Small Cell Lung CancerNCT04782089
Study of PD-1 Antibody and PARP Inhibitor in Extensive Stage Small Cell Lung Cancer
A study testing Camrelizumab Anti-PD-1 antibody Fluzoparib PARP inhibitors in people with Small Cell Lung Cancer, run by Qilu Hospital of Shandong University.
Trial summary
This is a Phase II, Open, Single-center Study of Camrelizumab and Fluzoparib as Consolidation Treatment for Patients With Extensive stage small cell lung cancer Who Have Not Progressed after first-line treatment Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- Camrelizumab Anti-PD-1 antibody Fluzoparib PARP inhibitors
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 6 May 2021to 1 Jun 2024
- Phase
- Interventional
- 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
- All subjects were required to sign the informed consent before starting the study;
- Histologically documented Extensive stage small cell lung cancer；
- ECOG PS 0~1 ；
- 18-75 years；
- According to recist1.1, CR or PR was achieved after 4-6 cycles of first-line etoposide and platinum chemotherapy;
- .Life expectancy ≥ 3 months；
Who cannot join
- Recurrence or distant metastasis of localized small cell lung cancer after chemotherapy or concurrent chemoradiotherapy；
- Active infection including tuberculosis, HIV, hepatitis B and C；
- Interstitial pneumonia (ILD), drug-induced pneumonia, radiation-induced pneumonia requiring steroid therapy or active pneumonia with clinical symptoms, or other moderate to severe lung diseases that seriously affect lung function;
- Severe infection existed, including but not limited to infection complications, bacteremia, severe pneumonia, etc;
- Symptomatic brain metastasis and cancerous meningitis;
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase II, Open, Single-center Study of PD-1 Antibody and PARP Inhibitor as Consolidation Treatment for Patients With Extensive Stage Small Cell Lung Cancer Who Have Not Progressed After First-line Treatment
This is a Phase II, Open, Single-center Study of Camrelizumab and Fluzoparib as Consolidation Treatment for Patients With Extensive stage small cell lung cancer Who Have Not Progressed after first-line treatment
- Conditions
- Small Cell Lung Cancer
- Being tested
- Camrelizumab Anti-PD-1 antibody Fluzoparib PARP inhibitors
- 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.
Camrelizumab Anti-PD-1 antibody Fluzoparib PARP inhibitorsDrug
Camrelizumab+Fluzoparib：Q3W, Administration until disease progression or intolerable
| Study group | Role | What they receive |
|---|---|---|
| Camrelizumab+Fluzoparib | Experimental | Not described Receives: Drug: Camrelizumab Anti-PD-1 antibody Fluzoparib PARP inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
To assess the efficacy of Camrelizumab and Fluzoparib combination therapy in terms of PFS
Measured: Approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start6 May 2021 (estimated)
- Primary completion1 May 2023 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04782089
- Sponsor's protocol ID
- ES-SCLC-2nd-IIT-SHR3162-APA
- Status last verified
- Feb 2021
- First submitted
- 1 Mar 2021
- Last updated
- 4 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open, Single-center Study of PD-1 Antibody and PARP Inhibitor as Consolidation Treatment for Patients With Extensive Stage Small Cell Lung Cancer Who Have Not Progressed After First-line Treatment
- ClinicalTrials.gov ID
- NCT04782089
- Acronym / sponsor ID
- ES-SCLC-2nd-IIT-SHR3162-APA
- Conditions
- Small Cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- 6 May 2021 (estimated)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 4 Mar 2021 (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.
This is a Phase II, Open, Single-center Study of Camrelizumab and Fluzoparib as Consolidation Treatment for Patients With Extensive stage small cell lung cancer Who Have Not Progressed after first-line treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Camrelizumab+Fluzoparib | Experimental | Drug: Camrelizumab Anti-PD-1 antibody Fluzoparib PARP inhibitors |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- All subjects were required to sign the informed consent before starting the study;
- Histologically documented Extensive stage small cell lung cancer；
- ECOG PS 0~1 ；
- 18-75 years；
- According to recist1.1, CR or PR was achieved after 4-6 cycles of first-line etoposide and platinum chemotherapy;
Key exclusion criteria (5 listed)
- Recurrence or distant metastasis of localized small cell lung cancer after chemotherapy or concurrent chemoradiotherapy；
- Active infection including tuberculosis, HIV, hepatitis B and C；
- Interstitial pneumonia (ILD), drug-induced pneumonia, radiation-induced pneumonia requiring steroid therapy or active pneumonia with clinical symptoms, or other moderate to severe lung diseases that seriously affect lung function;
- Severe infection existed, including but not limited to infection complications, bacteremia, severe pneumonia, etc;
- Symptomatic brain metastasis and cancerous meningitis;
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 |
|---|---|---|
| Camrelizumab Anti-PD-1 antibody Fluzoparib PARP inhibitorsCamrelizumab+Fluzoparib：Q3W, Administration until disease progression or intolerable | Drug | Camrelizumab+Fluzoparib |
Primary outcome
Progression-free survival (PFS)
Time frame: Approximately 3 years
To assess the efficacy of Camrelizumab and Fluzoparib combination therapy in terms of PFS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2021.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Camrelizumab Anti-PD-1 antibody Fluzoparib PARP inhibitors in people with Small Cell Lung Cancer, run by Qilu Hospital of Shandong University.
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 6 inclusion and 5 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 4 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Jisheng Li, PhD (0531-82169841, lijisheng@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: Approximately 3 years). 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 4 Mar 2021.