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Small Cell Lung Cancer (SCLC)Phase 2NCT04727853

Study of Irinotecan Liposome Injection as Second-line Regimen in Patients With Small Cell Lung Cancer (SCLC)

A Phase 2 study testing irinotecan liposome injection in people with Small Cell Lung Cancer (SCLC), run by CSPC Ouyi Pharmaceutical Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a multicenter, open-label, single-arm phase 2 study of irinotecan liposome injection in patients with small cell lung cancer (SCLC) who have progressed after platinum-based first-line therapy. Subjects will receive irinotecan liposome injection until progression or unacceptable toxicity. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Small Cell Lung Cancer (SCLC)
What is being tested?
irinotecan liposome injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteChina
Study dates
1 Mar 2021to 26 Apr 2022
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

  • At least 18 years of age. Males or females.
  • Histopathologically or cytologically confirmed small cell lung cancer.
  • At least one measurable lesion as defined by RECIST V1.1 guidelines. A previously irradiated lesion may be counted as a measurable lesion only if there is a clear sign of progression since the irradiation.
  • Must have recurrence or progression after platinum-based, first-line chemotherapy or chemoradiation therapy for the treatment of SCLC.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Life expectancy >3 months.
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  • Recovered from the effects of any prior chemotherapy, surgery, radiotherapy or other anti-neoplastic therapy (recovered to no more than Grade 1 of CTCAE 5.0 criteria or baseline, with the exception of alopecia or other toxicity without safety concerns by the investigators' judgment).
  • Patient should not receive blood transfusion or supportive care (eg. EPO, G-CSF or others) within 14 days before the initiate dose, and laboratory test should meet the following criteria: neutrophile count (ANC) ≥1.5×10^9/L, platelet count ≥100×10^9/L, hemoglobin ≥90 g/L or ≥5.6 mmol/L, serum creatinine ≤1.5×ULN and creatinine clearance rate ≥30 mL/min, total bilirubin ≤1×ULN, AST and ALT ≤2.5×ULN (for patients with liver metastasis: ≤5×ULN)
  • Female or male patient of childbearing age must agree to take effective contraception for the duration of treatment plus six months post-treatment completion; female patient must have a negative serum pregnancy test within 7 days before enrollment and must not be lactating female.
  • Able to understand and provide an informed consent.

Who cannot join

  • Patients with large cell neuroendocrine lung carcinoma or combined small cell lung carcinoma.
  • Patients with history of immunotherapy-induced colitis or pneumonia, confirmed by clinical assessment and/or biopsy.
  • Patients with central Nervous System (CNS) metastasis meet any of the following criteria: a) Patient who have developed new or progressive brain metastasis following cranial radiation; b) Patients with the symptomatic Central Nervous System (CNS) metastasis who have used cortisol, radiotherapy, dehydration drugs, etc. to control symptoms in the past two weeks; c) Patients with carcinomatous meningitis; d) Patients with brain stem (midbrain, pons, medulla oblongata) or spinal cord metastasis.
  • Uncontrolled third lacunar effusion, not suitable for enrollment by investigator's assessment.
  • Previous malignancies in the past five years (except for basal cell carcinoma, squamous cell carcinoma, superficial bladder carcinoma, local prostate carcinoma, carcinoma in situ of cervical, or of others that have been radically resected and have not recurred).
  • Patients who have received any of the following treatments, a) Patients who have received prior topoisomerase I inhibitor treatment, including irinotecan or other investigational agents; b) Patients who have used any antibody-drug conjugates or molecular targeted preparation alone or in combination setting; c) Patients who have received more than one line of immunotherapy (immunotherapy in first-line as single or combination is permitted).
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  • Concomitant use of strong CYP3A4 inducers within 2 weeks or strong CYP3A4 inhibitors or strong UGT1A1 inhibitors within 1 week of the first dose of the study drug.
  • Patients who have received any chemotherapy, biological therapy, endocrinotherapy, immunotherapy or investigational therapy within 4 weeks (5 half-lives of the agent, whichever is longer) of the first dose of the study drug, or local palliative radiotherapy or Chinese herbal medicine with anti-tumor indications within 2 weeks of the first dose of the study drug.
  • Any major surgery or severe trauma within 4 weeks of the first dose, not including biopsy.
  • Severe cardiovascular disease within 6 months prior to enrollment.
  • Severe pulmonary disease within 6 months prior to enrolment, such as interstitial pneumonia, pulmonary fibrosis, radiation induced pneumonitis requiring steroid therapy, and other moderate and severe lung diseases which affect lung function.
  • Uncontrolled active bleeding or known hemorrhagic constitution.
  • Any active infection, in the investigator's opinion, would increase the risk or have an influence on the result of the study, such as acute bacterial infection, tuberculosis, active hepatitis B/C, or HIV infection.
  • Known hypersensitivity to any of the components of irinotecan liposome injection, or other liposomal products.
  • Clinically significant gastrointestinal disorder, including hepatic disorders, bleeding, inflammation, occlusion, or diarrhea > grade 1.
  • History of explicit neurological or psychiatric disorders, including epilepsy or dementia.
  • Pregnant or lactating female.
  • Patient is not suitable for the study in the investigator's opinion.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Jilin Cancer Hospital

