Perioperative Immunotherapy for NSCLC (ECTOP-1030)

Fudan University

Status and phase: Not yet enrolling; Phase 2

Conditions: Lung Cancer

Treatments: Drug: Pembrolizumab; Drug: Atezolizumab; Drug: Nivolumab

Study type: Interventional

Funder types: Other

Identifiers

NCT06572722

ECTOP- 1030

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 3 patient groups

Atezolizumab

Experimental group

Treatment:

Drug: Atezolizumab

Nivolumab

Experimental group

Treatment:

Drug: Nivolumab

Pembrolizumab

Experimental group

Treatment:

Drug: Pembrolizumab