Sintilimab Combined With Docetaxel for Standard Chemotherapy Failure Non-driver Gene Mutation Metastatic Non-small Cell Lung Cancer

NCT ID: NCT04144582

Last Updated: 2022-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2021-12-31

Brief Summary

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The purpose of this study is to assess the safety and effectiveness of Sintilimab Combined With Docetaxel in Non-driver Gene Mutation NSCLC patients who failed with double platinum-based chemotherapy

Detailed Description

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Conditions

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Non-small Cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single Group Assignment
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sintilimab Combined With Docetaxel

Sintilimab Combined With Docetaxel for Metastatic or Non-driver Gene Mutation Non-small Cell Lung Cancer

Group Type EXPERIMENTAL

Sintilimab Combined With Docetaxel Monotherapy

Intervention Type DRUG

Sintilimab 200mg i.v q3w , Docetaxel 75mg/m2 i.v q3w

Interventions

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Sintilimab Combined With Docetaxel Monotherapy

Sintilimab 200mg i.v q3w , Docetaxel 75mg/m2 i.v q3w

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Life expectancy exceeds 3 months
* The investigator confirmed at least one measurable lesion according to the RECIST 1.1 standard.

Exclusion Criteria

* small cell lung cancer or small cell lung cancer
* Currently involved in interventional clinical research or treatment, or have received other research drugs or used research equipment within 4 weeks prior to the first dose;
* Previously received the following treatments: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that stimulate or synergistically inhibit T cell receptors (eg, CTLA-4, OX-40, CD137);
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yongchang Zhang

OTHER

Sponsor Role lead

Responsible Party

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Yongchang Zhang

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Yongchang Z MD, MD

Role: PRINCIPAL_INVESTIGATOR

Hunan Province Tumor Hospital

Locations

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Hunan Provincal Tumor Hospital

Changsha, Hunan, China

Site Status

Yongchang Z MD

Changsha, Hunan, China

Site Status

Countries

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China

Other Identifiers

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STORM

Identifier Type: -

Identifier Source: org_study_id

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