RecruitingPhase 2NCT05281406

Additional Chemotherapy for EGFRm Patients with the Continued Presence of Plasma CtDNA EGFRm At Week 3 After Start of Osimertinib 1st-line Treatment (PACE-LUNG)

Sponsor

Goethe University

Enrollment

50 participants

Start Date

Nov 12, 2021

Study Type

INTERVENTIONAL

Conditions

NSCLC Stage IV NSCLC Stage IIIB

Summary

PACE is a prospective multicenter single-arm investigator-initiated phase II trial that examines the value of a treatment escalation strategy by the addition of platinum-based doublet chemotherapy to osimertinib in patients with treatment-naïve NSCLC harboring L858R or del19 EGFR mutation who are suspected to have poor response upon single-agent TKI treatment.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether adding chemotherapy to osimertinib (a targeted lung cancer drug) can help patients whose cancer hasn't fully responded after 3 weeks on osimertinib alone. It uses a blood test (liquid biopsy) to detect tiny pieces of tumor DNA still circulating in the blood — a sign the cancer may need more aggressive treatment. **You may be eligible if...** - You are 18 or older with stage IIIB or IV non-small cell lung cancer (NSCLC) - Your tumor has a specific mutation (EGFR exon 19 deletion or L858R) - You are starting or recently started osimertinib as your first treatment - A blood test 3 weeks into treatment still detects tumor DNA in your blood - You have not previously received systemic chemotherapy for advanced disease **You may NOT be eligible if...** - You have symptomatic brain metastases - You have a history of serious lung inflammation (interstitial lung disease) - You have significant heart problems (certain ECG abnormalities, heart failure) - You have been on another clinical trial drug recently - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOsimertinib

80 mg daily or reduced dose 40 mg daily

DRUGPemetrexed

500 mg/m² i.v. d1 of every 21-day cycle for a maximum of 4 cycles

DRUGCisplatin

75mg/m² i.v. d1 of every 21-day cycle for a maximum of 4 cycles

DRUGCarboplatin

AUC 5 mg/mL/min i.v. d1 of every 21-day cycle for a maximum of 4 cycles

Locations(16)

Charité Universitätsmedizin Berlin Campus Virchow Klinikum Klinik mit Schwerpunkt Infektiologie und Pneumologie

Berlin, Germany

Universitätsklinik Köln, Lung Cancer Group Cologne - Innere Medizin I

Cologne, Germany

Technische Universität Dresden Medizinische Fakultät Carl Gustav Carus Medizinische Klinik und Poliklinik I

Dresden, Germany

Universitätsklinikum Essen, Westdeutsches Tumorzentrum - Innere Klinik

Essen, Germany

University Hospital Frankfurt

Frankfurt, Germany

Asklepios Lungenklinik Gauting

Gauting, Germany

MVZ II der Niels Stensen Kliniken; Franziskus Hospital Harderberg

Georgsmarienhütte, Germany

Universitätsmedizin Göttingen, Klinik für Hämatologie und Medizinische Onkologie

Göttingen, Germany

Krankenhaus Martha-Maria Halle-Dölau Klinik für Innere Medizin II

Halle, Germany

Universitätsklinikum Hamburg-Eppendorf Hubertus Wald Tumorzentrum - UCCH II. Medizinische Klinik und Poliklinik

Hamburg, Germany

Universitätsklinikum Heidelberg, Thoraxklinik Heidelberg gGmbH

Heidelberg, Germany

DGD Lungenklinik Hemer

Hemer, Germany

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, Germany

LMU-München Pneumologie und Thorakale Onkologie Medizinische Klinik V; Innenstadt

München, Germany

Klinikum Nürnberg Nord Paracelsus Med. Privat Universität Pneumologie und Lungentumorzentrum

Nuremberg, Germany

Pius Hospital Oldenburg Medizinischer Campus Universität Oldenburg

Oldenburg, Germany

View Full Details on ClinicalTrials.gov

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NCT05281406

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