Pemetrexed-free vs. Pemetrexed-based Immunochemotherapy in Metastatic TTF-1 Negative Lung Adenocarcinoma

Phase 4 Active not recruiting 136 enrolled Nikolaj Frost MD Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · collab Roche Pharma AG · collab

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2023-12-06
Primary completion: 2026-03-05
Completion: 2026-10

Publications

Background 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Atezolizumab	Monoclonal antibody	1200 mg	Intravenous
Comparator	Carboplatin	Small molecule	—	Intravenous
Comparator	Cisplatin	Other / unclassified	75 mg/m2	Intravenous
Subject	Paclitaxel	Small molecule	100 mg/m2	Intravenous
Comparator	Pembrolizumab	Monoclonal antibody	200 mg	Intravenous
Comparator	Pemetrexed	Small molecule	500 mg/m2	Intravenous

Pemetrexed-free vs. Pemetrexed-based Immunochemotherapy in Metastatic TTF-1 Negative Lung Adenocarcinoma

Summary

Timeline

Publications

Drugs

Indications