A Study of BMS-663513 in Combination With Chemoradiation in Subjects With Non Small Cell Lung Carcinoma (NSCLC)

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 1

Conditions: Non Small Cell Lung Cancer

Treatments: Drug: BMS-663513

Study type: Interventional

Funder types: Industry

Identifiers

NCT00461110

CA186-005

Details and patient eligibility

About

The purpose of this study is to determine the maximum tolerated dose and assess the safety and tolerability of escalating doses of BMS-663513 when given in combination with either radiotherapy alone or radiotherapy plus paclitaxel and carboplatin.

Enrollment: 35 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• NSCLC who are eligible to receive a 6 week course of RT
• Part 1 - not candidates for definitive RT
• Part 2 - candidates for definitive RT

Exclusion criteria

• Severe COPD, pulmonary infection or interstitial pneumonitis
• Recent cellulitis
• Autoimmune disease

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

1

Experimental group

Description:

Active

Treatment:

Drug: BMS-663513

2

Experimental group

Description:

Active

Treatment:

Drug: BMS-663513