Perioperative Immunotherapy for NSCLC (ECTOP-1030) | NCT06572722

Studies
Perioperative Immunotherapy for NSCLC (ECTOP-1030)

NCT06572722

Sponsor

Fudan University

Status

Withdrawn

Last Update Posted

Apr 27, 2026Actual

Enrollment

0Actual

Phase

Phase 2

Conditions

Lung Cancer

Interventions

Atezolizumab
Nivolumab
Pembrolizumab

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

This trial has not been initiated

Expanded Access Info

Start Date

Sep 1, 2024Estimated

Primary Completion Date

Sep 1, 2026Estimated

Completion Date

Sep 1, 2029Estimated

First Submitted Date

Aug 23, 2024

First Submission Date that Met QC Criteria

Aug 23, 2024

First Posted Date

Aug 27, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 22, 2026

Last Update Posted Date

Apr 27, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Atezolizumab	Experimental	Drug: Atezolizumab
Nivolumab	Experimental	Drug: Nivolumab
Pembrolizumab	Experimental	Drug: Pembrolizumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Atezolizumab	Drug	atezolizumab adjuvant therapy	Atezolizumab
Nivolumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Haiquan Chen, M.D.	Fudan University	Principal Investigator

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008175	Lung Neoplasms

Ancestor Terms

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000594389	atezolizumab
D000077594	Nivolumab
C582435	pembrolizumab

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

Browse Leaves

Not provided

Browse Branches

Not provided