Carcinoma, Non-Small-Cell LungPhase 1NCT05573373
Pamiparib (BGB-290) Was Used in EGFR-TkIs Resistant Non-small Cell Lung Cancer
A Phase 1 study testing Parimparib, Chemotherapy drug and Targeted Therapy Agent in people with Carcinoma, Non-Small-Cell Lung and EGF-R Positive Non-Small Cell Lung Cancer, run by Affiliated Hospital of Jiangnan University at 1 site in China.
Trial summary
The purpose of this study was to investigate the efficacy and safety of pamiparib in patients with EGFR-TKIs-resistant NSCLC, using a single-center, dual-arm, open-label design. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung, EGF-R Positive Non-Small Cell Lung Cancer
- What is being tested?
- Parimparib, Chemotherapy drug and Targeted Therapy Agent
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2022to 30 Dec 2025
- Phase
- Phase 1
- 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
- Male or female patients: ≥18 years old
- Histologically or cytologically confirmed non-small cell lung cancer, and the disease has progressed after first-generation and/or second-generation TKIs treatment with first-line therapy and no T790 mutation, or after third-generation EGFR-TKI treatment After the disease progresses, the guidelines do not recommend a standard protocol.
- No other concurrent cancer.
- At least one previously unirradiated lesion that can be accurately measured at baseline with longest diameter ≥ 10 mm (must have a short lymph node excluding axis ≥ 15 mm) according to RECIST criteria with computed tomography (CT), magnetic resonance imaging (MRI) or clinical examination for accurate repeated measures. Or an unevaluable lesion, including but not limited to pleural and ascites, bone metastasis, etc.
- ECOG physical condition score: 0-3 points.
- Expected survival period ≥ 3 months.
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- The function of major organs is good, that is, the relevant inspection indicators within 14 days before randomization meet the following requirements: a) Routine blood test:i. Hemoglobin ≥ 90 g/L (no blood transfusion within 14 days); ii. Neutrophil count > 1.5×109/L; iii. Platelet count ≥ 90×109/L; b) Biochemical examination: i. Total bilirubin ≤ 1.5×ULN (upper limit of normal); ii. Blood alanine aminotransferase (ALT) or blood aspartate aminotransferase (AST) ≤ 2.5×ULN; if liver metastasis, ALT or AST ≤ 5×ULN; iii. Endogenous creatinine clearance ≥ 60 ml/min (Cockcroft-Gault formula); c) Cardiac Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) ≥ 50%.
- Sign the informed consent.
- The patient is willing and able to comply with the protocol during the study, including receiving treatment and scheduled visits and examinations, including follow-up.
Who cannot join
- Participated in clinical trials of other drugs within four weeks.
- Histologically or cytologically confirmed small cell, large cell neuroendocrine or carcinoid.
- There are clinical symptoms or diseases of the heart that cannot be well controlled, such as: NYHA class 2 or higher heart failure, unstable angina pectoris, myocardial infarction within 1 year, clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention of patients.
- For female subjects: should be surgically sterilized, postmenopausal patients, or agree to use a medically approved contraceptive during the study treatment period and within 6 months after the end of the study treatment period; Serum or urine pregnancy test must be negative within 7 days and must be non-nursing. Male subjects: Patients who should be surgically sterilized, or who agree to use a medically-approved contraceptive method during the study treatment period and within 6 months after the end of the study treatment period.
- The patient has active pulmonary tuberculosis, bacterial or fungal infection (≥ grade 2 of NCI-CTC, 3rd edition); HIV infection, HBV infection, HCV infection.
- Those who have a history of psychotropic substance abuse and cannot quit or have mental disorders.
- The subject has any active autoimmune disease or has a history of autoimmune disease (such as the following, but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism, thyroid Reduced function; subjects with vitiligo or complete remission of asthma in childhood without any intervention in adulthood can be included; subjects with asthma requiring bronchodilator medical intervention are not included).
- According to the judgment of the investigator, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, 214000
liu quan, doctor, 15995299079, quanliu@jiangnan.edu.cn; quanliu.lq@outlook.com
liu quan, doctor
About this study
Official title: Double Arm Single Center Clinical Trial of Pamiparib (BGB-290) for EGFR TKIs Resistant Non-small Cell Lung Cance
The purpose of this study was to investigate the efficacy and safety of pamiparib in patients with EGFR-TKIs-resistant NSCLC, using a single-center, dual-arm, open-label design.
