Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT04728724

Neoadjuvant Immunotherapy for Stage III Non-small Cell Lung Cancer

Led by Shanghai Pulmonary Hospital, Shanghai, China · Updated on 2023-09-13

100

Participants Needed

1

Research Sites

276 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a phase II, non-randomized, open-label, multi-center study to evaluate the efficacy of neoadjuvant Sintilimab (PD-1 antibody) or combined with chemotherapy as first-line treatment in patients with stage III non-small cell lung cancer (NSCLC).

CONDITIONS

Official Title

Neoadjuvant Immunotherapy for Stage III Non-small Cell Lung Cancer

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent form
  • Age 18 years or older
  • Diagnosis of non-small cell lung cancer (NSCLC) confirmed by biopsy
  • Stage III NSCLC confirmed by imaging (CT, PET-CT, or EBUS)
  • ECOG performance status of 0 or 1
  • Life expectancy of at least 12 weeks
  • At least one measurable tumor lesion
  • Feasibility or anticipated feasibility of radical surgery after neoadjuvant therapy
  • Good function of main organs including liver, kidney, and blood system
  • Normal lung function able to tolerate surgery
  • No systemic metastasis (M1a, M1b, M1c)
  • Fertile females must use effective contraception during and for 120 days after treatment with negative pregnancy test
  • Unsterilized males must use effective contraception during and for 120 days after treatment
Not Eligible

You will not qualify if you...

  • Non-squamous cell carcinoma with EGFR mutation or ALK rearrangement
  • Prior systemic anti-cancer treatment for thymic epithelial tumor
  • Use of Chinese medicine against cancer before study drug administration
  • Other cancers within five years except certain cured or in situ cancers
  • Unstable systemic diseases including active infection, uncontrolled hypertension, recent angina, heart failure, recent heart attack, severe arrhythmia, or liver/kidney/metabolic diseases
  • Active or suspected autoimmune disease requiring systemic treatment
  • Antibiotic use for infection within 4 weeks prior to study
  • Systemic corticosteroids or immunosuppressive treatment within 2 weeks prior to first dose
  • Allergy to study drug or its components
  • Active hepatitis B, hepatitis C, or HIV infection
  • Vaccine administration within 4 weeks before study
  • Major surgery or severe trauma within 2 months prior to study
  • Uncontrolled pleural, pericardial, or abdominal effusions
  • Active brain metastases or pia meningioma
  • Pregnant or lactating women
  • Nervous system or mental diseases preventing cooperation
  • Participation in another therapeutic clinical study
  • Other factors deemed unsuitable by researchers

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Shanghai Pulmonary Hospital

Shanghai, China, 200433

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

2

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