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Phase 2 Study of S-1 as 2nd Line Therapy in Advanced Non-Small Cell Lung Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Phase 2 Study of S-1 as 2nd Line Therapy in Advanced Non-Small Cell Lung Cancer

An Open-Label, Non-Randomized, Multicenter, Three Stage, Phase 2 Study of S-1 as 2nd Line Therapy for Patients With Advanced Non-Small Cell Lung Cancer (Stage IIIB/Stage IV)

NCT00652561•Taiho Oncology, Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine whether S-1 is effective as 2nd line therapy in slowing tumor activity in patients with advanced non-small cell lung cancer. The study is also looking at the safety of S-1.

Detailed Description

Advanced non-small cell lung cancer is relatively unresponsive to chemotherapy. This is true for the nucleoside analogue gemcitabine, with a response rate of approximately 10%, as well as for 5-fluorouracil (5-FU). Even when gemcitabine is combined with other chemotherapeutic drugs or biological agents, the overall tumor response rate remains basically unchanged. S-1 is a new generation oral fluoropyrimidine that combines Tegafur (5-fluoro-1-(tetrahydro-2-furanyl)-2,4(1H,3H)-pyrimidinedione \[FT\]), an oral prodrug of 5-FU, with two modulators, Gimeracil (5-chloro-2,4-dihydroxypyridine \[CDHP\]), which inhibits 5-FU degradation by dihydropyrimidine dehydrogenase (DPD) inhibition, and Oteracil potassium (Oxo), which inhibits 5-FU phosphorylation in the digestive tract. This combination of 3 compounds is designed to achieve enhanced antitumor activity while decreasing gastrointestinal toxicity. This is an open-label, multicenter, single-arm, 3-stage, Phase 2 study evaluating the efficacy and safety of single agent S-1 as 2nd line therapy for patients with advanced NSCLC. The 3 stages of this study correspond to a futility stage (stage 1), a decision stage (stage 2), and a stage for improvement of precision of ORR (stage 3).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1\. Has given written informed consent. 2. Has histologically and/or cytologically proven unresectable or recurrent NSCLC stage IIIB with pleural effusion or pericardial effusion, or stage IV (mixed forms with small cell lung cancer are excluded).
•3\. Has received prior 1st line chemotherapy combination (platinum or non-platinum-based) treatment and has not received any 2nd line therapy.
•4\. Has measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria, ie, has at least one measurable lesion. A measurable lesion is one that can be accurately measured in at least one dimension with the longest diameter ≥ 20 mm using conventional techniques or ≥ 10 mm using spiral Computed Tomography (CT) scan.
•5\. Is able to take medications orally. 6. Is ≥ 18 years of age. 7. Has an ECOG performance status 0 or 1. 8. Has adequate organ function as defined by the following criteria:
•1. AST (SGOT) and ALT (SGPT) ≤ 2.5 x ULN; if liver function abnormalities are due to underlying liver metastasis AST (SGOT) and ALT (SGPT) ≤ 5 x ULN.
•2. Total serum bilirubin of ≤ 1.5 x ULN.
•3. Absolute granulocyte count of ≥ 1,500/mm3.
•4. Platelet count ≥ 100,000/mm3.
•5. Hemoglobin of ≥ 9.0 g/dL.
•6. Calculated creatinine clearance (CrCl) ≥ 60 mL/min (Cockcroft-Gault formula). 9. Is willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

Exclusion Criteria

•1\. Has had treatment with any of the following within the specified time frame prior to study drug administration:
•1. Any investigational agent either concurrently or within the past 30 days.
•2. Any prior 1st line treatment with S-1 for NSCLC.
•3. Previous therapy for NSCLC within the past 21 days, including any chemotherapy, immunotherapy, biologic or hormonal therapy (6 weeks for nitrosureas or mitomycin C).
•4. Radiotherapy within the prior 2 weeks.
•5. Any radiation therapy to a target lesion within the past 3 months, unless there was evidence of PD after radiotherapy (and this target lesion must not be the only site of measurable disease).
•6. Current enrollment in another clinical study with an investigational agent. Patients participating in surveys or observational studies are eligible to participate in this study.
•2\. Has a serious illness or medical condition(s) including, but not limited to, the following:
•
•1. Other active malignancies.
+14 more criteria

Key Dates

Start Date

February 1, 2005

Primary Completion Date

November 1, 2007

Completion Date

November 1, 2007

Last Updated

September 3, 2024

Enrollment

ACTUAL participants

Conditions

Advanced Non-Small Cell Lung Cancer

Interventions

S-1

DRUG

Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)

NCT06731413

Non-Small Cell Lung CancerNSCLC+2 more

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RECRUITING

Observational, Prospective, Multi-centric Study Exploring HER2 Mutations Incidence and Therapeutic Management in aNSCLC

NCT07356544

NSCLC (Advanced Non-small Cell Lung Cancer)HER2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 3, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Phase 2 Study of S-1 as 2nd Line Therapy in Advanced Non-Small Cell Lung Cancer

Inclusion Criteria

Exclusion Criteria

Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)

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