NCT04580498

Brief Summary

The study is being conducted to evaluate the efficacy and safety of SHR-1701 with or without chemotherapy in the treatment of unresectable stage III non-small cell lung cancer

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
107

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2020

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

September 28, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 8, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

November 10, 2020

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2023

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

May 19, 2023

Status Verified

May 1, 2023

Enrollment Period

2.7 years

First QC Date

September 28, 2020

Last Update Submit

May 17, 2023

Conditions

Non-Small-Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

  • ORR

    Objective response rate

    From the initiation of the first dose to 3 years

  • EFS

    event free survival

    From the initiation of the first dose to 3 years

Secondary Outcomes (4)

  • OS

    From the initiation of the first dose to 3 years

  • EFS rate

    From the initiation of the first dose to 3 years

  • TDDM

    From the initiation of the first dose to 3 years

  • Adverse events(AEs)

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

Study Arms (2)

Treatment group A

EXPERIMENTAL

SHR-1701+Paclitaxel+carboplatin

Drug: SHR-1701+Paclitaxel+carboplatin

Treatment group B

EXPERIMENTAL

SHR-1701

Drug: SHR-1701

Interventions

SHR-1701+Paclitaxel+carboplatinDRUG

Drug: SHR-1701 30mg/kg Drug: Paclitaxel 175mg/m2 Drug: Carboplatin AUC 5

Treatment group A
SHR-1701DRUG

Drug: SHR-1701 30mg/kg

Treatment group B

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Voluntarily participate in the study and sign the informed consent form;
  • to 70 years old, both male and female;
  • ECOG score: 0-1
  • histopathologically or cytologically confirmed, inoperable stage III squamous cell or non-squamous cell lung cancer;
  • subjects who can provide fresh or archival tumor tissue;
  • Measurable lesions available;
  • Major organ function is basically normal;
  • Non-surgically sterile female subjects of childbearing age must have a negative serum HCG test before randomization;

You may not qualify if:

  • histologically or cytologically confirmed mixed SCLC and NSCLC;
  • subjects who have malignant pleural effusion;
  • Previous systemic anti-tumor therapy 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)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

SHR-1701

Condition Hierarchy (Ancestors)

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

Study Officials

  • Yilong Wu, MD

    Guangdong Provincial People's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2020

First Posted

October 8, 2020

Study Start

November 10, 2020

Primary Completion

July 15, 2023

Study Completion

March 1, 2025

Last Updated

May 19, 2023

Record last verified: 2023-05

Locations

CN(1)