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

NCT05689671 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2026-03-10

No results posted yet for this study

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.

Conditions

  • Non-Small Cell Lung Cancer Metastatic

Interventions

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

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

    collaborator OTHER

  • Nikolaj Frost MD

    lead OTHER

Principal Investigators

  • Nikolaj Frost, PD Dr. · Charite University, Berlin, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-06
Primary Completion
2026-03-05
Completion
2026-10-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05689671 on ClinicalTrials.gov