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

NCT ID: NCT04213937

Last Updated: 2019-12-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 386 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-31
• Study Completion Date: 2022-01-31

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.

Conditions

Extensive Stage Small Cell Lung Cancer

Keywords

nab-paclitaxel Topotecan

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

nab-paclitaxel

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

Group Type: EXPERIMENTAL

nab-paclitaxel

Intervention Type: DRUG

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

Topotecan

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

Group Type: ACTIVE_COMPARATOR

Topotecan

Intervention Type: DRUG

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

Interventions

nab-paclitaxel

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

Intervention Type: DRUG

Topotecan

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

Intervention Type: DRUG

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

1. symptomatic brain metastases;

2. 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.;

3. Have dementia, altered mental state or any mental illness that would prevent understanding or informed consent or fill out questionnaires;

4. Received any investigational drug within 30 days of the planned first dose of this study treatment.

5. Prior Grade ≥ 2 peripheral neuropathy(according to (NCI CTCAE), version 5.0);

6. Known to be hypersensitive, highly sensitive, or intolerant to study-related medications or their excipients;

7. 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;

8. 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;

9. Patients need other anti-tumor drugs;

10. Known HIV, hepatitis B/C virus positive ;

11. The researchers considered the patients who were not suitable for enrollment.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Jie Wang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jie MD Wang, PhD

Role: CONTACT

Phone: 86 13910704669

Email: wangjiezgyxkxy@163.com

Facility Contacts

Jie Wang

Role: primary

Other Identifiers

KAL-SCLC-01

Identifier Type: -

Identifier Source: org_study_id