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Antibody-drug conjugate

Patritumab Deruxtecan for Non-Small Cell Lung Cancer

Phase 3

Waitlist Available

Research Sponsored by Daiichi Sankyo

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has histologically or cytologically documented metastatic or locally advanced non-squamous NSCLC not amenable to curative surgery or radiation.

Is willing to have a tumor biopsy or provide recently obtained tumor tissue

Must not have

Has a known human immunodeficiency virus (HIV) infection that is not well controlled

Has clinically significant corneal disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to approximately 49 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a new drug to see if it's effective and safe for patients with a certain type of lung cancer.

Who is the study for?

Adults with advanced non-squamous non-small cell lung cancer (NSCLC) that has an EGFR mutation and worsened after EGFR TKI therapy. They should not have had other systemic treatments in the metastatic setting, must be able to perform daily activities with minimal assistance (ECOG PS of 0 or 1), and have adequate organ function.

What is being tested?

The trial is testing Patritumab Deruxtecan against standard platinum-based chemotherapy in patients whose NSCLC has progressed despite previous treatment with EGFR TKI drugs. The goal is to find a more effective and tolerable treatment for these patients.

What are the potential side effects?

Potential side effects include reactions related to drug infusion, issues affecting blood cells, liver enzymes changes, kidney function alterations, possible lung problems like interstitial lung disease, and general symptoms such as fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My non-squamous NSCLC cannot be cured with surgery or radiation.

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I am willing to undergo a tumor biopsy or provide recent tumor samples.

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My advanced lung cancer cannot be cured with surgery or radiation.

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My cancer progressed despite treatment with a specific lung cancer medication.

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My cancer has a specific EGFR mutation.

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I haven't had any treatments like chemotherapy or immunotherapy for my advanced cancer.

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My blood counts and organ functions are within the required ranges.

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My cancer has a specific EGFR mutation.

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I've had 1 or 2 treatments with specific lung cancer drugs, including a newer type.

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I haven't had any treatments like chemotherapy or immunotherapy for my advanced cancer.

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I am 18 years old or older.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I've had 1 or 2 treatments with specific lung cancer drugs, including a newer type.

Exclusion Criteria

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

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My HIV infection is not well controlled.

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I have a serious eye condition affecting my cornea.

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I am taking more than 10 mg of prednisone or similar medication daily.

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I have untreated or symptomatic brain or spinal cord tumors needing medication.

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My cancer is confirmed as small cell, mixed small/non-small cell, or squamous non-small cell lung cancer.

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I have or might have a lung condition like ILD or pulmonary fibrosis.

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I have serious heart problems that are not under control.

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I have or had cancer spread to the lining of my brain and spinal cord.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to approximately 49 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to approximately 49 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to approximately 49 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) Based on RECIST v1.1

Secondary study objectives

Clinical Benefit Rate (CBR) as Assessed by BICR and Investigator Review Based on RECIST v1.1

Disease Control Rate (DCR) as Assessed by BICR and Investigator Review Based on RECIST v1.1

Duration of Response (DoR) as Assessed by BICR and Investigator Review Based on RECIST v1.1

+15 more

Side effects data

From 2023 Phase 1 & 2 trial • 182 Patients • NCT02980341

73%

Nausea

67%

Aspartate aminotransferase increased

67%

Platelet count decreased

67%

Neutrophil count decreased

60%

Decreased appetite

60%

White blood cell count decreased

60%

Alanine aminotransferase increased

53%

Vomiting

53%

Anaemia

40%

Stomatitis

40%

Nasopharyngitis

33%

Diarrhoea

33%

Fatigue

27%

Hypoalbuminaemia

20%

Dyspnoea

20%

Alopecia

20%

Hypokalaemia

20%

Blood alkaline phosphatase increased

20%

Headache

20%

Pain

20%

Constipation

13%

Epistaxis

13%

Malaise

13%

Pyrexia

13%

Dysgeusia

13%

Urticaria

13%

Dry skin

13%

Rash maculo-papular

13%

Electrocardiogram QT prolonged

13%

Peripheral sensory neuropathy

13%

Cough

Iodine allergy

Eczema

Somnolence

Pubic pain

Thrombocytopenia

Hypomagnesaemia

Hypoglycaemia

Parkinsonism

Conjunctival deposit

Seborrhoeic dermatitis

Arthralgia

Weight decreased

Leukopenia

Acne

Pneumonia

Hand-foot-and-mouth disease

Embolism

Skin sensitisation

Dyspepsia

Purpura

Hyponatraemia

Herpes zoster

Neuropathy peripheral

Pneumonitis

Paronychia

Strabismus

Gamma-glutamyltransferase increased

Urinary tract infection

Neutropenia

Agitation

Myalgia

Menstruation irregular

Performance status decreased

Lymphocyte count decreased

Haemorrhoids

Infusion related reaction

Intraocular pressure increased

Vertigo

Upper-airway cough syndrome

Rash

Oedema peripheral

Mucosal inflammation

100%

80%

60%

40%

20%

Study treatment Arm

Dose Escalation/Dose Finding: Cohort 4.8 mg/kg

Dose Finding: 3.2/4.8/6.4 mg/kg

Dose Escalation/Dose Finding: Cohort 6.4 mg/kg

Dose Expansion: HER3-High 6.4 mg/kg

Dose Expansion: HER3 High 4.8 mg/kg

Dose Escalation: Cohort 1.6 mg/kg

Dose Expansion: TNBC 6.4 mg/kg

Dose Expansion: HER3-Low 6.4 mg/kg

Dose Finding: 4.2/6.4 mg/kg

Dose Escalation: Cohort 8.0 mg/kg

Dose Escalation: Cohort 3.2 mg/kg

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Patritumab deruxtecanExperimental Treatment1 Intervention

Participants who will be randomized to receive patritumab deruxtecan (HER3-DXd) 5.6 mg/kg q3W.

Group II: Platinum-based chemotherapyActive Control1 Intervention

Participants who will be randomized to receive platinum-based chemotherapy for 4 cycles: pemetrexed plus either cisplatin or carboplatin. Participants without disease progression after 4 cycles of platinum plus pemetrexed therapy may continue treatment with maintenance pemetrexed with no restriction on the number of cycles.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Patritumab Deruxtecan

2016

Completed Phase 2

~190

0 / 21Eligibility criteria met