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Randomized Phase 3 Trial of Gemcitabine/Carboplatin With or Without Iniparib (SAR240550) (a PARP1 Inhibitor) in Subjects With Previously Untreated Stage IV Squamous Non-Small-Cell Lung Cancer (NSCLC)


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Squamous Cell Lung Cancer

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Trial Information

Randomized Phase 3 Trial of Gemcitabine/Carboplatin With or Without Iniparib (SAR240550) (a PARP1 Inhibitor) in Subjects With Previously Untreated Stage IV Squamous Non-Small-Cell Lung Cancer (NSCLC)


Inclusion Criteria:



Eligible patients must meet the following criteria to be enrolled in the study:

1. Newly diagnosed, stage IV squamous cell lung cancer. This includes patients who
present with disseminated metastases, and those with a malignant pleural or
pericardial effusion (i.e., formerly stage IIIB in the 6th TNM staging system).

2. Patients who have received prior adjuvant therapy for early-stage lung cancer are
eligible if at least 12 months have elapsed from that treatment.

3. Histologically confirmed squamous cell bronchogenic carcinoma. Patients whose tumors
contain mixed non-small cell histologies are eligible, as long as squamous carcinoma
is the predominant histology. Mixed tumors with small cell anaplastic elements are
not eligible. Cytologic specimens obtained by brushings, washings, or needle
aspiration of the defined lesion are acceptable.

4. Patients with previous radiotherapy as definitive therapy for locally advanced
non-small cell lung cancer are eligible, as long as the recurrence is outside the
original radiation therapy port. Radiation therapy must have been completed >4 weeks
prior to the initiation of study treatment. Patients who have received
chemo/radiation for locally advanced NSCLC are not eligible. Patients who have
received palliative radiation therapy for symptomatic metastases must have completed
treatment >14 days prior the initiation of the study treatment.

5. Presence of evaluable (measureable or non-measurable) disease.

6. ECOG Performance Status of 0 or 1.

7. Laboratory values as follows:

- Absolute neutrophil count (ANC) >1,500/microL and platelets >100,000/microL (≤72
hours prior to initial treatment).

- Hemoglobin >9 g/dL (Note: Patients may be transfused or receive erythropoietin
to maintain or exceed this level).

- Bilirubin < ULN.

- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times
the upper limit of normal if no liver involvement or ≤5 times the upper limit of
normal with liver involvement.

- Creatinine <2.0 mg/dL, or creatinine clearance >40 mL/min (as calculated by the
Cockcroft-Gault method.

8. Women of childbearing potential must have a negative serum pregnancy test performed
within 7 days prior to start of treatment. Women of childbearing potential or men
with partners of childbearing potential must use effective birth control measures
during treatment and at least 6 months after the last dose of the study treatment.
If a woman becomes pregnant or suspects she is pregnant while participating in this
study, she must agree to inform her treating physician immediately. Sexually active
men must agree to use a medically acceptable form of birth control during treatment
and at least 6 months after the last dose. If a female partner becomes pregnant
during the course of the study the treating physician should be informed immediately.

9. >18 years of age.

10. Ability to understand the nature of this study, give written informed consent, and
comply with study requirements.

11. Patients entering this study must be willing to provide tissue from a previous tumor
biopsy (if available) for correlative testing. An exception to this is when the
national/local regulations prohibits some of the key activities of this research like
the export of samples to third countries, storage of coded samples or global gene
expression profiling without a pre-specified list of target genes. If tissue is not
available, a patient will still be eligible for enrollment into the study.

Exclusion Criteria:

1. Prior treatment with gemcitabine, carboplatin (except in the adjuvant setting), or
Iniparib.

2. Past or current history of neoplasm other than the entry diagnosis, with the
exception of treated non-melanoma skin cancer or carcinoma in-situ of any primary
site, or invasive cancers treated definitively, with treatment ending >5 years
previously and no evidence of recurrences.

3. A history of cardiac disease, as defined by:

- Malignant hypertension

- Unstable angina

- Congestive heart failure

- Myocardial infarction within the previous 6 months

- Symptomatic, unstable or uncontrolled, cardiac arrhythmias. Patients who have
stable, rate-controlled atrial fibrillation are eligible for study enrollment.

4. Active brain metastases. Patients with treated brain metastases are eligible, if (1)
radiation therapy was completed at least 2 weeks prior to study entry; (2) follow-up
scan shows no disease progression; and (3) patient does not require steroids.

5. Women who are pregnant or lactating.

6. Any serious, active infection (> Grade 2) at the time of treatment.

7. A serious underlying medical condition that would impair the ability of the patient
to receive protocol treatment.

8. A major surgical procedure, or significant traumatic injury ≤28 days of beginning
treatment, or anticipation of the need for major surgery during the course of the
study.

9. Uncontrolled or intercurrent illness including, that in the opinion of the
investigator may increase the risks associated with study participation or
administration of the investigational products, or that may interfere with the
interpretation of the results.

