Clinical trial · Interventional
Temozolomide With or Without Veliparib in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer
A Multi-Center, Randomized, Double-Blind Phase II Study Comparing ABT-888, a PARP Inhibitor, Versus Placebo With Temozolomide in Patients With Relapsed Sensitive or Refractory Small Cell Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This randomized phase II trial studies how well temozolomide with or without veliparib works in treating patients with small cell lung cancer that has returned or does not respond to treatment. Temozolomide works by damaging molecules inside the cancer cells, such as deoxyribonucleic acid (DNA), that are needed for cancer survival and growth. Veliparib may stop the growth of tumor cells by blocking proteins that are needed for repairing the damaged DNA and it may also help temozolomide to kill more cancer cells. It is not yet know whether temozolomide is more effective with or without veliparib in treating patients with relapsed or refractory small cell lung cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Lung Small Cell Carcinoma | Lung Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Placebo Administration | Other | — | UNRESOLVED |
| Temozolomide | Drug | Temozolomide | ALIAS |
| Veliparib | Drug | Veliparib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (veliparib and temozolomide)
- description
- Patients receive veliparib PO BID on days 1-7 and temozolomide PO on days 1-5.
- interventionNames
- Other: Laboratory Biomarker Analysis
- Drug: Temozolomide
- Drug: Veliparib
- type
- ACTIVE_COMPARATOR
- label
- Arm II (placebo and temozolomide)
- description
- Patients receive placebo PO BID on days 1-7 and temozolomide as in Arm I.
- interventionNames
- Other: Laboratory Biomarker Analysis
- Other: Placebo Administration
- Drug: Temozolomide
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDPietanza MC, Waqar SN, Krug LM, Dowlati A, Hann CL, Chiappori A, Owonikoko TK, Woo KM, Cardnell RJ, Fujimoto J, Long L, Diao L, Wang J, Bensman Y, Hurtado B, de Groot P, Sulman EP, Wistuba II, Chen A, Fleisher M, Heymach JV, Kris MG, Rudin CM, Byers LA. Randomized, Double-Blind, Phase II Study of Temozolomide in Combination With Either Veliparib or Placebo in Patients With Relapsed-Sensitive or Refractory Small-Cell Lung Cancer. J Clin Oncol. 2018 Aug 10;36(23):2386-2394. doi: 10.1200/JCO.2018.77.7672. Epub 2018 Jun 15. PMID 29906251