Actively Recruiting
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)
Led by Goethe University · Updated on 2025-02-21
50
Participants Needed
16
Research Sites
259 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed stage IIIB or IV non-small cell lung cancer
- Tumor positive for Ex19del or L858R EGFR mutation
- Planned or ongoing osimertinib 80mg daily treatment for up to 28 days
- Available chest and abdominal CT or MRI scans within 42 days before starting osimertinib
- No prior systemic treatment for advanced or metastatic disease except osimertinib for up to 28 days
- At least one measurable tumor site by RECISTv1.1 criteria
- Female participants of childbearing potential must use effective contraception and have a negative pregnancy test within 7 days before treatment
- Female participants not of childbearing potential must meet defined menopause or sterilization criteria
- ECOG performance status 0 to 2
- Willing and able to comply with study protocol and visits
- Osimertinib use no longer than 10 weeks before chemotherapy start in treatment phase
You will not qualify if you...
- History of other primary malignancy within 6 months, except certain low-risk cancers
- History of leptomeningeal carcinomatosis
- Enrolled in another interventional clinical study or previously enrolled in this study
- Symptomatic central nervous system metastases (asymptomatic allowed)
- Use of strong CYP3A4 inducers or inability to stop them 3 weeks prior to treatment
- Osimertinib withheld or reduced for toxicity over 7 days or unresolved toxicities precluding treatment
- Unresolved toxicities > grade 1 excluding alopecia and certain neuropathies
- Hypersensitivity to osimertinib or chemotherapy drugs used
- Severe or uncontrolled systemic diseases including active infections (e.g., hepatitis B/C, HIV)
- Gastrointestinal conditions affecting drug absorption
- Certain cardiac abnormalities or risk factors for QTc prolongation
- History or evidence of active interstitial lung disease
- Inadequate bone marrow or organ function based on lab values
- Pregnant or breastfeeding women
- Patients unwilling to use effective contraception during and after study
- Inability to consent or understand the trial
- Recent treatment with investigational drugs or chemotherapy within specified time frames
- Major surgery within 4 weeks before study start without full recovery
AI-Screening
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Trial Site Locations
Total: 16 locations
1
Charité Universitätsmedizin Berlin Campus Virchow Klinikum Klinik mit Schwerpunkt Infektiologie und Pneumologie
Berlin, Germany, 13353
Actively Recruiting
2
Universitätsklinik Köln, Lung Cancer Group Cologne - Innere Medizin I
Cologne, Germany, 50937
Actively Recruiting
3
Technische Universität Dresden Medizinische Fakultät Carl Gustav Carus Medizinische Klinik und Poliklinik I
Dresden, Germany, 01307
Actively Recruiting
4
Universitätsklinikum Essen, Westdeutsches Tumorzentrum - Innere Klinik
Essen, Germany, 45147
Actively Recruiting
5
University Hospital Frankfurt
Frankfurt, Germany, 60590
Actively Recruiting
6
Asklepios Lungenklinik Gauting
Gauting, Germany, 82131
Actively Recruiting
7
MVZ II der Niels Stensen Kliniken; Franziskus Hospital Harderberg
Georgsmarienhütte, Germany, 49124
Actively Recruiting
8
Universitätsmedizin Göttingen, Klinik für Hämatologie und Medizinische Onkologie
Göttingen, Germany, 37075
Actively Recruiting
9
Krankenhaus Martha-Maria Halle-Dölau Klinik für Innere Medizin II
Halle, Germany, 06120
Actively Recruiting
10
Universitätsklinikum Hamburg-Eppendorf Hubertus Wald Tumorzentrum - UCCH II. Medizinische Klinik und Poliklinik
Hamburg, Germany, 20246
Actively Recruiting
11
Universitätsklinikum Heidelberg, Thoraxklinik Heidelberg gGmbH
Heidelberg, Germany, 69126
Actively Recruiting
12
DGD Lungenklinik Hemer
Hemer, Germany, 58675
Actively Recruiting
13
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, Germany, 55131
Actively Recruiting
14
LMU-München Pneumologie und Thorakale Onkologie Medizinische Klinik V; Innenstadt
München, Germany, 80336
Actively Recruiting
15
Klinikum Nürnberg Nord Paracelsus Med. Privat Universität Pneumologie und Lungentumorzentrum
Nuremberg, Germany, 90419
Actively Recruiting
16
Pius Hospital Oldenburg Medizinischer Campus Universität Oldenburg
Oldenburg, Germany, 26121
Actively Recruiting
Research Team
M
Martin Sebastian, MD
CONTACT
J
Jan Stratmann, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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