Center for Global Research Data

Clinical value and optimal candidate of cranial radiotherapy in atezolizumab-treated advanced non-small cell lung cancer with baseline brain metastasis

Lead Investigator: Zhengfei Zhu, Fudan University Shanghai Cancer Center
Title of Proposal Research: Clinical value and optimal candidate of cranial radiotherapy in atezolizumab-treated advanced non-small cell lung cancer with baseline brain metastasis
Vivli Data Request: 7322
Funding Source: STCSM funding (Grant No. 20Y11913500)
Potential Conflicts of Interest: None

Summary of the Proposed Research:

While cancer burden is expected to grow globally in recent years, lung cancer remains the leading cause of cancer-related death. Approximately 10%-30% of newly diagnosed patients with advanced non-small cell lung cancer (NSCLC) have brain metastases. Patients with brain metastases have complex symptom experiences, limited life expectancy and worsening quality of life. And that’s why there is a high unmet need to identify a more efficient treatment strategy for brain lesions. Given the importance of radiotherapy as the mainstay of local treatment for patients with brain metastases for advanced NSCLC, the relative roles of cranial radiotherapy and immunotherapy like anti-PD-(L)1(Programmed Death-Ligand 1) therapy are of considerable clinical interest for defining the optimal treatment strategy for advanced NSCLC with brain metastasis.

For most of the studies, patients with asymptomatic baseline brain metastases are usually eligible but subgroup analysis for brain metastases is difficult to conduct due to small number of patients in a single study.

This individual level data pooled analysis from atezolizumab trials aims to offer insights into the clinical value of treatment strategy, e.g. optimal timing, potential candidate and treatment-related toxicities of cranial radiotherapy in relation to atezolizumab administration, focusing particularly on subgroups of patients stratified by the status of baseline brain metastases (number, size).

Requested Studies:

A Phase III, Open-Label, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Paclitaxel or Atezolizumab in Combination With Carboplatin+Nab-Paclitaxel Versus Carboplatin+Nab-Paclitaxel in Chemotherapy-Naive Patients With Stage IV Squamous Non-Small Cell Lung Cancer
Data Contributor: Roche
Study ID: NCT02367794
Sponsor ID: GO29437

A Phase III Multicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Nab-Paclitaxel for Chemotherapy-Naive Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer
Data Contributor: Roche
Study ID: NCT02367781
Sponsor ID: GO29537

A Phase III, Open-Label, Randomized Study of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Paclitaxel With or Without Bevacizumab Compared With Carboplatin + Paclitaxel + Bevacizumab in Chemotherapy-Naïve Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer
Data Contributor: Roche
Study ID: NCT02366143
Sponsor ID: GO29436

A Phase II, Multicenter, Single-Arm Study OF Atezolizumab In Patients With PD-L1-Positive Locally Advanced Or Metastatic Non-Small Cell Lung Cancer
Data Contributor: Roche
Study ID: NCT02031458
Sponsor ID: GO28754

A Phase III, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Docetaxel in Patients With Non-Small Cell Lung Cancer After Failure With Platinum Containing Chemotherapy
Data Contributor: Roche
Study ID: NCT02008227
Sponsor ID: GO28915

A Phase II, Open-label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of MPDL3280A (Anti−PD-L1 Antibody) Compared With Docetaxel in Patients With Non−Small Cell Lung Cancer After Platinum Failure
Data Contributor: Roche
Study ID: NCT01903993
Sponsor ID: GO28753

A Phase II, Multicenter, Single-arm Study of MPDL3280A in Patients With PD-L1-Positive Locally Advanced or Metastatic Non-small Cell Lung Cancer
Data Contributor: Roche
Study ID: NCT01846416
Sponsor ID: GO28625