Lung CancerPhase 2NCT05392686
PD1 and PARP for Maintenance Therapy in NSLLC
A Phase 2 study testing PD-1 inhibitor and PARP inhibitor in people with Lung Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
PARP inhibitor and PD1 in lung squamous cell carcinoma The current study will compare PD1 plus maintenance PARP for the treatment of squamous NSCLC. The study's 2 primary hypotheses are: respect to progression-free survival (PFS) per RECIST 1.1 by blinded independent clinical review (BICR). Overall survival (OS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- PD-1 inhibitor and PARP inhibitor
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2022to 1 Apr 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1 NSCLC confirmed by pathology (histology or cytology)
- 2. First line treatment of patients with immune combined with chemotherapy into immune maintenance treatment;
- 3. 18-75 years old, both male and female;
- 2. There are stage IIIA, IIIB or IIIc NSCLC diagnosed according to the 8th edition of the American Joint Committee on cancer.
- 3. Stage III NSCLC that cannot undergo radical surgery was confirmed and recorded by the multidisciplinary tumor committee or the treating physician in consultation with the thoracic surgeon.
- 4. In the whole body fluorodeoxyglucose (FDG) - pet or FDG-PET / CT and diagnostic quality CT or MRI scans of the chest, abdomen, pelvis and brain, there was no evidence of metastatic disease as stage IV NSCLC.
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- Note: unless otherwise demonstrated, the presence of pleural / pericardial effusion is considered to indicate metastatic disease. For pleural effusion in both CT chest scan and frontal chest X-ray examination, pleural puncture is required to confirm that the pleural effusion is cytologically negative. Participants whose effusion was exudate were excluded, even if their effusion was cytologically negative. Subjects who have met the remaining inclusion / exclusion criteria, and pleural effusion is not visible on chest X-ray examination in front and side views, or there is too little effusion to be safely extracted can enter the study.
- 5. Having a measurable disease as defined in RECIST 1.1, at least one lesion is suitable as a target lesion (determined by the investigator / imaging review of the local research center).
- 4. No more than 28 days before the first study, CT or MRI scan, at least one previous target lesion without radiotherapy (recistv1.1).
- 5. No previous treatment (chemotherapy, targeted therapy or radiotherapy) for stage III NSCLC.
- 6. ECoG physical fitness status is 0 or 2 points.
- 7. Life expectancy is at least 12 weeks.
- 8. No antiangiogenic drugs or PARP inhibitors have been used in previous treatment;
- 9. All acute toxic reactions caused by previous anti-tumor treatment or surgery are relieved before the screening period
- Level 10.0-1 (judged according to NCI CTCAE 5.0) or to the level specified in the inclusion / exclusion criteria
- (except for hair loss and other toxicity that the researchers believe does not pose a safety risk to the subject).
- 11. No blood transfusion and blood products were used within 14 days before the first administration, and G-CSF and other hematopoietic stimulating factors were not used for correction.
- 12. Before the first drug study, the laboratory test values meet the following conditions:
- Blood routine:
- White blood cell count (WBC) ≥ 3.0 × 109/L；
- Absolute neutrophil count (ANC) ≥ 1.5 × 109/L；
- Platelet (PLT) ≥ 100 × 109/L；
- Hemoglobin content (Hgb) ≥ 9.0 g / dl;
- Liver function:
- Aspartate aminotransferase (AST) ≤ 2.5xuln in subjects without liver metastasis,
- Alanine liver aminotransferase (ALT) ≤ 2.5x ULN;
- ALT and AST of patients with liver metastasis were < 5xuln;
- Serum total bilirubin (TBIL) ≤ 1.5xuln (excluding Gilbert syndrome, total bilirubin < 3.0mg/dl); Albumin (ALB) ≥ 3G / dl;
- Renal function:
- Serum creatinine ≤ 1.5xuln or creatinine clearance rate (CrCl) ≥ 40ml / minute
- Coagulation function:
- International standardization ratio (INR) ≤ 1.5, activated partial thromboplastin time (APTT) ≤ 1.5 x ULN;
- Others:
- Lipase ≤ 1.5xuln. If lipase > 1.5xuln but there is no clinical or imaging confirmed pancreatitis, it can be included in the group;
- Amylase ≤ 1.5xuln. If amylase > 1.5xuln but there is no clinical or imaging confirmed pancreatitis, it can be included in the group.
