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Non-small Cell Lung CancerPhase 2NCT05741021

A Phase II Study of Rulonilimab Combined With Chemotherapy in the First-Line Treatment for Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

A Phase 2 study testing F520, Pemetrexed and Carboplatin in people with Non-small Cell Lung Cancer and NSCLC, run by Shandong New Time Pharmaceutical Co., LTD 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 The sponsor has not verified this record for over two years, so it may be out of date.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 single-arm, open-label, and multicenter phase Ⅱ study designed to evaluate the efficacy and safety of rulonilimab combined with chemotherapy in patients with advanced or metastatic non-small cell lung Cancer (NSCLC). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer, NSCLC, PD-1
What is being tested?
F520, Pemetrexed and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteChina
Study dates
1 Mar 2023to 25 Oct 2024
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

  • Male or female aged ≥18 years;
  • Understand and voluntarily sign the written informed consent form;
  • Study population:
  • Patients with histologically or cytologically confirmed locally advanced (stage IIIB/IIIC) or metastatic (stage IV) NSCLC who cannot receive surgery or radical concurrent chemoradiotherapy, based on the "8th Edition of the TNM Classification for Lung Cancer" issued by the International Association for the Study of Lung Cancer (IASLC); Have not received any prior systemic anti-tumor therapy for advanced/metastatic disease; Subjects who received adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 12 months prior to the development of stage IIIB, IIIC, IV.
  • Without mutation of epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK) or ROS-1; Note: The results of blood tests alone were not accepted;
  • With a life expectancy of more than 3 months;
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  • With at least one measurable lesion (extra nodal lesions: long diameter > 10 mm, nodal lesions: long diameter > 15 mm) confirmed by contrast-enhanced CT or MRI according to RECIST v1.1;
  • Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1;
  • Vital organ functions meet the following requirements (Reception of granulocyte colony-stimulating factor (G-CSF) or pegylated granulocyte colony-stimulating factor (PEG-G-CSF) or blood transfusion within 14 days prior to laboratory tests is not permitted for prophylactic use):
  • Blood routine examination: absolute neutrophil count (ANC) ≥ 1.5×109/L, hemoglobin (HGB) ≥ 90g/L, platelet count (PLT) ≥ 100×109/L; Hepatic function: total bilirubin (TBIL) ≤ 1.5×ULN, and alanine transaminase (ALT) and aspartate amino transferase (AST) ≤ 2.5×ULN for all patients, or AST and ALT levels ≤ 5×ULN for patients with liver metastases; Renal function: serum creatinine (Cr) ≤ 1.5×ULN or clearance of creatinine (CCr) ≥ 60 mL/min (Cr > 1.5×ULN); Coagulation function: international normalized ratio (INR) ≤ 1.5×ULN and Activated partial thromboplastin time (APTT) ≤ 1.5×ULN； Thyroid stimulating hormone (TSH) is within the normal range; If TSH is abnormal, free triiodothyronine (FT3) and free thyroxine (FT4) should be normal or abnormal without clinical significance;
  • Have provided tumor tissue specimens at or after the diagnosis of advanced or metastatic disease (Formalin-fixed, paraffin-embedded (FFPE) tumor tissues that were archived or freshly obtained within 6 months before the first dose; Tissue specimens require PD-L1 expression to be evaluable).

