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

Non-small Cell Lung Cancer Clinical Trial

Official title:

Multiple-center, Single-arm, Phase II Study on Sintilimab Combined With Docetaxel in Non-driver Gene Mutation Advanced NSCLC Patients Who Had Failed With Double Platinum-based Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04144582
• Other study ID #: STORM
• Status: Completed
• Phase: Phase 2
• Start date: January 1, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2022
• Source: Hunan Province Tumor Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 31, 2021
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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);

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• Sintilimab Combined With Docetaxel Monotherapy
Sintilimab 200mg i.v q3w , Docetaxel 75mg/m2 i.v q3w

Locations

Country	Name	City	State
China	Hunan Provincal Tumor Hospital	Changsha	Hunan
China	Yongchang Z MD	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Yongchang Zhang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR	To measure the patients's overall response rate	Approximately 1 years
Secondary	PFS	Progression free survival	Approximately 1 years
Secondary	OS	Overall survival	Approximately 1 years