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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04144582
Enrollment
30
Registered
2019-10-30
Start date
2019-01-01
Completion date
2021-12-31
Last updated
2022-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

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

Interventions

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

Sponsors

Yongchang Zhang
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Single Group Assignment

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
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);

Design outcomes

Primary

MeasureTime frameDescription
ORRApproximately 1 yearsTo measure the patients's overall response rate

Secondary

MeasureTime frameDescription
PFSApproximately 1 yearsProgression free survival
OSApproximately 1 yearsOverall survival

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026