Combined Atezolizumab and Chemotherapy (Carboplatin Plus Etoposide) in Neoadjuvant Treating Limited-Stage Small Cell Lung Cancer Patients
Clinical Study of Programmed Cell Death Ligand-1(PD-L1) Antibody (Atezolizumab) Plus Chemotherapy (Carboplatin Plus Etoposide) for Previously Untreated Small Cell Lung Cancer
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2021
CompletedFirst Submitted
Initial submission to the registry
January 4, 2021
CompletedFirst Posted
Study publicly available on registry
January 6, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2023
CompletedJanuary 6, 2021
January 1, 2021
1.6 years
January 4, 2021
January 4, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease free survival（DFS）
To assess disease free survival（DFS）after surgery.
12 months
Secondary Outcomes (6)
Disease control rate (DCR)
3 months
Overall survival (OS)
24 months
Objective response rate (ORR)
3 months
Duration of response (DOR)
3 months
Major pathological response (MPR)
3 months
- +1 more secondary outcomes
Study Arms (2)
Atezolizumab + Carboplatin +Etoposide +surgery
EXPERIMENTALNeoadjuvant 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.
Carboplatin +Etoposide +surgery
ACTIVE COMPARATORNeoadjuvant 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.
Interventions
Atezolizumab intravenous infusion was administered at a dose of 1200mg on Day 1 of each 21-day cycle.
Carboplatin intravenous infusion was administered at a dose of 75mg/m\^2 on Day 1 of each 21-day cycle.
Etoposide intravenous infusion was administered at a dose of 100 mg/m\^2 on Day 1 of every 3-day cycle.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433, China
Related Publications (5)
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.
PMID: 31590988BACKGROUNDHorn 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.
PMID: 30280641BACKGROUNDYang 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.
PMID: 28475559BACKGROUNDYang 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.
PMID: 28385378BACKGROUNDFaivre-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.
PMID: 28642008BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lei Zhang, Doctor
Shanghai Pulmonary Hospital, Tongji University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 4, 2021
First Posted
January 6, 2021
Study Start
January 1, 2021
Primary Completion
August 1, 2022
Study Completion
October 1, 2023
Last Updated
January 6, 2021
Record last verified: 2021-01