Pemetrexed-free vs. Pemetrexed-based Immunochemotherapy in Metastatic TTF-1 Negative Lung Adenocarcinoma
NCT ID: NCT05689671
Last Updated: 2025-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
136 participants
INTERVENTIONAL
2023-12-06
2026-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Pemetrexed-free Immunochemotherapy (Arm A)
Atezolizumab 1200 mg q3w, carboplatin AUC 5-6 q3w, nab-paclitaxel 100 mg/m2 qw (administered for 4 cycles with subsequent maintenance with atezolizumab monotherapy 1200 mg q3w until loss of clinical benefit or occurrence of unacceptable toxicity)
Atezolizumab
1200 mg i.v. q3w
Nab paclitaxel
100 mg/m² i.v. qw
Carboplatin
AUC 5-6 i.v. q3w
Pemetrexed-based Immunochemotherapy (Arm B)
Pembrolizumab 200 mg q3w, cisplatin 75 mg/m2 q3w OR carboplatin AUC 5-6 (each) q3w, pemetrexed 500 mg/m2 q3w (administered for 4 cycles with subsequent maintenance with pembrolizumab 200 mg AND pemetrexed 500 mg/m2 (each) q3w until loss of clinical benefit or occurrence of unacceptable toxicity)
Pembrolizumab
200 mg i.v. q3w
Cisplatin
75 mg/m² i.v. q3w
Carboplatin
AUC 5-6 i.v. q3w
Pemetrexed
500 mg/m² i.v. q3w
Interventions
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Atezolizumab
1200 mg i.v. q3w
Nab paclitaxel
100 mg/m² i.v. qw
Carboplatin
AUC 5-6 i.v. q3w
Pembrolizumab
200 mg i.v. q3w
Cisplatin
75 mg/m² i.v. q3w
Carboplatin
AUC 5-6 i.v. q3w
Pemetrexed
500 mg/m² i.v. q3w
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patient\* 18 years or older at time of signing the informed consent form
3. Histologically or cytologically confirmed metastatic stage IV non-squamous NSCLC
4. Negative local testing for TTF-1
5. Negative molecular testing for EGFR mutations and ALK rearrangements (tested locally). Exception: In specific individual cases, treatment can be initiated prior to receiving molecular diagnostics after consulting with the sponsor, if the local principal investigator assesses the likelihood of an EGFR mutation or ALK fusion to be negligible. However, this should only be done in exceptional cases if the patient has particularly high demand for treatment. If it is subsequently found that patients are positive for EGFR mutations and/or ALK rearrangements, they must be withdrawn from the study immediately and must not receive any further study medication. Instead, patients should receive adequate SOC therapy outside the study.
Awaiting results for molecular testing remains standard procedure for patient inclusion.
6. PD-L1 tumor proportion score (TPS) \< 50%, tested locally by QUiP®-certified immunohistochemistry
7. ECOG performance status ≤ 1
8. Measurable lesions according to RECIST v1.1
9. Life expectancy ≥ 12 weeks
10. Adequate hepatic, renal and bone marrow function
1. Hemoglobin ≥ 8.0 g/dL
2. Absolute neutrophil count ≥ 1.5 x 109/L
3. Platelets ≥ 100 x 109/L
4. Calculated creatine clearance ≥ 50 mL/min as determined by the Cockcroft-Gault equation and/or creatinin ≤ 1,5x upper limit of normal (ULN)
5. Serum bilirubin ≤ 1.5 x institutional ULN
6. AST/ ALT and alkaline phosphatase ≤ 2.5 x ULN
7. International normalized ratio (INR)/ Activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PTT is within therapeutic range of intended use of anticoagulants
11. The patient is willing and able to comply with the protocol for the duration of the study, including hospital visits for treatment and scheduled follow-up visits and examinations.
