Extensive-stage Small Cell Lung CancerPhase 3NCT03516084
A Study of Niraparib as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Patients With Extensive Stage Small Cell Lung Cancer
A Phase 3 study testing ZL-2306(nirapairb) in people with Extensive-stage Small Cell Lung Cancer, run by Zai Lab (Shanghai) Co., Ltd. at 33 sites in China.
Trial summary
Niraparib is a PARP inhibitor. The study is a 2:1 randomized, double-blind, placebo-controlled, multi-center,phase 3 study of ZL-2306 (niraparib) as maintenance therapy following first-line platinum-based chemotherapy in patients with extensive-stage disease small cell lung cancer (ED-SCLC) to evaluate the efficacy… 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?
- ZL-2306(nirapairb)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 185 participants
- Where
- 33 sitesChina
- Study dates
- 20 Aug 2018to 20 Mar 2020
- Phase
- Phase 3
- 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
- Aged 18-75 years
- Histologically or cytologically confirmed extensive-stage disease small cell lung cancer (ED SCLC)
- Ongoing clinical benefit (partial response [PR], or complete response [CR] per RECIST version 1.1) following completion of 4 cycles of first-line platinum-based therapy (cisplatin or carboplatin, plus etoposide)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Subjects must have adequate bone marrow, renal and hepatic function
Who cannot join
- Subjects with Central Nervous System (CNS) metastases
- Subjects receiving consolidative chest radiation after last dose of first-line chemotherapy.
- Subjects with pleural effusions that cannot be controlled with appropriate interventions.
- All side effects attributed to prior anti-cancer therapy must have resolved to Grade 1 or baseline
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
China33 sites
Beijing Cancer Hospital
Beijing, Beijing Municipality
Beijing Chest Hospital, Capital Medical University
Beijing, Beijing Municipality
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality
Hospital, Academy of Military Medical Sciences
Beijing, Beijing Municipality
Peking union medical college hospital
Beijing, Beijing Municipality
The First Hospital of Jilin University
Changchun, Jilin
Hunan Cancer Hospital
Changsha, Hunan
The second xiangya hospital of central south university
Changsha, Hunan
Fujian Cancer Hospital
Fuzhou, Fujian
Nanfang Hospital
Guangzhou, Guangdong
The first affiliated hospital of Guangzhou medical school
Guangzhou, Guangdong
Second Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang
Zhejiang cancer hospital
Hangzhou, Zhejiang
First Affiliated Hospital, Zhejiang University
Hanzhou, Zhejiang
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang
Anhui Provincal Hospital
Hefei, Anhui
Jinzhou Central Hospital
Jinzhou, Liaoning
Lin Yi Cancer Hospital
Linyi, Shandong
The first affiliated hospital of Nanchang University
Nanchang, Jiangxi
The Second Affiliated hospital of Nanchang University
Nanchang, Jiangxi
Nanjing General Hospital
Nanjing, Jiangsu
The first affiliated hospital of Guangxi Medical University
Nanning, Guangxi
Nantong Tumor Hospital
Nantong, Jiangsu
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
Shanghai Chest Hospital, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality
China shenyang chest hospital
Shenyang, Liaoning
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning
Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei
Xinjiang Cancer Hospital
Ürümqi, Xinjiang
Union hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Tangdu Hospital
Xi’an, Shanxi
Henan Cancer Hospital
Zhengzhou, Henan
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multi-center Phase 3 Study of ZL-2306 (Niraparib) as Maintenance Therapy Following First-line Platinum-based Chemotherapy in Patients With Extensive-stage Disease Small Cell Lung Cancer (ED-SCLC) to Evaluate the Efficacy and Safety
Niraparib is a PARP inhibitor. The study is a 2:1 randomized, double-blind, placebo-controlled, multi-center,phase 3 study of ZL-2306 (niraparib) as maintenance therapy following first-line platinum-based chemotherapy in patients with extensive-stage disease small cell lung cancer (ED-SCLC) to evaluate the efficacy and safety.
- Conditions
- Extensive-stage Small Cell Lung Cancer
- Being tested
- ZL-2306(nirapairb), Placebo
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZL-2306(nirapairb)Drug
The initial dose is 300mg QD or 200mg QD based on baseline weight and platelet count.
PlaceboDrug
The initial dose is 300mg QD or 200mg QD based on baseline weight and platelet count.
| Study group | Role | What they receive |
|---|---|---|
| ZL-2306(nirapairb) | Experimental | Not described Receives: Drug: ZL-2306(nirapairb) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
BICR-assessed progression-free survival (PFS)
The time assessed by the Blinded Independent Central Review (BICR) from randomization to progressive disease or death due to various causes, whichever occurs; progressive disease will be assessed in accordance with RECIST 1.1 criteria.
Measured: Approximately 14 months since the first subject enrolled
Overall survival (OS)
The time from randomization to death due to any cause.
Measured: Approximately 48 months since first subject enrolled
Secondary outcomes (1)
Investigator-assessed PFS
the investigator-assessed time from randomization to progressive disease or death due to various causes, whichever occurs; progressive disease will be assessed in accordance with RECIST 1.1 criteria.
