A Study on the Efficacy of Atezolizumab Combined with Chemotherapy

NCT06780826 | Recruiting

• 1 other identifier: SHDC2024CRI067
• Study Type: observational
• Target: 1,430
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer, Small Cell

Outcome Measures

Primary Outcomes (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).

  12 months

Secondary Outcomes (2)

• objective response rate

  12 months

• duration of response

  12 months

Study Arms (2)

atezolizumab combined with chemotherapy

Patients receive atezolizumab in combination with carboplatin and etoposide

Drug: Atezolizumab; Drug: Etoposide; Drug: Carboplatin

chemotherapy

Patients received carboplatin and etoposide

Drug: Etoposide; Drug: Carboplatin

Interventions

Atezolizumab DRUG

Atezolizumab, 1200 mg intravenous infusion, 21 days per cycle

Also known as: Tecentriq

atezolizumab combined with chemotherapy

Etoposide DRUG

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

Also known as: VP16

atezolizumab combined with chemotherapy; chemotherapy

Carboplatin DRUG

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

Also known as: CBP

atezolizumab combined with chemotherapy; chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, 200433, China

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

atezolizumab; Etoposide; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Coordination Complexes

Central Study Contacts

Chunxia Su, doctor

CONTACT

+8613601899076; susu_mail@126.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Clinical Research Center

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: January 17, 2025
• Study Start: August 28, 2024
• Primary Completion: June 30, 2025
• Study Completion: September 30, 2025
• Last Updated: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)