Pembrolizumab With Standard Cytotoxic Chemotherapy in Treatment Naive NSCLC Patients With Asymptomatic Brain Metastases

Sponsor
Samsung Medical Center
Study ID
NCT04967417
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Pemetrexed, Carboplatin, Pembrolizumab — DRUG
    * Pemetrexed 500mg/m2 * Carboplatin AUC 5.0 * Pembrolizumab 200mg
  • Paclitaxel, Carboplatin, Pembrolizumab — DRUG
    * Paclitaxel 200mg/m2 * Caboplatin AUC 6.0 * Pembrolizumab 200mg

Study Details

This is a Phase II single center, open-label, single arm study in patients with advanced non-small cell lung cancer (stage IV) with brain metastases. This study will be treated with combination of Pembrolizumab 200mg plus platinum doublet based on histology subtypes.

Key Dates

Start date
May 26, 2022
Status verified
May 2025
Primary completion
Jun 30, 2024
Completion
Dec 2, 2024

Study Design

Enrollment
13 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Non-squamous cell carcinoma
    * 4 cycles of pemetrexed 500mg/m2 + carboplatin AUC 5.0 + pembrolizumab 200mg every 3 weeks * Followed by pemetrexed 500mg/m2 + pembrolizumab 200mg every 3 weeks up to 35 cycles
  • Experimental: Squamous cell carcinoma
    * 4 cycles of paclitaxel 200mg/m2 + carboplatin AUC 6.0 + pembrolizumab 200mg every 3 weeks * Followed by pembrolizumab 200mg every 3 weeks up to 35 cycles

Primary Outcome Measure

Intracranial Objective Response Rate [ Time Frame: Up to 24 months ]

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