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

Shionogi

Status and phase: Completed; Phase 2; Phase 1

Conditions: Stage IIIB Non Small Cell Lung Cancer; Stage IIIA Non Small Cell Lung Cancer; Lung Cancer; Non Small Cell Lung Cancer

Treatments: Other: Chemo-irradiation; Drug: S-3304

Study type: Interventional

Funder types: Industry

Identifiers

NCT00078390

0207P1421

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 9 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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9 participants in 2 patient groups

S-3304 plus chemo-irradiation

Experimental group

Description:

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

Treatment:

Drug: S-3304

Other: Chemo-irradiation

Chemo-irradiation

Active Comparator group

Description:

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

Treatment:

Other: Chemo-irradiation