# Pre-surgery platform trials that test combinations on pathological response in months

Source: https://onco.cc/ideas/idea-tr2-neoadjuvant-combo-platform/  
OnCo record `idea-tr2-neoadjuvant-combo-platform` (Idea). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Give drug combinations before surgery and measure how much tumour remains at resection; that answer arrives in months. A standing neoadjuvant platform with a shared control arm, as I-SPY 2 runs in breast cancer, would test combinations quickly in lung, bladder, melanoma, head and neck and oesophago-gastric cancer.

## Summary

I-SPY 2 established graduation of arms by pathological complete response in breast cancer. The same model applies to lung, bladder, melanoma, head and neck and oesophago-gastric cancer where neoadjuvant therapy is now standard. Each cancer needs a standing neoadjuvant platform with a shared control arm and pre-agreed rules for graduating an arm to a confirmatory trial.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- Hypothesis: Neoadjuvant platforms will screen at least five combination arms per year per cancer, with pathological response predicting event-free survival well enough that graduated arms confirm in phase 3 at least 60% of the time.
- Rationale: Pathological complete response and major pathological response correlate with survival in breast, lung and melanoma, and the neoadjuvant window allows paired biopsies that explain why a combination did or did not work.
- Proposed test: Open a neoadjuvant platform in one cancer without one (oesophago-gastric or head and neck), graduate two arms by pathological response, and track confirmation.
- Maturity: being-tested-at-scale
- Actor: research

## Sources

- I-SPY trials: https://www.ispytrials.org/

## Connected records

- terms: [Basket, umbrella, and platform trials](https://onco.cc/terms/basket-umbrella-platform/), [Major pathological response (MPR)](https://onco.cc/terms/major-pathological-response/), [Pathologic complete response (pCR)](https://onco.cc/terms/pcr/), [Residual cancer burden (RCB)](https://onco.cc/terms/rcb/)
- pairings: [Neoadjuvant immunotherapy → response-adapted adjuvant](https://onco.cc/pairings/neoadjuvant-io-response-adapted/)
- cancers: [Head and neck squamous cell carcinoma](https://onco.cc/cancers/head-and-neck/), [Melanoma](https://onco.cc/cancers/melanoma/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/), [Oesophageal cancer](https://onco.cc/cancers/esophageal/), [Resectable stage I to III non-small-cell lung cancer](https://onco.cc/cancers/resectable-nsclc/)
- trials: [KEYNOTE-522](https://onco.cc/trials/keynote-522/), [NADINA](https://onco.cc/trials/nadina/)
- bottlenecks: [Too many combinations to test](https://onco.cc/bottlenecks/b-combination-space/), [Trial design, endpoints and cost](https://onco.cc/bottlenecks/b-trial-design/)
- ideas: [Let the trial learn: response-adaptive allocation across many combination arms](https://onco.cc/ideas/idea-tr2-bandit-allocation/), [Two-week pre-operative windows to compare combination biology head to head](https://onco.cc/ideas/idea-tr2-window-of-opportunity-triplets/)
- roadmaps: [Surgery roadmap: radical operations → less surgery → no surgery when a drug has done the work](https://onco.cc/roadmaps/surgery-roadmap/), [Trial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on](https://onco.cc/roadmaps/trial-modernisation-roadmap/)

---
JSON: https://onco.cc/api/v1/entities/idea-tr2-neoadjuvant-combo-platform.json