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Combined Atezolizumab and Chemotherapy (Carboplatin Plus Etoposide) in Neoadjuvant Treating Limited-Stage Small Cell Lung Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04696939
Recruitment Status : Not yet recruiting
First Posted : January 6, 2021
Last Update Posted : January 6, 2021
Sponsor:
Information provided by (Responsible Party):
Yayi He, Shanghai Pulmonary Hospital, Shanghai, China

Study Description
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Brief Summary:
This Phase II study was designed to evaluate the safety and efficacy of Atezolizumab in combination with Chemotherapy compared with treatment with Chemotherapy alone in previously untreated Limited-Stage Small Cell Lung Cancer patients.

Condition or disease Intervention/treatment Phase
Small-cell Lung Cancer Neoadjuvant Therapy Drug: Atezolizumab Drug: Carboplatin Drug: Etoposide Phase 2

Detailed Description:
This Phase II study was designed to evaluate the safety and efficacy of Atezolizumab in combination with Chemotherapy (Carboplatin plus Etoposide) compared with treatment with Chemotherapy (Carboplatin plus Etoposide) alone in previously untreated Limited-Stage Small Cell Lung Cancer patients. Participants will be divided in a 1:1 ratio to receive either Atezolizumab + Carboplatin + Etoposide or Carboplatin + Etoposide followed by radical surgery.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study of Programmed Cell Death Ligand-1(PD-L1) Antibody (Atezolizumab) Plus Chemotherapy (Carboplatin Plus Etoposide) for Previously Untreated Small Cell Lung Cancer
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Atezolizumab + Carboplatin +Etoposide +surgery

Neoadjuvant therapy: Atezolizumab, 1200 milligrams(mg) on Day 1 of every 21-day cycle, 2 cycles; Carboplatin, 75 mg per square meter(mg/m^2) on Day 1 of every 21-day cycle, 2 cycles; Etoposide, 100 mg/m^2 on Day 1 of every 3-day cycle, 2 cycles.

Surgery: patients will receive surgery.

 Drug: Atezolizumab
Atezolizumab intravenous infusion was administered at a dose of 1200mg on Day 1 of each 21-day cycle.

Drug: Carboplatin
Carboplatin intravenous infusion was administered at a dose of 75mg/m^2 on Day 1 of each 21-day cycle.

Drug: Etoposide
Etoposide intravenous infusion was administered at a dose of 100 mg/m^2 on Day 1 of every 3-day cycle.
Active Comparator: Carboplatin +Etoposide +surgery

Neoadjuvant therapy: Carboplatin, 75 mg/m^2 on Day 1 of every 21-day cycle, 2 cycles; Etoposide, 100 mg/m^2 on Day 1 of every 3-day cycle, 2 cycles.

Surgery: patients will receive surgery.

 Drug: Carboplatin
Carboplatin intravenous infusion was administered at a dose of 75mg/m^2 on Day 1 of each 21-day cycle.

Drug: Etoposide
Etoposide intravenous infusion was administered at a dose of 100 mg/m^2 on Day 1 of every 3-day cycle.


Outcome Measures
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Primary Outcome Measures :
  1. Disease free survival（DFS） [ Time Frame: 12 months ]
    To assess disease free survival（DFS）after surgery.


Secondary Outcome Measures :
  1. Disease control rate (DCR) [ Time Frame: 3 months ]
    To assess disease control rate (DCR) after treatment.

  2. Overall survival (OS) [ Time Frame: 24 months ]
    To estimate overall survival (OS) of patients with ES-SCLC.

  3. Objective response rate (ORR) [ Time Frame: 3 months ]
    To evaluate objective response rate (ORR)after treatment.

  4. Duration of response (DOR) [ Time Frame: 3 months ]
    To evaluate duration of response (DOR) after treatment.

  5. Major pathological response (MPR) [ Time Frame: 3 months ]
    To evaluate major pathological response (MPR) after treatment.

  6. Complete pathological response (CPR） [ Time Frame: 3 months ]
    To evaluate complete pathological response (CPR）after treatment.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must be volunteered to participate in the clinical trial. Patients must sign the informed Consent form (ICF) and be willing to follow and able to complete all test procedures.
  2. Histologically or cytologically confirmed stage IIb-IIIb SCLC.
  3. Patients with good physical condition and good organ function.
  4. Previously untreated patients.
  5. Patients must have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
  6. Patients can tolerate chemotherapy, immunotherapy, and surgery.

Exclusion Criteria:

  1. Unclear diagnosis of SCLC.
  2. Contraindicated chemotherapy, immunotherapy, and surgery.
  3. Undergoing other active malignancies within 5 years or at the same time.Patients with localized curable tumors, such as basal cell carcinoma, squamous cell carcinoma, superficial bladder carcinoma, prostate carcinoma in situ, cervical carcinoma in situ, or breast carcinoma in situ, will not be excluded.
  4. Positive test result for human immunodeficiency virus (HIV).
  5. Positive test result for active tuberculosis.
  6. Pregnant or lactating women
  7. A history of psychotropic substance abuse, drug abuse, or alcoholism.
  8. Other factors assessed by the sponsors.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04696939


Contacts
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Contact: Yayi He, Doctor +86-21-65115006 ext 3056 2250601@qq.com

Locations
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China, Shanghai
Shanghai Pulmonary Hospital
Shanghai, Shanghai, China, 200433
Contact: Yayi He, Doctor    +86-21-65115006    2250601@qq.com   
Sponsors and Collaborators
Shanghai Pulmonary Hospital, Shanghai, China
Investigators
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Principal Investigator: Lei Zhang, Doctor Shanghai Pulmonary Hospital, Tongji University
More Information
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Publications:

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Responsible Party: Yayi He, Professor, Shanghai Pulmonary Hospital, Shanghai, China
ClinicalTrials.gov Identifier: NCT04696939    
Other Study ID Numbers: 2020LY032
First Posted: January 6, 2021    Key Record Dates
Last Update Posted: January 6, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yayi He, Shanghai Pulmonary Hospital, Shanghai, China:
Limited-Stage Small Cell Lung Cancer
Atezolizumab
Immunotherapy
Carboplatin
Etoposide
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
 Carboplatin
Etoposide
Atezolizumab
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action