# Neotorch

Source: https://onco.cc/trials/neotorch/  
OnCo record `neotorch` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A Chinese trial showing that adding the PD-1 antibody toripalimab to chemotherapy before and after lung cancer surgery more than doubles the time before the cancer comes back.

## Summary

Neotorch enrolled 501 patients with resectable stage II or III non-small-cell lung cancer at 50 hospitals in China between March 2020 and June 2023, randomising them 1:1 to toripalimab or placebo with platinum-based chemotherapy for three cycles before surgery and one after, followed by toripalimab or placebo alone for up to 13 cycles. Non-squamous tumours had to be free of EGFR and ALK alterations. The dual primary endpoints were investigator-assessed event-free survival and blinded independently reviewed major pathological response.

The interim analysis, with a data cutoff of 30 November 2022, reported the 404 stage III patients (202 in each arm); the 97 stage II patients were excluded from it. Median age was 62, 92 percent were male and median follow-up was 18.3 months. Median event-free survival was not estimable (95 percent confidence interval 24.4 months to not estimable) with toripalimab against 15.1 months (10.6 to 21.9) with placebo, a hazard ratio of 0.40 (0.28 to 0.57).

Neotorch is one of four perioperative trials, with KEYNOTE-671, AEGEAN and CheckMate 77T, that made chemotherapy plus a checkpoint inhibitor before and after surgery a standard for stage II to III disease. Its population is almost entirely Chinese and male, which limits how far it transfers.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-25
- Also known as: NEOTORCH
- Registry id: NCT04158440
- Phase: 3
- Setting: Resectable stage II or III non-small-cell lung cancer in China, without EGFR or ALK alterations for non-squamous disease: toripalimab 240 mg or placebo every three weeks with platinum chemotherapy for three cycles before surgery and one after, then toripalimab or placebo alone for up to 13 cycles, with dual primary endpoints of event-free survival and major pathological response
- Sponsor: Shanghai Junshi Biosciences
- Enrolled: 501
- Result: Median event-free survival not estimable against 15.1 months in stage III disease (hazard ratio 0.40, 95 percent confidence interval 0.28 to 0.57).
- Outcomes: Event-free survival (stage III population): Toripalimab with chemotherapy vs Placebo with chemotherapy 15.1 months, HR 0.4
- Replication: RATIONALE-315 (tislelizumab), CheckMate 77T (nivolumab), KEYNOTE-671 (pembrolizumab) and AEGEAN (durvalumab) all found the same direction of effect with the same design.

## Sources

- ClinicalTrials.gov NCT04158440: https://clinicaltrials.gov/study/NCT04158440
- Neotorch (JAMA 2024): https://doi.org/10.1001/jama.2023.24735

## Connected records

- cancers: [Lung cancer (all types)](https://onco.cc/cancers/lung-cancer/), [Resectable stage I to III non-small-cell lung cancer](https://onco.cc/cancers/resectable-nsclc/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/), [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/), [Platinum agents](https://onco.cc/technologies/platinum/)
- targets: [PD-1](https://onco.cc/targets/pd1/)
- drugs: [Carboplatin](https://onco.cc/drugs/carboplatin/), [Cisplatin](https://onco.cc/drugs/cisplatin/), [Toripalimab](https://onco.cc/drugs/toripalimab/)
- companies: [Shanghai Junshi Biosciences](https://onco.cc/companies/junshi/)
- terms: [Major pathological response (MPR)](https://onco.cc/terms/major-pathological-response/), [Neoadjuvant / adjuvant / perioperative](https://onco.cc/terms/neoadjuvant-adjuvant/), [Pathologic complete response (pCR)](https://onco.cc/terms/pcr/)
- trials: [A Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Removal and Adjuvant Treatment With Nivolumab or Placebo for Participants With Surgically Removable Early Stage Non-small Cell Lung Cancer](https://onco.cc/trials/nct04025879/), [A Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Non-small Cell Lung Cancer](https://onco.cc/trials/nct03800134/), [Comparing the Efficacy and Safety of a New Additional Treatment With Tislelizumab in Non-Small Cell Lung Cancer (NSCLC)](https://onco.cc/trials/nct04379635/), [KEYNOTE-671](https://onco.cc/trials/keynote-671/)

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