NCT05940532

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for phase_2

Timeline
6mo left

Started Jun 2023

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Jun 2023Dec 2026

Study Start

First participant enrolled

June 14, 2023

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 26, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 11, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

July 11, 2023

Status Verified

June 1, 2023

Enrollment Period

1.6 years

First QC Date

June 26, 2023

Last Update Submit

July 7, 2023

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

immunotherapychemotherapyradiotherapysurgerynon-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

  • ORR

    Objective response rate

    From the initiation of the first dose to 3 years

Secondary Outcomes (7)

  • PFS

    From the initiation of the first dose to 3 years

  • OS

    From the initiation of the first dose to 3 years

  • iORR

    From the initiation of the first dose to 3 years

  • AEs

    From the initiation of the first dose to 90 days after the last dose

  • Measurement of Quality of Life with EORTC QLQ-C30 questionnaire

    From the initiation of the first dose to 3 years

  • +2 more secondary outcomes

Study Arms (1)

Interventional arm

EXPERIMENTAL

Patients will receive 3 cycles of induction therapy with sugemalimab and chemotherapy before curative local therapy.

Drug: Sugemalimab and Chemotherapy

Interventions

Sugemalimab and ChemotherapyDRUG

Chemotherapy: Paclitaxel 175mg/m2 D1, Carboplatin AUC=5 or DDP 75mg/m2 D1 for NSCLC; Pemetrexed 500mg/m2 D1, Carboplatin AUC=5 or DDP 75mg/m2 D1 for non-squamous NSCLC; intravenous infusion every 3 weeks, for up to four cycles. Sugemalimab: 1200 mg by intravenous infusion every 3 weeks, for up to 2 years.

Interventional arm

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 75 years old, both male and female;
  • ECOG score: 0-1;
  • Histopathologically or cytologically confirmed, stage III (AJCC 8th) non-small cell lung cancer;
  • Multidisciplinary team (MDT) discussion confirmed unresectable disease but can be treated by curative radiotherapy;
  • Measurable lesions available;
  • Major organ function is basically normal;
  • Estimated survival time is at least 6 months;

You may not qualify if:

  • Histologically or cytologically confirmed mixed SCLC and NSCLC;
  • Subjects with driver gene mutations(EGFR mutation, ALK fusion, etc.);
  • Previous systemic anti-tumor therapy including immune checkpoint inhibitors for NSCLC;
  • Previous thoracic radiotherapy;
  • Subjects who participated in other clinical trials within 4 weeks or 5 drug half-lives(whichever is shorter) before the first dose;
  • Systemic immunostimulant therapy before the first dose;
  • Systemic immunosuppressive therapy before the first dose or were expected to require systemic immunosuppressive drugs during the study treatment;
  • Subjects with autoimmune diseases;
  • Other malignant tumors other than non-small cell lung cancer within 5 years before screening;
  • Known or suspected interstitial pneumonia;
  • Other moderate to severe lung diseases that may interfere with the detection or treatment of drug-related pulmonary toxicity and seriously affect respiratory function;
  • Severe cardiovascular and cerebrovascular diseases;
  • Clinically significant bleeding symptoms or significant bleeding tendency within 1 month before the first dose;
  • Arteriovenous thrombotic events within 3 months before the first dose;
  • Positive HIV test;
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hunan Cancer Hospital

Changsha, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

sugemalimabDrug Therapy

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Hui Wang, MD

    the Department of Radiation Oncology

    PRINCIPAL INVESTIGATOR

  • Huai Liu, MD

    the Department of Radiation Oncology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Huai Liu, MD

CONTACT

+8619918909231liuhuai@hnca.org.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2023

First Posted

July 11, 2023

Study Start

June 14, 2023

Primary Completion

January 1, 2025

Study Completion (Estimated)

December 1, 2026

Last Updated

July 11, 2023

Record last verified: 2023-06

Locations

CN(1)