Who cannot join

  • Cohort 1: Have a histologically confirmed diagnosis of NSCLC with predominant squamous cells; Patients with mixed histology are not allowed if there is small cell component in the specimen; Cohort2: Have a histologically confirmed diagnosis of NSCLC with predominant Non-squamous cells; Mixed tumors will be categorized by the predominant cell type; if small cell carcinoma, neuroendocrine carcinomas and sarcomas elements are present, the subject is ineligible; Patients with mixed histology are allowed if there is squamous component >50% in the specimen.
  • Has active central nervous system (CNS) metastases and/or carcinomatous meningitis in the past or during screening, except for the following cases:
  • Subjects with asymptomatic brain metastases (i.e., no neurological symptoms, no requirements for corticosteroids, and no lesion >1.5 cm) may participate but will require regular imaging of the brain as a site of disease; Subjects with adequate treatmen may participate provided they are clinically stable for at least 4 weeks, and his nervous system and other clinical symptoms can return to the baseline level at least 2 weeks before the first dose (Except for residual signs or symptoms related to CNS therapy).
  • Subjects with spinal cord compression not curatively cured by surgery and/or radiotherapy.
  • Had prior treatment with anti-PD-1, or PD-L1, or PD-L2, or CD137, or CTLA-4 antibody or fusion protein or any other antibodies or drugs that specifically target T cell co-stimulatory or checkpoint pathways.
  • Have suffered from interstitial lung disease, non-infectious pneumonia or uncontrolled lung disease in the past 3 years, including but not limited to pulmonary fibrosis, acute lung disease, etc. (Except chemotherapy-induced interstitial lung disease that is currently asymptomatic).
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  • Patients with uncontrolled or severe cardiovascular diseases, such as Class II-IV congestive heart failure, unstable angina, myocardial infarction and other cardiovascular diseases assessed by New York Heart Association (NYHA), uncontrolled hypertension (systolic blood pressure ≥ 180mmHg and/or diastolic pressure ≥ 100mmHg), poorly controlled arrhythmia (Including QTc interval male ≥ 450 ms, female ≥ 470 ms) within 6 months before the first dose.
  • Subjects with symptomatic ascites, pericardial effusion or pleural effusion whose clinical status is stable for more than 1 month after receiving treatment (including therapeutic chest X-ray or puncture) can be enrolled.
  • Subjects who are using or have recently used (within 7 days before the first dose of study drug) aspirin therapy, or is unable to interrupt nonsteroidal anti-inflammatory drugs (NSAIDs) during the study. (apply to cohort 1)
  • Is unable or unwilling to take folic acid or vitamin B12 supplementation; Is unable to take corticosteroids; (Apply to cohort 1)
  • Has the following conditions in physical examination and laboratory examination:
  • With a known positive history of human immunodeficiency virus (HIV), Has known history of Human Immunodeficiency Virus (HIV) positive or acquired immunodeficiency syndrome (AIDS); Subjects with positive for treponema pallidum (TP) antibody； With active hepatitis, hepatitis B: HBsAg positive and/or HBcAb positive,a nd HBV-DNA level positive or above the ULN; hepatitis C: HCV antibody positive and HCV-RNA level positive or above the ULN;
  • Has a known contraindications or history of hypersensitivity to any component of test drug or to any excipients.
  • Has received organ in the past or autologous stem cell transplantation within 3 months before the first dose.
  • Received radiation therapy to the lung in the past.
  • Has other history of malignancy within the past 3 years, except locally curable cancer (such as radical melanoma, basal or squamous cell carcinoma, in situ cancer of the bladder or cervix).
  • Has received any drugs with anti-cancer indications (including Chinese herbal or patent medicine, immunosuppressants, systemic or topical hormones) for immunosuppression within 14 days before the first dose (Daily dose of systemic corticosteroid equivalent to prednisone >10 mg).
  • Had major surgery (<28 days prior to first dose) or have not recovered from major surgery.
  • Has active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  • Patients with unexplained fever > 38.5°C during the screening period and before the first dose (judged by the investigator, patients with fever due to tumors can be enrolled).
  • Received any other study therapy (drugs or devices) within 4 weeks prior to first dose.
  • Had a history of substance abuse or alcoholism (<6 months prior to first dose).
  • Have received a live-virus vaccination within 28 days prior to the first dose or plan to receive a live-virus vaccination during the study (Inactivated virus vaccines such as injectable seasonal flu vaccine and COVID-19 vaccine are allowed during the study period).
  • Is pregnant or breastfeeding; Female of childbearing potential or male with a female partner(s) of child-bearing potential is unwillingness to use effective contraception measures during the study or through 6 months after last dose.
  • The investigator believes that it is not suitable for enrollment.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cancer Hospital, Chinese Academy of Medical Sciences

    Beijing

    Yuankai Shi, Doctor, 010-87788525, syuankaipumc@126.com

Other trials in China

About this study

Official title: A Single-arm, Open-label, and Multicenter Phase Ⅱ Study Designed to Evaluate the Efficacy and Safety of Rulonilimab Combined With Chemotherapy in Patients With Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)

This is a single-arm, open-label, and multicenter phase Ⅱ study designed to evaluate the efficacy and safety of rulonilimab combined with chemotherapy in patients with advanced or metastatic non-small cell lung Cancer (NSCLC). Two cohorts were designed in this study: cohort 1 (non-squamous NSCLC) and cohort 2 (squamous NSCLC). About 84 patients with advanced or metastatic NSCLC plan to be enrolled in about 20 study sites of the study.

