Extensive-stage Small Cell Lung CancerPhase 1/2NCT05975944
Study of Selinexor Combined With Olaparib in Relapsed/Refractory Extensive Stage Small Cell Lung Cancer
A Phase 1/2 study testing Selinexor，Olaparib in people with Extensive-stage Small Cell Lung Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This study is a multicenter, single arm, open, non-randomized, dose-escalation/ expansion phase Ib/II clinical study. The dose-escalation part of phase Ib clinical trial was conducted according to the Bayesian Optimal Interval Design (BOIN), with a total of three dose groups: low, medium, and high. 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?
- Selinexor，Olaparib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteChina
- Study dates
- Sep 2023to May 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The diagnosis of SCLC is confirmed by histology or cytology, and according to VALSG and AJCC8, the imaging diagnosis is extensive stage.
- The condition progresses after receiving at least 1 line of treatment, and within 6 months after the last treatment.
- The expected survival time is not less than 12 weeks.
- According to RECIST V1.1, there is at least one measurable lesion that has not undergone radiation therapy.
- The Eastern Cooperative Oncology Group (ECOG) physical condition score is evaluated as 0 or 1.
- When screening, there is sufficient bone marrow reserve, and no blood transfusion or hematopoietic stimulating factor treatment has been received 10 days before the test. The definition is as follows: absolute neutrophil counts (ANC) ≥ 1.5×109/L, platelet (PLT) ≥ 100×109/L and hemoglobin (HGB) ≥ 90g/L.
- Appropriate organ function during screening, meeting the following criteria: aspartate aminotransferase (AST) ≤ 2.5×ULN (with liver metastasis ≤ 5×ULN); alanine aminotransferase (ALT) ≤ 2.5ULN (with liver metastasis ≤ 5ULN); total serum bilirubin ≤ 1.5×ULN (with tumor infiltration ≤ 3×ULN); serum creatinine (Scr) ≤ 1.5×ULN, or creatinine clearance rate ≥ 60mL/min; international normalized ratio (INR) ≤ 1.5×ULN, and activated partial thromboplastin time (APTT) ≤ 1.5×ULN; the urine pregnancy test for women of childbearing age needs to be negative, and any male and female patients with fertility must agree to use effective contraceptive methods throughout the entire study process and for at least 1 year after treatment.
Who cannot join
- During screening, patients with symptomatic central nervous system (CNS) metastasis (asymptomatic CNS metastasis, or asymptomatic and stable condition after local treatment for 4 weeks can be enrolled).
- Individuals with a history of central nervous system diseases before screening, such as epilepsy, cerebral ischemia/bleeding, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, mental illness, or any autoimmune disease associated with central nervous system involvement.
- Received chemotherapy, radiation therapy, immunotherapy, targeted therapy, biological therapy, endocrine therapy within 4 weeks of screening, and was evaluated by the researcher as not suitable for enrollment.
- The adverse reactions of previous anti-tumor treatments have not yet recovered to level 1 (CTCAE5.0), except for toxicity that the researchers have determined to have no safety risk, such as hair loss and level 2 peripheral neurotoxicity.
- Those who discontinue systemic hormone therapy for less than 72 hours before the first administration, but are allowed to use physiological replacement doses of hormones (such as prednisone < 10mg/d or equivalent).
- Received organ/tissue transplantation before screening.
Show all 19Show fewer
- Prior to screening, it was known that the patient had active systemic autoimmune diseases and was currently undergoing treatment.
- Those who meet any of the following conditions during screening: hepatitis B surface antigen (HBsAg) is positive, and the copy number of HBV DNA is greater than the measurable lower limit; hepatitis C antibody (HCV Ab) is positive; treponema pallidum antibody (TP-Ab) is positive; HIV antibody is positive; The copy numbers of EBV-DNA and CMV-DNA are higher than the measurable lower limit.
- Individuals who have undergone major surgery or experienced significant trauma within 4 weeks prior to screening, or who require elective surgery during the trial period, have been evaluated by the researchers as unsuitable for inclusion.
- Within 2 years prior to screening or currently suffering from other malignant tumors.
