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A Prospective Cohort Study of Neoadjuvant Chemotherapy Plus Sintillumab in the Treatment of Resectable NSCLC

NCT06485557 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-07-03

No results posted yet for this study

Summary

This study uses a prospective cohort design.Subjects are randomly divided into three groups (A, B, C) before surgery. Group A gets 3 cycles of sintilimab + chemo, Group B gets 2 cycles + 1 cycle, and Group C gets 1 cycle + 2 cycles.

Non-squamous NSCLC subjects receive pemetrexed/albumin paclitaxel + platinum, while squamous NSCLC subjects get albumin paclitaxel + platinum.

Conditions

  • Resectable Non-small Cell Lung Cancer

Interventions

DRUG

sintilimab plus platinum-based chemotherapy

The subjects in group A will receive 3 cycles of sintilimab plus platinum-based chemotherapy

DRUG

sintilimab plus platinum-based chemotherapy

The subjects in group B will receive 2 cycles of sintilimab plus platinum-based chemotherapy plus 1 cycle of sintilimab

DRUG

sintilimab plus platinum-based chemotherapy

The subjects in group C will receive 1 cycle of sintilimab plus platinum-based chemotherapy plus 2 cycles of sintilimab.

Sponsors & Collaborators

  • Tang-Du Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-01
Primary Completion
2025-12-31
Completion
2026-08-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06485557 on ClinicalTrials.gov