12. Female patients who are considered as woman of childbearing potential (WOCBP) must use any contraceptive method with a failure rate of less than 1% per year during the treatment as well as up to 6 months after the last dose of study treatment. Male patients who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year during the treatment as well as at least 6 months after the last dose of IMP. Female patients who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) as well as azoospermic male patients do not require contraception
Exclusion Criteria
2. Patients having received:
1. Systemic treatment for metastatic or locally advanced disease
2. prior PD-1/PD-L1 immunotherapies (prior treatment with CD137 agonists or immune checkpoint blockade therapies, including, but not limited to, anti-cytotoxic T lymphocyte associated protein 4 \[anti-CTLA-4\], anti T cell immunoreceptor with Ig and tyrosine-based inhibition motif domains \[anti-TIGIT\], anti-PD-1 and anti-PD-L1 therapeutic antibodies)
3. Symptomatic, neurologically unstable CNS metastases or requiring increasing doses of steroids to manage CNS symptoms within 2 weeks prior to study entry (maximal acceptable dose must be ≤ 10 mg of prednisolone). Patients with asymptomatic, incidentally detected CNS metastases may be enrolled. Palliative radiotherapy for asymptomatic brain metastases (and any other, non-brain metastases, e.g. bone metastases) may be conducted after study entry.
4. Leptomeningeal disease
5. History of interstitial lung disease
6. Severe infection within 2 weeks prior to study entry. Clinical signs must have been resolved to CTCAE grade ≤ 1
7. Active infection with hepatitis B or C virus (HBV, HCV), human immunodeficiency virus (HIV) or Mycobacterium tuberculosis
8. Known additional malignancies other than NSCLC, either untreated or having required active treatment within the past 3 years
9. Significant cardiovascular disease (≥ NYHA 3)
10. Active or prior documented autoimmune or inflammatory disorders (including but not limited to diverticulitis \[with the exception of diverticulosis\], celiac disease, systemic lupus erythematosus, Sarcoidosis, or Wegener's syndrome \[granulomatosis with polyangiitis\], Graves' disease, rheumatoid arthritis, hypophysitis, uveitis). The following are exceptions to this criterion:
1. Patients with vitiligo or alopecia
2. Patients with hypothyroidism (e.g., following Hashimoto's disease) stable on hormone replacement
3. Patients with controlled Type I diabetes mellitus on an insulin regimen
4. Any chronic skin condition that does not require systemic therapy
5. Patients without active disease in the last 5 years may be included but only after consultation with the study physician
11. Current or prior use of immunosuppressive medication within 14 days before the first dose of atezolizumab/pembrolizumab. The following are exceptions to this criterion:
1. Intranasal, inhaled, topical steroids, or local steroid injections (e.g. intra articular injection)
2. Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
3. Steroids as premedication for hypersensitivity reactions (e.g. CT scan premedication)
12. Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and IL-2) within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment
13. Live vaccine within 30 days prior to first dose of trial treatment
14. Known allergy or hypersensitivity to any component of the chemotherapy regimen or to atezolizumab or pembrolizumab or any constituents of the products
15. Any co-existing medical condition that in the investigator's judgement will substantially increase the risk associated with the patient's participation in the study.
16. Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities.
18 Years
ALL
No
Sponsors
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Roche Pharma AG
INDUSTRY
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
OTHER
Nikolaj Frost MD
OTHER
Responsible Party
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Nikolaj Frost MD
Nikolaj Frost, PD Dr. med., Principal Investigator
Principal Investigators
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Nikolaj Frost, PD Dr.
Role: PRINCIPAL_INVESTIGATOR
Charite University, Berlin, Germany
Locations
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Klinikum St. Marien
Amberg, , Germany
Universitätsklinikum Augsburg
Augsburg, , Germany
MVZ Taunus GmbH
