Combined Atezolizumab and Chemotherapy (Carboplatin Plus Etoposide) in Neoadjuvant Treating Limited-Stage Small Cell Lung Cancer Patients
NCT ID: NCT04696939
Last Updated: 2021-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
100 participants
INTERVENTIONAL
2021-01-31
2023-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Atezolizumab
Atezolizumab intravenous infusion was administered at a dose of 1200mg on Day 1 of each 21-day cycle.
Carboplatin
Carboplatin intravenous infusion was administered at a dose of 75mg/m\^2 on Day 1 of each 21-day cycle.
Etoposide
Etoposide intravenous infusion was administered at a dose of 100 mg/m\^2 on Day 1 of every 3-day cycle.
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.
Carboplatin
Carboplatin intravenous infusion was administered at a dose of 75mg/m\^2 on Day 1 of each 21-day cycle.
Etoposide
Etoposide intravenous infusion was administered at a dose of 100 mg/m\^2 on Day 1 of every 3-day cycle.
Interventions
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Atezolizumab
Atezolizumab intravenous infusion was administered at a dose of 1200mg on Day 1 of each 21-day cycle.
Carboplatin
Carboplatin intravenous infusion was administered at a dose of 75mg/m\^2 on Day 1 of each 21-day cycle.
Etoposide
Etoposide intravenous infusion was administered at a dose of 100 mg/m\^2 on Day 1 of every 3-day cycle.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Shanghai Pulmonary Hospital, Shanghai, China
OTHER
Responsible Party
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Yayi He
Professor
Principal Investigators
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Lei Zhang, Doctor
Role: PRINCIPAL_INVESTIGATOR
Shanghai Pulmonary Hospital, Tongji University
Locations
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Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
Other Identifiers
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2020LY032
Identifier Type: -
Identifier Source: org_study_id
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