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

NCT00527735 | Completed Phase 2 Results DMC

• 1 other identifier: CA184-041
• Study Type: interventional
• Target: 334
• Locations: 8 countries
• Sites: 72

Brief 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.

Conditions

Lung Cancer; Small Cell Lung Cancer; Carcinoma, Non-Small-Cell Lung

Keywords

Non Small Cell Lung Cancer (NSCLC); Small Cell Lung Cancer (SCLC)

Outcome Measures

Primary Outcomes (1)

• Immune-related Progression-free Survival (irPFS) in Participants With Nonsmall-cell Lung Cancer (NSCLC) Per Immune-related Response Criteria (irRC)

  irPFS is defined as the time between the randomization date and date of immune-related Progressive Disease (irPD) (at least 25% increase percentage change in total tumor burden, including new lesions) or death, whichever occurs first. For patients with no recorded postbaseline tumor assessments, irPFS is censored at randomization. Participant who die without reported irPD are considered to have progressed on the date of death. For those who remain alive and have no irPD, irPFS is censored on the date of last evaluable tumor assessment. Independent review committee performed tumor assessment.

  Tumor assessed at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance until immune-related Progressive Disease (irPD) or death (of censored, maximum reached: 16.5 months)

Secondary Outcomes (21)

• Progression-free Survival (PFS) in Participants With NSCLC Per Modified World Health Organization (mWHO) Criteria

  Randomization date to date of progression or death (of censored, maximum reached: 13.6 months)

• Overall Survival in Participants With NSCLC

  Randomization date to date of death (of censored, maximum reached: 26.5 months)

• Best Overall Response Rate (BORR) Per mWHO Criteria in Participants With NSCLC and SCLC

  Tumor assessment at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance

• Immune-related Best Overall Response Rate (irBORR) Per irRC in Participants With NSCLC and Small-cell Lung Cancer (SCLC)

  Tumor assessment at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance

• Immune-related Disease Control Rate (irDCR) Per irRC and Disease Control Rate (DCR) Per mWHO Criteria in Participants With NSCLC and SCLC

  Tumor assessment at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance until irPD, progressive disease, or death (maximum reached: 22 months)

Study Arms (3)

Ipilimumab/ placebo + paclitaxel + carboplatin (concurrent)

EXPERIMENTAL

Drug: Ipilimumab; Drug: Placebo; Drug: Paclitaxel; Drug: Carboplatin

Ipilimumab/ placebo + paclitaxel + carboplatin (sequential)

EXPERIMENTAL

Drug: Ipilimumab; Drug: Placebo; Drug: Paclitaxel; Drug: Carboplatin

Ipilimumab placebo + paclitaxel + carboplatin

ACTIVE COMPARATOR

Drug: Placebo; Drug: Paclitaxel; Drug: Carboplatin

Interventions

Ipilimumab DRUG

Ipilimumab, 10 mg/kg, administered as a single-dose, intravenously (IV), over 90 minutes depending on randomization every 3 weeks (up to 6 doses). Participants could receive additional maintenance ipilimumab at a dose of 10 mg/kg every 12 weeks starting 24 weeks after the first ipilimumab dose.

Ipilimumab/ placebo + paclitaxel + carboplatin (concurrent); Ipilimumab/ placebo + paclitaxel + carboplatin (sequential)

Placebo DRUG

Matched placebo for ipilimumab administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants could also receive additional maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first placebo dose.

Ipilimumab placebo + paclitaxel + carboplatin; Ipilimumab/ placebo + paclitaxel + carboplatin (concurrent); Ipilimumab/ placebo + paclitaxel + carboplatin (sequential)

Paclitaxel DRUG

175 mg/m\^2, administered as a single IV dose over 3 hours every 3 weeks (up to 6 doses). Dose modifications (reductions as well as delays) done as per product label.

Ipilimumab placebo + paclitaxel + carboplatin; Ipilimumab/ placebo + paclitaxel + carboplatin (concurrent); Ipilimumab/ placebo + paclitaxel + carboplatin (sequential)

Carboplatin DRUG

Area under the concentration curve (AUC)=6, administered as a single IV dose over 30 minutes every 3 weeks (up to 6 doses) as per randomization. Dose modifications (reductions as well as delays) done as per product label.

Ipilimumab placebo + paclitaxel + carboplatin; Ipilimumab/ placebo + paclitaxel + carboplatin (concurrent); Ipilimumab/ placebo + paclitaxel + carboplatin (sequential)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• Inadequate hematologic function defined by an absolute neutrophil count \<1,500/mm\^3, a platelet count \<100,000/mm\^3, or hemoglobin level \<9 g/dL.
• Inadequate hepatic function defined by a total bilirubin level \>2.0 times the upper limit of normal (ULN), or ≥2.5 times the ULN if liver metastases are present, aspartate aminotransferase and alanine aminotransferase levels ≥2.5 times the ULN or ≥5 times the ULN if liver metastases are present.
• Inadequate renal function defined by a serum creatinine level ≥2.5 times the ULN
• Inadequate creatinine clearance defined as less than 50 mL/min.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (72)

Birmingham Hematology & Oncology Assoc. Llc

Birmingham, Alabama, 35235, United States

Location

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

Acrc/Arizona Clinical Research Center, Inc.

