trial, there is insufficient data to draw conclusions on Necitumumab's safety and efficacy. As such, it was given a score of 1."

Answered by AI

How many individuals have opted to take part in this research initiative?

"This clinical trial has closed applications, initially posted on March 24th 2016 and last edited July 1st 2022. For those seeking alternative trials, 3658 are recruiting patients with metastatic lung non-small cell carcinoma and 102 for Necitumumab."

Answered by AI

How many medical centers offer access to this trial?

"Fifteen clinics, spread between Duarte, Durham and Sacramento amongst other cities are presently running this clinical trial. It is recommended to find the nearest location in order to reduce travel strain for those who choose to join."

Answered by AI
~4 spots leftby Jun 2024