Organ-specific response to atezolizumab and radiotherapy in advanced non-small cell lung cancer patients: a pooled analysis

Lead Investigator: Zhengfei Zhu, Fudan University Shanghai Cancer Center
Title of Proposal Research: Organ-specific response to atezolizumab and radiotherapy in advanced non-small cell lung cancer patients: a pooled analysis
Vivli Data Request: 9960
Funding Source: None
Potential Conflicts of Interest: None

Summary of the Proposed Research:

Immunotherapy is a treatment used against cancer that works by helping the body’s immune system recognize and attack cancer cells. Immune checkpoint inhibitors (ICIs) are a type of immunotherapy. They block proteins that stop the immune system from attacking the cancer cells. Two such proteins are programmed cell death protein 1 (PD-1) and programmed death-ligand 1 (PD-L1). PD-L1 is present on tumor cells, and PD-1 is present on the body’s immune ‘T’ cells. Anti- PD-1 and anti-PD-L1 are types of ICI which block the binding of PD-L1 to PD-1 allowing the T cells to recognize and kill tumor cells.

The advent of ICIs, such as anti-PD-1/PD-L1, has revolutionized the treatment landscape for advanced or metastatic (cancer which has spread to other parts of the body) non-small cell lung cancer (NSCLC). NSCLC is a major form of lung cancer, which accounts for 85% patients.
Another type of treatment for cancer is radiotherapy (RT). This uses high-energy rays called radiation which destroy cancer cells in the area where the radiotherapy is given. Understanding the interplay between RT and anti-PD-1/PD-L1 therapy is pivotal in optimizing treatment strategies for NSCLC patients with brain metastases (cancer which has spread to the brain).

Our project aims to shed light on the organ-specific responses to atezolizumab (an ICI) and in combination with RT, with a focus on elucidating survival benefits across various metastatic sites. Through a comprehensive pooled study, where the results from several clinical trials will be combined, we intend to analyze survival outcomes and disease progression patterns in advanced NSCLC patients receiving atezolizumab. By assessing how different metastatic organs respond to atezolizumab and predicting its therapeutic efficacy, we seek to compare outcomes among patients based on their specific metastatic sites. Furthermore, we will investigate the response of various metastatic organs to RT to ascertain whether there are organ-specific survival advantages.

Requested Studies:

A Phase III, Open Label, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) Compared With a Platinum Agent (Cisplatin or Carboplatin) in Combination With Either Pemetrexed or Gemcitabine for PD-L1-Selected, Chemotherapy-Naive Patients With Stage IV Non-Squamous Or Squamous Non-Small Cell Lung Cancer
Data Contributor: Roche
Study ID: NCT02409342
Sponsor ID: GO29431

A Phase III/IV, Single Arm, Multicenter Study of Atezolizumab (Tecentriq) to Investigate Long-term Safety and Efficacy in Previously-treated Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (TAIL)
Data Contributor: Roche
Study ID: NCT03285763
Sponsor ID: MO39171

A Phase III, Open-Label, Randomized Study of Atezolizumab (MPDL3280A, Anti-Pd-L1 Antibody) in Combination With Carboplatin or Cisplatin + Pemetrexed Compared With Carboplatin or Cisplatin + Pemetrexed in Patients Who Are Chemotherapy-Naive and Have Stage IV Non-Squamous Non-Small Cell Lung Cancer
Data Contributor: Roche
Study ID: NCT02657434
Sponsor ID: GO29438

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, 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, 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 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

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