- When screening, the heart meets any of the following conditions: New York Heart Association (NYHA) ≥ Level II, Left Ventricular Ejection Fraction (LVEF) ≤ 50% (ECHO); Hypertension (systolic blood pressure ≥ 140mmHg and/or diastolic blood pressure ≥ 90mmHg) or pulmonary hypertension that has not been controlled after standardized treatment; Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other Grade 3 or higher cardiovascular and cerebrovascular events occurred within 6 months before the first administration; valvular disease with clinical significance; There are serious cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias that require clinical intervention, II-III degree atrioventricular block, etc.
- Patients with tumor involving the atrium or ventricle during screening.
- When screening, there are clinical emergencies that require urgent treatment due to tumor obstruction or compression (such as intestinal obstruction or vascular compression).
- Individuals with active bleeding during screening.
- Those with a history of deep vein thrombosis or pulmonary embolism within 6 months before screening.
- Individuals who have received live vaccines within 6 weeks before screening.
- Subjects with uncontrolled systemic bacterial, viral, or fungal infections after optimal treatment.
- Participated in other interventional clinical studies within 4 weeks before the first administration.
- Individuals with poor adherence or those who are deemed unsuitable for clinical trials by researchers due to other reasons.
Trial locations and contacts
1 site in 1 country.
huang ding zhi, M.D. contact
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, 300060
Huang Ding Zhi, PHD
About this study
Official title: A Phase Ib/II Clinical Study Evaluating the Safety, Tolerability, and Efficacy of Selinexor Combined With Olaparib in the Treatment of Recurrent/Refractory Extensive-stage Small Cell Lung Cancer
This study is a multicenter, single arm, open, non-randomized, dose-escalation/ expansion phase Ib/II clinical study. The dose-escalation part of phase Ib clinical trial was conducted according to the Bayesian Optimal Interval Design (BOIN), with a total of three dose groups: low, medium, and high. Dose level 1: Selinexor 40mg PO QW, Olaparib 150mg PO BID; Dose level 2: Selinexor 60mg PO QW, Olaparib 150mg PO BID; Dose level 3: Selinexor 80mg PO QW, Olaparib 150mg PO BID. The number of patients in each group is 3, with a maximum sample size of 9, to evaluate the safety and effectiveness of the medication, and to provide a basis for recommended phase II dose (RP2D). Eligible subjects received medication on the first day and then entered a 21 day observation period of dose-limiting toxicity (DLT). DLT is defined as the occurrence of level 3 non hematological toxicity or level 4 hematological toxicity. Evaluate the efficacy every 6 weeks. In this study, an independent Data Safety Monitoring Committee (DSMC) and an Independent Review Committee (IRC) were established to regularly review the safety and effectiveness data of each research center, with the aim of protecting subjects safety, ensuring the reliability of clinical trials and the objectivity of trial results.
Read the detailed description
This study is a multicenter, single arm, open, non-randomized, dose-escalation/ expansion phase Ib/II clinical study. The dose-escalation part of phase Ib clinical trial was conducted according to the Bayesian Optimal Interval Design (BOIN), with a total of three dose groups: low, medium, and high. Dose level 1: Selinexor 40mg PO QW, Olaparib 150mg PO BID; Dose level 2: Selinexor 60mg PO QW, Olaparib 150mg PO BID; Dose level 3: Selinexor 80mg PO QW, Olaparib 150mg PO BID. The number of patients in each group is 3, with a maximum sample size of 9, to evaluate the safety and effectiveness of the medication, and to provide a basis for recommended phase II dose (RP2D). Eligible subjects received medication on the first day and then entered a 21 day observation period of dose-limiting toxicity (DLT). DLT is defined as the occurrence of level 3 non hematological toxicity or level 4 hematological toxicity. Evaluate the efficacy every 6 weeks. In this study, an independent Data Safety Monitoring Committee (DSMC) and an Independent Review Committee (IRC) were established to regularly review the safety and effectiveness data of each research center, with the aim of protecting subjects safety, ensuring the reliability of clinical trials and the objectivity of trial results.
- Conditions
- Extensive-stage Small Cell Lung Cancer
- Being tested
- Selinexor，Olaparib
- 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.
