Maintenance Therapy for Small-cell Lung Cancer

NCT03769935 | Completed Phase 2 DMC

• 1 other identifier: QingdaoCH2018-12-02
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Progression Free Survival

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Percentage of Participants Experiencing an Adverse Event (AE)

  2.5 years

• The overall survival in this population of patients.

  2.5 years

Study Arms (2)

experimental arm

EXPERIMENTAL

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

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

Interventions

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

active comparator; experimental arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Qingdao Central Hospital: lead

Study Sites (1)

Qingdao Central Hospital, Qingdao Cancer Hospital

Qingdao, Shandong, 266042, China

Location

MeSH Terms

Interventions

Cisplatin; Etoposide; S 1 (combination)

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2018
• First Posted: December 10, 2018
• Study Start: January 1, 2017
• Primary Completion: January 1, 2022
• Study Completion: July 1, 2022
• Last Updated: March 29, 2023

Record last verified: 2023-03

Locations

CN (1)