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

Last updated: January 4, 2021
Sponsor: Shanghai Pulmonary Hospital, Shanghai, China
Overall Status: Active - Not Recruiting

Phase

2

Condition

Small Cell Lung Cancer

Treatment

N/A

Clinical Study ID

NCT04696939
2020LY032
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients must be volunteered to participate in the clinical trial. Patients must signthe informed Consent form (ICF) and be willing to follow and able to complete all testprocedures.
  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 SolidTumors (RECIST) 1.1
  6. Patients can tolerate chemotherapy, immunotherapy, and surgery.

Exclusion

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 withlocalized 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 Design

Total Participants: 100
Study Start date:
January 01, 2021
Estimated Completion Date:
October 31, 2023

Study 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.

Connect with a study center

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai 200433
    China

    Site Not Available

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