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

NCT ID: NCT02631460

Last Updated: 2015-12-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 470 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2019-12-31

Brief 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）

Conditions

NSCLC

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

S1 and Carboplatin

S1 80-120 mg/d+Carboplatin AUC=5 Patients without progression received maintenance until disease progression with S1

Group Type: EXPERIMENTAL

S1 80-120 mg/d

Intervention Type: DRUG

d1, every 3 weeks

carboplatin AUC=5

Intervention Type: DRUG

d1, every 3 weeks

pemetrexed and Carboplatin

pemetrexed 500 mg/m2+ Carboplatin AUC=5 Patients without progression received maintenance until disease progression with pemetrexed

Group Type: ACTIVE_COMPARATOR

pemetrexed 500 mg/m2

Intervention Type: DRUG

d1, every 3 weeks

carboplatin AUC=5

Intervention Type: DRUG

d1, every 3 weeks

Interventions

S1 80-120 mg/d

d1, every 3 weeks

Intervention Type: DRUG

pemetrexed 500 mg/m2

d1, every 3 weeks

Intervention Type: DRUG

carboplatin AUC=5

d1, every 3 weeks

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Li Zhang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yan Huang, MD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Sun yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Li Zhang, MD

Role: CONTACT

Email: zhangli@sysucc.org.cn

Yan Huang, MD

Role: CONTACT

Email: huangyan@sysucc.org.cn

Facility Contacts

Yan Huang, MD

Role: primary

Other Identifiers

5010-2015023

Identifier Type: -

Identifier Source: org_study_id