Bad Homburg, , Germany
Evangelische Lungenklinik Krankenhausbetriebs gGmbH
Berlin, , Germany
Evangelische Lungenklinik
Berlin, , Germany
Charité Universitätsmedizin
Berlin, , Germany
Helios Klinikum Emil von Behring
Berlin, , Germany
Klinikum Bielefeld
Bielefeld, , Germany
Kliniken der Stadt Köln GmbH
Cologne, , Germany
Technische Universität Dresden Medizinische Fakultät Carl Gustav Carus
Dresden, , Germany
Universitätsklinikum Essen
Essen, , Germany
KEM Evang. Kliniken Essen-Mitte
Essen, , Germany
Klinikum Esslingen GmbH
Esslingen am Neckar, , Germany
Krankenhaus Nordwest
Frankfurt, , Germany
Universitätsklinikum Frankfurt am Main
Frankfurt am Main, , Germany
Asklepios Klinik Gauting GmbH
Gauting, , Germany
Universitätsmedizin Göttingen
Göttingen, , Germany
LungenClinic Großhansdorf GmbH
Großhansdorf, , Germany
Asklepios Klinkum Hamburg
Hamburg, , Germany
Thoraxklinik Heidelberg gGmbH
Heidelberg, , Germany
Lungenklinik Hemer
Hemer, , Germany
Thoraxzentrum Ruhrgebiet Ev. Krankenhaus Herne
Herne, , Germany
Helios Klinikum Krefeld
Krefeld, , Germany
ÜBAG- Medizinisches Versorgungszentrum Dr. Vehling-Kaiser GmbH
Landshut, , Germany
Klinikum Lippe GmbH
Lemgo, , Germany
Klinikum Ludwigsburg
Ludwigsburg, , Germany
UKSH, Campus Lübeck
Lübeck, , Germany
Medizinische Fakultät Mannheim der Universität Heidelberg
Mannheim, , Germany
LMU Klinikum
München, , Germany
Unversitätsklinikum Münster
Münster, , Germany
Überörtliche Gemeinschaftspraxis für Hämatologie und Onkologie
Münster, , Germany
Pius Hospital
Oldenburg, , Germany
MVZ für Hämatologie und Onkologie Ravensburg GmbH
Ravensburg, , Germany
Barmherzige Brüder Krankenhaus Regensburg
Regensburg, , Germany
Elblandkliniken Stiftung & Co. KG Elblandklinikum Riesa
Riesa, , Germany
Klinikum Stuttgart
Stuttgart, , Germany
Countries
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Central Contacts
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Facility Contacts
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Ludwig Fischer von Weikersthal, Dr. med.
Role: primary
Björn Hackanson, Dr.
Role: primary
Migle Link, Dr. med.
Role: primary
Christian Grohé, Prof. Dr.
Role: primary
Christian Grohé, Prof. Dr.
Role: primary
Nikolaj Frost, Dr.
Role: primary
Jens Kollmeier, Dr.
Role: primary
Martin Görner, Dr.
Role: primary
Carolin Groß-Ophoff-Müller, Dr. med.
Role: primary
Felix Saalfeld, Dr.
Role: primary
Marcel Wiesweg, Dr.
Role: primary
Sebastian Ertl, Dr.
Role: primary
Martin Faehling, PD Dr.
Role: primary
Akin Atmaca, PD DR.
Role: primary
Martin Sebastian, Dr. med.
Role: primary
Niels Reinmuth, Prof. Dr.
Role: primary
Tobias Overbeck, Dr.
Role: primary
Martin Reck, Prof. Dr.
Role: primary
Claas Wesseler, Dr.
Role: primary
Farastuk Bozorgmehr, Dr.
Role: primary
Karsten Schulmann, PD Dr. med.
Role: primary
Daniel Christoph, PD Dr. med.
Role: primary
Benoit Krämer
Role: primary
Florian Kaiser, Dr.
Role: primary
Christian Constantin, Dr.
Role: primary
Matthias Ulmer, Dr.
Role: primary
Sabine Bohnert, Dr.
Role: primary
Melanie Janning, Dr.
Role: primary
Amanda Tufman, Prof. Dr.
Role: primary
Annalen Bleckmann, Prof. Dr.
Role: primary
Rüdiger Liersch, PD Dr.
Role: primary
Frank Griesinger, Prof. Dr.
Role: primary
Tobias Dechow, Prof. Dr.
Role: primary
Veronika Berberich, Dr.
Role: primary
Jörg Schubert, Prof. Dr.
Role: primary
Markus Knott
Role: primary
References
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Frost N, Zhamurashvili T, von Laffert M, Klauschen F, Ruwwe-Glosenkamp C, Raspe M, Brunn M, Ochsenreither S, Temmesfeld-Wollbruck B, Suttorp N, Grohe C, Witzenrath M. Pemetrexed-Based Chemotherapy Is Inferior to Pemetrexed-Free Regimens in Thyroid Transcription Factor 1 (TTF-1)-Negative, EGFR/ALK-Negative Lung Adenocarcinoma: A Propensity Score Matched Pairs Analysis. Clin Lung Cancer. 2020 Nov;21(6):e607-e621. doi: 10.1016/j.cllc.2020.05.014. Epub 2020 May 22.
Related Links
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Study description on the webpage of the "Oncology in Internal Medicine Working Group" (AIO) within the German Cancer Society
Other Identifiers
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2022-002990-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AIO-TRK-0122
Identifier Type: OTHER
Identifier Source: secondary_id
SAP131705
Identifier Type: -
Identifier Source: org_study_id
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