Read the detailed description
Lung cancer is the second most common cancer type worldwide and remains the leading cause of cancer death worldwide. Non-small cell lung cancer accounts for 80% of the total number of lung cancers, 15-55% of NSCLC have EGFR mutations, of which about 50% of Asians, targeted drugs - epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs) ) showed good clinical benefit. However, patients with EGFR-mutant lung cancer experience disease progression within about a year of treatment with EGFR-TKIs, and acquired resistance develops and limits the long-term efficacy of these EGFR-TKIs. About 50% of EGFR-TKIs acquired resistance mutations by the mechanism of T790 mutation. Third-generation EGFR-TKIs can be used to overcome drug resistance against T790 mutation. Unfortunately, acquired resistance to third-generation EGFR-TKIs will eventually emerge, and when third-generation EGFR-TKIs acquire resistance, effective treatment options are still being explored. PARP (poly(ADP-ribose) polymerase) inhibitors represent a new class of anticancer therapy. They exploit synthetic lethality and induce cell death by exploiting defects in DNA repair, poly(ADP-ribose) polymerase-1 (PARP1) and poly(ADP-ribose) polymerase-2 (PARP2) are PARP enzymes Members of the family that play key roles in the DNA damage response (DDR) by acting as DNA damage sensors and signal transducers. PARP inhibitors can be used in combination with conventional NSCLC treatment regimens or as monotherapy. In clinical applications, PARP inhibitors have demonstrated sustained antitumor responses as single agents in BRCA1- or BRCA2-mutated patients. Studies have shown that the single-drug toxicity of PARP inhibitors is much lower than that of platinum drugs, and experimental results in NSCLC cell lines have shown that PARP inhibitors have single-drug activity in NSCLC. The characteristics of the domestic PARP inhibitor, Pamiparib, reflect its advantages over other PARP inhibitors: 1)low drug resistance, 2)high selectivity, 3)high capture of PARP-DNA complexes, 4)high membrane permeability, 5)Dual pathway metabolism, 6)Blood-brain barrier permeability. Multiple clinical data show that Pamiparib as a single agent has favorable safety and antitumor activity in advanced recurrent solid tumors.
- Being tested
- Parimparib, Chemotherapy drug, Targeted Therapy Agent
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParimparibDrug
Also called BGB-290, Poly (ADP-ribose) polymerase (PARP) inhibitor
The dosage and protocol of the drug were carried out according to the description.
Chemotherapy drugDrug
Also called Chemotherapy Drug, Cancer
The dosage and protocol of the drug were carried out according to the description.
Targeted Therapy AgentDrug
Also called Targeted drug
The dosage and protocol of the drug were carried out according to the description.
| Study group | Role | What they receive |
|---|---|---|
| Pamilarib in combination with Chemotherapy Drugs | Experimental | The specific chemotherapy regimen was formulated by the investigator. The dosage of chemotherapy drugs is selected according to the drug use guidelines. Combination medication, the initial dose is 40mg each time (2 capsules), 2 times a day, the total daily dose is 80mg. Can be taken with a meal or on an empty stomach. If the patient misses a dose, no additional dose should be taken, and the next prescribed dose should be taken normally at the planned time. Continue the treatment until the disease progresses or unacceptable adverse reactions occur, and the dose is adjusted. Receives: Drug: Parimparib; Drug: Chemotherapy drug |
| Pamiparib in combination with Targeted Therapy Drugs | Experimental | The specific targeted therapy plan is formulated by the investigator. The dosage of targeted therapeutic drugs is selected according to the drug use guidelines. Combination medication, the initial dose is 40mg each time (2 capsules), 2 times a day, the total daily dose is 80mg. Can be taken with a meal or on an empty stomach. If the patient misses a dose, no additional dose should be taken, and the next prescribed dose should be taken normally at the planned time. Continue the treatment until the disease progresses or unacceptable adverse reactions occur, and the dose is adjusted. Receives: Drug: Parimparib; Drug: Targeted Therapy Agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Total response and partial response ratio
Measured: 8 weeks
Secondary outcomes (6)
Progression-free survival
Time from randomization to any disease progression and/or death, defined according to strict RECIST (Response Evaluation Criteria in Solid Tumors) v1.1. Lesion will be assessed in comparison to baseline measurements.
