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Lung Cancer, Small CellNCT06780826

A Study on the Efficacy of Atezolizumab Combined with Chemotherapy

An observational study of Lung Cancer, Small Cell, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a multicenter phase III simulated RCT study aimed to compare the efficacy and safety of atezolizumab combined with chemotherapy versus placebo combined with chemotherapy in small cell lung cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer, Small Cell
What is being tested?
Atezolizumab, Etoposide and Carboplatin
Type of treatment
Injection or infusion
How many people
1,430 participants
Where
1 siteChina
Study dates
28 Aug 2024to 30 Sep 2025
Phase
Observational
Are there results?
Not yet: the study is under way

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

Study population: This is a multi-center study to compare the efficacy and safety of atezolizumab plus chemotherapy versus placebo plus chemotherapy in small cell lung cancer.

Who may be able to join

  • Signed Informed Consent Form
  • Male or female, 18 years of age or older
  • ECOG performance status of 0 or 1
  • Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group (VALG) staging system
  • No prior treatment for ES-SCLC
  • Patients with a history of treated asymptomatic CNS metastases are eligible, provided they meet all of the following criteria:
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  • Only supratentorial and cerebellar metastases allowed (i.e., no metastases
  • to midbrain, pons, medulla or spinal cord)
  • No ongoing requirement for corticosteroids as therapy for CNS disease
  • No stereotactic radiation within 7 days
  • No evidence of interim progression between the completion of CNS- directed therapy and the screening radiographic study.
  • Patients with new asymptomatic CNS metastases detected at the screening scan must receive radiation therapy and/or surgery for CNS metastases. Following treatment, these patients may then be eligible without the need for an additional brain scan prior to randomization, if all other criteria are met.
  • Measurable disease, as defined by RECIST v1.1 Previously irradiated lesions can only be considered as measurable disease if disease progression has been unequivocally documented at that site since radiation and the previously irradiated lesion is not the only site of disease.
  • Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to randomization:
  • ANC ≥ 1500 cells/μL without granulocyte colony-stimulating factor support; Lymphocyte count ≥ 500/μL; Platelet count ≥ 100,000/μL without transfusion; Hemoglobin ≥ 9.0 g/dL; Patients may be transfused to meet this criterion. INR or aPTT ≤ 1.5 × upper limit of normal (ULN) This applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose. AST, ALT, and alkaline phosphatase ≤ 2.5 × ULN, with the following exceptions: Patients with documented liver metastases: AST and/or ALT ≤ 5 × ULN Patients with documented liver or bone metastases: alkaline phosphatase
  • 5 × ULN. Serum bilirubin ≤ 1.25 × ULN Patients with known Gilbert disease who have serum bilirubin level ≤ 3 × ULN may be enrolled. Serum creatinine ≤ 1.5 × ULN
  • Patients must submit a pre-treatment tumor tissue sample during the study. Any available tumor tissue sample can be submitted. The tissue sample may be submitted after enrollment.
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 90 days after the last dose of study treatment.

Who cannot join

  • Active or untreated CNS metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments
  • Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for ≥ 1 week prior to randomization
  • Leptomeningeal disease
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently) Patients with indwelling catheters (e.g., PleurX®) are allowed.
  • Uncontrolled or symptomatic hypercalcemia (> 1.5 mmol/L ionized calcium or calcium > 12 mg/dL or corrected serum calcium > ULN) Patients who are receiving denosumab prior to randomization must be willing and eligible to discontinue its use and replace it with a bisphosphonate while in the study.
  • Malignancies other than SCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death (e.g., expected 5-year OS > 90%) treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous-cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent)
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  • Women who are pregnant, lactating, or intending to become pregnant during the study
  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
  • Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
  • History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible for this study. Patients with controlled Type I diabetes mellitus on a stable dose of insulin regimen are eligible for this study. Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions: Rash must cover less than 10% of body surface area Disease is well controlled at baseline and only requires low potency topical steroids No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, high potency, or oral steroids)
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
  • Positive test for HIV
  • Patients with active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as the presence of hepatitis B core antibody [HBcAb] and absence of HBsAg) are eligible. HBV DNA must be obtained in these patients prior to randomization. Patients positive for hepatitis C virus (HCV) antibody are eligible only if PCR is negative for HCV RNA.
  • Active tuberculosis
  • Severe infections at the time of enrollment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
  • Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within 3 months prior to randomization, unstable arrhythmias, or unstable angina Patients with known coronary artery disease, congestive heart failure not meeting the above criteria, or left ventricular ejection fraction < 50% must be on a stable medical regimen that is optimized in the opinion of the treating physician, in consultation with a cardiologist if appropriate.
  • Major surgical procedure other than for diagnosis within 28 days prior to randomization or anticipation of need for a major surgical procedure during the course of the study
  • Prior allogeneic bone marrow transplantation or solid organ transplant
  • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk for treatment complications
  • Previous anti-cancer therapy for ES-SCLC
  • Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 28 days prior to randomization
  • Administration of a live, attenuated vaccine within 4 weeks before randomization or anticipation that such a live attenuated vaccine will be required during the study