Measured: Approximately 14 months since the first subject enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2018
- Study start20 Aug 2018
- Primary completion21 Feb 2020
- Study completion20 Mar 2020
Why it stopped: As the treatment model of extensive-stage small cell lung cancer changed rapidly and the enrollment speed significantly lower than expected, ZaiLab decided to terminate this study
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zai Lab (Shanghai) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zai Lab, Study director, Zai Lab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03516084
- Sponsor's protocol ID
- ZL-2306-005
- Status last verified
- Dec 2020
- First submitted
- 23 Apr 2018
- Last updated
- 21 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multi-center Phase 3 Study of ZL-2306 (Niraparib) as Maintenance Therapy Following First-line Platinum-based Chemotherapy in Patients With Extensive-stage Disease Small Cell Lung Cancer (ED-SCLC) to Evaluate the Efficacy and Safety
- ClinicalTrials.gov ID
- NCT03516084
- Acronym / sponsor ID
- ZL-2306-005
- Conditions
- Extensive-stage Small Cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: As the treatment model of extensive-stage small cell lung cancer changed rapidly and the enrollment speed significantly lower than expected, ZaiLab decided to terminate this study
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Zai Lab (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Aug 2018 (actual)
- Primary completion
- 21 Feb 2020 (actual)
- Study completion
- 20 Mar 2020 (actual)
- First posted
- 4 May 2018 (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.
Niraparib is a PARP inhibitor. The study is a 2:1 randomized, double-blind, placebo-controlled, multi-center,phase 3 study of ZL-2306 (niraparib) as maintenance therapy following first-line platinum-based chemotherapy in patients with extensive-stage disease small cell lung cancer (ED-SCLC) to evaluate the efficacy and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ZL-2306(nirapairb) | Experimental | Drug: ZL-2306(nirapairb) |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18-75 years
- Histologically or cytologically confirmed extensive-stage disease small cell lung cancer (ED SCLC)
- Ongoing clinical benefit (partial response [PR], or complete response [CR] per RECIST version 1.1) following completion of 4 cycles of first-line platinum-based therapy (cisplatin or carboplatin, plus etoposide)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Subjects must have adequate bone marrow, renal and hepatic function
Key exclusion criteria (4 listed)
- Subjects with Central Nervous System (CNS) metastases
- Subjects receiving consolidative chest radiation after last dose of first-line chemotherapy.
- Subjects with pleural effusions that cannot be controlled with appropriate interventions.
- All side effects attributed to prior anti-cancer therapy must have resolved to Grade 1 or baseline
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 |
|---|---|---|
| ZL-2306(nirapairb)The initial dose is 300mg QD or 200mg QD based on baseline weight and platelet count. | Drug | ZL-2306(nirapairb) |
| PlaceboThe initial dose is 300mg QD or 200mg QD based on baseline weight and platelet count. | Drug | Placebo |
Primary outcome
BICR-assessed progression-free survival (PFS)
Time frame: Approximately 14 months since the first subject enrolled
The time assessed by the Blinded Independent Central Review (BICR) from randomization to progressive disease or death due to various causes, whichever occurs; progressive disease will be assessed in accordance with RECIST 1.1 criteria.
Overall survival (OS)
Time frame: Approximately 48 months since first subject enrolled
The time from randomization to death due to any cause.
1 secondary outcome
Investigator-assessed PFS
Time frame: Approximately 14 months since the first subject enrolled
Results and safety
The study was stopped early (reason given: As the treatment model of extensive-stage small cell lung cancer changed rapidly and the enrollment speed significantly lower than expected, ZaiLab decided to terminate this study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2020.
Related trials for Extensive-stage Small Cell Lung Cancer
Active, not recruitingPhase 3
Study Comparing Tarlatamab and Durvalumab Versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following Platinum, Etoposide and Durvalumab
Extensive-Stage Small-Cell Lung Cancer, Small-Cell Lung Cancer
RecruitingPhase 2
A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC
Extensive-stage Small-cell Lung Cancer
Active, not recruitingPhase 2
Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy
Extensive-stage Small-cell Lung Cancer, Small-cell Lung Cancer
RecruitingPhase 2
MOnaliZumab in Combination With durvAlumab (MEDI4736) for tRreatmenT of Small Cell Lung Cancer
Small Cell Lung Cancer, SCLC
Not yet recruitingPhase 2
Low-Dose Radiotherapy Plus Adebrelimab and Chemotherapy for Extensive-Stage Small Cell Lung Cancer
Small Cell Lung Cancer (SCLC), SCLC, Extensive Stage
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.
Zai Lab study director
Zai Lab
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ZL-2306(nirapairb) in people with Extensive-stage Small Cell Lung Cancer, run by Zai Lab (Shanghai) Co., Ltd. at 33 sites 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 5 inclusion and 4 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: stopped early, as of the sponsor's last update on 21 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: As the treatment model of extensive-stage small cell lung cancer changed rapidly and the enrollment speed significantly lower than expected, ZaiLab decided to terminate this study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BICR-assessed progression-free survival (PFS) (time frame: Approximately 14 months since the first subject enrolled). The study lists 2 primary outcomes in all. 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 21 Dec 2020.