Selinexor，OlaparibDrug
Dose level 1: Selinexor 40mg PO QW, Olaparib 150mg PO BID; Dose level 2: Selinexor 60mg PO QW, Olaparib 150mg PO BID; Dose level 3: Selinexor 80mg PO QW, Olaparib 150mg PO BID.
| Study group | Role | What they receive |
|---|---|---|
| dose-escalation part of phase Ib clinical trial | Experimental | Dose level 1: Selinexor 40mg PO QW, Olaparib 150mg PO BID; Dose level 2: Selinexor 60mg PO QW, Olaparib 150mg PO BID; Dose level 3: Selinexor 80mg PO QW, Olaparib 150mg PO BID. Receives: Drug: Selinexor，Olaparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD
MTD
Measured: through study completion, an average of 1 year
ORR
ORR
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
DCR
DCR
Measured: through study completion, an average of 1 year
PFS
PFS
Measured: through study completion, an average of 1 year
OS
OS
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study startSep 2023 (estimated)
- Primary completionSep 2023 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Extensive-stage Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- huang ding zhi, M.D., Principal investigator, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05975944
- Sponsor's protocol ID
- SOS-001
- Status last verified
- May 2023
- First submitted
- 28 May 2023
- Last updated
- 4 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individul participant data for all primary and secondary outcome measures will be made available.
Publications
Wang J, Sun T, Meng Z, Wang L, Li M, Chen J, Qin T, Yu J, Zhang M, Bie Z, Dong Z, Jiang X, Lin L, Zhang C, Liu Z, Jiang R, Yang G, Li L, Zhang Y, Huang D. XPO1 inhibition synergizes with PARP1 inhibition in small cell lung cancer by targeting nuclear transport of FOXO3a. Cancer Lett. 2021 Apr 10;503:197-212. doi: 10.1016/j.canlet.2021.01.008. Epub 2021 Jan 23.
PubMed 33493586
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Clinical Study Evaluating the Safety, Tolerability, and Efficacy of Selinexor Combined With Olaparib in the Treatment of Recurrent/Refractory Extensive-stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05975944
- Acronym / sponsor ID
- SOS-001
- Conditions
- Extensive-stage Small Cell Lung Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- Sep 2023 (estimated)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 4 Aug 2023 (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 study is a multicenter, single arm, open, non-randomized, dose-escalation/ expansion phase Ib/II clinical study. The dose-escalation part of phase Ib clinical trial was conducted according to the Bayesian Optimal Interval Design (BOIN), with a total of three dose groups: low, medium, and high. Dose level 1: Selinexor 40mg PO QW, Olaparib 150mg PO BID; Dose level 2: Selinexor 60mg PO QW, Olaparib 150mg PO BID; Dose level 3: Selinexor 80mg PO QW, Olaparib 150mg PO BID. The number of patients in each group is 3, with a maximum sample size of 9, to evaluate the safety and effectiveness of the medication, and to provide a basis for recommended phase II dose (RP2D). Eligible subjects received medication on the first day and then entered a 21 day observation period of dose-limiting toxicity (DLT). DLT is defined as the occurrence of level 3 non hematological toxicity or level 4 hematological toxicity. Evaluate the efficacy every 6 weeks. In this study, an independent Data Safety Monitoring Committee (DSMC) and an Independent Review Committee (IRC) were established to regularly review the safety and effectiveness data of each research center, with the aim of protecting subjects safety, ensuring the reliability of clinical trials and the objectivity of trial results.