- Alkaline phosphatase (ALP) ≤ 2.5uln, ALP ≤ 5uln in subjects with bone metastasis;
- 13. For female subjects of childbearing age who are not sterilized surgically, the serum hCG test must be negative and non lactating within 3 days before the first medication. Contraceptive drugs must be used by male subjects within 6 months after the end of the reproductive age;
- 14. The subjects voluntarily joined the study, with good compliance, safety and survival follow-up.
Who cannot join
- Suffering from small cell lung cancer or mixed tumor with small cell components. Note: subjects with squamous NSCLC are not eligible for pemetrexed containing chemotherapy.
- Have a history of MDS / AML, current diagnosis or characteristics suggestive of these diseases.
- Weight loss > 10% (from baseline) has been recorded in the past 3 months.
- There is a radiotherapy plan, in which the volume (V20) of the whole lung (whole lung v20-gtv) with a total radiation dose of > 20 Gy may exceed that of the lung. 34% of the volume. Note: subjects must be evaluated by a radiation oncologist during screening.
- received previous chest radiotherapy, including radiotherapy for esophageal, mediastinal or breast cancer.
- Previous treatment with anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs targeting another stimulatory or co inhibitory T cell receptor (e.g. CTLA-4, OX-40, CD137).
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- Previous treatment with fluzopari or any other PARP inhibitor.
- Major surgery (other than vascular access implantation) was performed within 4 weeks before the first administration of the study drug. Note: if the subject has had major surgery or vascular access implantation, he must have fully recovered from therapeutic toxicity and / or complications before starting the study intervention.
- It is expected that any other form of antitumor treatment will be required during the study period.
- Have received live vaccine within 30 days before the first administration of the test drug. Examples of live vaccines include, but are not limited to, the following vaccines: measles, mumps, rubella, chickenpox / shingles (varicella), yellow fever, BCG and typhoid vaccines. Since seasonal influenza vaccines for injection are usually inactivated virus vaccines, they are allowed to be used; But intranasal influenza vaccines (e.g., FluMist ®） It is a live attenuated vaccine, so it is not allowed to be used.
- 11Strong inducers of CYP3A4 (phenobarbital, enzalutamide, phenytoin, rifampicin, rifampicin, rifapentine, carbamazepine, nevirapine and St. John's grass) or medium inducers (e.g. bosentan, faviren and modafinil) that cannot be stopped during the study period are currently being received. Before starting fluzopari treatment, pentobarbital needs a 5-week washout period, and other drugs need a 3-week washout period.
- 12At present, they are receiving potent inhibitors of cytochrome P450 (CYP) 3A4 (such as itraconazole, telithromycin, clarithromycin, protease inhibitors strengthened with ritonavir or kirostat, indinavir, saquinavir, nefinavir, bosepovir, terapivir) or intermediate inhibitors (such as ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil) that cannot be stopped during the study period. The elution period required before starting fluzopari is 2 weeks.
- 13 The dose of piroxicam (e.g. at least 2.5 days before or after administration of piroxicam) and other drugs other than piroxicam (at least 2.5 days after administration of NSD).
- 14 In the judgment of the investigator, resting electrocardiogram (ECG) indicates uncontrolled and potentially reversible heart disease (e.g., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, electrolyte disorder, etc.), or the subject has congenital long QT syndrome.
- 15 Having a diagnosis of immune deficiency or being treated with chronic systemic steroids (more than 10mg prednisone or equivalent per day) or any form of immunosuppressive therapy within 7 days before the first administration of the study drug.
- Note: glucocorticoids are permitted for the following indications:
- eye, intranasal or topical use.
- inhalants for the management of asthma or chronic obstructive pulmonary disease.
- systemic physiological corticosteroid replacement therapy for hormone replacement therapy, preventing vomiting, regulating symptoms suspected of immunological etiology, or as a pretreatment of IV contrast agent allergy or chemotherapeutic agent.
