The Study
FDA Approval Summary: Sotorasib for KRAS G12C Mutated Metastatic NSCLC
This study watched what happened when 124 people with a specific kind of lung cancer took a new medicine. It saw that some tumors got smaller, but it didn't compare them to people who didn't take the medicine. So we know the medicine was taken and some people got better, but we don't know if the medicine caused it or if something else did.
Analysis score
Maximum 90 for a randomized controlled trial.
Where the score came from
This medicine, sotorasib, is a pill that targets a specific glitch (KRAS G12C) in some lung cancers that used to be impossible to treat.
Where does this study sit?
Reviews of RCTs (Meta-analyses)
Max 100Randomized Trials
Max 90Reviews of Cohort Studies
Max 85Cohort Studies
Max 72Reviews of Case-Control Studies
Max 63Case-Control Studies
Max 58Cross-Sectional & Case Series
Max 50Expert Opinion
Max 520 / 100
Quality score
Participants are randomly assigned to treatment or control groups, minimizing bias. The gold standard for testing whether an intervention causes an effect.
Key takeaways
Summary
Based on the study abstract and findings.
- 1Yes — for patients who ran out of other options, this pill gave them a real chance of tumor shrinkage lasting months, which is meaningful when survival was previously measured in months.
- 236 out of 100 patients had their tumors shrink, and the shrinkage lasted about 10 months on average.
Score breakdown, methodology, conflicts of interest, evidence analysis & raw study data
Publication
Journal
Clinical cancer research : an official journal of the American Association for Cancer Research
Year
2021
Authors
Erica C Nakajima, N. Drezner, Xiaoxue Li, P. Mishra-Kalyani, Yajun Liu, Hong Zhao, Y. Bi, Jiang Liu, Atiqur Rahman, E. Wearne, Idara Ojofeitimi, L. T. Hotaki, Dianne Spillman, R. Pazdur, J. Beaver, H. Singh
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Not medical advice. For informational purposes only. Always consult a qualified healthcare professional before making health decisions.