Measured: 1 year
Overall survival
Randomize time to date of death or last known alive date calculation.
Measured: 72 weeks
Disease control rate
The proportion of patients with a best response grade of complete response, partial response, or stable disease that has shrunk or stabilized for a period of time.
Measured: an average of 1 year
Objective response rate
Assessed according to disease progression as defined by RECIST (Response Evaluation Criteria in Solid Tumors) v1.1
Measured: 72 weeks
Changes in tumor volume shrinking
Change in tumor volume reduction from randomization to 6 months
Measured: 6 months
Tolerability and Safety
Assessed based on the number of treatment reductions, delays and withdrawals, including the incidence and nature of dose-limiting toxicities.
Measured: 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 posted10 Oct 2022
- Study start20 Dec 2022
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Jiangnan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- liu quan, doctor, Principal investigator, Affiliated Hospital of Jiangnan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05573373
- Sponsor's protocol ID
- 136266
- Status last verified
- Jan 2024
- First submitted
- 22 Sep 2022
- Last updated
- 31 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The associated efficacy is uncertain.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Arm Single Center Clinical Trial of Pamiparib (BGB-290) for EGFR TKIs Resistant Non-small Cell Lung Cance
- ClinicalTrials.gov ID
- NCT05573373
- Acronym / sponsor ID
- 136266
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Jiangnan UniversityUniversity, hospital or other
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 10 Oct 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.
The purpose of this study was to investigate the efficacy and safety of pamiparib in patients with EGFR-TKIs-resistant NSCLC, using a single-center, dual-arm, open-label design.
Detailed description
Lung cancer is the second most common cancer type worldwide and remains the leading cause of cancer death worldwide. Non-small cell lung cancer accounts for 80% of the total number of lung cancers, 15-55% of NSCLC have EGFR mutations, of which about 50% of Asians, targeted drugs - epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs) ) showed good clinical benefit. However, patients with EGFR-mutant lung cancer experience disease progression within about a year of treatment with EGFR-TKIs, and acquired resistance develops and limits the long-term efficacy of these EGFR-TKIs. About 50% of EGFR-TKIs acquired resistance mutations by the mechanism of T790 mutation. Third-generation EGFR-TKIs can be used to overcome drug resistance against T790 mutation. Unfortunately, acquired resistance to third-generation EGFR-TKIs will eventually emerge, and when third-generation EGFR-TKIs acquire resistance, effective treatment options are still being explored. PARP (poly(ADP-ribose) polymerase) inhibitors represent a new class of anticancer therapy. They exploit synthetic lethality and induce cell death by exploiting defects in DNA repair, poly(ADP-ribose) polymerase-1 (PARP1) and poly(ADP-ribose) polymerase-2 (PARP2) are PARP enzymes Members of the family that play key roles in the DNA damage response (DDR) by acting as DNA damage sensors and signal transducers. PARP inhibitors can be used in combination with conventional NSCLC treatment regimens or as monotherapy. In clinical applications, PARP inhibitors have demonstrated sustained antitumor responses as single agents in BRCA1- or BRCA2-mutated patients. Studies have shown that the single-drug toxicity of PARP inhibitors is much lower than that of platinum drugs, and experimental results in NSCLC cell lines have shown that PARP inhibitors have single-drug activity in NSCLC. The characteristics of the domestic PARP inhibitor, Pamiparib, reflect its advantages over other PARP inhibitors: 1)low drug resistance, 2)high selectivity, 3)high capture of PARP-DNA complexes, 4)high membrane permeability, 5)Dual pathway metabolism, 6)Blood-brain barrier permeability. Multiple clinical data show that Pamiparib as a single agent has favorable safety and antitumor activity in advanced recurrent solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pamilarib in combination with Chemotherapy Drugs | Experimental | Drug: Parimparib, Drug: Chemotherapy drugThe specific chemotherapy regimen was formulated by the investigator. The dosage of chemotherapy drugs is selected according to the drug use guidelines. Combination medication, the initial dose is 40mg each time (2 capsules), 2 times a day, the total daily dose is 80mg. Can be taken with a meal or on an empty stomach. If the patient misses a dose, no additional dose should be taken, and the next prescribed dose should be taken normally at the planned time. Continue the treatment until the disease progresses or unacceptable adverse reactions occur, and the dose is adjusted. |
| Pamiparib in combination with Targeted Therapy Drugs | Experimental | Drug: Parimparib, Drug: Targeted Therapy AgentThe specific targeted therapy plan is formulated by the investigator. The dosage of targeted therapeutic drugs is selected according to the drug use guidelines. Combination medication, the initial dose is 40mg each time (2 capsules), 2 times a day, the total daily dose is 80mg. Can be taken with a meal or on an empty stomach. If the patient misses a dose, no additional dose should be taken, and the next prescribed dose should be taken normally at the planned time. Continue the treatment until the disease progresses or unacceptable adverse reactions occur, and the dose is adjusted. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female patients: ≥18 years old
- Histologically or cytologically confirmed non-small cell lung cancer, and the disease has progressed after first-generation and/or second-generation TKIs treatment with first-line therapy and no T790 mutation, or after third-generation EGFR-TKI treatment After the disease progresses, the guidelines do not recommend a standard protocol.
