NCT05689671

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

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

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: Nikolaj Frost MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Thyroid transcription factor 1 (TTF-1) is expressed in the majority of lung adenocarcinoma and has a clear prognostic value. Pemetrexed-based immunochemotherapy is a standard of care for advanced lung adenocarcinoma. However, real-world data suggest that TTF-1 negative patients might derive superior outcome using pemetrexed-free regimens. The aim of this study is to compare a pemetrexed-free (Arm A) vs. a pemetrexed-based immunochemotherapy (Arm B) as first-line treatment for metastatic TTF-1 negative lung adenocarcinoma without actionable genomic alterations.

Conditions

• Non-Small Cell Lung Cancer Metastatic

Interventions

Type	Name	Description
DRUG	Atezolizumab	1200 mg i.v. q3w
DRUG	Nab paclitaxel	100 mg/m² i.v. qw
DRUG	Carboplatin	AUC 5-6 i.v. q3w
DRUG	Pembrolizumab	200 mg i.v. q3w
DRUG	Cisplatin	75 mg/m² i.v. q3w
DRUG	Carboplatin	AUC 5-6 i.v. q3w
DRUG	Pemetrexed	500 mg/m² i.v. q3w

Timeline

• Start date: 2023-12-06
• Primary completion: 2026-03-05
• Completion: 2026-10-01
• First posted: 2023-01-19
• Last updated: 2026-03-10

Locations

36 sites across 1 country: Germany