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

• Sponsor: Yongchang Zhang (Other)
• Overall Status: Completed
• CT.gov ID: NCT04144582
• Collaborator: (none)
• Enrollment: 30
• Locations: 2
• Arm: 1
• Actual Duration (Months): 36
• Patients Per Site: 15
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Non-small Cell Lung Cancer	Drug: Sintilimab Combined With Docetaxel Monotherapy	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Single Group AssignmentSingle Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jan 1, 2019
• Actual Primary Completion Date: Sep 30, 2020
• Actual Study Completion Date: Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sintilimab Combined With Docetaxel Sintilimab Combined With Docetaxel for Metastatic or Non-driver Gene Mutation Non-small Cell Lung Cancer	Drug: Sintilimab Combined With Docetaxel Monotherapy; Sintilimab 200mg i.v q3w , Docetaxel 75mg/m2 i.v q3w

Outcome Measures

Primary Outcome Measures

1. ORR [Approximately 1 years]

   To measure the patients's overall response rate

Secondary Outcome Measures

1. PFS [Approximately 1 years]

   Progression free survival

2. OS [Approximately 1 years]

   Overall survival

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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);

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hunan Provincal Tumor Hospital	Changsha	Hunan	China	410013
2	Yongchang Z MD	Changsha	Hunan	China	410013

Sponsors and Collaborators

• Yongchang Zhang

Investigators

• Principal Investigator: Yongchang Z MD, MD, Hunan Province Tumor Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yongchang Zhang, Professor, Hunan Province Tumor Hospital
• ClinicalTrials.gov Identifier: NCT04144582
• Other Study ID Numbers: STORM
• First Posted: Oct 30, 2019
• Last Update Posted: Mar 2, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Docetaxel

Study Results

No Results Posted as of Mar 2, 2022