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

Extensive Stage Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04213937
• Other study ID #: KAL-SCLC-01
• Status: Recruiting
• Phase: Phase 2
• Start date: January 31, 2020
• Est. completion date: January 31, 2022

Study information

• Verified date: December 2019
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: Jie MD Wang, PhD
• Phone: 86 13910704669
• Email: wangjiezgyxkxy[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 386
• Est. completion date: January 31, 2022
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Extensive Stage Small Cell Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• nab-paclitaxel
Drug: nab-paclitaxel 125mg/m2, i.v. d1, d8, Repeated every 3 weeks for 4-6 cycles.
• Topotecan
Drug: Topotecan 1.25mg/m2/d, i.v, 1hour, d1-d5, Repeated every 3 weeks for 4-6 cycles.

Locations

Country	Name	City	State
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Progression free survival (PFS)	The time from treatment to tumor progression or death	1 years
Secondary	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	3 years