Perioperative Immunotherapy for NSCLC (ECTOP-1030)

NCT ID: NCT06572722

Last Updated: 2024-08-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2029-09-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Atezolizumab

Group Type: EXPERIMENTAL

Atezolizumab

Intervention Type: DRUG

atezolizumab adjuvant therapy

Nivolumab

Group Type: EXPERIMENTAL

Nivolumab

Intervention Type: DRUG

nivolumab neoadjuvant therapy

Pembrolizumab

Group Type: EXPERIMENTAL

Pembrolizumab

Intervention Type: DRUG

pembrolizumab neoadjuvant+adjuvant therapy

Interventions

Atezolizumab

atezolizumab adjuvant therapy

Intervention Type: DRUG

Nivolumab

nivolumab neoadjuvant therapy

Intervention Type: DRUG

Pembrolizumab

pembrolizumab neoadjuvant+adjuvant therapy

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Haiquan Chen

Director in the Department of Thoracic Surgery, FUSCC

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Haiquan Chen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Central Contacts

Chaoqiang Deng, M.D.

Role: CONTACT

fdudengcq@163.com

+86-13122677592

Other Identifiers

ECTOP- 1030

Identifier Type: -

Identifier Source: org_study_id