Surgical conversion and survival outcomes after induction chemoimmunotherapy in potentially resectable or unresectable stage III NSCLC: Preliminary results from the prospective phase II study (CTONG 1804 part 3)

CTONG 1804

Patient / Population Intervention / Exposition Vergleich Endpunkt

In patients with potentially resectable or unresectable stage III NSCLC, induction chemoimmunotherapy enabled surgical conversion in 48.8% of patients, with a 12-month event-free survival of 84.6% after surgery.

N

215Patienten

Design

Prospective, single-arm phase II study (Part 3) in treatment-naïve, EGFR/ALK wild-type stage III NSCLC that a multidisciplinary team judged potentially resectable or unresectable: at least 3 cycles of induction PD-1/PD-L1 inhibitor plus platinum-doublet chemotherapy, then team reassessment, with surgery for resectable patients and definitive chemoradiotherapy for unresectable patients, followed by immunotherapy for up to 1 year (NCT04015778).

Endpunkt

Dual primary endpoints: surgical resection rate and 18-month event-free survival in surgical patients.

ErgebnisSurgery in 105 of 215 patients (48.8%), with R0 resection in 98.1% of surgical patients and minimally invasive surgery in 84.8%. The abstract does not report 18-month EFS. In surgical patients 12-month EFS was 84.6% and median EFS was not reached, vs 66.7% and 20.5 months with chemoradiotherapy (60 patients, 27.9%). pCR 48.6% and MPR 64.8% in surgical patients. Overall ORR 67.9%, 12-month EFS 68.6% and median EFS 29.2 months at 31.3 months median follow-up. In EORTC-defined unresectable stage IIIB-IIIC disease (n=155), 73 (47.1%) had surgery, with pCR 42.5%, MPR 63.0% and 12-month EFS 82.0% vs 68.3% with chemoradiotherapy. In the 27 patients (12.6%) who withdrew consent and had no local therapy, 12-month EFS was 69.8% and median EFS 15.2 months. Five patients (2.3%) died during induction: 2 from treatment-related pneumonitis and 3 from unrelated causes.

Pan Y, Tang L, Yang X, et al. Presented at ESMO Congress 2026, abstract LBA65, 26 October. Not yet published.

Diskussion & Kritik

This single-arm phase II study shows that induction chemoimmunotherapy allowed surgery in about half of patients with stage III NSCLC, most of whom were judged unresectable at baseline, with high R0 and pathological response rates. The surgery and chemoradiotherapy groups were assigned after the response to induction, so comparing their EFS reflects patient selection and cannot show that surgical conversion itself improves survival. These results are preliminary: the co-primary endpoint of 18-month EFS and the secondary endpoint of OS are not reported, and median EFS in surgical patients has not been reached. Apart from deaths during induction the abstract gives no safety or surgical complication data, and the population was 89.8% male.