Perioperative Immunotherapy for NSCLC (ECTOP-1030)

NCT06572722 | Withdrawn Phase 2

• 1 other identifier: ECTOP- 1030
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Disease-free survival

  the time from randomisation to the date of first recurrence, occurrence of new primary lung cancer, or death from any cause

  2 years

Secondary Outcomes (2)

• Overall survival

  2 years

• Major pathological response

  2 years

Study Arms (3)

Atezolizumab

EXPERIMENTAL

Drug: Atezolizumab

Nivolumab

EXPERIMENTAL

Drug: Nivolumab

Pembrolizumab

EXPERIMENTAL

Drug: Pembrolizumab

Interventions

Atezolizumab DRUG

atezolizumab adjuvant therapy

Atezolizumab

Nivolumab DRUG

nivolumab neoadjuvant therapy

Nivolumab

Pembrolizumab DRUG

pembrolizumab neoadjuvant+adjuvant therapy

Pembrolizumab

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fudan University: lead

MeSH Terms

Conditions

Lung Neoplasms

Interventions

atezolizumab; Nivolumab; pembrolizumab

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Haiquan Chen, M.D.

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director in the Department of Thoracic Surgery, FUSCC

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: August 27, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2029
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share