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Phase II Study for Previously Untreated Subjects With Non Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Phase II Study for Previously Untreated Subjects With Non Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC)

A Randomized, Double Blind, Parallel, Three Arm Trial Evaluating the Efficacy and Safety of Ipilimumab (BMS-734016) in Combination With Paclitaxel/Carboplatin Compared to Paclitaxel/Carboplatin Alone in Previously Untreated Subjects With Lung Cancer

NCT00527735•Bristol-Myers Squibb

View on ClinicalTrials.gov

Summary

The purpose of the study is to determine whether ipilimumab given with paclitaxel/carboplatin has clinical benefit when compared with paclitaxel/carboplatin alone in patients with previously untreated lung cancer.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically or cytologically confirmed lung cancer (Stage IIIb/IV nonsmall-cell lung cancer or extensive stage small-cell lung cancer \[SCLC\])
•Measurable tumor lesion (as long as it is not located in a previously irradiated area) as defined by modified World Health Organization criteria
•Eastern Cooperative Oncology Group performance status of ≤1 at study entry
•Accessible for treatment and follow-up

Exclusion Criteria

•Brain metastases
•Malignant pleural effusion
•Autoimmune disease
•Motor neuropathy of autoimmune origin
•SCLC-related paraneoplastic syndromes
•Any concurrent malignancy other than nonmelanoma skin cancer; carcinoma in situ of the cervix or breast; or prostate cancer treated with systemic therapy (participants with a previous malignancy but without evidence of disease for 5 years were allowed to enter the study)
•Prior systemic therapy for lung cancer. Prior radiation therapy or locoregional surgeries performed later than at least 3 weeks prior to randomization date were allowed.
•* Grade 2 peripheral neuropathy (motor or sensory)
•Known HIV or hepatitis B or C infection
•Chronic use of immunosuppressants and/or systemic corticosteroids (used in the management of cancer or noncancer-related illnesses). However, use of corticosteroids was allowed if used as premedication for paclitaxel infusion or for treating immune-related adverse events or adrenal insufficiencies.
+4 more criteria

Locations (72)

Birmingham Hematology & Oncology Assoc. Llc

Birmingham, Alabama, United States

Mayo Clinic

Scottsdale, Arizona, United States

Acrc/Arizona Clinical Research Center, Inc.

Tucson, Arizona, United States

Compassionate Cancer Care Medical Group

Corona, California, United States

Compassionate Cancer Care Medical Group, Inc.

Fountain Valley, California, United States

The Angeles Clinic & Research Institute, Inc

Los Angeles, California, United States

Oncology Care Medical Associates

Montebello, California, United States

Compassionate Cancer Care Medical Group

Riverside, California, United States

Sharp Clinical Oncology Research

San Diego, California, United States

M D Anderson Cancer Center- Orlando

Orlando, Florida, United States

Key Dates

Start Date

February 1, 2008

Primary Completion Date

October 1, 2009

Completion Date

December 1, 2011

Last Updated

July 18, 2018

Enrollment

334

ACTUAL participants

Conditions

Lung CancerSmall Cell Lung CancerCarcinoma, Non-Small-Cell Lung

Interventions

Ipilimumab

DRUG

Placebo

DRUG

Paclitaxel

DRUG

Carboplatin

DRUG

Andamertinib With or Without Platinum-doublet Chemotherapy Versus Platinum-doublet Chemotherapy in Patients With NSCLC Harboring Atypical EGFR Mutations

NCT07336732

Non-Small-Cell Lung Cancer

View study

RECRUITINGPHASE3

Immunotherapy After Surgery for People Who Have No Remaining Cancer Cells After Standard Treatment for Early-Stage Non-Small Cell Lung Cancer, INSIGHT Trial

NCT06498635

Lung Non-Small Cell CarcinomaStage II Lung Cancer AJCC v8+2 more

View study

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: July 18, 2018Data 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 II Study for Previously Untreated Subjects With Non Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC)

Inclusion Criteria

Exclusion Criteria

Andamertinib With or Without Platinum-doublet Chemotherapy Versus Platinum-doublet Chemotherapy in Patients With NSCLC Harboring Atypical EGFR Mutations

Immunotherapy After Surgery for People Who Have No Remaining Cancer Cells After Standard Treatment for Early-Stage Non-Small Cell Lung Cancer, INSIGHT Trial

Testing the Addition of an Anti-Cancer Drug, TRC102, to the Usual Chemotherapy Treatment (Pemetrexed, Cisplatin or Carboplatin) During Radiation Therapy for Stage III Non-Squamous Non-Small Cell Lung Cancer

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors