Tislelizumab as Cross-line Treatment for Advanced NSCLC | NCT05192681

Studies
Tislelizumab as Cross-line Treatment for Advanced NSCLC

NCT05192681

Sponsor

Fujian Cancer Hospital

Status

Unknown status

Last Update Posted

Jan 14, 2022Actual

Enrollment

35Estimated

Phase

Phase 2

Conditions

Advanced Non-small-cell Lung Cancer

Interventions

Tislelizumab

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 10, 2021Actual

Primary Completion Date

Oct 10, 2023Estimated

Completion Date

Oct 10, 2023Estimated

First Submitted Date

Jan 5, 2022

First Submission Date that Met QC Criteria

Jan 13, 2022

First Posted Date

Jan 14, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 13, 2022

Last Update Posted Date

Jan 14, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is a single-arm, prospective, open phase II clinical study, exploring the efficacy and safety for advanced non-small cell lung cancer after progression of first-line Tislelizumab combined with chemotherapy and continuing Tislelizumab in combination with docetaxel. The primary study endpoint of this study is measured by progression-free survival (PFS).

Tislelizumab: The recommended dose is 200 mg/dose administered every three weeks on the first day of each cycle.
Docetaxel: 60-75 mg/m2 every 3 weeks, administered on day 1 of each cycle.
Treatment cycle: Tislelizumab in combination with docetaxel until the development of PD, unacceptable toxicities, withdrawal of informed consent, end of study, lost to follow-up, or death, whichever occurs first.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tislelizumab arm	Experimental	Tislelizumab: 200 mg, intravenous infusion, administered on the 1st day of each cycle, every 3 weeks Docetaxel: 60-75mg/m2 administered on the 1st day of each cycle, every 3 weeks Treatment until the disease progresses or intolerable side effects appear.	Drug: Tislelizumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tislelizumab	Drug	Tislelizumab in combination with docetaxel until the development of PD, unacceptable toxicities, withdrawal of informed consent, end of study, lost to follow-up, or death, whichever occurs first.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-free survival	the PFS of Tislelizumab combining with Docetaxel	five to six months

Secondary Outcomes

Measure	Description	Time Frame
Overall survival	the OS of Tislelizumab combining with Docetaxel	ten to eleven months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Advanced non-small cell lung cancer diagnosed by histology or pathology, and has progressed after first-line treatment with tislelizumab combined with platinum-containing dual-drug chemotherapy
Patients who have progressed after first-line tislelizumab treatment for more than 3 months
No EGFR, ALK gene mutations (the genetic test is not required for patients with lung squamous cell carcinoma)
At least one measurable lesion (RECIST standard version 1.1)
The expected survival period is ≥3 months
The ECOG-PS score is 0-2 points

Exclusion Criteria:

The tumor histology or cytology is confirmed to be mixed adenosquamous carcinoma or combined with small cell lung cancer
Known or suspected active autoimmune diseases
A history of immunodeficiency or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation and history of allogeneic bone marrow transplantation
Interstitial lung disease, drug-induced pneumonia, radiation pneumonia requiring steroid therapy or clinical symptoms, active pneumonia or severe lung dysfunction
Symptomatic brain metastases
Those who are known or suspected to be allergic to test drugs and their excipients
Women who are pregnant or breastfeeding

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic

ID	Term
C000707970	tislelizumab
D000077143	Docetaxel