NCT04177290

Brief Summary

this is a phase I study comparing PK similarity of sintilimab by different production process (approved versus M1b) in Chinese advanced or metastatic NSCLC patients who have failed or been intolerant to at least one prior line of standard treatment

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2020

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

November 14, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 26, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

April 2, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2021

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2022

Completed
Last Updated

February 27, 2023

Status Verified

February 1, 2023

Enrollment Period

11 months

First QC Date

November 14, 2019

Last Update Submit

February 24, 2023

Conditions

Advanced or Metastatic NSCLC

Outcome Measures

Primary Outcomes (1)

  • PK is defined as AUC0-∞.

    28 days

Secondary Outcomes (2)

  • PK is defined as Cmax.

    28 days

  • Safety of sintilimab (approved) versus sintilimab (M1b). AE is defined as treatment-related adverse events assessed by CTCAE v5.0.

    from randomization through 90 days after last dosing

Study Arms (2)

sintilimab (M1b) 200mg

EXPERIMENTAL
Drug: Sintilimab (M1b)

sintilimab (approved) 200mg

ACTIVE COMPARATOR
Drug: Sintilimab (approved)

Interventions

Sintilimab (M1b)DRUG

Intravenous infusion

sintilimab (M1b) 200mg
Sintilimab (approved)DRUG

Intravenous infusion

sintilimab (approved) 200mg

Eligibility Criteria

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

You may qualify if:

  • Histologically or cytologically confirmed locally advanced, recurrent or metastatic NSCLC patients who have received or been intolerant to at least one prior line of standard treatment.
  • No EGFR mutation or ALK rearrangement.
  • ECOG PS score 0 or 1.
  • BMI ≥ 21.0kg/m2 and ≤ 26.0kg/m2
  • Body weight ≥ 60.0kg and ≤ 75.0kg.
  • Adequate organ function per protocol-defined criteria.

You may not qualify if:

  • Exposure to any anti-PD-1, PD-L1, PD-L2 antibodies.
  • Allergic to any component of sintilimab.
  • Active autoimmune diseases.
  • Clinically unstable central nervous system metastasis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

sintilimab

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2019

First Posted

November 26, 2019

Study Start

April 2, 2020

Primary Completion

February 28, 2021

Study Completion

September 4, 2022

Last Updated

February 27, 2023

Record last verified: 2023-02

Locations

CN(1)