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

NCT04213937 | Unknown Phase 2

• 1 other identifier: KAL-SCLC-01
• Study Type: interventional
• Target: 386
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 (3)

• Objective response rate (ORR)

  1 years

• Progression free survival (PFS)

  1 years

• Adverse events (AE)

  3 years

Study Arms (2)

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

Interventions

nab-paclitaxel DRUG

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

nab-paclitaxel

Topotecan DRUG

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

Topotecan

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Interventions

130-nm albumin-bound paclitaxel; Topotecan

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Central Study Contacts

Jie MD Wang, PhD

CONTACT

86 13910704669; wangjiezgyxkxy@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 25, 2019
• First Posted: December 30, 2019
• Study Start: January 31, 2020
• Primary Completion: July 31, 2021
• Study Completion: January 31, 2022
• Last Updated: December 30, 2019

Record last verified: 2019-12

Locations

CN (1)