Cisplatin and Etoposide With or Without Veliparib in Treating Patients With Extensive Stage Small Cell Lung Cancer

Study summary

This randomized phase I/II trial studies the side effects and best dose of veliparib when given together with or without cisplatin and etoposide and to see how well they work in treating patients with extensive stage small cell lung cancer or large cell neuroendocrine non-small cell lung cancer that has spread to other parts of the body. Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving cisplatin and etoposide with or without veliparib may work better in treating patients with extensive stage small cell lung cancer or metastatic large cell neuroendocrine non-small cell lung cancer.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedCisplatin and Etoposide

Plus 2 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Small cell lung cancer (SCLC) · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jun 24, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?428 U.S. locations

Locations may change over time.

Who runs it?National Cancer Institute (NCI)

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1 / Phase 2
Sponsor: National Cancer Institute (NCI)
Interventions being studied: Drug: Cisplatin; Drug: Etoposide; Drug: Veliparib; Drug: Placebo

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→Small cell lung cancer (SCLC)→

Disease setting

Metastatic or stage IV→

Treatment approach

Chemotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

PHASE I (phase I):
Women must not be pregnant or breastfeeding; breastfeeding must be discontinued or the subject is not eligible for the study
All females of childbearing potential must have a blood test within 2 weeks prior to randomization to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception
Patients must have histologically or cytologically confirmed:
Extensive stage small cell lung cancer (SCLC) or
Stage IV (M1a or M1b according to American Joint Committee on Cancer \[AJCC\] Staging Manual, 7th edition) large cell neuroendocrine non-small cell lung cancer (NSCLC) or
Small cell carcinoma of unknown primary or extrapulmonary origin and must be a candidate for systemic therapy
NOTE: The extensive disease SCLC classification for this protocol includes all patients with disease sites not defined as limited stage; limited stage disease category includes patients with disease restricted to one hemithorax with regional lymph node metastases, including hilar, ipsilateral and contralateral mediastinal, and/or ipsilateral supraclavicular nodes; extensive disease patients are defined as those patients with extrathoracic metastatic disease, malignant pleural effusion, bilateral or contralateral supraclavicular adenopathy
Patients must have measurable or non-measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1; baseline measurements and evaluations of all sites of disease must be obtained =\< 4 weeks prior to registration (Phase I)
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Absolute neutrophil count \>= 1,500/mm\^3
Platelets \>= 100,000/mm\^3
Leukocytes \>= 3,000/mm\^3
Hemoglobin \>= 9 g/dL
Total bilirubin =\< 1.5 times institutional upper limit of normal (ULN)
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase\[SGPT\]) =\< 3 times institutional ULN (=\< 5 times if liver function test \[LFT\] elevations due to known liver metastases)
Creatinine =\< 1.5 X ULN OR creatinine clearance \>= 60 mL/min/1.73 m\^2 for patients with creatinine levels \> 1.5 x ULN
Patients with central nervous system (CNS) metastases or a history of CNS metastases are ineligible
Patients cannot have had prior chemotherapy or biologic therapy for SCLC or large cell neuroendocrine NSCLC, or small cell carcinoma of unknown primary or extrapulmonary origin; patients receiving prior radiation cannot register within 7 days after completion of radiation, and must have resolved adverse events attributed to radiation to =\< grade 1; no previous irradiation to the only site of measurable or evaluable disease, unless that site had subsequent evidence of progression
Patients receiving prior radiation cannot register within 7 days after completion of radiation, and must have resolved adverse events attributed to radiation to =\< grade 1; no previous irradiation to the only site of measurable or evaluable disease, unless that site had subsequent evidence of progression
Patients must NOT have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible
Patient must be able to swallow pills

Reasons someone may not be able to joinExclusion criteria

(phase I):
Patients have active seizure(s) or history of seizure(s)
Patients have history of allergic reactions attributed to compounds of similar chemical or biologic composition to veliparib or other agents used in the study PHASE II Inclusion Criteria (phase II):
Women must not be pregnant or breastfeeding; breastfeeding must be discontinued or the subject is not eligible for the study
All females of childbearing potential must have a blood test within 2 weeks prior to randomization to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) with the current month counted as month 1
Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception
Patients must have extensive stage, histologically or cytologically confirmed small cell lung cancer; NOTE: the extensive disease classification for this protocol includes all patients with disease sites not defined as limited stage; limited stage disease category includes patients with disease restricted to one hemithorax with regional lymph node metastases, including hilar, ipsilateral and contralateral mediastinal, and/or ipsilateral supraclavicular nodes; extensive disease patients are defined as those patients with extrathoracic metastatic disease, malignant pleural effusion, bilateral or contralateral supraclavicular adenopathy
Patients must have measurable disease based on RECIST 1.1; baseline measurements and evaluations of all sites of disease must be obtained =\< 4 weeks prior to registration
ECOG performance status 0 or 1
Absolute neutrophil count \>= 1,500/mm\^3
Platelets \>= 100,000/mm\^3
Leukocytes \>= 3,000/mm\^3
Hemoglobin \>= 9 g/dL
Total bilirubin =\< 1.5 times institutional upper limit of normal (ULN)
AST (SGOT) and ALT (SGPT) =\< 3 times institutional ULN (=\< 5 times if LFT elevations due to known liver metastases)
Creatinine =\< 1.5 X ULN OR creatinine clearance \>= 60 mL/min/1.73 m\^2 for patients with creatinine levels \> 1.5 x ULN
Patients cannot have had prior chemotherapy or biologic therapy for small cell lung cancer; patients receiving prior radiation cannot register within 7 days after completion of radiation, and must have resolved adverse events attributed to radiation to =\< grade 1; no previous irradiation to the only site of measurable or evaluable disease, unless that site had subsequent evidence of progression
Patient must be able to swallow pills
Patients may not be receiving any other investigational agents while on study

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Loma Linda University Medical CenterLoma Linda, California
Stanford Cancer Institute Palo AltoPalo Alto, California
Rocky Mountain Cancer Centers-AuroraAurora, Colorado
The Medical Center of AuroraAurora, Colorado
Boulder Community HospitalBoulder, Colorado
Rocky Mountain Cancer Centers-BoulderBoulder, Colorado
Penrose-Saint Francis HealthcareColorado Springs, Colorado
Rocky Mountain Cancer Centers-PenroseColorado Springs, Colorado
Porter Adventist HospitalDenver, Colorado
Colorado Blood Cancer InstituteDenver, Colorado
Presbyterian - Saint Lukes Medical Center - Health OneDenver, Colorado
Rocky Mountain Cancer Centers-MidtownDenver, Colorado

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 24, 2026. Always confirm current availability with the study team.

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