Extensive Stage Small Cell Lung CancerPhase 2NCT04213937
Nab-paclitaxel Versus Topotecan As Second-Line Treatment for Patients With Extensive Stage Small Cell Lung Cancer
A Phase 2 study testing nab-paclitaxel and Topotecan in people with Extensive Stage Small Cell Lung Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Extensive Stage Small Cell Lung Cancer
- What is being tested?
- nab-paclitaxel and Topotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 386 participants
- Where
- 1 siteChina
- Study dates
- 31 Jan 2020to 31 Jan 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Jie Wang
About this study
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
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
- Being tested
- nab-paclitaxel, Topotecan
- Keywords
- nab-paclitaxel Topotecan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nab-paclitaxelDrug
Drug: nab-paclitaxel 125mg/m2, i.v. d1, d8, Repeated every 3 weeks for 4-6 cycles.
TopotecanDrug
Drug: Topotecan 1.25mg/m2/d, i.v, 1hour, d1-d5, Repeated every 3 weeks for 4-6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| nab-paclitaxel | Experimental | nab-paclitaxel 125mg/m2, i.v. d1, d8, Repeated every 3 weeks for 4-6 cycles Receives: Drug: nab-paclitaxel |
| Topotecan | Active comparator | Topotecan 1.25mg/m2/d, i.v, 1hour, d1-d5, Repeated every 3 weeks for 4-6 cycles. Receives: Drug: Topotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 years post treatment
Secondary outcomes (3)
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.
Measured: 1 years
Progression free survival (PFS)
The time from treatment to tumor progression or death
Measured: 1 years
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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2019
- Study start31 Jan 2020 (estimated)
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extensive Stage Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 386 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jie Wang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04213937
- Sponsor's protocol ID
- KAL-SCLC-01
- Status last verified
- Dec 2019
- First submitted
- 25 Dec 2019
- Last updated
- 30 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04213937
- Acronym / sponsor ID
- KAL-SCLC-01
- Conditions
- Extensive Stage Small Cell Lung Cancer
- Keywords
- nab-paclitaxel Topotecan
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 386 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 31 Jan 2020 (estimated)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 30 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nab-paclitaxel | Experimental | Drug: nab-paclitaxelnab-paclitaxel 125mg/m2, i.v. d1, d8, Repeated every 3 weeks for 4-6 cycles |
| Topotecan | Active comparator | Drug: TopotecanTopotecan 1.25mg/m2/d, i.v, 1hour, d1-d5, Repeated every 3 weeks for 4-6 cycles. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (11 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nab-paclitaxelDrug: nab-paclitaxel 125mg/m2, i.v. d1, d8, Repeated every 3 weeks for 4-6 cycles. | Drug | nab-paclitaxel |
| TopotecanDrug: Topotecan 1.25mg/m2/d, i.v, 1hour, d1-d5, Repeated every 3 weeks for 4-6 cycles. | Drug | Topotecan |
Primary outcome
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).
3 secondary outcomes
Objective response rate (ORR)
Time frame: 1 years
Progression free survival (PFS)
Time frame: 1 years
Adverse events (AE)
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing nab-paclitaxel and Topotecan in people with Extensive Stage Small Cell Lung Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jie MD Wang, PhD (86 13910704669, wangjiezgyxkxy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: 1 years post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2019; AzTrials last refreshed its copy on 6 Nov 2026.