Detailed description
This study is a multicenter, single arm, open, non-randomized, dose-escalation/ expansion phase Ib/II clinical study. The dose-escalation part of phase Ib clinical trial was conducted according to the Bayesian Optimal Interval Design (BOIN), with a total of three dose groups: low, medium, and high. Dose level 1: Selinexor 40mg PO QW, Olaparib 150mg PO BID; Dose level 2: Selinexor 60mg PO QW, Olaparib 150mg PO BID; Dose level 3: Selinexor 80mg PO QW, Olaparib 150mg PO BID. The number of patients in each group is 3, with a maximum sample size of 9, to evaluate the safety and effectiveness of the medication, and to provide a basis for recommended phase II dose (RP2D). Eligible subjects received medication on the first day and then entered a 21 day observation period of dose-limiting toxicity (DLT). DLT is defined as the occurrence of level 3 non hematological toxicity or level 4 hematological toxicity. Evaluate the efficacy every 6 weeks. In this study, an independent Data Safety Monitoring Committee (DSMC) and an Independent Review Committee (IRC) were established to regularly review the safety and effectiveness data of each research center, with the aim of protecting subjects safety, ensuring the reliability of clinical trials and the objectivity of trial results.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dose-escalation part of phase Ib clinical trial | Experimental | Drug: Selinexor，OlaparibDose level 1: Selinexor 40mg PO QW, Olaparib 150mg PO BID; Dose level 2: Selinexor 60mg PO QW, Olaparib 150mg PO BID; Dose level 3: Selinexor 80mg PO QW, Olaparib 150mg PO BID. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The diagnosis of SCLC is confirmed by histology or cytology, and according to VALSG and AJCC8, the imaging diagnosis is extensive stage.
- The condition progresses after receiving at least 1 line of treatment, and within 6 months after the last treatment.
- The expected survival time is not less than 12 weeks.
- According to RECIST V1.1, there is at least one measurable lesion that has not undergone radiation therapy.
- The Eastern Cooperative Oncology Group (ECOG) physical condition score is evaluated as 0 or 1.
Key exclusion criteria (19 listed)
- During screening, patients with symptomatic central nervous system (CNS) metastasis (asymptomatic CNS metastasis, or asymptomatic and stable condition after local treatment for 4 weeks can be enrolled).
- Individuals with a history of central nervous system diseases before screening, such as epilepsy, cerebral ischemia/bleeding, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, mental illness, or any autoimmune disease associated with central nervous system involvement.
- Received chemotherapy, radiation therapy, immunotherapy, targeted therapy, biological therapy, endocrine therapy within 4 weeks of screening, and was evaluated by the researcher as not suitable for enrollment.
- The adverse reactions of previous anti-tumor treatments have not yet recovered to level 1 (CTCAE5.0), except for toxicity that the researchers have determined to have no safety risk, such as hair loss and level 2 peripheral neurotoxicity.
- Those who discontinue systemic hormone therapy for less than 72 hours before the first administration, but are allowed to use physiological replacement doses of hormones (such as prednisone < 10mg/d or equivalent).
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 |
|---|---|---|
| Selinexor，OlaparibDose level 1: Selinexor 40mg PO QW, Olaparib 150mg PO BID; Dose level 2: Selinexor 60mg PO QW, Olaparib 150mg PO BID; Dose level 3: Selinexor 80mg PO QW, Olaparib 150mg PO BID. | Drug | dose-escalation part of phase Ib clinical trial |
Primary outcome
MTD
Time frame: through study completion, an average of 1 year
MTD
ORR
Time frame: through study completion, an average of 1 year
ORR
3 secondary outcomes
DCR
Time frame: through study completion, an average of 1 year
PFS
Time frame: through study completion, an average of 1 year
OS
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
- Results publication: PubMed 33493586Wang J, Sun T, Meng Z, Wang L, Li M, Chen J, Qin T, Yu J, Zhang M, Bie Z, Dong Z, Jiang X, Lin L, Zhang C, Liu Z, Jiang R, Yang G, Li L, Zhang Y, Huang D. XPO1 inhibition synergizes with PARP1 inhibition in small cell lung cancer by targeting nuclear transport of FOXO3a. Cancer Lett. 2021 Apr 10;503:197-212. doi: 10.1016/j.canlet.2021.01.008. Epub 2021 Jan 23.
- Individual participant dataSharing planned: Yes. De-identified individul participant data for all primary and secondary outcome measures will be made available.
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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.
huang ding zhi, M.D. contact
huang ding zhi, M.D. principal investigator
Tianjin Medical University Cancer Institute and 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 Selinexor，Olaparib in people with Extensive-stage Small Cell Lung Cancer, run by Tianjin Medical University Cancer Institute and Hospital 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 7 inclusion and 19 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 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact huang ding zhi, M.D. (+86-22-23340123-3200, dingzhih72@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MTD (time frame: through study completion, an average of 1 year). 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?
On the ClinicalTrials.gov record for NCT05975944, which also lists 1 linked publication.
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 Aug 2023.