- 16 Active autoimmune diseases requiring systemic treatment (i.e. use of disease regulating drugs, corticosteroids or immunosuppressants) in the past 2 years. Alternative treatment (e.g., thyroxine, insulin or physiological corticosteroid replacement treatment due to adrenal or pituitary insufficiency) is not considered systemic treatment and is allowed.
- 17 Currently or previously participated in the study of investigational drugs, or used investigational devices within 4 weeks before the first administration of the study intervention. Note: subjects who have entered the follow-up period of the experimental study can participate in this study as long as they are > 4 weeks after the last administration of previous research drugs.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Zhanyu Pan, Master, 86-13512035574 ext. 1392029, s0010027@163.com
About this study
Official title: Single Arm, Single Center, Phase II Clinical Study of First-line in PD1 and PARP for Maintenance Therapy for Advanced Non-small Cell Lung Cancer (Lung Squamous Cell Carcinoma)
PARP inhibitor and PD1 in lung squamous cell carcinoma The current study will compare PD1 plus maintenance PARP for the treatment of squamous NSCLC. The study's 2 primary hypotheses are: respect to progression-free survival (PFS) per RECIST 1.1 by blinded independent clinical review (BICR).
Overall survival (OS).
Read the detailed description
This study has 2 phases: an Induction Phase (4 Cycles) and a Maintenance Phase (Up to 31 cycles ). In the Induction Phase, participants receive pd1 plus carboplatin plus a taxane (paclitaxel or nab-paclitaxel). In the Maintenance Phase, participants with a partial or complete disease response or with stable disease after completing four cycles of induction therapy and who meet eligibility criteria will be randomly assigned to receive PD1 plus maintenance PAPR. In the Maintenance Phase, participants randomly assigned to receive pembrolizumab for up to 31 cycles plus maintenance until centrally verified progressive disease (PD), intolerable toxicities, or physician decision."
- Conditions
- Lung Cancer
- Being tested
- PD-1 inhibitor, PARP inhibitor
- Keywords
- pd1, PARP
- Medical subject headings
- Lung Neoplasms, Parkinson Disease 4, Autosomal Dominant Lewy Body
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-1 inhibitorDrug
Tirelizumab
PARP inhibitorDrug
Fluzopari capsule
| Study group | Role | What they receive |
|---|---|---|
| Experimental: PD1 + PARP | Experimental | For the Induction Phase, participants receive 4 cycles:
PD1 200 mg, intravenous (IV) on Day 1 of each 21-day cycle PLUS carboplatin PLUS a taxane (either paclitaxel or nab-paclitaxel) for 4 cycles (21-day cycles). If the participant has a complete or partial response or stable disease to induction therapy, the participant to maintenance therapy.
For the Maintenance Phase, participants receive PD1 IV on Day 1 of each 21-day for up to 31 cycles PLUS maintenance oral PARP 100 mg twice daily. Until centrally verified progressive disease, physician decision or intolerable toxicity. Receives: Drug: PD-1 inhibitor; Drug: PARP inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Progression-free Survival is the time from the date of randomization until either documented disease progression or death due to any cause, whichever occurs first.
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start20 Jun 2022 (estimated)
- Primary completion21 Jun 2022 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05392686
- Sponsor's protocol ID
- E20220325
- Status last verified
- May 2022
- First submitted
- 23 May 2022
- Last updated
- 26 May 2022
- 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 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Arm, Single Center, Phase II Clinical Study of First-line in PD1 and PARP for Maintenance Therapy for Advanced Non-small Cell Lung Cancer (Lung Squamous Cell Carcinoma)
- ClinicalTrials.gov ID
- NCT05392686
- Acronym / sponsor ID
- E20220325
- Conditions
- Lung Cancer
- Keywords
- pd1, PARP
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 20 Jun 2022 (estimated)
- Primary completion
- 21 Jun 2022 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 26 May 2022 (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.
