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Atezolizumab in Combination With Carboplatin Plus Pemetrexed in Chemotherapy-naïve Patients With Asymptomatic Brain Metastasis

NCT03526900 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-10-09

Study results available
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Summary

This is a multicenter, national, nonrandomized, phase II trial in subjects with nonsquamous NSCLC patients that have untreated asymptomatic BM. A pre-screening period using brain MRI for patients diagnosed with advanced non-squamous NSCLC EGFR/ALK wild type and ECOG PS 0-1 will be crucial to identify patients with asyntomatic BM. Forty patients will be recruited.

Conditions

  • Non-small Cell Lung Cancer Stage IV

Interventions

DRUG

Atezolizumab

* Induction (four or six 21-day cycles) : Atezolizumab 1200 mg / iv + carboplatin 5 AUCs + pemetrexed 500 mg/m2 * Maintenance (21-day cycles): atezolizumab 1200 mg/iv + pemetrexed 500 mg/m2.

Sponsors & Collaborators

  • Spanish Lung Cancer Group

    lead OTHER

Principal Investigators

  • Ernest Nadal, MD · Hospital Universitari de Bellvitge

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-07
Primary Completion
2022-03-31
Completion
2022-09-15

Countries

  • Spain

Study Locations

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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 NCT03526900 on ClinicalTrials.gov