S1 vs.Pemetrexed Plus Carboplatin in Patients With EGFR Wild Type Stage IIIB or IV Nonsquamous NSCLC

NSCLC Clinical Trial

Official title:

A Randomized Phase II Study of S1 Plus Carboplatin Followed by Maintenance S1versus Pemetrexed Plus Carboplatin Followed by Maintenance Pemetrexed in Patients With EGFR Wild Type Stage IIIB or IV Nonsquamous Non-Small-Cell Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02631460
• Other study ID #: 5010-2015023
• Status: Recruiting
• Phase: Phase 2
• First received: December 12, 2015
• Last updated: December 15, 2015
• Start date: December 2015
• Est. completion date: December 2019

Study information

• Verified date: December 2015
• Source: Sun Yat-sen University
• Contact: Li Zhang, MD
• Email: zhangli[@]sysucc.org.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study compared the efficacy and safety of S1 plus carboplatin (C) followed by S1 with pemetrexed plus carboplatin (C) followed by pemetrexed in patients with epidermal growth factor receptor (EGFR) wild type advanced nonsquamous non-small-cell lung cancer (NSCLC).Patients with previously untreated EGFR wild type stage IIIB or IV nonsquamous NSCLC and Eastern Cooperative Oncology Group performance status of 0 to 1 were randomly assigned to receive pemetrexed 500 mg/m2 or S1（80-120 mg/d）combined with carboplatin area under the curve (AUC) 5 every 3 weeks for up to four cycles. Eligible patients received maintenance until disease progression: pemetrexed or S1. The primary end point of this non-inferiority study was progression free survival（PFS）

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 470
• Est. completion date: December 2019
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Chemotherapy-naive patients with histologically or cytologically confirmed nonsquamous NSCLC, classified as stage IIIB not amenable to curative treatment or stage IV; EGFR wild type.

2. At least one unidimensionally measurable lesion according to the Response Evaluation Criteria in Solid Tumors

3. Eastern Cooperative Oncology Group performance status of 0 or 1

4. 18 <age<75 years

5. Patients had adequate bone marrow reserve and organ function.

6. Prior radiation therapy was permitted if it was completed at least 4 weeks before study treatment and patients had fully recovered from its acute effects

7. Written informed consent was obtained directly from every patient

8. Estimated life expectancy of at least 12 weeks.

9. Patient compliance and geographic proximity that allow adequate follow up.

10. Male and female patients with reproductive potential must use an approved contraceptive method, if appropriate during and for 3 months after the study. Women with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment.

Exclusion Criteria:

1. Brain metastasis associated with central nervous symptoms (patients were eligible if symptoms were controlled by steroids or other treatments);

2. Serious infections or other serious complications.

3. Uncontrolled third-space fluid retention before study entry. unable to interrupt aspirin and other nonsteroidal anti-inflammatory drugs or if they were unable or unwilling to take folic acid, vitamin B12, or corticosteroids

4. Have a prior malignancy other than NSCLC, carcinoma in situ of the cervix, or nonmelanoma skin cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence.

5. Pregnant or breast feeding.

6. A distinct history of drug allergies

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• NSCLC

Intervention

Drug:
• S1 80-120 mg/d
d1, every 3 weeks
• pemetrexed 500 mg/m2
d1, every 3 weeks
• carboplatin AUC=5
d1, every 3 weeks

Locations

Country	Name	City	State
China	Sun yat-sen University Cancer Center	Guang Zhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival(PFS)		3 years	No
Secondary	Overall survival(OS)		4 years	No
Secondary	Disease control rate(DCR)		3 years	No
Secondary	Health-related quality of life		3 years	No
Secondary	Number of Participants with Adverse Events		3 years	Yes