Nab-paclitaxel Versus Topotecan As Second-Line Treatment for Patients With Extensive Stage Small Cell Lung Cancer

Nab-paclitaxel Versus Topotecan As Second-Line Treatment for Patients With Extensive Stage Small Cell Lung Cancer: Condition:   Extensive Stage Small Cell Lung Cancer Interventions:   Drug: nab-paclitaxel;   Drug: Topotecan Sponsor:   Cancer Institute and Hospital, Chinese Academy of Medical Sciences Recruiting (Source: ClinicalTrials.gov)




Hide glossaryGlossary

Study record managers: refer to the Data Element Definitions if submitting registration or results information.



Search for terms



x

Accepts healthy volunteers

Active comparator arm

Adverse event

Age or age group

All-cause mortality

Allocation

Arm

Arm type

Baseline characteristics

Canceled submission

Certain agreements

Certification

Certification/extension first posted

Certification/extension first submitted

Certification/extension first submitted that met QC criteria

City and distance

Clinical study

Clinical trial

ClinicalTrials.gov identifier (NCT number)

Collaborator

Condition/disease

Contact

Country

Cross-over assignment

Data Monitoring Committee (DMC)

Early Phase 1 (formerly listed as Phase 0)

Eligibility criteria

Enrollment

Exclusion criteria

Expanded access

Expanded access status

Expanded access type

Experimental arm

Extension request

Factorial assignment

First posted

First submitted

First submitted that met QC criteria

Food and Drug Administration Amendments Act of 2007, Section 801 (FDAAA 801)

Funder type

Gender-based eligibility

Group/cohort

Human subjects protection review board

Inclusion criteria

Informed consent

Informed consent form (ICF)

Intervention model

Intervention/treatment

Interventional study (clinical trial)

Investigator

Last update posted

Last update submitted

Last update submitted that met QC criteria

Last verified

Listed location countries

Location terms

Masking

NCT number

No intervention arm

Observational study

Observational study model

Other adverse event

Other study IDs

Other terms

Outcome measure

Parallel assignment

Participant flow

Patient registry

Phase

Phase 1

Phase 2

Phase 3

Phase 4

Phase Not Applicable

Placebo

Placebo comparator arm

Primary completion date

Primary outcome measure

Primary purpose

Principal investigator (PI)

Protocol

Quality control (QC) review

Randomized allocation

Recruitment status

Registration

Removed location countries

Reporting group

Responsible party

Results database

Results delayed

Results first posted

Results first submitted

Results first submitted that met QC criteria

Results returned after quality control review

Results submitted to ClinicalTrials.gov

Secondary outcome measure

Serious adverse event

Sex

Sham comparator arm

Single group assignment

Sort studies by

Sponsor

State

Statistical analysis plan (SAP)

Status

Study completion date

Study design

Study documents

Study IDs

Study record

Study registry

Study results

Study start date

Study type

Submitted date

Title

Title acronym

U.S. Agency for Healthcare Research and Quality (AHRQ)

U.S. Food and Drug Administration (FDA)

Unknown

Skip to Main Content

ClinicalTrials.gov

Find StudiesFind Studies Menu

About StudiesAbout Studies Menu

Submit StudiesSubmit Studies Menu

ResourcesResources Menu

About SiteAbout Site Menu

HomeSearch ResultsStudy Record Detail Save this study

Nab-paclitaxel Versus Topotecan As Second-Line Treatment for Patients With Extensive Stage Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.



ClinicalTrials.gov Identifier: NCT04213937

Recruitment Status  : Recruiting

First Posted  : December 30, 2019

Last Update Posted  : December 30, 2019

See Contacts and Locations

Sponsor:

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Information provided by (Responsible Party):

Jie Wang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences



Study DetailsTabular ViewNo Results PostedDisclaimerHow to Read a Study Record

Study Description

Go to  sections

Brief Summary:

The purpose of this study is to compare the efficacy and safety of nab-paclitaxel with topotecan as second-line treatment for patients with extensive stage small cell lung cancer.



