Small Cell Lung CancerPhase 1/2NCT04400188
A Study of Fluzoparib (SHR-3162) and Temozolomide With or Without SHR-1316 in Treating Patients With Replapsed Small Cell Lung Cancer
A Phase 1/2 study testing Fluzoparib, temozolomide and SHR-1316 in people with Small Cell Lung Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This research study is a multicentre phase Ⅰb/Ⅱ Study to evaluate the efficacy and safety of the combination of Fluzoparib (SHR-3162) and temozolomide with or without SHR-1316 in small cell lung cancer Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- Fluzoparib, temozolomide and SHR-1316
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 11 Jun 2020to 15 Jan 2022
- Phase
- Phase 1/2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who have recurrent small cell lung cancer confirmed by histology or cytology.
- Failed one prior line of platinum-based chemotherapy.
- Subjects must have measurable disease, at least one lesion, by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) per RECIST 1.1 criteria (within 28 days prior to administration of study treatment) ;
- Freshly acquired samples or archived specimens within 12 months before randomization must be provided.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Participant must have a life expectancy ≥ 12 weeks.
Who cannot join
- Active or untreated central nervous system (CNS) metastases.
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
- History of autoimmune disease.
- Positive test result for human immunodeficiency virus (HIV).
- Active hepatitis B or hepatitis C.
- Severe infections.
Show all 9Show fewer
- Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first administration of study treatment.
- Significant cardiovascular disease.
- History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase Ⅰb/Ⅱ Study of Fluzoparib (SHR-3162) and Temozolomide With or Without SHR-1316 in Treating Patients With Replapsed Small Cell Lung Cancer
This research study is a multicentre phase Ⅰb/Ⅱ Study to evaluate the efficacy and safety of the combination of Fluzoparib (SHR-3162) and temozolomide with or without SHR-1316 in small cell lung cancer
- Conditions
- Small Cell Lung Cancer
- Being tested
- Fluzoparib, temozolomide, SHR-1316
- 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.
FluzoparibDrug
Given PO
temozolomideDrug
Given PO
SHR-1316Biological
Given injection
| Study group | Role | What they receive |
|---|---|---|
| Experimental A (part 1) : Fluzoparib + temozolomide | Experimental | Not described Receives: Drug: Fluzoparib; Drug: temozolomide |
| Experimental B (part 2) : Fluzoparib + temozolomide + SHR-1316 | Experimental | Not described Receives: Drug: Fluzoparib; Drug: temozolomide; Biological: SHR-1316 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase Ⅰb: Number of Subjects Experienced Any Dose-Limiting Toxicity (DLT) over the DLT period.
Measured: At the end of Cycle1 (each cycle is 21 days )
Phase Ⅰb: Determination of Recommended Phase II dose (RP2D) of Escalating Dose of Fluzoparib and temozolomide with or without SHR-1316.
Measured: Up to approximately 2 Years
Phase Ⅱ: Progression Free Survival (PFS) at four months.
Measured: Up to approximately 2 Years
Phase Ⅱ: Progression Free Survival (PFS) as Assessed by the Investigator according to RECIST v1.1.
Progression Free Survival, defined as the time from randomization to first assessment of disease progression or death, whichever is earlier.
Measured: Up to approximately 2 Years
Secondary outcomes (5)
Objective Response Rate
Objective Response Rate, determined using RECIST v1.1 criteria, defined as best overall response (complete or partial response) across all assessment time points.
Measured: up to approximately 2 Years
Duration of Response
Duration of Response, determined using RECIST v1.1 criteria.
Measured: Up to approximately 2 Years
Disease Control Rate
Disease Control Rate, determined using RECIST v1.1 criteria.
Measured: Up to approximately 2 Years
Time to Response
Time to Response, defined as the time from randomization to PR or CR.
Measured: Up to approximately 2 Years
Overall survival and overall survival at 6 months, 9months and 12 months
Overall survival is the time interval from the date of randomization to death due to any reason or lost of follow-up.
