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

January 4, 2021 updated by: Yayi He, Shanghai Pulmonary Hospital, Shanghai, China

Clinical Study of Programmed Cell Death Ligand-1(PD-L1) Antibody (Atezolizumab) Plus Chemotherapy (Carboplatin Plus Etoposide) for Previously Untreated Small Cell Lung Cancer

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yayi He, Doctor
  • Phone Number: 3056 +86-21-65115006
  • Email: 2250601@qq.com

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200433
        • Shanghai Pulmonary Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease free survival（DFS）
Time Frame: 12 months
To assess disease free survival（DFS）after surgery.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease control rate (DCR)
Time Frame: 3 months
To assess disease control rate (DCR) after treatment.
3 months
Overall survival (OS)
Time Frame: 24 months
To estimate overall survival (OS) of patients with ES-SCLC.
24 months
Objective response rate (ORR)
Time Frame: 3 months
To evaluate objective response rate (ORR)after treatment.
3 months
Duration of response (DOR)
Time Frame: 3 months
To evaluate duration of response (DOR) after treatment.
3 months
Major pathological response (MPR)
Time Frame: 3 months
To evaluate major pathological response (MPR) after treatment.
3 months
Complete pathological response (CPR）
Time Frame: 3 months
To evaluate complete pathological response (CPR）after treatment.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Investigators

  • Principal Investigator: Lei Zhang, Doctor, Shanghai pulmonary hospital, Tongji University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2021

Primary Completion (Anticipated)

August 1, 2022

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

January 4, 2021

First Submitted That Met QC Criteria

January 4, 2021

First Posted (Actual)

January 6, 2021

Study Record Updates

Last Update Posted (Actual)

January 6, 2021

Last Update Submitted That Met QC Criteria

January 4, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020LY032

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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