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Neoadjuvant Immunotherapy Plus Chemotherapy for Potentially Resectable Stage IIIA/IIIB Non-Small Cell Lung Cancer

NCT04326153 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-02-01

No results posted yet for this study

Summary

Cancer has always been one of the leading causes of death in the world, and China is facing more and more severe challenges from cancer. Among all the causes of cancer death, lung cancer (25.2%) ranks first, among which non-small cell lung cancer (NSCLC) accounts for about 80% to 85%, of which about 1 / 3 of the patients have been in the local advanced stage (IIIA stage / IIIB stage) at the time of initial diagnosis. For the patients with stage IIIA NSCLC who can be operated on, surgery is still the most effective way to treat them. Even so, NSCLC in stage I-III undergoing radical surgery is the most effective way 30-60% of the patients eventually had relapse or distant metastasis. Therefore, people began to explore a new treatment mode, preoperative neoadjuvant chemotherapy, to improve the survival rate of NSCLC 2.

At present, the NCCN guidelines for the new adjuvant treatment of NSCLC mainly recommend platinum based dual drug chemotherapy.

Immunotherapy combined with chemotherapy will be a potential new adjuvant therapy in the future, which can improve the resection rate of patients, reduce the recurrence rate after surgery, and have tolerable adverse reactions.

Conditions

  • IIIA Stage Non-small Cell Lung Cancer

Interventions

DRUG

Sintilimab Injection

Preoperative: Sintilimab: 200mg QD, one cycle every 21 days, the first day of each cycle, a total of two cycles. Albumin paclitaxel: 135mg / m2 QD, 1 cycle every 21 days, 1 day and 8 days of each cycle, 2 cycles in total. Carboplatin: AUC 5mg QD, one cycle every 21 days, two cycles in total Postoperative: Patients began to receive postoperative adjuvant treatment within 21-60 days after the operation. Specific medication plan: Sintilimab: 200mg QD, one cycle every 21 days, the first day of each cycle, a total of 8 cycles. Albumin paclitaxel: 135mg / m2 QD, 1 cycle every 21 days, 1 day and 8 days of each cycle, 2 cycles in total. Carboplatin: AUC 5mg QD, one cycle every 21 days, two cycles in total.

Sponsors & Collaborators

  • The First Hospital of Jilin University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-20
Primary Completion
2023-09-06
Completion
2027-12-31

Countries

  • China

Study Locations

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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 NCT04326153 on ClinicalTrials.gov