Measured: Up to approximately 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start11 Jun 2020
- Primary completion15 Jan 2022
- Study completion15 Jan 2022
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 Jiangsu HengRui Medicine Co., Ltd.The 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Fluzoparib (SHR-3162) combined with temozolomide or Fluzoparib (SHR-3162) and temozolomide with SHR-1316
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- You Lu, MD, Study chair, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04400188
- Sponsor's protocol ID
- SHR-3162-Ib-115
- Status last verified
- Jun 2025
- First submitted
- 7 May 2020
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅰb/Ⅱ Study of Fluzoparib (SHR-3162) and Temozolomide With or Without SHR-1316 in Treating Patients With Replapsed Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04400188
- Acronym / sponsor ID
- SHR-3162-Ib-115
- Conditions
- Small Cell Lung Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Jun 2020 (actual)
- Primary completion
- 15 Jan 2022 (actual)
- Study completion
- 15 Jan 2022 (actual)
- First posted
- 22 May 2020 (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 research study is a multicentre phase Ⅰb/Ⅱ Study to evaluate the efficacy and safety of the combination of Fluzoparib (SHR-3162) and temozolomide with or without SHR-1316 in small cell lung cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Fluzoparib (SHR-3162) combined with temozolomide or Fluzoparib (SHR-3162) and temozolomide with SHR-1316
| Arm | Type | Receives |
|---|---|---|
| Experimental A (part 1) : Fluzoparib + temozolomide | Experimental | Drug: Fluzoparib, Drug: temozolomide |
| Experimental B (part 2) : Fluzoparib + temozolomide + SHR-1316 | Experimental | Drug: Fluzoparib, Drug: temozolomide, Biological: SHR-1316 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects who have recurrent small cell lung cancer confirmed by histology or cytology.
- Failed one prior line of platinum-based chemotherapy.
- Subjects must have measurable disease, at least one lesion, by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) per RECIST 1.1 criteria (within 28 days prior to administration of study treatment) ;
- Freshly acquired samples or archived specimens within 12 months before randomization must be provided.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Key exclusion criteria (9 listed)
- Active or untreated central nervous system (CNS) metastases.
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
- History of autoimmune disease.
- Positive test result for human immunodeficiency virus (HIV).
- Active hepatitis B or hepatitis C.
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 |
|---|---|---|
| FluzoparibGiven PO | Drug | Experimental A (part 1) : Fluzoparib + temozolomide, Experimental B (part 2) : Fluzoparib + temozolomide + SHR-1316 |
| temozolomideGiven PO | Drug | Experimental A (part 1) : Fluzoparib + temozolomide, Experimental B (part 2) : Fluzoparib + temozolomide + SHR-1316 |
| SHR-1316Given injection | Biological | Experimental B (part 2) : Fluzoparib + temozolomide + SHR-1316 |
Primary outcome
Phase Ⅰb: Number of Subjects Experienced Any Dose-Limiting Toxicity (DLT) over the DLT period.
Time frame: At the end of Cycle1 (each cycle is 21 days )
Phase Ⅰb: Determination of Recommended Phase II dose (RP2D) of Escalating Dose of Fluzoparib and temozolomide with or without SHR-1316.
Time frame: Up to approximately 2 Years
Phase Ⅱ: Progression Free Survival (PFS) at four months.
Time frame: Up to approximately 2 Years
Phase Ⅱ: Progression Free Survival (PFS) as Assessed by the Investigator according to RECIST v1.1.
Time frame: Up to approximately 2 Years
Progression Free Survival, defined as the time from randomization to first assessment of disease progression or death, whichever is earlier.
5 secondary outcomes
Objective Response Rate
Time frame: up to approximately 2 Years
Duration of Response
Time frame: Up to approximately 2 Years
Disease Control Rate
Time frame: Up to approximately 2 Years
Time to Response
Time frame: Up to approximately 2 Years
Overall survival and overall survival at 6 months, 9months and 12 months
Time frame: Up to approximately 1 Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
Related trials for Small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
RecruitingPhase 2
A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity
Carcinoma, Neuroendocrine, Tumor, Neuroendocrine
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
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.
You Lu, MD study chair
West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Fluzoparib, temozolomide and SHR-1316 in people with Small Cell Lung Cancer, run by Jiangsu HengRui Medicine Co., Ltd. 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 6 inclusion and 9 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: finished, as of the sponsor's last update on 29 Jun 2025. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Phase Ⅰb: Number of Subjects Experienced Any Dose-Limiting Toxicity (DLT) over the DLT period. (time frame: At the end of Cycle1 (each cycle is 21 days )). The study lists 4 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 29 Jun 2025.