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

Small-cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04696939
• Other study ID #: 2020LY032
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: January 2021
• Est. completion date: October 2023

Study information

• Verified date: January 2021
• Source: Shanghai Pulmonary Hospital, Shanghai, China
• Contact: Yayi He, Doctor
• Phone: +86-21-65115006
• Email: 2250601[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: October 2023
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Neoplasms
• Neoadjuvant Therapy
• Small Cell Lung Carcinoma
• Small-cell Lung Cancer

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Shanghai Pulmonary Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Pulmonary Hospital, Shanghai, China

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View 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. — View Citation

Paz-Ares L, Dvorkin M, Chen Y, Reinmuth N, Hotta K, Trukhin D, Statsenko G, Hochmair MJ, Özgüroglu 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease free survival(DFS)	To assess disease free survival(DFS)after surgery.	12 months
Secondary	Disease control rate (DCR)	To assess disease control rate (DCR) after treatment.	3 months
Secondary	Overall survival (OS)	To estimate overall survival (OS) of patients with ES-SCLC.	24 months
Secondary	Objective response rate (ORR)	To evaluate objective response rate (ORR)after treatment.	3 months
Secondary	Duration of response (DOR)	To evaluate duration of response (DOR) after treatment.	3 months
Secondary	Major pathological response (MPR)	To evaluate major pathological response (MPR) after treatment.	3 months
Secondary	Complete pathological response (CPR)	To evaluate complete pathological response (CPR)after treatment.	3 months