Condition or disease Intervention/treatment Phase

Extensive Stage Small Cell Lung Cancer

Drug: nab-paclitaxel

Drug: Topotecan

Phase 2



Study Design

Go to  sections

Study Type  : Interventional  (Clinical Trial)

Estimated Enrollment  : 386 participants

Allocation: Randomized

Intervention Model: Parallel Assignment

Masking: None (Open Label)

Primary Purpose: Treatment

Official Title: The Efficacy and Safety of Nab-paclitaxel Versus Topotecan As Second-Line Treatment for Patients With Extensive Stage Small Cell Lung Cancer: A Multicenter, Randomized Controlled Study

Estimated Study Start Date  : January 31, 2020

Estimated Primary Completion Date  : July 31, 2021

Estimated Study Completion Date  : January 31, 2022

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Lung cancer

MedlinePlus related topics: Lung Cancer

Drug Information available for: Paclitaxel Topotecan hydrochloride Topotecan

Genetic and Rare Diseases Information Center resources: Small Cell Lung Cancer

U.S. FDA Resources



Arms and Interventions

Go to  sections

Arm Intervention/treatment

Experimental: nab-paclitaxel

nab-paclitaxel 125mg/m2, i.v. d1, d8, Repeated every 3 weeks for 4-6 cycles

Drug: nab-paclitaxel

Drug: nab-paclitaxel 125mg/m2, i.v. d1, d8, Repeated every 3 weeks for 4-6 cycles.



Active Comparator: Topotecan

Topotecan 1.25mg/m2/d, i.v, 1hour, d1-d5, Repeated every 3 weeks for 4-6 cycles.

Drug: Topotecan

Drug: Topotecan 1.25mg/m2/d, i.v, 1hour, d1-d5, Repeated every 3 weeks for 4-6 cycles.







Outcome Measures

Go to  sections

Primary Outcome Measures  :

Overall survival (OS) [ Time Frame: 1 years post treatment ]

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).





Secondary Outcome Measures  :

Objective response rate (ORR) [ Time Frame: 1 years ]

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.





Progression free survival (PFS) [ Time Frame: 1 years ]

The time from treatment to tumor progression or death



Adverse events (AE) [ Time Frame: 3 years ]

Adverse events (AE) were monitored on an ongoing basis and classified according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0. Patients were assessed for toxicities before each administration, and toxicity was graded accordingly





Eligibility Criteria

Go to  sections

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.





Ages Eligible for Study:  18 Years to 75 Years   (Adult, Older Adult)

Sexes Eligible for Study:  All

Accepts Healthy Volunteers:  No

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.

Contacts and Locations

Go to  sections

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.



Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04213937





Contacts

Contact: Jie MD Wang, PhD 86 13910704669 wangjiezgyxkxy@163.com



Locations

China, Beijing

Cancer Hospital Chinese Academy of Medical Sciences Recruiting

Beijing, Beijing, China, 100021

Contact: Jie Wang       

Sponsors and Collaborators

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

More Information

Go to  sections



Responsible Party: Jie Wang, Principal Investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

ClinicalTrials.gov Identifier: NCT04213937     History of Changes

Other Study ID Numbers: KAL-SCLC-01

First Posted: December 30, 2019    Key Record Dates

Last Update Posted: December 30, 2019

Last Verified: December 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No

Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jie Wang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences:

nab-paclitaxel Topotecan

Additional relevant MeSH terms:

Lung Neoplasms

Small Cell Lung Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Neoplasms by Site

Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Paclitaxel

Albumin-Bound Paclitaxel

Topotecan

Antineoplastic Agents, Phytogenic

Antineoplastic Agents

Tubulin Modulators

Antimitotic Agents

Mitosis Modulators

Molecular Mechanisms of Pharmacological Action

Topoisomerase I Inhibitors

Topoisomerase Inhibitors

Enzyme Inhibitors





TO TOP

For Patients and Families For Researchers For Study Record Managers

HOME RSS FEEDS SITE MAP TERMS AND CONDITIONS DISCLAIMER CUSTOMER SUPPORT

Copyright Privacy Accessibility Viewers and Players Freedom of Information Act USA.gov

U.S. National Library of Medicine U.S. National Institutes of Health U.S. Department of Health and Human Services