Being tested
F520, Pemetrexed, Carboplatin, Paclitaxel
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.

  • F520Drug

    Also called Rulonilimab

    F520 is a recombinant, humanized programmed death receptor-1 (PD-1) monoclonal antibody that binds to PD-1 and prevents binding of PD-1 with programmed death ligands 1 (PD-L1) and 2 (PD-L2).

  • PemetrexedDrug

    A chemotherapy medication used to treat a number of types of cancer.

  • CarboplatinDrug

    A chemotherapy medication used to treat a number of types of cancer.

  • PaclitaxelDrug

    A chemotherapy medication for the treatment of pleural mesothelioma and non-small cell lung cancer (NSCLC).

Study groups in NCT05741021
Study groupRoleWhat they receive
F520+ChemotherapyExperimentalCohort 1: Treatment period (3 weeks/cycle): On the first day of each cycle, F520 (200 mg), pemetrexed and carboplatin were administered sequentially by intravenous infusion (at least 30 min between doses). Maintenance period (3 weeks/cycle): On the first day of each cycle, F520 (200 mg) and pemetrexed were administered sequentially by intravenous infusion (at least 30 min between doses). Cohort 2: Treatment period (3 weeks/cycle): On the first day of each cycle, F520 (200 mg), paclitaxel and carboplatin were administered sequentially by intravenous infusion (at least 30 min between doses). Maintenance period (3 weeks/cycle): On the first day of each cycle, F520 (200 mg) was administered sequentially by intravenous infusion (at least 30 min between doses).
Receives: Drug: F520; Drug: Pemetrexed; Drug: Carboplatin; Drug: Paclitaxel

What is being measured

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

  1. Objective response rate (ORR)

    ORR (CR+PR) as assessed by the investigator per RECIST v1.1.

    Measured: up to 2 years

Secondary outcomes (7)

  1. Overall survival (OS)

    OS defined as the time from the date of randomization to the date of death due to any cause.

    Measured: up to 2 years

  2. Progression-free survival (PFS)

    PFS as assessed by the investigator per RECIST v1.1.

    Measured: up to 2 years

  3. disease control rate (DCR)

    DCR as assessed by the investigator per RECIST v1.1.

    Measured: up to 2 years

  4. Duration of remission (DOR)

    DOR as assessed by the investigator per RECIST v1.1.

    Measured: up to 2 years

  5. Time to progression (TTP)

    TTP as assessed by the investigator per RECIST v1.1.

    Measured: up to 2 years

  6. Incidence and severity of adverse events (AEs)

    All toxicities or AEs graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), v5.0.

    Measured: up to 2 years

  7. Incidence and severity of serious adverse events (SAEs)

    All toxicities or AEs graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), v5.0.

    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 posted23 Feb 2023
  2. Study start1 Mar 2023 (estimated)
  3. Primary completion25 Oct 2024 (estimated)
  4. Study completion25 Oct 2024 (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
Not applicable
Intervention model
Single group
Model description
Rulonilimab+Chemotherapy
Masking
None (open label)
Enrolment
84 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05741021
Sponsor's protocol ID
NTP-F520-103
Status last verified
Feb 2023
First submitted
12 Feb 2023
Last updated
24 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing F520, Pemetrexed and Carboplatin in people with Non-small Cell Lung Cancer and NSCLC, run by Shandong New Time Pharmaceutical 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 11 inclusion and 25 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 24 Feb 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?

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?

Objective response rate (ORR) (time frame: up to 2 years). 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 NCT05741021.

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 24 Feb 2023.

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