PARP inhibitor and PD1 in lung squamous cell carcinoma The current study will compare PD1 plus maintenance PARP for the treatment of squamous NSCLC. The study's 2 primary hypotheses are: respect to progression-free survival (PFS) per RECIST 1.1 by blinded independent clinical review (BICR).
Overall survival (OS).
Detailed description
This study has 2 phases: an Induction Phase (4 Cycles) and a Maintenance Phase (Up to 31 cycles ). In the Induction Phase, participants receive pd1 plus carboplatin plus a taxane (paclitaxel or nab-paclitaxel). In the Maintenance Phase, participants with a partial or complete disease response or with stable disease after completing four cycles of induction therapy and who meet eligibility criteria will be randomly assigned to receive PD1 plus maintenance PAPR. In the Maintenance Phase, participants randomly assigned to receive pembrolizumab for up to 31 cycles plus maintenance until centrally verified progressive disease (PD), intolerable toxicities, or physician decision."
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: PD1 + PARP | Experimental | Drug: PD-1 inhibitor, Drug: PARP inhibitorFor the Induction Phase, participants receive 4 cycles: PD1 200 mg, intravenous (IV) on Day 1 of each 21-day cycle PLUS carboplatin PLUS a taxane (either paclitaxel or nab-paclitaxel) for 4 cycles (21-day cycles). If the participant has a complete or partial response or stable disease to induction therapy, the participant to maintenance therapy. For the Maintenance Phase, participants receive PD1 IV on Day 1 of each 21-day for up to 31 cycles PLUS maintenance oral PARP 100 mg twice daily. Until centrally verified progressive disease, physician decision or intolerable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (38 listed)
- 1 NSCLC confirmed by pathology (histology or cytology)
- 2. First line treatment of patients with immune combined with chemotherapy into immune maintenance treatment;
- 3. 18-75 years old, both male and female;
- 2. There are stage IIIA, IIIB or IIIc NSCLC diagnosed according to the 8th edition of the American Joint Committee on cancer.
- 3. Stage III NSCLC that cannot undergo radical surgery was confirmed and recorded by the multidisciplinary tumor committee or the treating physician in consultation with the thoracic surgeon.
Key exclusion criteria (21 listed)
- 11Strong inducers of CYP3A4 (phenobarbital, enzalutamide, phenytoin, rifampicin, rifampicin, rifapentine, carbamazepine, nevirapine and St. John's grass) or medium inducers (e.g. bosentan, faviren and modafinil) that cannot be stopped during the study period are currently being received. Before starting fluzopari treatment, pentobarbital needs a 5-week washout period, and other drugs need a 3-week washout period.
- 12At present, they are receiving potent inhibitors of cytochrome P450 (CYP) 3A4 (such as itraconazole, telithromycin, clarithromycin, protease inhibitors strengthened with ritonavir or kirostat, indinavir, saquinavir, nefinavir, bosepovir, terapivir) or intermediate inhibitors (such as ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil) that cannot be stopped during the study period. The elution period required before starting fluzopari is 2 weeks.
- 13 The dose of piroxicam (e.g. at least 2.5 days before or after administration of piroxicam) and other drugs other than piroxicam (at least 2.5 days after administration of NSD).
- 14 In the judgment of the investigator, resting electrocardiogram (ECG) indicates uncontrolled and potentially reversible heart disease (e.g., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, electrolyte disorder, etc.), or the subject has congenital long QT syndrome.
- 15 Having a diagnosis of immune deficiency or being treated with chronic systemic steroids (more than 10mg prednisone or equivalent per day) or any form of immunosuppressive therapy within 7 days before the first administration of the study drug.
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 |
|---|---|---|
| PD-1 inhibitorTirelizumab | Drug | Experimental: PD1 + PARP |
| PARP inhibitorFluzopari capsule | Drug | Experimental: PD1 + PARP |
Primary outcome
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Time frame: Up to approximately 2 years
Progression-free Survival is the time from the date of randomization until either documented disease progression or death due to any cause, whichever occurs first.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
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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.
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China
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 PD-1 inhibitor and PARP inhibitor in people with 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 38 inclusion and 21 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 26 May 2022. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) (time frame: Up to approximately 2 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 26 May 2022.