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Chunxia Su, doctor contact

+8613601899076

susu_mail@126.com

China1 site, 1 recruiting

  • Shanghai Pulmonary Hospital

    Shanghai, 200433

    Chunxia Su, 13601899076, susu_mail@126.com

    Chunxia Su, doctor

    Recruiting

Other trials in China

About this study

Official title: A Simulated RCT Study on the Efficacy of Atezolizumab Combined with Chemotherapy Versus Placebo Combined with Chemotherapy in Small Cell Lung Cancer

This is a multicenter phase III simulated RCT study aimed to compare the efficacy and safety of atezolizumab combined with chemotherapy versus placebo combined with chemotherapy in small cell lung cancer.

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.

  • AtezolizumabDrug

    Also called Tecentriq

    Atezolizumab, 1200 mg intravenous infusion, 21 days per cycle

  • EtoposideDrug

    Also called VP16

    Etoposide,intravenous infusion, 100mg/m,21 days per cycle

  • CarboplatinDrug

    Also called CBP

    carboplatin,intravenous infusion, AUC=5, 21 days per cycle.

Study groups in NCT06780826
Study groupRoleWhat they receive
atezolizumab combined with chemotherapyPatients receive atezolizumab in combination with carboplatin and etoposide
Receives: Drug: Atezolizumab; Drug: Etoposide; Drug: Carboplatin
chemotherapyPatients received carboplatin and etoposide
Receives: Drug: Etoposide; Drug: Carboplatin

What is being measured

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

  1. progression free survival

    Progression-free survival (PFS): refers to the time from the date of initiation of combination therapy to any objectively documented tumor progression or patient death (the last follow-up time for patients lost to follow-up; Patients who are still alive at the end of the study will be the end of follow-up at the end of the study).

    Measured: 12 months

Secondary outcomes (2)

  1. objective response rate

    Objective response rate (ORR): refers to the proportion of patients whose tumors shrink to a certain amount and remain for a certain period of time, including complete response (CR) and partial response (PR) cases.

    Measured: 12 months

  2. duration of response

    Duration of response (DOR): refers to the duration of a patient's time from the first documented confirmed response (CR or PR) to the first documentation of disease progression (PD) or death due to any cause, whichever occurs first.

    Measured: 12 months

Timeline

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

  1. First posted17 Jan 2025
  2. Study start28 Aug 2024
  3. Primary completion30 Jun 2025 (estimated)
  4. Study completion30 Sep 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
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
1,430 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06780826
Sponsor's protocol ID
SHDC2024CRI067
Status last verified
Jan 2025
First submitted
12 Dec 2024
Last updated
17 Jan 2025
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?

An observational study of Lung Cancer, Small Cell, run by Shanghai Pulmonary Hospital, Shanghai, China 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 18 inclusion and 22 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: looking for participants now, as of the sponsor's last update on 17 Jan 2025. 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.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Chunxia Su, doctor (+8613601899076, susu_mail@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

progression free survival (time frame: 12 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 NCT06780826.

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 17 Jan 2025.

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