    Changchun, Jilin, 130012

Other trials in China

About this study

Official title: A Multicenter, Open-label, Single-arm Phase 2 Study of Irinotecan Liposome Injection in Patients With Small Cell Lung Cancer (SCLC) Who Have Progressed After Platinum-based First-line Therapy

This study is a multicenter, open-label, single-arm phase 2 study of irinotecan liposome injection in patients with small cell lung cancer (SCLC) who have progressed after platinum-based first-line therapy. Subjects will receive irinotecan liposome injection until progression or unacceptable toxicity.

Read the detailed description

Patients with small cell lung cancer who have progressed after platinum-based first-line therapy will be enrolled in this study. Patients will receive irinotecan liposome injection at 70 mg/m^2 intravenously, over 90 min on Days 1 of every 14-day cycle until progression or unacceptable toxicity. Imaging assessments will be conducted every three cycles to evaluate the preliminary efficacy of irinotecan liposome injection as second-line regimen in patients with SCLC.

Being tested
irinotecan liposome injection
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.

  • irinotecan liposome injectionDrug

    Drug: irinotecan liposome injection

Study groups in NCT04727853
Study groupRoleWhat they receive
irinotecan liposome injectionExperimentalPatients will receive irinotecan liposome injection at 70 mg/m^2 intravenously, over 90 min on Days 1 of every 14-day cycle.
Receives: Drug: irinotecan liposome injection

What is being measured

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

  1. Objective Response Rate (ORR)

    ORR was defined as the proportion of patients who achieved partial response or complete response according to RECIST V1.1 guidelines.

    Measured: From date of first dose until the date of first documented progression, assessed up to 24 months

Secondary outcomes (4)

  1. Progression-free survival (PFS)

    from date of the first dose to date of the first documented disease progression (PD) per RECIST v1.1 or death due to any cause, whichever occurs first.

    Measured: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

  2. Overall survival (OS)

    from date of the first dose to date of death from any cause

    Measured: From date of first dose until the date of death from any cause , assessed up to 24 months

  3. Proportion of Patients with Symptom Improvement

    Patient-reported EORTC-QLQ symptom scales

    Measured: date of the first dose to 30 days after permanent treatment termination

  4. Incidence of treatment-emergent adverse events (AEs), serious adverse events (SAEs) and laboratory abnormalities

    Incidence of AE, SAE and laboratory abnormalities

    Measured: date of the first dose to 30 days after permanent treatment termination

Timeline

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

  1. First posted27 Jan 2021
  2. Study start1 Mar 2021
  3. Primary completion26 Apr 2022
  4. Study completion26 Apr 2022

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
Masking
None (open label)
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04727853
Sponsor's protocol ID
HE072-CSP-001
Status last verified
Jun 2024
First submitted
18 Jan 2021
Last updated
10 Jul 2024
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 irinotecan liposome injection in people with Small Cell Lung Cancer (SCLC), run by CSPC Ouyi 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 10 inclusion and 18 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: finished, as of the sponsor's last update on 10 Jul 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 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: From date of first dose until the date of first documented progression, assessed up to 24 months). 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 NCT04727853.

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 10 Jul 2024.

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