Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
ID06241807

A Phase II Trial of Neoadjuvant Camrelizumab Combined With Chemotherapy for Resectable Stage IIIA-IIIB Non-Small Cell Lung Cancer

Led by Shandong Cancer Hospital and Institute · Updated on 2024-02-14

30

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the efficacy and safety of neoadjuvant camrelizumab combined with chemotherapy in patients with resectable stage IIIA and IIIB non-small cell lung cancer (NSCLC). This Phase II trial focuses on patients aged 18 to 75 with specific tumor stages and no EGFR, ALK, or ROS1 gene mutations. The goal is to assess the treatment's ability to improve tumor response before surgery and to monitor safety and progression outcomes. Participants receive three cycles of camrelizumab (200 mg) combined with chemotherapy drugs including nab-paclitaxel or pemetrexed plus platinum-based agents such as cisplatin or carboplatin. After completing chemotherapy, patients undergo curative surgery within 4 to 6 weeks. Imaging with 18F-fluorodeoxyglucose (FDG) PET/CT scans is performed one week before treatment starts and one week before surgery. Blood samples are collected to analyze biomarkers. During the study, patients are monitored for major pathological response and complete pathological response within 14 days after surgery. Safety is assessed over 24 weeks, and disease-free survival is followed for up to 24 months. Researchers also explore molecular imaging and biomarker analysis. The total involvement includes treatment, surgery, imaging, sample collection, and follow-up evaluations to understand treatment effects and safety.

CONDITIONS

Brief Title

Neoadjuvant Camrelizumab Combined With Chemotherapy for Resectable Stage IIIA-IIIB NSCLC

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 75 years
  • Pathologically confirmed resectable stage IIIA-IIIB (T3-4N2) non-small cell lung cancer
  • No EGFR, ALK, or ROS1 gene mutations
  • Eastern Cooperative Oncology Group (ECOG) status 0 to 1
  • Signed written informed consent before any trial procedures
  • Adequate organ function based on laboratory tests with no contraindications to chemotherapy, including specified blood counts and liver and kidney function limits
Not Eligible

You will not qualify if you...

  • Diagnosis of any other malignant tumor
  • Prior treatment with chemotherapy or immune checkpoint inhibitors
  • Insufficient calorie or fluid intake despite nutritional support
  • Active infections needing systemic therapy unresolved within 3 to 7 days before treatment
  • Inability to tolerate chemoradiotherapy or surgery due to severe heart or lung problems
  • History of interstitial lung disease or non-infectious pneumonia
  • Active autoimmune disease requiring systemic therapy within the past 2 years
  • Known HIV or viral hepatitis infection
  • Previous allogeneic stem cell or solid organ transplantation
  • Pregnancy or breastfeeding

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Duration of 3 treatment cycles

Participants receive 3 cycles of camrelizumab combined with chemotherapy before surgery.

3 treatment visits for drug administration

Follow-up

Duration - Up to 24 months

Participants are monitored for adverse events and disease-free survival after surgery.

Visits for safety and disease monitoring during follow-up

Trial Site Locations

Total: 1 location

1

Shandong Cancer Hospital and Institute

Jinan, Shandong, China, 250117

Actively Recruiting

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Research Team

X

Xue Meng, MD, PhD

G

Guoxin Cai, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

Molecular imaging using 18F-FDG PET/CT and circulating inflammatory and immune indicators to predict pathological response to neoadjuvant camrelizumab plus chemotherapy in resectable stage IIIA-IIIB NSCLC.

Kaiyue Wang, Xiaohan Wang, Xue Meng...

https://pubmed.ncbi.nlm.nih.gov/40348946