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NSCLCPhase 2NCT05932264

Apatinib and Fluzoparib With or Without Adebrelimab in Previously-treated TP53-mutant Advanced Non-small Cell Lung Cancer

A Phase 2 study testing Apatinib + Fluzoparib and Apatinib + Fluzoparib + Adebrelimab in people with NSCLC and Non-small Cell Lung Cancer, run by Sun Yat-sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a phase 2, open-label study to evaluate the efficacy and safety of combination of Apatinib and Fluzoparib with or without Adebrelimab in previously-treated TP53-mutant advanced non-small cell lung cancer. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
NSCLC, Non-small Cell Lung Cancer
What is being tested?
Apatinib + Fluzoparib and Apatinib + Fluzoparib + Adebrelimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
Jul 2023to Dec 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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Willing to participate and sign the informed consent in person
  • Male or female patients, aged ≥18 years and ≤75 years
  • Histologically or cytologically confirmed non-small cell lung cancer with clinical stage IIIB-IV (International Association for the Study of Lung Cancer, 8th Edition)
  • TP53 gain-of-function mutations (P151S, Y163C, R175H, L194R, Y220C, R248Q, R248W, R249S, R273C, R273H, R273L, R151S, Y163C, R175H, L194R, R220C, R248W, R249S, R273C, R273H, R273L, R282W) or p53 protein high expression (≥80% nuclear staining positive) confirmed by immunohistochemistry; Consent to provide previously stored tumor tissue specimens or fresh biopsy tumor lesion tissue
  • Have at least one measurable lesion (RECIST 1.1 criteria)
  • Disease has been progressed after the approved first-line therapy. In brief, patients with positive driver genes (EGFR, ALK, ROS1, BRAF, MET, RET) must have received the corresponding targeted therapy approved in China, and were subsequently treated with platinum-based standard chemotherapy; Patients who are negative for driver genes have to be previously treated with approved chemoimmunotherapy.
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  • ECOG score 0-1
  • Expected survival time ≥12 weeks, as assessed by the investigator.
  • Normal organ function, includes:
  • Neutrophil count ≥1.5 × 10^9 / L,
  • Platelet count ≥100 × 10^9 / L,
  • Hemoglobin ≥10 g/dL
  • Serum creatinine ≤1.5× upper limit of normal (ULN), creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula)
  • Total bilirubin ≤ 1.5×ULN
  • AST and ALT ≤ 2.5×ULN; Patients with liver metastasis, AST and ALT≤5×ULN, were determined by the investigator
  • Normal coagulation function: INR and PT≤ 1.5 ×ULN
  • The pregnancy test is negative at enrollment. To be enrolled, men or women are required to commit to using adequate, effective contraception or abstinence from sex from the start of the study until the end of the study and for 3 months after the last dose of the study drug
  • The toxic effects of any previous treatment have returned to ≤CTCAE1 or baseline level
  • Stopping other antineoplastic therapy including but not limited to chemotherapy, radiotherapy and surgery 4 weeks before receiving the study drugs; targeted therapy should be discontinued for at least 5 half-lives of the corresponding drug before receiving the study drugs.

Who cannot join

  • Non-small cell lung cancer admixed with components of small cell lung cancer or sarcomatoid carcinoma, as confirmed by histology or cytology.
  • Patients with > 2 lines of prior chemotherapy, or previously treated with PARP inhibitor or small-molecule angiogenesis inhibitors.
  • Patients with coagulation disorders or who are considered to have a risk of hemorrhage, or the tumor had invades the large blood vessels or wrapped the blood vessels with unclear boundaries on CT or MR imaging.
  • Patients with a known allergy to the active or inactive ingredient of any of the drugs in the study, or a history of severe hypersensitivity reaction to any monoclonal antibody
  • Symptomatic, uncontrolled brain or leptomeningeal metastases
  • Had undergone major surgery within 4 weeks before the start of the study, or had complications/sequelae that have not yet recovered
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  • Patients with previously or currently diagnosed myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)
  • Suffering from serious or uncontrolled illness, including but not limited to:
  • Uncontrollable nausea and vomiting, intestinal obstruction, inability to swallow the study drug, and any gastrointestinal disorders that may interfere with the absorption and metabolism of the drug.
  • Patients with respiratory syndrome due to pleural effusion or ascites (≥CTCAE grade 2 dyspnea)
  • Active viral infections such as human immunodeficiency virus, hepatitis B, hepatitis C, etc
  • Uncontrolled grand mal seizures, unstable spinal cord compression, superior vena cava syndrome, or other mental disorders that prevent the patient from signing informed consent
  • Immunodeficiency (other than splenectomy), or other conditions considered by the investigator to be likely to expose the patient to a high risk of toxicity
  • A history of active autoimmune disease or possibly recurrent autoimmune disease that may affect vital organ function or require immunosuppressive therapy including systemic corticosteroids
  • Systemic treatment with either corticosteroid (> 10mg/ day prednisone) or other immunosuppressive drugs within 14 days of the study drug; Inhaled or topical steroids and adrenal-replacement doses (≤10mg per day of prednisone) were allowed in the absence of active autoimmune disease. Topical, intraocular, intra-articular, intranasal, and inhaled corticosteroids (with low systemic absorption) were allowed; Physiological alternative doses of systemic corticosteroids (≤10mg/ day prednisone) were allowed; Short-term corticosteroid therapy for prophylaxis (e.g., contrast allergy) or treatment of nonautoimmune conditions (e.g., delayed hypersensitivity due to contact allergens) was permitted
  • Bleeding tendency and history of thrombosis:
  • Any bleeding event of CTCAE2 grade within 3 months before screening or of CTCAE grade 3 or higher within 6 months before screening
  • They have active bleeding or abnormal coagulation function, have a tendency to bleed, or are receiving thrombolytic or anticoagulant therapy
  • Patients require anticoagulant therapy with drugs such as warfarin or heparin
  • Long-term antiplatelet therapy (e.g., aspirin, clopidogrel) is required.
  • Thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attack), pulmonary embolism within the past 6 months
  • History of severe cardiovascular disease:
  • New York Heart Association (NYHA) grade 3 and 4 congestive heart failure
  • Unstable angina or newly diagnosed angina or myocardial infarction within 12 months before screening
  • Arrhythmias requiring therapeutic intervention (patients taking beta-blockers or digoxin are eligible)
  • CTCAE≥ grade 2 valvular heart disease
  • Hypertension that cannot be controlled with medications (systolic blood pressure > 150 mmHg or diastolic blood pressure > 100 mmHg)
  • Patients who were pregnant or breastfeeding, or expected to plan to become pregnant during the study treatment
  • Any previous or current medical conditions, treatments, or laboratory abnormalities that may interfere with the results of the study or prevent the patient from participating fully in the study, or the investigator considers the patient to be unsuitable for the study; Patients could not receive platelet or red-cell transfusions for 4 weeks before starting the study drug

