Back to results

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

Primary Purpose

Extensive Stage Small Cell Lung Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

nab-paclitaxel

Topotecan

About this trial

This is an interventional treatment trial for Extensive Stage Small Cell Lung Cancer focused on measuring nab-paclitaxel Topotecan

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Cancer Hospital Chinese Academy of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

nab-paclitaxel

Topotecan

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Progression free survival (PFS)

The time from treatment to tumor progression or death

Adverse events (AE)

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

Full Information

NCT ID

NCT04213937

First Posted

December 25, 2019

Last Updated

December 27, 2019

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT04213937

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Unknown status

Study Start Date

January 31, 2020 (Anticipated)

Primary Completion Date

July 31, 2021 (Anticipated)

Study Completion Date

January 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Extensive Stage Small Cell Lung Cancer

Keywords

nab-paclitaxel Topotecan

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

386 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

nab-paclitaxel

Arm Type

Experimental

Arm Description

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

Arm Title

Topotecan

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

nab-paclitaxel

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Topotecan

Intervention Description

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

Primary Outcome Measure Information:

Title

Overall survival (OS)

Description

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).

Time Frame

1 years post treatment

Secondary Outcome Measure Information:

Title

Objective response rate (ORR)

Description

Time Frame

1 years

Title

Progression free survival (PFS)

Description

The time from treatment to tumor progression or death

Time Frame

1 years

Title

Adverse events (AE)

Description

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jie MD Wang, PhD

Phone

86 13910704669

wangjiezgyxkxy@163.com

Facility Information:

Facility Name

Cancer Hospital Chinese Academy of Medical Sciences

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100021

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jie Wang

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs