Atezolizumab/Carboplatin/Nab-Paclitaxel vs. Pembrolizumab/Platinum/Pemetrexed in Metastatic TTF-1 Negative Lung Adenocarcinoma

Status: Recruiting
Location: See all (31) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

This is an open-label randomized, controlled, multicenter, phase II trial with two arms. Patients with metastatic TTF-1 negative, treatment-naive lung adenocarcinoma without actionable genomic alterations are randomized in a 1:1 manner to investigate the efficiency of atezolizumab, carboplatin and nab-paclitaxel (Arm A) versus pembrolizumab, cis-/carboplatin and pemetrexed (Arm B) as first-line treatment.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patient has provided written informed consent

• Patient\* 18 years or older at time of signing the informed consent form

• Histologically or cytologically confirmed metastatic stage IV non-squamous NSCLC

• Negative local testing for TTF-1

• 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 If it is subsequently found that patients are positive for EGFR mutations and/or ALK rearrangements, they must be withdrawn from the study immediately and must not receive any further study medication.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.

• PD-L1 tumor proportion score (TPS) \< 50%, tested locally by QUiP®-certified immunohistochemistry

• ECOG performance status ≤ 1

• Measurable lesions according to RECIST v1.1

• Life expectancy ≥ 12 weeks

⁃ Adequate hepatic, renal and bone marrow function

∙ Hemoglobin ≥ 8.0 g/dL

‣ Absolute neutrophil count ≥ 1.5 x 109/L

‣ Platelets ≥ 100 x 109/L

‣ Calculated creatine clearance ≥ 50 mL/min as determined by the Cockcroft-Gault equation and/or creatinin ≤ 1,5x upper limit of normal (ULN)

‣ Serum bilirubin ≤ 1.5 x institutional ULN

‣ AST/ ALT and alkaline phosphatase ≤ 2.5 x ULN

‣ 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

⁃ 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.

⁃ 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

Locations
Other Locations
Germany
Klinikum St. Marien
RECRUITING
Amberg
MVZ Taunus GmbH
RECRUITING
Bad Homburg
Charité Universitätsmedizin
RECRUITING
Berlin
Evangelische Lungenklinik
RECRUITING
Berlin
Evangelische Lungenklinik Krankenhausbetriebs gGmbH
RECRUITING
Berlin
Helios Klinikum Emil von Behring
RECRUITING
Berlin
Klinikum Bielefeld
RECRUITING
Bielefeld
Kliniken der Stadt Köln GmbH
RECRUITING
Cologne
Technische Universität Dresden Medizinische Fakultät Carl Gustav Carus
RECRUITING
Dresden
KEM Evang. Kliniken Essen-Mitte
RECRUITING
Essen
Klinikum Esslingen GmbH
RECRUITING
Esslingen Am Neckar
Krankenhaus Nordwest
RECRUITING
Frankfurt
Universitätsklinikum Frankfurt am Main
RECRUITING
Frankfurt Am Main
Asklepios Klinik Gauting GmbH
RECRUITING
Gauting
Universitätsmedizin Göttingen
RECRUITING
Göttingen
LungenClinic Großhansdorf GmbH
RECRUITING
Großhansdorf
Asklepios Klinkum Hamburg
RECRUITING
Hamburg
Thoraxklinik Heidelberg gGmbH
RECRUITING
Heidelberg
Lungenklinik Hemer
RECRUITING
Hemer
Helios Klinikum Krefeld
RECRUITING
Krefeld
ÜBAG- Medizinisches Versorgungszentrum Dr. Vehling-Kaiser GmbH
RECRUITING
Landshut
Klinikum Lippe GmbH
RECRUITING
Lemgo
UKSH, Campus Lübeck
RECRUITING
Lübeck
Klinikum Ludwigsburg
RECRUITING
Ludwigsburg
Medizinische Fakultät Mannheim der Universität Heidelberg
RECRUITING
Mannheim
LMU Klinikum
RECRUITING
München
Überörtliche Gemeinschaftspraxis für Hämatologie und Onkologie
RECRUITING
Münster
Unversitätsklinikum Münster
RECRUITING
Münster
Pius Hospital
RECRUITING
Oldenburg
Barmherzige Brüder Krankenhaus Regensburg
RECRUITING
Regensburg
Elblandkliniken Stiftung & Co. KG Elblandklinikum Riesa
RECRUITING
Riesa
Contact Information
Primary
Nikolaj Frost, PD Dr.
nikolaj.frost@charite.de
+49 30 450 565 005
Backup
Daniel Müller, Dr.
mueller.daniel@ikf-khnw.de
+49 69 7601 125
Time Frame
Start Date: 2023-12-06
Estimated Completion Date: 2026-10
Participants
Target number of participants: 136
Treatments
Experimental: 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)
Active_comparator: 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)
Sponsors
Collaborators: Roche Pharma AG, Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Leads: Nikolaj Frost MD

This content was sourced from clinicaltrials.gov