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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

Age >= 18 years

Must not have

Major surgery within 21 days of starting protocol treatment

Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

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.

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.

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 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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had major surgery in the last 3 weeks.

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I have had lung conditions caused by drugs, disease, or radiation.

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I do not have any unmanaged ongoing illnesses.

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I have a heart condition related to abnormal heart rhythms.

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My heart's pumping ability is below normal.

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I am HIV-positive and on combination antiretroviral therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of toxicity

Maximum tolerated dose (MTD) of necitumumab combined with osimertinib

Secondary study objectives

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 study objectives

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 2024 Phase 3 trial • 1093 Patients • NCT00981058

49%

Nausea

44%

Rash

41%

Neutropenia

41%

Anaemia

30%

Hypomagnesaemia

29%

Decreased appetite

28%

Vomiting

23%

Asthenia

21%

Fatigue

20%

Constipation

19%

Thrombocytopenia

16%

Dyspnoea

16%

Cough

15%

Dermatitis acneiform

15%

Diarrhoea

14%

Alopecia

13%

Leukopenia

13%

Pyrexia

13%

Weight decreased

11%

Stomatitis

10%

Dizziness

10%

Headache

Acne

Blood creatinine increased

Haemoptysis

Oedema peripheral

Hypokalaemia

Dry skin

Epistaxis

Pruritus

Paronychia

Back pain

Abdominal pain upper

Dysgeusia

Hyperglycaemia

Productive cough

Skin fissures

Rash generalised

Non-small cell lung cancer

Dyspepsia

Urinary tract infection

Insomnia

Pulmonary embolism

Hyponatraemia

Pneumonia

Medication error

Renal failure

Renal failure acute

Cardio-respiratory arrest

Death

General physical health deterioration

Pleural effusion

Febrile neutropenia

Pancytopenia

Atrial fibrillation

Dysphagia

Bronchitis

Convulsion

Ischaemic stroke

Deep vein thrombosis

Lower respiratory tract infection

Dehydration

Hypercalcaemia

Syncope

100%

80%

60%

40%

20%

Study treatment Arm

Necitumumab + Gemcitabine + Cisplatin

Gemcitabine + Cisplatin

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: Treatment (osimertinib, necitumumab)Experimental Treatment7 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 ECHO or MUGA and 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 3

~2020

Echocardiography

2013

Completed Phase 4

~11580