Nab-paclitaxel Versus Topotecan As Second-Line Treatment... | NCT04213937

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
nab-paclitaxel	Experimental	nab-paclitaxel 125mg/m2, i.v. d1, d8, Repeated every 3 weeks for 4-6 cycles	Drug: nab-paclitaxel
Topotecan	Active Comparator	Topotecan 1.25mg/m2/d, i.v, 1hour, d1-d5, Repeated every 3 weeks for 4-6 cycles.	Drug: Topotecan

Name	Type	Description	Arm Group Labels	Other Names
nab-paclitaxel	Drug	Drug: nab-paclitaxel 125mg/m2, i.v. d1, d8, Repeated every 3 weeks for 4-6 cycles.	nab-paclitaxel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall survival (OS)	OS was defined as the time from the date of the first administration of trial regimen to the date of death from any cause (event) or last follow-up (censored data).	1 years post treatment

Secondary Outcomes

Measure	Description	Time Frame
Objective response rate (ORR)	Response evaluation disease progression defined by Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) criteria. Response (PR), refers to the number of cases with complete and partial response after treatment as a percentage of the total number of evaluable cases.	1 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1.18 to 75years, male or female; 2.Histological or pathological diagnosis of small cell lung caner; 3.Progression or relapse after first-line chemotherapy, extensive disease; 4.ECOG performance status of 0-2; 5.Life expectancy of 3 months or more; 6.Patient must be accessible for treatment and follow-up; 7.For women of child-bearing age, the pregnancy test results (serum or urine) within 72 hours before enrolment must be negative. They will take appropriate methods for contraception during the study; 8.Signed informed consent.

Exclusion Criteria:

symptomatic brain metastases;
Uncontrolled serious medical conditions that, in the opinion of the investigator, would affect the ability of the subject to receive the study regimen, such as concomitant serious medical conditions, including severe heart disease, cerebrovascular disease, uncontrolled diabetes mellitus, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc.;
Have dementia, altered mental state or any mental illness that would prevent understanding or informed consent or fill out questionnaires;
Received any investigational drug within 30 days of the planned first dose of this study treatment.
Prior Grade ≥ 2 peripheral neuropathy(according to (NCI CTCAE), version 5.0);
Known to be hypersensitive, highly sensitive, or intolerant to study-related medications or their excipients;
Have malignant tumors in the past 5 years, except for clinically cured basal cell or squamous cell skin cancer, local prostate cancer after radical operation, and ductal carcinoma in situ after radical operation;
Bone marrow function: Neutrophils < 1.5×109/L, platelets < 100×109/L, hemoglobin < 90 g/L; Hepatic and renal function: Serum creatinine > 1.5×ULN; AST and ALT > 2.5×ULN or > 5×ULN in the presence of hepatic metastasis; Total bilirubin >1.5×ULN;
Patients need other anti-tumor drugs;
Known HIV, hepatitis B/C virus positive ;
The researchers considered the patients who were not suitable for enrollment.

ID	Term
C520255	130-nm albumin-bound paclitaxel
D019772	Topotecan

ID	Term
D002166	Camptothecin
D000470	Alkaloids
D006571	Heterocyclic Compounds