Could a PARP inhibitor boost chemo for tough lung cancer?
NCT ID NCT01638546
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether adding veliparib (a PARP inhibitor) to the chemotherapy drug temozolomide helps people with small cell lung cancer that has come back or stopped responding to treatment. About 97 participants received either the drug combo or a placebo with temozolomide. The goal was to see if the combination slows cancer growth better than chemo alone.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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97 people
The number who actually took part.
- Started
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Jul 2012
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients must have histologically or cytologically confirmed small cell lung cancer; confirmation will be done at Memorial Sloan-Kettering Cancer Center (MSKCC) or locally for participating sites * Patients' disease has relapsed or progressed after one or two prior chemotherapy regimens, one of which must have been an etoposide-platinum doublet; eligible patients will be defined as follows: * "Sensitive" disease: patients who had one previous line of chemotherapy and maintained an appropriate response for \> 60 days * "Refractory" disease: those patients with either (a) no response to first-line chemotherapy or progression =\< 60 days after completing treatment, or (b) "sensitive" or "refractory" disease in need of third-line therapy (i.e. completed or failed two previous lines of chemotherapy) * Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 (Karnofsky \>= 70%) * Patients with asymptomatic brain metastases that do not require immediate whole brain radiation therapy and are on stable doses of steroids are allowed * Patients must have measurable disease, which is defined as at least one lesion that can be accurately measured in at least one dimension on a computed tomography (CT) scan as per RECIST version 1.1; brain metastases can be considered measurable disease if they meet this criterion * Absolute neutrophil count \>= 1,500/mcL * Platelets \>= 100,000/mcL * Hemoglobin \>= 8.5 g/dL; the use of transfusion to achieve this criterion should be at the discretion of the investigators * Total bilirubin =\< 1.5 mg/dL x institutional upper limit of normal * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3.0 x institutional upper limit of normal * Creatinine =\< 1.5 x institutional upper limit of normal OR creatinine clearance \>= 50 mL/min/1.73 m\^2 for patients with creatinine levels \>= 1.5 x upper limit of institutional normal * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately * For women of child-bearing potential, negative pregnancy test within 14 days prior to starting temozolomide and ABT-888 * Ability to understand and the willingness to sign a written informed consent document * Able to swallow pills * Patients will not be excluded based on the diagnosis of acquired immune deficiency syndrome (AIDS); given the increased risk of infection, these patients should have cluster of differentiation (CD)4 counts above 200 cells/mm\^3; patients with AIDS or human immunodeficiency virus (HIV) not receiving agents with the potential for pharmacokinetic interactions with ABT-888 may be eligible Exclusion Criteria: * Patients who have had chemotherapy or radiotherapy within 3 weeks prior to entering the study * Patients who have not recovered from adverse events due to agents administered more than 3 weeks earlier; toxicities should have resolved to baseline or to within one grade level of their baseline (not to exceed grade 2) * Patients who have been administered ABT-888, any other PARP-inhibitor, or temozolomide * Patients may not be receiving any other investigational agents * Patients with leptomeningeal involvement * Patients with active seizures or a history of seizures * History of allergic reactions attributed to compounds of similar chemical or biologic composition to ABT-888 or temozolomide * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with ABT-888; these potential risks also apply to temozolomide * Patients with either AIDS or HIV on combination antiretroviral therapy are ineligible * Patients with a synchronous active malignancy requiring treatment
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Case Western Reserve University
Cleveland, Ohio, 44106, United States
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Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
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Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224, United States
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Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287, United States
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Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920, United States
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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Memorial Sloan Kettering Commack
Commack, New York, 11725, United States
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Memorial Sloan Kettering Nassau
Uniondale, New York, 11553, United States
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Memorial Sloan Kettering Sleepy Hollow
Sleepy Hollow, New York, 10591, United States
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Moffitt Cancer Center
Tampa, Florida, 33612, United States
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UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
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UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
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VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298, United States
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Washington University School of Medicine
St Louis, Missouri, 63110, United States
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Other studies related to the condition(s) this trial covers.
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