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Monoclonal Antibodies

Necitumumab + Trastuzumab + Osimertinib for Lung Cancer

Phase 1 & 2

Waitlist Available

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

Must not have

Known allergy or contraindication to treatment components, clinically relevant coronary artery disease, uncontrolled heart failure, or recent myocardial infarction

Unresolved acute toxicities from previous therapy, known small cell lung cancer, or small cell transformation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

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

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My last treatment was osimertinib, and my cancer progressed after it.

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I am fully active or can carry out light work.

Exclusion Criteria

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

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I do not have allergies to the treatment, heart disease, uncontrolled heart failure, or recent heart attacks.

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I don't have ongoing side effects from past treatments or small cell lung cancer.

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

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

59%

Nausea

33%

Vomiting

32%

Neutropenia

31%

Anorexia

30%

Fatigue

29%

Anaemia

27%

Constipation

22%

Asthenia

16%

Diarrhoea

15%

Cough

13%

Dyspnoea

13%

Oedema peripheral

12%

Hypomagnesaemia

12%

Leukopenia

10%

Dysgeusia

Mucosal inflammation

Headache

Hypertension

Abdominal pain upper

Weight decreased

Dizziness

Hypokalaemia

Thrombocytopenia

Pyrexia

Dyspepsia

Blood creatinine increased

Hyponatraemia

Back pain

Alopecia

Rash

Lymphopenia

Tinnitus

Lacrimation increased

Abdominal pain

Non-cardiac chest pain

Urinary tract infection

Musculoskeletal pain

Pain in extremity

Insomnia

Pulmonary embolism

Fluid retention

Hypocalcaemia

Dry skin

Stomatitis

Hyperglycaemia

Pruritus

Epistaxis

Haemoptysis

Non-small cell lung cancer

Paraesthesia

Depression

Pneumonia

Conjunctivitis

Dehydration

Renal failure

Oral candidiasis

Productive cough

Rash generalised

Cerebral infarction

Cerebrovascular accident

Respiratory tract infection

Pericardial effusion

General physical health deterioration

Atrial fibrillation

Arthralgia

Febrile neutropenia

Bronchitis

Infection

Incorrect dose administered

Medication error

Hemiparesis

Spinal cord compression

Pleural effusion

Respiratory failure

Circulatory collapse

100%

80%

60%

40%

20%

Study treatment Arm

Pemetrexed+Cisplatin

Necitumumab+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