Actively Recruiting

Phase 3
Age: 18Years - 75Years
All Genders
ID06734702

Neoadjuvant Immunotherapy Plus Chemotherapy Followed by Concurrent Chemoradiotherapy and Consolidative Immunotherapy Compared With Concurrent Chemoradiotherapy and Consolidative Immunotherapy in Locally Advanced Non-small Cell Lung Cancer: A Randomized, Phase III Controlled Study

Led by Sun Yat-sen University · Updated on 2025-07-24

497

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the best timing and combination of treatments for patients with locally advanced non-small cell lung cancer (LANSCLC), focusing on neoadjuvant immuno-chemotherapy combined with chemoradiotherapy and consolidative immunotherapy. This phase III randomized controlled trial compares the effectiveness and safety of adding neoadjuvant immuno-chemotherapy before concurrent chemoradiotherapy and consolidative immunotherapy, versus chemoradiotherapy and consolidative immunotherapy alone. The study builds on previous findings from the PACIFIC trial that established immunotherapy after chemoradiotherapy as a standard care, aiming to improve survival outcomes further. Participants are randomly assigned into three groups. Group A receives neoadjuvant chemo-immunotherapy with albumin-bound paclitaxel, cisplatin, and tislelizumab every three weeks, followed by hypofractionated thoracic radiotherapy (hypo-RT) with concurrent chemotherapy, then consolidative immunotherapy for up to 12 months. Group B undergoes the same neoadjuvant chemo-immunotherapy but with conventionally fractionated thoracic radiotherapy (CFRT) and concurrent chemotherapy, followed by consolidative immunotherapy for up to 12 months. Group C receives CFRT with concurrent chemotherapy first, then consolidative immunotherapy for up to 12 months. During the trial, participants will have regular assessments including tumor response evaluations, survival tracking, and safety monitoring for adverse events. Quality of life will be measured using specific questionnaires at one year after treatment. Researchers will also monitor eligibility for consolidative immunotherapy following chemoradiotherapy. The primary outcome is progression-free survival at 18 months, with additional follow-ups for overall survival and treatment safety planned over two years. The total participation duration may extend up to several years, including long-term monitoring.

CONDITIONS

Brief Title

Neoadjuvant Immunotherapy Plus Chemotherapy Followed by Concurrent Chemoradiotherapy and Consolidative Immunotherapy for Locally Advanced Non-small Cell Lung Cancer

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed and dated informed consent before any study procedures
  • Male or female patients aged 18 to 75 years
  • Locally advanced, unresectable (stage III) non-small cell lung cancer confirmed by tissue analysis
  • No prior chemotherapy, radiotherapy, surgery, targeted therapy, or immunotherapy
  • Provide sufficient unstained archived tumor tissue samples
  • Expected survival of at least 12 weeks
  • WHO Performance Status of 0 or 1
  • Negative pregnancy test for postmenopausal women or women of childbearing potential within 14 days before study medication
  • Women must not be breastfeeding
  • Women of childbearing potential must agree to contraception during treatment and 5 months after last dose
  • Men with sexual relations with women of childbearing potential must agree to contraception during treatment and 7 months after last dose
  • Men with no sperm production are exempt from contraception
  • Adequate organ and bone marrow function as defined by specific laboratory values
Not Eligible

You will not qualify if you...

  • Participation in another clinical trial except observational studies
  • Mixed small-cell and non-small-cell lung cancer histology
  • Use of immunosuppressive drugs within 28 days before treatment, with some corticosteroid exceptions
  • Prior treatment with anti-PD-1 or anti-PD-L1 antibodies
  • Major surgery within 4 weeks before enrollment (except vascular access procedures)
  • History or active autoimmune diseases within past two years
  • History or active inflammatory bowel disease
  • History of primary immunodeficiency
  • History of organ transplantation requiring immunosuppressive therapy
  • Average QTc interval ≥470 ms on ECG
  • Uncontrolled comorbidities including infections, heart failure, hypertension, angina, arrhythmias, bleeding disorders, hepatitis C, HIV, or high HBV DNA
  • Mental or social conditions limiting study adherence or informed consent
  • Known tuberculosis
  • Receipt of live attenuated vaccine within 30 days before or planned during study
  • History of other primary malignancy within past 5 years except certain treated skin or cervical cancers
  • Pregnancy, breastfeeding, or not using effective contraception
  • For experimental group: distant metastases, locoregional progression preventing chemoradiotherapy, WHO performance status 2-4, impaired organ or bone marrow function below defined thresholds
  • Patient withdrawal from study
  • For consolidation immunotherapy: disease progression during chemoradiotherapy, recent immunosuppressive drug use except certain corticosteroids, unresolved grade >2 toxicities or pneumonitis from prior therapy, prior severe immune-related adverse events

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Neoadjuvant Therapy

Duration - Every 3 weeks, duration depends on the number of cycles before radiotherapy

Participants in study groups A and B receive neoadjuvant chemotherapy combined with immunotherapy prior to radiotherapy.

Repeated visits every 3 weeks during neoadjuvant treatment

Radiotherapy and Concurrent Chemotherapy

Duration - Duration varies based on radiotherapy type (hypofractionated or conventional fractionation)

Participants receive thoracic radiotherapy with concurrent chemotherapy. Group A receives hypofractionated radiotherapy; Groups B and C receive conventionally fractionated radiotherapy.

Daily or frequent visits during radiotherapy period

Consolidative Immunotherapy

Duration - Up to 12 months starting 1-2 months after chemoradiotherapy

Following chemoradiotherapy, participants receive consolidative immunotherapy with Tislelizumab for up to 12 months, starting 1 to 2 months after chemoradiotherapy.

Regular visits during 12 months of consolidative immunotherapy

Trial Site Locations

Total: 1 location

1

Sun yat-sen University Cancer Center

Guangzhou, Guangdong, China, 510060

Actively Recruiting

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Research Team

B

Bo Qiu, Professor

H

Hui Liu, Professor

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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