Actively Recruiting
Additional Chemotherapy for EGFR Mutation Patients with Persistent Plasma EGFR Mutation at Week 3 After Starting Osimertinib First-line Treatment (PACE-LUNG)
Led by Goethe University · Updated on 2025-02-21
50
Participants Needed
16
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a treatment strategy for patients with advanced non-small cell lung cancer (NSCLC) that have specific EGFR mutations (L858R or exon 19 deletions) and are starting first-line treatment with osimertinib. This phase II trial focuses on patients who show a poor response to osimertinib alone, as indicated by the continued presence of EGFR mutations in their blood after three weeks of treatment. The purpose is to see if adding platinum-based chemotherapy to osimertinib can improve progression-free survival (PFS) and overall survival (OS) compared to historical data. Participants will initially receive standard osimertinib at 80 mg daily. After approximately seven weeks, those with persistent EGFR mutation signals in their plasma will have their treatment escalated by adding up to four cycles of platinum-based chemotherapy, either cisplatin or carboplatin combined with pemetrexed, administered intravenously every three weeks. Patients without persistent EGFR mutations will continue with osimertinib alone and are not eligible for the treatment escalation. This single-arm trial is conducted across multiple centers and is investigator-initiated. Throughout the study, participants will undergo regular assessments including imaging scans and liquid biopsies to monitor disease progression and treatment response. Safety and tolerability of the combined treatment will be evaluated up to 16 weeks after starting chemotherapy, alongside quality of life measurements using questionnaires. The primary outcome is progression-free survival over two years, with overall survival and other secondary outcomes also tracked. Participants are expected to comply with scheduled treatment and follow-up visits for the duration of the study.
CONDITIONS
Brief 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 Exon 19 deletion or L858R EGFR mutation
- Planned or ongoing osimertinib 80 mg daily first-line treatment for up to 28 days
- At least one measurable disease site by RECISTv1.1 criteria
- Available recent chest and abdominal CT or MRI scans within 42 days before osimertinib start
- No prior systemic treatment for advanced or metastatic disease except osimertinib for up to 28 days
- Female participants of childbearing potential must use effective contraception and have a negative pregnancy test before treatment
- Women not of childbearing potential must meet specific criteria confirming this status
- ECOG performance status 0-2
- Persistent EGFR mutation detected by liquid biopsy 21 to 28 days after osimertinib start
- Willing and able to comply with study visits and procedures
- Osimertinib treatment not exceeding 10 weeks before chemotherapy start
You will not qualify if you...
- History of other primary malignancies except certain treated cancers without active disease
- History of leptomeningeal carcinomatosis
- Concurrent participation in other interventional clinical studies
- Previous enrollment in this study
- Symptomatic central nervous system metastases (asymptomatic brain metastases allowed)
- Use of strong CYP3A4 inducers within 3 weeks before treatment
- Osimertinib withheld or dose-reduced for toxicity for more than 7 days
- Unresolved toxicities from prior therapies greater than grade 1 except alopecia and grade 2 neuropathy
- Hypersensitivity to osimertinib or chemotherapy drugs used in this trial
- Severe or uncontrolled systemic diseases including active infections
- Gastrointestinal conditions preventing adequate drug absorption
- Specific cardiac abnormalities or risks for QT prolongation
- History or active interstitial lung disease
- Inadequate bone marrow or organ function as defined by laboratory criteria
- Pregnancy or breastfeeding
- Patients unwilling to use effective contraception during and after treatment
- Inability to consent or understand trial implications
- Recent investigational drug use within five half-lives or 3 months
- Recent chemotherapy, biologic, or hormonal cancer treatments within 6 months
- Major surgery within 4 weeks prior to study start without recovery from effects
- Investigator judgment that the patient cannot comply with study procedures or requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 19 weeks (7 weeks osimertinib monotherapy plus up to 12 weeks chemotherapy)
Participants receive osimertinib daily for approximately 7 weeks. If EGFR mutation persists in plasma at week 3, they then receive up to 4 cycles of platinum-based chemotherapy (pemetrexed with cisplatin or carboplatin) combined with osimertinib.
Up to 4 chemotherapy cycles every 3 weeks combined with daily osimertinib
Duration - Up to 2 years
Participants are monitored for progression-free survival and overall survival for up to 2 years after treatment.
Visits scheduled periodically during follow-up for up to 2 years
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
J
Jan Stratmann, MD
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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