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Her2-positive Lung Cancer Treated With Dedicated Drug | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Her2-positive Lung Cancer Treated With Dedicated Drug

Phase II Trial of Trastuzumab in Combination With Pertuzumab in Pretreated Patients With Non-small Cell Lung Cancer (NSCLC) Harboring a Her2 Mutation and Receiving Docetaxel

NCT03845270•Intergroupe Francophone de Cancerologie Thoracique

View on ClinicalTrials.gov

Summary

HER2 (erbB-2/neu) is a member of the erbB receptor tyrosine kinase family. ERBB2 gene which encodes human epidermal growth factor 2 (HER2) is a major proliferative driver activating downstream signaling through PI3K-AKT and MEK-ERK. HER2 overexpression or gene amplification is associated with sensitivity to trastuzumab and lapatinib in breast cancer. Among actual lung cancer biomarker, HER2 remains apart. HER2 involvement is known for a long time but clinical research has been stopped for many years since the first clinical trials in unselected patients were negative. Recently trastuzumab + pertuzumab + docetaxel has been tested for first-line treatment of HER2-positive metastatic breast cancer (CLEOPATRA trial). Analysis of the primary end point showed that patients who received pertuzumab, trastuzumab, and docetaxel (pertuzumab group) had a significantly longer median progression-free survival, as assessed by independent reviewers an did those who received placebo, trastuzumab, and docetaxel (control group) (hazard ratio favoring the pertuzumab group, 0.62). There is thus a strong rational for treating HER2 mutated lung cancer patient with these drugs.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patient having signed an informed consent form
•2. Histologically or cytologically confirmed NSCLC (per 2015 8th edition TNM classification)
•3. Not suitable for radiation, inoperable stage III or stage IV
•4. HER2 exon 20 mutation or insertion among which: in-frame insertions in exon 20 between codons 775 and 881 including the 12bp insertion with a duplication / insertion of 4 amino acids (YVMA) at codon 775, the 3bp insertion with a complex insertion-substitution G776\>VC and point mutations L755S and G776C. Other mutation/insertion should be discussed with IFCT. Analysis must be performed in INCa-labelled laboratories or platforms according to a validated procedure.
•5. Prior treatment with at least one regimen of platinum-based chemotherapy with documented disease progression.
•Note: taxanes are allowed provided that no grade \>2 associated adverse event occurred (except hematological toxicity).
•6. Presence of at least one lesion that can be measured by CT scan (RECIST v1.1)
•7. Age ≥ 18 years
•8. Adequate organ function, as evidenced by the following laboratory results:
•ANC \> 1500 cells/mm3 Platelet count \> 100,000 cells/mm3 Hemoglobin \> 9.0 g/dL Patients are allowed to receive transfused RBC to achieve this level. Total bilirubin ≤ 1.5 × ULN, except in patients with previously documented Gilbert's syndrome, in which case the direct bilirubin should be less than or equal to the ULN SGOT and SGPT ≤ 2.5 × ULN Alkaline phosphatase ≤ 2.5 × ULN, Alkaline phosphatase \< 5×ULN and SGOT and SGPT \< 5×ULN for patients with hepatic and/or bone metastases Clearance creatinine ≥ 30 mL/min INR and aPTT ≤ 1.5 x ULN This applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose.
+21 more criteria

Exclusion Criteria

•1. History of cancer except cancer dating from over two years ago and considered to be cured, appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma and stage I uterine cancer.
•2. Any approved anti-cancer therapy ≤ 21 days before enrollment. Note: TKIs approved for the treatment of NSCLC must be discontinued ≥ 7 days prior to the first study treatment on Cycle 1, Day 1. (The baseline scan must be completed after discontinuation of TKIs).
•3. Patients with concomitant EGFR, ALK, ROS1, MET, BRAF and KRAS mutation. Other molecular co-alterations should be discussed with IFCT before patient's enrollment.
•4. Previous treatment with an anti-HER2 agent.
•5. Any other investigational therapy ≤ 28 days before inclusion
•6. Previous irradiation \<14 days before enrollment.
•7. Brain metastases that are symptomatic, or require any radiation, surgery, or corticosteroid therapy to control symptoms from brain metastases within 4 weeks before enrollment. Asymptomatic brain metastases with a fixed dose of steroids for at least 2 weeks are eligible.
•8. Carcinomatous meningitis
•9. History of intolerance (including Grade 3 or 4 infusion reaction) or hypersensitivity to trastuzumab, pertuzumab or docetaxel or murine proteins or one of the excipients
•10. Pregnancy and breast-feeding
+4 more criteria

Locations (18)

CHU Besançon

Besançon, France

CHU de Bordeaux

Bordeaux, France

Caen - CHU Côte de Nacre

Caen, France

Clermont-Ferrand - CHU

Clermont-Ferrand, France

CHI Créteil

Créteil, France

CHRU Grenoble

Grenoble, France

Centre Hospitalier - Pneumologie

Le Mans, France

Lyon - URCOT

Lyon, France

Hôpital Nord APHM

Marseille, France

Montpellier - CHRU

Montpellier, France

Key Dates

Start Date

May 17, 2019

Primary Completion Date

February 1, 2021

Completion Date

December 18, 2023

Last Updated

December 19, 2023

Enrollment

ACTUAL participants

Conditions

Non Small Cell Lung Cancer MetastaticNon Small Cell Lung Cancer Stage IIIHER2 Gene Mutation

Interventions

pertuzumab + trastuzumab + docetaxel

DRUG

HEAT Trial (HER2 Antibody Therapy With Lutetium-177)

NCT06824155

HER2 Gene MutationAdvanced Solid Tumors

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ACTIVE_NOT_RECRUITINGPHASE2

Randomized Study of Stereotactic Body Radiation Therapy (SBRT) in Patients With Oligoprogressive Metastatic Cancers of the Breast and Lung

NCT03808662

TNBC - Triple-Negative Breast CancerTriple Negative Breast Cancer+5 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 19, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Her2-positive Lung Cancer Treated With Dedicated Drug

Inclusion Criteria

Exclusion Criteria

HEAT Trial (HER2 Antibody Therapy With Lutetium-177)

Randomized Study of Stereotactic Body Radiation Therapy (SBRT) in Patients With Oligoprogressive Metastatic Cancers of the Breast and Lung

Safety and Efficacy Study of GEN1046 as a Single Agent or in Combination With Pembrolizumab for Treatment of Recurrent (Non-small Cell) Lung Cancer

Phase 1/2 Trial of Gavo-cel (TC-210) in Patients With Advanced Mesothelin-Expressing Cancer

Lorlatinib After Failure of First-line Second-generation ALK Kinase Inhibitor in Patients With Advanced ALK-positive Non-small Cell Lung Cancer

Neratinib and Trastuzumab Biosimilar in Patients with HER2 Mutated Advanced Solid Cancers