Tucson, Arizona, 85715, United States

Location

Compassionate Cancer Care Medical Group

Corona, California, 92879, United States

Location

Compassionate Cancer Care Medical Group, Inc.

Fountain Valley, California, 92708, United States

Location

The Angeles Clinic & Research Institute, Inc

Los Angeles, California, 90025, United States

Location

Oncology Care Medical Associates

Montebello, California, 90640, United States

Location

Compassionate Cancer Care Medical Group

Riverside, California, 92501, United States

Location

Sharp Clinical Oncology Research

San Diego, California, 92123, United States

Location

M D Anderson Cancer Center- Orlando

Orlando, Florida, 32806, United States

Location

Georgia Cancer Specialists

Atlanta, Georgia, 30341, United States

Location

University Of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Local Institution

Park Ridge, Illinois, 60068, United States

Location

Kentucky Cancer Clinic

Hazard, Kentucky, 41701, United States

Location

The John R. Marsh Cancer Center

Hagerstown, Maryland, 21740, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

The Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

Nevada Cancer Institute

Las Vegas, Nevada, 89135, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Local Institution

New York, New York, 10017, United States

Location

Cmc-Northeast/ Northeast Oncology Associates

Concord, North Carolina, 28025, United States

Location

Gabrail Cancer Center

Canton, Ohio, 44718, United States

Location

Hematology Oncology Consultants, Inc

Columbus, Ohio, 43235, United States

Location

St. Mary Medical Center

Langhorne, Pennsylvania, 19047, United States

Location

Guthrie Clinical Research

Sayre, Pennsylvania, 18840, United States

Location

Santee Hematology/Oncology

Sumter, South Carolina, 29150, United States

Location

Southwest Cancer Treatment And Research Center

Lubbock, Texas, 79415, United States

Location

Local Institution

Belfort, 90016, France

Location

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Caen, 14076, France

Location

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Marseille, 13274, France

Location

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Rennes, 35033, France

Location

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Bochum, 44791, Germany

Location

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Cologne, 51109, Germany

Location

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Coswig, 01640, Germany

Location

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Ebensfeld, 96250, Germany

Location

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Großhansdorf, 22927, Germany

Location

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Halle, 06120, Germany

Location

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Hamburg, 21075, Germany

Location

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Leipzig, 04103, Germany

Location

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Mainz, 55131, Germany

Location

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München, 81675, Germany

Location

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Hyderabad, Andhra Pradesh, 500082, India

Location

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Navrangpura, Ahmedabad, Gujarat, 380009, India

Location

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Manipal, Karnataka, 576104, India

Location

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Trivandrum, Kerala, 695011, India

Location

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Vellore, 632004, India

Location

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Genova, 16132, Italy

Location

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Siena, 53100, Italy

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Torino, 10143, Italy

Location

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Gdansk, 80-952, Poland

Location

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Krakow, 31-826, Poland

Location

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Olsztyn, 10-513, Poland

Location

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Szczecin, 70-891, Poland

Location

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Arkhangelsk, 163045, Russia

Location

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Chelyabinsk, 454087, Russia

Location

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Ivanovo, 153013, Russia

Location

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Moscow, 105077, Russia

Location

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Moscow, 115478, Russia

Location

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Moscow, 125284, Russia

Location

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Pyatigorsk, 357502, Russia

Location

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Saint Petersburg, 190005, Russia

Location

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Saint Petersburg, 194044, Russia

Location

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Saint Petersburg, 194291, Russia

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Saint Petersburg, 197022, Russia

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Saint Petersburg, 198255, Russia

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Sochi, 354057, Russia

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Dnipropetrovsk, 49102, Ukraine

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Donetsk, 83092, Ukraine

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Kharkiv, 46023, Ukraine

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Lviv, 79031, Ukraine

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Ternopil, 46023, Ukraine

Location

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Uzhhorod, 88014, Ukraine

Location

MeSH Terms

Conditions

Lung Neoplasms; Small Cell Lung Carcinoma; Carcinoma, Non-Small-Cell Lung

Interventions

Ipilimumab; Paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Results Point of Contact

• Title: BMS Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2007
• First Posted: September 11, 2007
• Study Start: February 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: December 1, 2011
• Last Updated: July 18, 2018
• Results First Posted: July 16, 2012

Record last verified: 2018-06

Locations

IN (5); DE (10); FR (4); PL (4); IT (3); UA (6); US (27); RU (13)