10. History of any medical or psychiatric condition or laboratory abnormality that, in
the opinion of the investigator, may increase the risks associated with the study
participation or administration of the investigational products, or that may
interfere with the interpretation of the results.

11. Known or suspected allergy/hypersensitivity to any agent given in the course of this
trial.

The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall survival

Outcome Time Frame:

12 months, 24 months

Safety Issue:

No

Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

United States: Food and Drug Administration

Study ID:

EFC11553

NCT ID:

NCT01082549

Start Date:

March 2010

Completion Date:

July 2013

Related Keywords:

  • Squamous Cell Lung Cancer
  • Patients with Previously Untreated Advanced Squamous Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Investigational Site Number 840306Birmingham, Alabama  35205
Investigational Site Number 840207Huntsville, Alabama  35805
Investigational Site Number 840351Muscle Shoals, Alabama  35661
Investigational Site Number 840338Anaheim, California  92801
Investigational Site Number 840353Burbank, California  91505
Investigational Site Number 840341Concord, California  73112
Investigational Site Number 840317Duarte, California  91010
Investigational Site Number 840339La Verne, California  91750
Investigational Site Number 840309Loma Linda, California  92354
Investigational Site Number 840307Los Angeles, California  90095-7059
Investigational Site Number 840327Maywood, California  60153
Investigational Site Number 840303San Diego, California  92123
Investigational Site Number 840321Santa Rosa, California  95403
Investigational Site Number 840326Stockton, California  95204
Investigational Site Number 840310Vallejo, California  94589
Investigational Site Number 840336Denver, Colorado  80205
Investigational Site Number 840346Norwich, Connecticut  06360
Investigational Site Number 840315Newark, Delaware  19713
Investigational Site Number 840216Ft. Lauderdale, Florida  33308
Investigational Site Number 840215Jacksonville, Florida  32256
Investigational Site Number 840217Lakeland, Florida  33805
Investigational Site Number 840205Orlando, Florida  32804
Investigational Site Number 840104Sarasota, Florida  34236
Investigational Site Number 840343Athens, Georgia  30607
Investigational Site Number 840213Augusta, Georgia  30901
Investigational Site Number 840347Augusta, Georgia  30901
Investigational Site Number 840201Gainesville, Georgia  30501
Investigational Site Number 840301Lawrenceville, Georgia  30045
Investigational Site Number 840305Marietta, Georgia  30060
Investigational Site Number 840314Tucker, Georgia  30084
Investigational Site Number 840313Chicago, Illinois  60637
Investigational Site Number 840218Evansville, Indiana  47630
Investigational Site Number 840319Indianapolis, Indiana  46260
Investigational Site Number 840329South Bend, Indiana  46601
Investigational Site Number 840316Wichita, Kansas  67214
Investigational Site Number 840320Louisville, Kentucky  40202
Investigational Site Number 840308Scarborough, Maine  04074-9308
Investigational Site Number 840202Bethesda, Maryland  20817
Investigational Site Number 840345Salisbury, Maryland  21801
Investigational Site Number 840337Royal Oak, Michigan  48073
Investigational Site Number 840328St. Louis Park, Minnesota  55426
Investigational Site Number 840210Bridgeton, Missouri  63044
Investigational Site Number 840212Omaha, Nebraska  68114
Investigational Site Number 840318Las Vegas, Nevada  89135
Investigational Site Number 840204Morristown, New Jersey  07960
Investigational Site Number 840350Chapel Hill, North Carolina  27599
Investigational Site Number 840330Durham, North Carolina  27710
Investigational Site Number 840105Cincinnati, Ohio  45242
Investigational Site Number 840302Cleveland, Ohio  44106
Investigational Site Number 840348Cleveland, Ohio  44195
Investigational Site Number 840335Columbus, Ohio  43219
Investigational Site Number 840311Bend, Oregon  97701
Investigational Site Number 840211West Reading, Pennsylvania  19611
Investigational Site Number 840352Charleston, South Carolina  29403
Investigational Site Number 840106Columbia, South Carolina  29210
Investigational Site Number 840220Spartanburg, South Carolina  29303
Investigational Site Number 840103Chattanooga, Tennessee  37404
Investigational Site Number 840208Chattanooga, Tennessee  37404
Investigational Site Number 840203Collierville, Tennessee  38017
Investigational Site Number 840101Nashville, Tennessee  37203
Investigational Site Number 840323Fort Worth, Texas  76104
Investigational Site Number 840219Newport News, Virginia  23601
Investigational Site Number 840102Richmond, Virginia  23230
Investigational Site Number 840312Seattle, Washington  98104
Investigational Site Number 840344Tacoma, Washington  98405
Investigational Site Number 840322Morgantown, West Virginia  26506
Investigational Site Number 840331Wauwatosa, Wisconsin  53226