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

Sponsor
Nikolaj Frost MD
Study ID
NCT05689671
Phase
PHASE4
Status
Active Not Recruiting

Conditions

  • Non-Small Cell Lung Cancer Metastatic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Dec 6, 2023
Status verified
Mar 2026
Primary completion
Mar 5, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
136 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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)

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: 30 months ]

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