Perioperative Immunotherapy for NSCLC (ECTOP-1030)

Phase 2

Not yet recruiting

• Conditions: Lung Cancer
• Interventions: Drug: Pembrolizumab; Drug: Nivolumab; Drug: Atezolizumab

• Registration Number: NCT06572722
• Lead Sponsor: Fudan University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-23
• Study First Submitted QC: 2024-08-23
• Last Update Submitted: 2024-08-23
• Study First Posted: 2024-08-27
• Last Update Posted: 2024-08-27
• Study Start: 2024-09-01
• Primary Completion: 2026-09-01
• Study Completion: 2029-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pembrolizumab	Pembrolizumab	-
Nivolumab	Nivolumab	-
Atezolizumab	Atezolizumab	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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