Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT05940532

A Trial of Sugemalimab and Chemotherapy in Unresectable Stage III NSCLC

Led by Hunan Cancer Hospital · Updated on 2023-07-11

41

Participants Needed

1

Research Sites

180 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this phase II, open-label, single-arm study is to evaluate the efficacy and safety of induction immunotherapy and chemotherapy followed by the multidisciplinary team (MDT)-guided radiotherapy or surgery in unresectable, stage III non-small cell lung cancer.

CONDITIONS

Official Title

A Trial of Sugemalimab and Chemotherapy in Unresectable Stage III NSCLC

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 to 75 years, male or female
  • ECOG performance status of 0 or 1
  • Histopathological or cytological confirmation of stage III non-small cell lung cancer
  • Disease declared unresectable but suitable for curative radiotherapy by a multidisciplinary team
  • Presence of measurable tumors
  • Normal major organ function
  • Expected survival of at least 6 months
  • Female participants of childbearing potential must have a negative serum HCG test before joining
Not Eligible

You will not qualify if you...

  • Mixed small cell and non-small cell lung cancer diagnosis
  • Presence of driver gene mutations like EGFR or ALK
  • Previous systemic anti-tumor therapy or immune checkpoint inhibitor treatment for NSCLC
  • Prior thoracic radiotherapy
  • Participation in other clinical trials within 4 weeks or 5 drug half-lives before study start
  • Use of systemic immunostimulants or immunosuppressive therapy before study or expected need during treatment
  • Autoimmune diseases
  • Other cancers within 5 years except NSCLC
  • Known or suspected interstitial pneumonia
  • Moderate to severe lung diseases affecting pulmonary function
  • Severe cardiovascular or cerebrovascular diseases
  • Significant bleeding or bleeding tendency within 1 month before study
  • Arteriovenous thrombotic events within 3 months before study
  • Positive HIV test
  • Active hepatitis B or C
  • Active tuberculosis infection within 1 year before study
  • Serious infection within 4 weeks before study
  • Recent attenuated live vaccination within 28 days before study or planned during study
  • Major surgery other than biopsy within 28 days before study
  • Previous or planned bone marrow or solid organ transplant
  • Severe allergic reactions to monoclonal antibodies or fusion proteins
  • Allergy to any study treatment component
  • Pregnancy, lactation, or plans to become pregnant during study
  • History of psychotropic drug abuse, alcoholism, or drug abuse
  • Any other condition making participation inappropriate as judged by the investigator

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

Hunan Cancer Hospital

Changsha, China

Actively Recruiting

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Research Team

H

Huai Liu, MD

CONTACT

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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