Study of S-3304 in Patients With Locally Advanced Non-Small Cell Lung Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2006-10-26

Brief Summary

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A study to measure the safety and effectiveness of S-3304 when given in combination with conventional chemo-radiation therapy in patients with locally advanced non-small cell lung cancer.

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Detailed Description

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A two part study to evaluate the safety and efficacy of S-3304 in combination with standard therapy in patients with locally advanced non-small cell lung cancer. The first part of the study is a Phase I design to evaluate the maximum tolerated dose of S-3304 when given in combination with radiation and paclitaxel/carboplatin chemotherapy that is appropriate for further evaluation. The second part of the study is a randomized Phase II design to evaluate the efficacy of recommended S-3304 dose in combination with chemo-radiation.

Conditions

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Non Small Cell Lung Cancer Lung Cancer Stage IIIA Non Small Cell Lung Cancer Stage IIIB Non Small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The Phase 1 part of the study will determine the tolerable dose of S-3304 in the presence of radiation and paclitaxel/carboplatin chemotherapy in a non-randomized manner.

The Phase 2 part will compare the effect combination of S-3304 in addition to chemo-irradiation therapy to the effect of radiation and paclitaxel/carboplatin chemotherapy alone on small cell lung tumors

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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S-3304 plus chemo-irradiation

The tolerable dose of S-3304 determined in the Phase 1 part of the study will be dosed BID along with a standard of care regimen of radiation and paclitaxel/carboplatin chemotherapy

Group Type EXPERIMENTAL

S-3304

Intervention Type DRUG

S-3304 will be administered at the tolerable dose BID along with chemo-irradiation

Chemo-irradiation

Intervention Type OTHER

Standard of care chemo-irradiation

Chemo-irradiation

The standard of care regimen of radiation and paclitaxel/carboplatin chemotherapy will be administered

Group Type ACTIVE_COMPARATOR

Chemo-irradiation

Intervention Type OTHER

Standard of care chemo-irradiation

Interventions

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S-3304

S-3304 will be administered at the tolerable dose BID along with chemo-irradiation

Intervention Type DRUG

Chemo-irradiation

Standard of care chemo-irradiation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* newly diagnosed non-small cell lung cancer of stage IIIA non-resectable or of stage IIIB without pleural effusion
* ECOG performance status 0-1
* adequate organ function
* clinically indicated and able to receive conventional chemoradiation therapy

Exclusion Criteria

* patients with prior history of cancer, other than basal cell carcinoma after appropriate treatment, or prior systemic chemotherapy treatment
* patients with other serious intercurrent illness including HIV/AIDS, or contraindicated for paclitaxel/carboplatin or thoracic irradiation treatment

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No