- No other concurrent cancer.
- At least one previously unirradiated lesion that can be accurately measured at baseline with longest diameter ≥ 10 mm (must have a short lymph node excluding axis ≥ 15 mm) according to RECIST criteria with computed tomography (CT), magnetic resonance imaging (MRI) or clinical examination for accurate repeated measures. Or an unevaluable lesion, including but not limited to pleural and ascites, bone metastasis, etc.
- ECOG physical condition score: 0-3 points.
Key exclusion criteria (8 listed)
- Participated in clinical trials of other drugs within four weeks.
- Histologically or cytologically confirmed small cell, large cell neuroendocrine or carcinoid.
- There are clinical symptoms or diseases of the heart that cannot be well controlled, such as: NYHA class 2 or higher heart failure, unstable angina pectoris, myocardial infarction within 1 year, clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention of patients.
- For female subjects: should be surgically sterilized, postmenopausal patients, or agree to use a medically approved contraceptive during the study treatment period and within 6 months after the end of the study treatment period; Serum or urine pregnancy test must be negative within 7 days and must be non-nursing. Male subjects: Patients who should be surgically sterilized, or who agree to use a medically-approved contraceptive method during the study treatment period and within 6 months after the end of the study treatment period.
- The patient has active pulmonary tuberculosis, bacterial or fungal infection (≥ grade 2 of NCI-CTC, 3rd edition); HIV infection, HBV infection, HCV infection.
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 |
|---|---|---|
| ParimparibAlso: BGB-290, Poly (ADP-ribose) polymerase (PARP) inhibitorThe dosage and protocol of the drug were carried out according to the description. | Drug | Pamilarib in combination with Chemotherapy Drugs, Pamiparib in combination with Targeted Therapy Drugs |
| Chemotherapy drugAlso: Chemotherapy Drug, CancerThe dosage and protocol of the drug were carried out according to the description. | Drug | Pamilarib in combination with Chemotherapy Drugs |
| Targeted Therapy AgentAlso: Targeted drugThe dosage and protocol of the drug were carried out according to the description. | Drug | Pamiparib in combination with Targeted Therapy Drugs |
Primary outcome
Objective response rate
Time frame: 8 weeks
Total response and partial response ratio
6 secondary outcomes
Progression-free survival
Time frame: 1 year
Overall survival
Time frame: 72 weeks
Disease control rate
Time frame: an average of 1 year
Objective response rate
Time frame: 72 weeks
Changes in tumor volume shrinking
Time frame: 6 months
Tolerability and Safety
Time frame: 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 31 Jan 2024.
- Individual participant dataSharing planned: No. The associated efficacy is uncertain.
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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.
liu quan, doctor principal investigator
Affiliated Hospital of Jiangnan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Parimparib, Chemotherapy drug and Targeted Therapy Agent in people with Carcinoma, Non-Small-Cell Lung and EGF-R Positive Non-Small Cell Lung Cancer, run by Affiliated Hospital of Jiangnan University 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 9 inclusion and 8 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 31 Jan 2024. 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 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.
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 liu quan, doctor (15995299079, quanliu@jiangnan.edu.cn; quanliu.lq@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: 8 weeks). 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 31 Jan 2024.