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Completed

NCT Number: NCT03769935

Maintenance Therapy for 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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Qingdao Central Hospital, Qingdao Cancer Hospital

Qingdao, Shandong, 266042, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cis Platinum, etoposide, S1

Drug

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

Primary outcomes

  1. The progression-free survival in this population of patients

    Time frame: 2.5 years

    The progression-free survival of the enrolled patients from start the combination treatment with cisplatin, etoposide and S1

Secondary outcomes

  1. Percentage of Participants Experiencing an Adverse Event (AE)

    Time frame: 2.5 years

    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. The overall survival in this population of patients.

    Time frame: 2.5 years

    The overall survival of the enrolled patients from start the combination from start the combination treatment with cisplatin, etoposide and S1

Sponsors and collaborators

Lead sponsor

Qingdao Central Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Dec 10, 2018
Registry last updated
Mar 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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