Trial locations and contacts

1 site in 1 country.

Wenfeng Fang, MD contact

86-20-87343894

fangwf@sysucc.org.cn

Li Zhang, MD contact

86-20-87343458

zhangli6@mail.sysu.edu.cn

China1 site

  • Sun Yat-Sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Wenfeng Fang, MD, 86-20-8734-3894, fangwf@sysucc.org.cn

    Li Zhang, MD, 86-20-87343458, zhangli6@mail.sysu.edu.cn

Other trials in China

About this study

Official title: A Phase II Study of Efficacy and Safety of Combination of Apatinib and Fluzoparib With or Without Adebrelimab in Previously-treated TP53-mutant Advanced Non-small Cell Lung Cancer

This is a phase 2, open-label study to evaluate the efficacy and safety of combination of Apatinib and Fluzoparib with or without Adebrelimab in previously-treated TP53-mutant advanced non-small cell lung cancer.

Read the detailed description

This study is an open-label, prospective phase II study to evaluate the efficacy and safety of of combination of Apatinib and Fluzoparib with or without Adebrelimab in previously-treated TP53-mutant advanced non-small cell lung cancer. The study is divided into 2 cohorts. Cohort 1 is a two-drug cohort [Apatinib 375 mg po qd; Fluzoparib 100mg po bid], and cohort 2 is a three-drug cohort [apatinib 375 mg po qd; fluzoparib 100mg po bid; Adebrelimab 1200mg, iv, d1, q3w]. The sample sizes of these two cohorts were determined according to Simon's Two-Stage Design, and enrollment of cohort 2 will be initiated after the enrollment of cohort 1 is completed. Ultimately, 34 patients are enrolled in the cohort 1 and 26 in the cohort 2.

Being tested
Apatinib + Fluzoparib, Apatinib + Fluzoparib + Adebrelimab
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.

  • Apatinib + FluzoparibDrug

    Cohort 1: Apatinib 375 mg po qd; Fluzoparib 100mg po bid

  • Apatinib + Fluzoparib + AdebrelimabDrug

    Cohort 2: Apatinib 375 mg po qd; Fluzoparib 100mg po bid; Adebrelimab 1200mg, iv, d1, q3w]

Study groups in NCT05932264
Study groupRoleWhat they receive
Cohort 1: Apatinib + FluzoparibExperimentalNot described
Receives: Drug: Apatinib + Fluzoparib
Cohort 2: Apatinib + Fluzoparib + AdebrelimabExperimentalNot described
Receives: Drug: Apatinib + Fluzoparib + Adebrelimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate

    Per RECIST v1.1 criteria, the proportion of patients whose best remission was CR or PR accounted for the total number of evaluable patients.

    Measured: up to 1 year

Secondary outcomes (5)

  1. Disease Control Rate

    Per RECIST v1.1 criteria, the proportion of patients whose best remission was CR , PR and SD accounted for the total number of evaluable patients.

    Measured: Time Frame: up to 1 year

  2. DOR

    Duration of Response, determined according to RECIST v1.1 criteria

    Measured: up to 2 years

  3. PFS

    Progression Free Survival, determined according to RECIST v1.1 criteria

    Measured: up to 2 years

  4. AEs

    Adverse events defined according to Common Terminology for Adverse Events (CTCAE) v5.0

    Measured: up to 1 years

  5. Overall survival（OS）

    Overall survival is the time from intervention to death due to any reason or lost of follow-up

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2023
  2. Study startJul 2023 (estimated)
  3. Primary completionJul 2024 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05932264
Sponsor's protocol ID
B2023-205-01/MA-NSCLC-II-029
Status last verified
Jun 2023
First submitted
27 Jun 2023
Last updated
6 Jul 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Apatinib + Fluzoparib and Apatinib + Fluzoparib + Adebrelimab in people with NSCLC and Non-small Cell Lung Cancer, run by Sun Yat-sen 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 19 inclusion and 29 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 6 Jul 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 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?

Contact Wenfeng Fang, MD (86-20-87343894, fangwf@sysucc.org.cn), 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: up to 1 year). 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 NCT05932264.

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 6 Jul 2023.

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