18 and older, any sex, with Non-small Cell Lung Cancer Stage IV. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Efficacy of Atezolizumab + CBDCA + Pemetrexed by Evaluating PFS RatePrimary· 12 weeks after enrollment
Percentage of subjects without disease progression (intracranial or systemic) at 12 weeks after enrollment. Determined by the investigator according to RANO and RECIST v1.1 criteria for brain and systemic disease respectively. Response Evaluation Criteria In Solid Tumors (RECIST v1.1) for target lesions and assessed by MRI:Complete Response(CR),Disappearance of all target lesions; Partial Response (PR) ≥30% decrease in the sum of the longest diameter of target lesions; Progressive disease (PD) ≥20% increase in the sum of diameters of target lesions. Reponse Evaluation criteria in brain metasta
Group
Value
95% CI
Atezolizumab
62.2
47.1 – 76.2
Efficacy of Atezolizumab + CBDCA + Pemetrexed by Measuring Objective Response.Secondary· Two consecutive evaluations 6 weeks apart
Objective response defined as a complete response or partial response on two consecutive evaluations 6 weeks apart, as determined by the investigator according to RANO and RECIST v1.1 criteria for brain and systemic disease respectively. Response Evaluation Criteria In Solid Tumors (RECIST v1.1) for target lesions and assessed by MRI: Complete Response(CR), Disappearance of all target lesions; Partial Response (PR) ≥30% decrease in the sum of the longest diameter of target lesions; Progressive disease (PD) ≥20% increase in the sum of diameters of target lesions. Reponse Evaluation criteria in
Group
Value
95% CI
Atezolizumab
18
Overall Response by RANO Criteria and SteroidsSecondary· From the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months.
To record the number of patients best response with steroid vs without steroid. Response Evaluation criteria in brain metastasis (RANO-BM) for target lesions and assessed by MRI: Complete Response (CR) Disappearance of all CNS target lesions, Partial response (PR) ≥30% decrease in the sum longest diameter of CNS target lesions; Overall Response (OR) = CR + PR. Progessive disease (PD) ≥20% increase in the sum longest diameter of CNS target lesions or a measurable increase in a non-target lesion, or the appearance of new lesions
Group
Value
95% CI
Atezolizumab
11
Atezolizumab
7
Atezolizumab
10
Atezolizumab
10
Median Time to Brain Radiotherapy (WBRT or SRS)Secondary· From date of randomization until the date of first needed salvage therapy, assessed up to 48 months.
Register the median time to needed brain radiotherapy (WBRT or SRS).
Group
Value
95% CI
Atezolizumab
10.9
7.8 – 15.9
Adverse events — posted to ClinicalTrials.gov
Time frame: 48 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07388524 — Testing the Impact of an Anti-Cancer Drug, Atezolizumab, After Surgery to Prevent Early Stage Non-small Cell Lung Cancer
· Phase 3
· not yet recruiting
NCT07322341 — SX-682 and Atezolizumab for the Treatment of Advanced or Metastatic, Recurrent Non-small Cell Lung Cancer
· Phase 2
· not yet recruiting
NCT07339059 — Phase II Study of Sacituzumab Govitecan With Atezolizumab/Durvalumab as Maintenance Therapy for Extensive-Stage Small Ce
· Phase 2
· recruiting
NCT07461675 — Effects of Neoadjuvant Immunotherapy on Anti-tumour Immunity in Hepatocellular Carcinoma Patients Undergoing Liver Resec
· Phase 3
· not yet recruiting
NCT07291076 — A Study to Evaluate the Safety and Tolerability of Pumitamig Alone or In Combination With Ipilimumab in Participants Wit
· Phase 1, PHASE2
· recruiting
Other recruiting trials for Non-small Cell Lung Cancer Stage IV
Currently open trials in the same condition.
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· active not recruiting
Other Spanish Lung Cancer Group trials
Trials by the same sponsor.
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· completed
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· Phase 2
· completed
NCT03496766 — Tipifarnib in Advanced Squamous NSCLC With Oncogen HRAS MutAtionS
· Phase 2
· terminated
NCT03363139 — T790M Mutation Testing in Blood by Different Methodologies
· completed
NCT03132493 — Nivolumab in the Real World: Analysis of the Expanded Use in Spanish Patient
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Spanish Lung Cancer Group
Last refreshed: 9 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03526900.