Study of Low-Dose Radiotherapy Concurrent Cisplatin/Carboplatin Plus Etoposide With Serplulimab for Patients With ES-SCLC

• Sponsor: Sichuan University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05765825
• Collaborator: (none)
• Enrollment: 61
• Locations: 7
• Arm: 1
• Anticipated Duration (Months): 33.2
• Patients Per Site: 8.7
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

This is a Phase II, single arm, multicenter study designed to evaluate the safety and efficacy of low-dose radiotherapy (LDRT) concurrent cisplatin/carboplatin plus etoposide with serplulimab in participants who have extensive-stage small cell lung cancer (ES-SCLC) and are chemotherapy-navïe for their extensive-stage disease.

Condition or Disease	Intervention/Treatment	Phase
Extensive-stage Small-cell Lung Cancer	Drug: serplulimab; Drug: Cisplatin; Drug: Carboplatin; Drug: Etoposide; Radiation: Thoracic radiation therapy (TRT)	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 61 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II, Single-Arm Study of Low-Dose Radiotherapy (LDRT) Concurrent Cisplatin/Carboplatin Plus Etoposide With Serplulimab for Patients With Extensive-Stage Small Cell Lung Cancer
• Anticipated Study Start Date: Mar 25, 2023
• Anticipated Primary Completion Date: Mar 25, 2024
• Anticipated Study Completion Date: Dec 30, 2025

Arms and Interventions

Arm

Intervention/Treatment

Experimental: LDRT concurrent cisplatin/carboplatin + etoposide + serplulimab Participants will receive the following treatment regimens: LDRT concurrent cisplatin/carboplatin + etoposide + serplulimab. Induction treatment will be administered on a 21-day cycle for four cycles. Concurrent radiation therapy will be conducted from Day 1 - Day 5 in the first cycle. Following the induction phase, participants will continue maintenance therapy with serplulimab and thoracic radiation therapy (30Gay/10f）. Participants will be treated until loss of clinical benefit, or unaccepted toxicity, or withdrawal of consent, or death (whichever occurs first).

Drug: serplulimab; Serplulimab will be administered by intravenous infusion at a dose of 4.5mg/kg on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator after an integrated assessment of radiographic and biochemical data, and clinical status.; Drug: Cisplatin; Cisplatin will be administered as intravenous infusion at a dose of 75 mg per meter squared (75 mg/m^2) after completion of serplulimab on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4).; Drug: Carboplatin; Carboplatin will be administered as intravenous infusion at a dose of area under the concentration-time curve (AUC) of 5 mg/mL/min on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4).; Drug: Etoposide; Etoposide will be administered intravenously at a dose of 100 mg/m^2 on Days 1, 2 and 3 of each 21-day cycle during the induction phase (Cycles 1-4).; Radiation: Thoracic radiation therapy (TRT); Participants will receive concurrent thoracic radiation therapy (TRT) treatment, in once daily fractions, 3 Gy per fraction, to a target dose of 15 Gy in 5 fractions from Day 1-Day 5 in the first cycle.Following the induction phase, participants will continue maintenance therapy with serplulimab thoracic radiation therapy (TRT) treatment, in once daily fractions, 3 Gy per fraction, to a target dose of 30 Gy in 10 fractions in the fifth and sixth cycle

Outcome Measures

Primary Outcome Measures

1. Progression-free survival (PFS) [Baseline up to approximately 24 months]

   The time from the date of first dosing of durvalumab to the first appearance of objective disease progression (according to RECIST1.1) or death from any cause (if it occurs before disease progression).

Secondary Outcome Measures

1. PFS Rate at 6 Months and 1 Year [Baseline up to 1 year]

   PFS rate at 6 months and 1 year, defined as the proportion of patients who have not experienced disease progression or death from any cause at 6 months and 1 year separately, as determined by the investigator according to RECIST v1.1.

2. Overall Survival (OS) [Baseline up to approximately 24 months]

   OS, defined as the time from initiation of study treatment to death from any cause.

3. OS Rate at 1 Year and 2 Years [Baseline to 2 years or death, whichever occurs first.]

   OS rate at 1 year and 2 years, defined as the proportion of patients who have not experienced death from any cause at 1 year and 2 years.

4. Duration of response (DOR) [Baseline to disease progression or death from any cause (whichever occurs first)(up to approximately 24 months)]

   defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1.

5. Disease control rate (DCR) [Baseline up to approximately 24 months]

   defined as the proportion of participants who have a best overall response of CR or PR or stable disease (SD), as determined by the investigator according to RECIST v1.1.

6. Percentage of Participants With Adverse Event [Baseline up to approximately 36 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Main Inclusion Criteria:

1. Histologically or cytologically confirmed ES-SCLC

2. No prior treatment for ES-SCLC

3. Measurable disease, as defined by RECIST v1.1. Previously irradiated lesions can be considered as measurable disease only if progressive disease has been unequivocally documented at that site since radiation.

4. ECOG performance status of 0 or 1

5. Life expectancy >= 3 months

6. Adequate hematologic and end-organ function

7. For participants receiving therapeutic anticoagulation: stable anticoagulant regimen

8. Negative human immunodeficiency virus (HIV) test at screening

9. Negative hepatitis B surface antigen (HBsAg) test at screening

10. Positive hepatitis B surface antibody (HBsAb) test at screening, or negative HBsAb at screening accompanied by either of the following: Negative total hepatitis B core antibody (HBcAb), or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test. The HBV DNA test will be performed only for participants who have a negative HBsAg test, a negative HBsAb test, and a positive total HBcAb test.

11. Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening. The HCV RNA test will be performed only for participants who have a positive HCV antibody test.

12. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception

13. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm

Main Exclusion Criteria:

1. Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases

2. Participants with pulmonary artery invasion

3. History of leptomeningeal disease

4. Uncontrolled tumor-related pain

5. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures

6. Uncontrolled or symptomatic hypercalcemia

7. Active or history of autoimmune disease or immune deficiency

8. History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan

9. Active tuberculosis

10. Significant cardiovascular disease within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina

11. History of malignancy other than small cell lung cancer (SCLC) within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cancer Hospital of Shantou University Medical College	Shantou	Guangdong	China	515041
2	The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine	Guangzhou	GuangGong	China	510405
3	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei	China	430022
4	LiaoNing Cancer Hospital & Institute	Shenyang	Liaoning	China	110801
5	Shandong Provincial Hospital	Jinan	Shandong	China	250021
6	Fudan University Shanghai Cancer Center	Shanghai	Shanghai	China	200032
7	China West Hospital	Chengdu	Sichuan	China	610000

Sponsors and Collaborators

• Sichuan University

Investigators

• Study Chair: You Lu, MD, West China Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: You Lu, professor, Sichuan University
• ClinicalTrials.gov Identifier: NCT05765825
• Other Study ID Numbers: ASTRUM-LC04
• First Posted: Mar 13, 2023
• Last Update Posted: Mar 13, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma; Carboplatin; Etoposide

Study Results

No Results Posted as of Mar 13, 2023