## Protocol Section
### Identification Module
**NCT ID:** NCT00042679

**Brief Title:** A Phase 2 Trial of Antisense Nucleotide to PKC-Alpha (LY900003, ISIS 3521) Plus Gemcitabine and Carboplatin in Patients With Advanced, Previously Untreated Non-Small Cell Lung Cancer.

**Official Title:** A Phase 2 Trial of Antisense Nucleotide to PKC-Alpha (LY900003, ISIS 3521) Plus Gemcitabine and Carboplatin in Patients With Advanced, Previously Untreated Non-Small Cell Lung Cancer.

#### Organization Study ID Info
**ID:** 6429
#### Organization
**Class:** INDUSTRY
**Full Name:** Eli Lilly and Company
#### Secondary ID Infos
**ID:** H7X-MC-JVAB
### Status Module
#### Last Update Post Date
**Date:** 2006-07-19

**Type:** ESTIMATED

**Last Update Submit Date:** 2006-07-18

**Overall Status:** COMPLETED

#### Start Date
**Date:** 2002-06

**Status Verified Date:** 2006-07

#### Study First Post Date
**Date:** 2002-08-06
**Type:** ESTIMATED
**Study First Submit Date:** 2002-08-02
**Study First Submit QC Date:** 2002-08-05
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Eli Lilly and Company

### Description Module

**Brief Summary:** The purposes of this study are to determine the following:

Whether LY900003 plus gemcitabine and carboplatin can make your tumor smaller or disappear, and for how long.

If treatment with LY900003 plus gemcitabine and carboplatin can help you live longer.

The safety of LY900003 plus gemcitabine and carboplatin and any side effects that might be associated with the combination of these three drugs.

How LY900003 is distributed and broken down by your body when it is given with carboplatin and gemcitabine.

Whether LY900003 affects the way gemcitabine and carboplatin are distributed and broken down by your body.

**Detailed Description:** Definition: The phase 2 study will provide important information regarding effects of LY900003 on safety and efficacy of patients treated with gemcitabine and carboplatin. LY900003 will be given at approximately 2 mg/kg/day for the first 14 days of a 21-day cycle. The dose and schedule for LY900003 administration are based on results of prior studies of LY900003 and are currently being used in other studies of LY900003. Gemcitabine will be administered on Days 1 and 8 at 1250 mg/m2 and carboplatin will be given on Day 1 at AUC 5.

### Conditions Module

**Conditions:**

- Carcinoma, Non-Small-Cell Lung

- Pulmonary Neoplasms

- Neoplasms, Lung

**Keywords:**

- Non-Small-Cell Lung Cancer

- Adenocarcinoma

- Carcinoma Squamous

- Adult Lung Cancer

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Name:** Gemcitabine

**Type:** DRUG

#### Intervention 2

**Name:** Carboplatin

**Type:** DRUG

#### Intervention 3

**Name:** LY900003

**Type:** DRUG

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Diagnosis of Non-Small-Cell Lung Cancer.
* Stage IV or Stage IIIB disease.
* ECOG Performance Status of 0 or 1.
* Adequate organ function
* One unidimensionally measurable lesion.

Exclusion Criteria:

* Prior therapy for NSCLC.
* Serious concomitant disorders.
* Untreated CNS metastases.
* Uncontrolled, active infection.
* Previous LY900003/ISIS trial participation.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Bakersfield

**Country:** United States

**State:** California

**Location 2:**

**City:** Berkeley

**Country:** United States

**State:** California

**Location 3:**

**City:** Torrance

**Country:** United States

**State:** California

**Location 4:**

**City:** Miami Beach

**Country:** United States

**State:** Florida

**Location 5:**

**City:** Chicago

**Country:** United States

**State:** Illinois

**Location 6:**

**City:** Park Ridge

**Country:** United States

**State:** Illinois

**Location 7:**

**City:** Baltimore

**Country:** United States

**State:** Maryland

**Location 8:**

**City:** Chattanooga

**Country:** United States

**State:** Tennessee

**Location 9:**

**City:** Lubbock

**Country:** United States

**State:** Texas

**Location 10:**

**City:** Charlottesville

**Country:** United States

**State:** Virginia

**Location 11:**

**City:** Milwaukee

**Country:** United States

**State:** Wisconsin

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012142

- Term: Respiratory Tract Neoplasms

- ID: D000013899

- Term: Thoracic Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000002283

- Term: Carcinoma, Bronchogenic

- ID: D000001984

- Term: Bronchial Neoplasms

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

### Condition Browse Module - Browse Leaves

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M11172

- Name: Lung Neoplasms

- Relevance: HIGH

- As Found: Pulmonary Neoplasms

- ID: M5546

- Name: Carcinoma, Non-Small-Cell Lung

- Relevance: HIGH

- As Found: Carcinoma, Non-Small-Cell Lung

- ID: M3585

- Name: Adenocarcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M14979

- Name: Respiratory Tract Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M16658

- Name: Thoracic Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5540

- Name: Carcinoma, Bronchogenic

- Relevance: LOW

- As Found: Unknown

- ID: M5260

- Name: Bronchial Neoplasms

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000008175

- Term: Lung Neoplasms

- ID: D000009369

- Term: Neoplasms

- ID: D000002289

- Term: Carcinoma, Non-Small-Cell Lung

### Intervention Browse Module - Ancestors

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000000964

- Term: Antimetabolites, Antineoplastic

- ID: D000000963

- Term: Antimetabolites

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M2985

- Name: Gemcitabine

- Relevance: HIGH

- As Found: Activity

- ID: M18650

- Name: Carboplatin

- Relevance: HIGH

- As Found: System

- ID: M4281

- Name: Antimetabolites

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000016190

- Term: Carboplatin

- ID: D000093542

- Term: Gemcitabine

### Misc Info Module

- Version Holder: 2024-05-24
