Perioperative Immunotherapy for NSCLC (ECTOP-1030)

Perioperative Immunotherapy for Early-stage Non-small-cell Lung Cancer: a Randomised, Multicentre, Open-label, Phase 2 Trial

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06572722

Enrollment

Registered

2024-08-27

Start date

2024-09-01

Completion date

2029-09-01

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Brief summary

This trial is a randomized, multicenter, open label phase II clinical study. The main objective is to evaluate the efficacy of three perioperative immunotherapy modalities (atezolizumab adjuvant therapy, nivolumab neoadjuvant therapy, pembrolizumab neoadjuvant+adjuvant therapy) in early-stage resectable NSCLC patients. The enrolled patients are randomly assigned in a 1:1:1 ratio to receive relevant treatment in the three perioperative immunotherapy groups mentioned above, and undergoing short-term pathological efficacy evaluation and long-term prognosis follow-up after surgery.

Interventions

DRUGAtezolizumab

atezolizumab adjuvant therapy

DRUGNivolumab

nivolumab neoadjuvant therapy

DRUGPembrolizumab

pembrolizumab neoadjuvant+adjuvant therapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

1. Patients who sign the informed consent form and are willing to complete the study according to the plan; 2. Aged from 18 to 80 years old; 3. ECOG equals 0 or 1; 4. Not receiving lung cancer surgery before; 5. Resectable cIB-IIIA tumors; 6. Not receiving chemotherapy or radiotherapy before.

Exclusion criteria

1. Not cIB-IIIA tumors; 2. Nodules not suitable for resection; 3. Not lung adenocarcinoma diagnosed cytologically or pathologically; 4. Receiving lung cancer surgery before; 5. Receiving radiotherapy or chemotherapy.

Design outcomes

Primary

Measure	Time frame	Description
Disease-free survival	2 years	the time from randomisation to the date of first recurrence, occurrence of new primary lung cancer, or death from any cause

Secondary

Measure	Time frame	Description
Overall survival	2 years	the time from randomisation to the date of death from any cause
Major pathological response	2 years	≤10% residual viable tumor cells in the primary tumor and sampled lymph nodes

Contacts

PRINCIPAL_INVESTIGATORHaiquan Chen, M.D.

Fudan University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 28, 2026