Phase 1: Background & Literature
Define your research topic and PICO framework. The AI analyses your topic, then searches PubMed, ClinicalTrials.gov, Cochrane, and other databases to map the evidence landscape and identify existing reviews on your topic. This data feeds directly into your proposal rationale.
PICO Framework
population
Treatment-naïve adults with advanced NSCLC (stage IIIB-IV)
intervention
PD-1/PD-L1 inhibitor immunotherapy
comparison
High vs low baseline gut microbiome diversity
outcomes
Objective response rate (RECIST 1.1), progression-free survival, overall survival
Research Gap
While checkpoint inhibitor immunotherapy has improved outcomes in advanced NSCLC, response rates remain suboptimal at 20-40%. Emerging evidence suggests the gut microbiota influences systemic immune responses and may predict immunotherapy efficacy, yet longitudinal studies are limited.
Significance
This study will establish the mechanistic link between microbiome diversity and immunotherapy response, enabling personalised treatment strategies.
Literature Landscape
847
Total studies
612
PubMed
89
ClinicalTrials.gov
6
Existing reviews
Feasibility Assessment
There is a substantial body of primary research (612 PubMed articles) examining the gut microbiome–immunotherapy axis. Six existing systematic reviews have been published, the most recent in 2024. However, none specifically focus on NSCLC with longitudinal microbiome sampling. The volume of new primary studies since the last review (>150 published after 2023) supports an updated, NSCLC-specific investigation. Recommend proceeding with a clearly defined scope distinguishing this from existing reviews.
Most Recent Reviews on This Topic
Gut microbiome and immunotherapy response: a systematic review and meta-analysis
Zhang Y, Chen L, Wu H et al.. J Immunother Cancer. 2024.
The role of gut microbiota in cancer immunotherapy: a systematic review
Liu M, Wang S, Fernandez J et al.. Clin Cancer Res. 2023.
Microbiome biomarkers for checkpoint inhibitor response: meta-analysis of observational studies
Park JH, Kim SK, Anderson R. Ann Oncol. 2023.
Strong evidence base — good candidate for a research proposal