Maintenance Therapy for Small-cell Lung Cancer

Preliminary Study of Maintenance Therapy for Patients With Extensive Stage of Small-cell Lung Cancer

This study involves patients treated with cisplatin and etoposide (induction therapy), followed by treatment with a drug called S1 (maintenance therapy). The main purpose of this study is to determine if this type of treatment will delay the growth of the tumor and if so, for how long. The primary endpoint is progression free survival and second endpoints are toxicities, overall survival.

Study Overview

• Status: Completed
• Conditions: Progression Free Survival
• Intervention / Treatment: Drug: cis Platinum, etoposide, S1

Detailed Description

Small cell lung cancer (SCLC) accounts for about 20% of lung cancer, has a high degree of malignancy, short doubling time, early and widespread metastasis, is sensitive to chemotherapy and radiotherapy, and has a high initial response rate, but is prone to secondary drug resistance and relapse. The treatment is mainly based on systemic chemotherapy, and if maintenance therapy with S1 after standard EP regimen induction therapy could prolong progression free survival.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shandong
    • Qingdao, Shandong, China, 266042
      • Qingdao Central Hospital, Qingdao Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 1. Histopathologically confirmed patients with extensive small cell lung cancer; 2. Karnofsky performance status ≥60; 3. At least one lesion that can measured by CT; 4. Expected to survive for at least 3 months; 5. Peripheral blood and liver and kidney function within the following allowable range (tested within 7 days before treatment); 6. White blood cell (WBC) ≥3.0×109/L or Neutrophils (ANC) ≥1.5×109/L; Hemoglobin (HGB) ≥80 g/L；Platelet (PLT) ≥100×109/L; 7. Liver transaminases（AST/ALT）<3.0 times the normal range limit; Total bilirubin（TBIL）<1.5 times the normal range limit; Creatinine（CREAT）<1.5 times the normal range limit; 8. Patients of childbearing age (including female and male patients' partner) must take effective contraception methods; Signed informed consent 9. Must be able to swallow tablets

Exclusion Criteria:

• 1. Limited stage disease 2. Metastastic meningitis, spinal compression, Tumor to main vesicular less than 5mm 3. Other pathological types of tumor except for small cell lung cancer; 4. Patients with a history of severe allergies or allergies; 5. Pregnancy or breastfeeding women; 6. Patients who have previously participated in other clinical trials and have not yet terminated the trial; 7. Patients who have acute infection that difficult to control; 8. Subjects with difficulties in swallowing or known drug malabsorption.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental arm; cisplatin 75 mg/m2, iv day1, Etoposide: 60 mg/m2 IV day 1-5, every 21 days for up to 4-6 cycles. S1 25 mg/m2 oral, everyday until progression disease	Drug: cis Platinum, etoposide, S1; cisplatin 75 mg/m2, iv day1, Etoposide: 60 mg/m2 IV day 1-5, every 21 days for up to 4-6 cycles. S1 25 mg/m2 oral, everyday until progression disease
Active Comparator: active comparator; cisplatin 75 mg/m2, iv day1, Etoposide: 60 mg/m2 IV day 1-5, every 21 days for up to 4-6 cycles.	Drug: cis Platinum, etoposide, S1; cisplatin 75 mg/m2, iv day1, Etoposide: 60 mg/m2 IV day 1-5, every 21 days for up to 4-6 cycles. S1 25 mg/m2 oral, everyday until progression disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The progression-free survival in this population of patients	The progression-free survival of the enrolled patients from start the combination treatment with cisplatin, etoposide and S1	2.5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Experiencing an Adverse Event (AE)	Adverse events were recorded and classified from start the treatment by grade according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0	2.5 years
The overall survival in this population of patients.	The overall survival of the enrolled patients from start the combination from start the combination treatment with cisplatin, etoposide and S1	2.5 years

Collaborators and Investigators

• Sponsor: Qingdao Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): January 1, 2022
• Study Completion (Actual): July 1, 2022

Study Registration Dates

• First Submitted: December 6, 2018
• First Submitted That Met QC Criteria: December 6, 2018
• First Posted (Actual): December 10, 2018

Study Record Updates

• Last Update Posted (Actual): March 29, 2023
• Last Update Submitted That Met QC Criteria: March 27, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Etoposide; Cisplatin
• Other Study ID Numbers: QingdaoCH2018-12-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No