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)
Public ClinicalTrials.gov record NCT01082549. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
To evaluate the overall survival (OS) of patients with advanced squamous cell lung cancer receiving the combination of gemcitabine/carboplatin either with or without Iniparib. Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines. Investigations into potential targets of iniparib and its metabolites are ongoing.
Study identification
- NCT ID
- NCT01082549
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 780 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 2010 (Type not available)
- Primary completion
- Apr 2013 (Actual)
- Completion
- Apr 2013 (Actual)
- Last update posted
- Mar 17, 2016
2010 – 2013
United States locations
- U.S. sites
- 67
- U.S. states
- 30
- U.S. cities
- 64
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 840306 | Birmingham | Alabama | 35205 | — |
| Investigational Site Number 840207 | Huntsville | Alabama | 35805 | — |
| Investigational Site Number 840351 | Muscle Shoals | Alabama | 35661 | — |
| Investigational Site Number 840338 | Anaheim | California | 92801 | — |
| Investigational Site Number 840353 | Burbank | California | 91505 | — |
| Investigational Site Number 840341 | Concord | California | 73112 | — |
| Investigational Site Number 840317 | Duarte | California | 91010 | — |
| Investigational Site Number 840339 | La Verne | California | 91750 | — |
| Investigational Site Number 840309 | Loma Linda | California | 92354 | — |
| Investigational Site Number 840307 | Los Angeles | California | 90095-7059 | — |
| Investigational Site Number 840327 | Maywood | California | 60153 | — |
| Investigational Site Number 840303 | San Diego | California | 92123 | — |
| Investigational Site Number 840321 | Santa Rosa | California | 95403 | — |
| Investigational Site Number 840326 | Stockton | California | 95204 | — |
| Investigational Site Number 840310 | Vallejo | California | 94589 | — |
| Investigational Site Number 840336 | Denver | Colorado | 80205 | — |
| Investigational Site Number 840346 | Norwich | Connecticut | 06360 | — |
| Investigational Site Number 840315 | Newark | Delaware | 19713 | — |
| Investigational Site Number 840216 | Fort Lauderdale | Florida | 33308 | — |
| Investigational Site Number 840215 | Jacksonville | Florida | 32256 | — |
| Investigational Site Number 840217 | Lakeland | Florida | 33805 | — |
| Investigational Site Number 840205 | Orlando | Florida | 32804 | — |
| Investigational Site Number 840104 | Sarasota | Florida | 34236 | — |
| Investigational Site Number 840343 | Athens | Georgia | 30607 | — |
| Investigational Site Number 840213 | Augusta | Georgia | 30901 | — |
| Investigational Site Number 840347 | Augusta | Georgia | 30901 | — |
| Investigational Site Number 840201 | Gainesville | Georgia | 30501 | — |
| Investigational Site Number 840301 | Lawrenceville | Georgia | 30045 | — |
| Investigational Site Number 840305 | Marietta | Georgia | 30060 | — |
| Investigational Site Number 840314 | Tucker | Georgia | 30084 | — |
| Investigational Site Number 840313 | Chicago | Illinois | 60637 | — |
| Investigational Site Number 840218 | Evansville | Indiana | 47630 | — |
| Investigational Site Number 840319 | Indianapolis | Indiana | 46260 | — |
| Investigational Site Number 840329 | South Bend | Indiana | 46601 | — |
| Investigational Site Number 840316 | Wichita | Kansas | 67214 | — |
| Investigational Site Number 840320 | Louisville | Kentucky | 40202 | — |
| Investigational Site Number 840308 | Scarborough | Maine | 04074-9308 | — |
| Investigational Site Number 840202 | Bethesda | Maryland | 20817 | — |
| Investigational Site Number 840345 | Salisbury | Maryland | 21801 | — |
| Investigational Site Number 840337 | Royal Oak | Michigan | 48073 | — |
| Investigational Site Number 840328 | Saint Louis Park | Minnesota | 55426 | — |
| Investigational Site Number 840210 | Bridgeton | Missouri | 63044 | — |
| Investigational Site Number 840212 | Omaha | Nebraska | 68114 | — |
| Investigational Site Number 840318 | Las Vegas | Nevada | 89135 | — |
| Investigational Site Number 840204 | Morristown | New Jersey | 07960 | — |
| Investigational Site Number 840350 | Chapel Hill | North Carolina | 27599 | — |
| Investigational Site Number 840330 | Durham | North Carolina | 27710 | — |
| Investigational Site Number 840105 | Cincinnati | Ohio | 45242 | — |
| Investigational Site Number 840302 | Cleveland | Ohio | 44106 | — |
| Investigational Site Number 840348 | Cleveland | Ohio | 44195 | — |
| Investigational Site Number 840335 | Columbus | Ohio | 43219 | — |
| Investigational Site Number 840311 | Bend | Oregon | 97701 | — |
| Investigational Site Number 840211 | West Reading | Pennsylvania | 19611 | — |
| Investigational Site Number 840352 | Charleston | South Carolina | 29403 | — |
| Investigational Site Number 840106 | Columbia | South Carolina | 29210 | — |
| Investigational Site Number 840220 | Spartanburg | South Carolina | 29303 | — |
| Investigational Site Number 840103 | Chattanooga | Tennessee | 37404 | — |
| Investigational Site Number 840208 | Chattanooga | Tennessee | 37404 | — |
| Investigational Site Number 840203 | Collierville | Tennessee | 38017 | — |
| Investigational Site Number 840101 | Nashville | Tennessee | 37203 | — |
| Investigational Site Number 840323 | Fort Worth | Texas | 76104 | — |
| Investigational Site Number 840219 | Newport News | Virginia | 23601 | — |
| Investigational Site Number 840102 | Richmond | Virginia | 23230 | — |
| Investigational Site Number 840312 | Seattle | Washington | 98104 | — |
| Investigational Site Number 840344 | Tacoma | Washington | 98405 | — |
| Investigational Site Number 840322 | Morgantown | West Virginia | 26506 | — |
| Investigational Site Number 840331 | Wauwatosa | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 75 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01082549, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 17, 2016 · Synced Oct 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01082549 live on ClinicalTrials.gov.