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

Primary Purpose

Small-cell Lung Cancer, Neoadjuvant Therapy

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Atezolizumab
Carboplatin
Etoposide
Sponsored by
Shanghai Pulmonary Hospital, Shanghai, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small-cell Lung Cancer focused on measuring Limited-Stage Small Cell Lung Cancer, Atezolizumab, Immunotherapy, Carboplatin, Etoposide

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shanghai Pulmonary Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Atezolizumab + Carboplatin +Etoposide +surgery

Carboplatin +Etoposide +surgery

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Disease free survival（DFS）
To assess disease free survival（DFS）after surgery.

Secondary Outcome Measures

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

Full Information

First Posted
January 4, 2021
Last Updated
January 4, 2021
Sponsor
Shanghai Pulmonary Hospital, Shanghai, China
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1. Study Identification

Unique Protocol Identification Number
NCT04696939
Brief Title
Combined Atezolizumab and Chemotherapy (Carboplatin Plus Etoposide) in Neoadjuvant Treating Limited-Stage Small Cell Lung Cancer Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 2021 (Anticipated)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Pulmonary Hospital, Shanghai, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small-cell Lung Cancer, Neoadjuvant Therapy
Keywords
Limited-Stage Small Cell Lung Cancer, Atezolizumab, Immunotherapy, Carboplatin, Etoposide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Atezolizumab + Carboplatin +Etoposide +surgery
Arm Type
Experimental
Arm Description
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.
Arm Title
Carboplatin +Etoposide +surgery
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Atezolizumab
Intervention Description
Atezolizumab intravenous infusion was administered at a dose of 1200mg on Day 1 of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Carboplatin intravenous infusion was administered at a dose of 75mg/m^2 on Day 1 of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Etoposide
Intervention Description
Etoposide intravenous infusion was administered at a dose of 100 mg/m^2 on Day 1 of every 3-day cycle.
Primary Outcome Measure Information:
Title
Disease free survival（DFS）
Description
To assess disease free survival（DFS）after surgery.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Disease control rate (DCR)
Description
To assess disease control rate (DCR) after treatment.
Time Frame
3 months
Title
Overall survival (OS)
Description
To estimate overall survival (OS) of patients with ES-SCLC.
Time Frame
24 months
Title
Objective response rate (ORR)
Description
To evaluate objective response rate (ORR)after treatment.
Time Frame
3 months
Title
Duration of response (DOR)
Description
To evaluate duration of response (DOR) after treatment.
Time Frame
3 months
Title
Major pathological response (MPR)
Description
To evaluate major pathological response (MPR) after treatment.
Time Frame
3 months
Title
Complete pathological response (CPR）
Description
To evaluate complete pathological response (CPR）after treatment.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Histologically or cytologically confirmed stage IIb-IIIb SCLC. Patients with good physical condition and good organ function. Previously untreated patients. Patients must have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Patients can tolerate chemotherapy, immunotherapy, and surgery. Exclusion Criteria: Unclear diagnosis of SCLC. Contraindicated chemotherapy, immunotherapy, and surgery. 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. Positive test result for human immunodeficiency virus (HIV). Positive test result for active tuberculosis. Pregnant or lactating women A history of psychotropic substance abuse, drug abuse, or alcoholism. Other factors assessed by the sponsors.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yayi He, Doctor
Phone
+86-21-65115006
Ext
3056
Email
2250601@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lei Zhang, Doctor
Organizational Affiliation
Shanghai Pulmonary Hospital, Tongji University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yayi He, Doctor
Phone
+86-21-65115006
Email
2250601@qq.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
31590988
Citation
Paz-Ares L, Dvorkin M, Chen Y, Reinmuth N, Hotta K, Trukhin D, Statsenko G, Hochmair MJ, Ozguroglu M, Ji JH, Voitko O, Poltoratskiy A, Ponce S, Verderame F, Havel L, Bondarenko I, Kazarnowicz A, Losonczy G, Conev NV, Armstrong J, Byrne N, Shire N, Jiang H, Goldman JW; CASPIAN investigators. Durvalumab plus platinum-etoposide versus platinum-etoposide in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): a randomised, controlled, open-label, phase 3 trial. Lancet. 2019 Nov 23;394(10212):1929-1939. doi: 10.1016/S0140-6736(19)32222-6. Epub 2019 Oct 4.
Results Reference
background
PubMed Identifier
30280641
Citation
Horn L, Mansfield AS, Szczesna A, Havel L, Krzakowski M, Hochmair MJ, Huemer F, Losonczy G, Johnson ML, Nishio M, Reck M, Mok T, Lam S, Shames DS, Liu J, Ding B, Lopez-Chavez A, Kabbinavar F, Lin W, Sandler A, Liu SV; IMpower133 Study Group. First-Line Atezolizumab plus Chemotherapy in Extensive-Stage Small-Cell Lung Cancer. N Engl J Med. 2018 Dec 6;379(23):2220-2229. doi: 10.1056/NEJMoa1809064. Epub 2018 Sep 25.
Results Reference
background
PubMed Identifier
28475559
Citation
Yang CJ, Chan DY, Shah SA, Yerokun BA, Wang XF, D'Amico TA, Berry MF, Harpole DH Jr. Long-term Survival After Surgery Compared With Concurrent Chemoradiation for Node-negative Small Cell Lung Cancer. Ann Surg. 2018 Dec;268(6):1105-1112. doi: 10.1097/SLA.0000000000002287.
Results Reference
background
PubMed Identifier
28385378
Citation
Yang CJ, Chan DY, Speicher PJ, Gulack BC, Tong BC, Hartwig MG, Kelsey CR, D'Amico TA, Berry MF, Harpole DH. Surgery Versus Optimal Medical Management for N1 Small Cell Lung Cancer. Ann Thorac Surg. 2017 Jun;103(6):1767-1772. doi: 10.1016/j.athoracsur.2017.01.043. Epub 2017 Apr 25.
Results Reference
background
PubMed Identifier
28642008
Citation
Faivre-Finn C, Snee M, Ashcroft L, Appel W, Barlesi F, Bhatnagar A, Bezjak A, Cardenal F, Fournel P, Harden S, Le Pechoux C, McMenemin R, Mohammed N, O'Brien M, Pantarotto J, Surmont V, Van Meerbeeck JP, Woll PJ, Lorigan P, Blackhall F; CONVERT Study Team. Concurrent once-daily versus twice-daily chemoradiotherapy in patients with limited-stage small-cell lung cancer (CONVERT): an open-label, phase 3, randomised, superiority trial. Lancet Oncol. 2017 Aug;18(8):1116-1125. doi: 10.1016/S1470-2045(17)30318-2. Epub 2017 Jun 20.
Results Reference
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Combined Atezolizumab and Chemotherapy (Carboplatin Plus Etoposide) in Neoadjuvant Treating Limited-Stage Small Cell Lung Cancer Patients

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