NCT01386385|Active Not RecruitingPhase 1Results

Veliparib With or Without Radiation Therapy, Carboplatin, and Paclitaxel in Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed by Surgery

A Dose Finding Study Followed by Phase II Randomized, Placebo-Controlled Study of Veliparib (ABT-888) Added to Chemoradiotherapy With Carboplatin and Paclitaxel for Unresectable Stage III Non-small Cell Lung Cancer (NSCLC), (NCI Study Number 8811)

National Cancer Institute (NCI)ClinicalTrials.gov

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9 other identifiers

NCI-2011-02592CHNMC-PHII-111CDR0000701003PHII-111S12068811N01CM62209U10CA032102U10CA180888

Study Type

interventional

Target

Locations

1 country

Sites

234

Timeline

RegisteredJul 2011

StartedJun 2011

CompletionDec 2026

Brief Summary

This phase I/II partially randomized trial studies the side effects and best dose of veliparib when given together with radiation therapy, carboplatin, and paclitaxel and to see how well it works in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as carboplatin and paclitaxel, 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. It is not yet known whether radiation therapy, carboplatin, and paclitaxel are more effective with or without veliparib in treating non-small cell lung cancer.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_1

Timeline

8mo left

Started Jun 2011

Longer than P75 for phase_1

Geographic Reach

1 country

234 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

15.5 years study duration

Study Progress96%

Jun 2011Dec 2026

Study Start

First participant enrolled

June 20, 2011

Completed

10 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2011

Completed

1 day until next milestone

First Posted

Study publicly available on registry

July 1, 2011

Completed

7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 26, 2019

Completed

2.1 years until next milestone

Results Posted

Study results publicly available

July 12, 2021

Completed

5.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected

Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

7.9 years

First QC Date

June 30, 2011

Results QC Date

May 6, 2021

Last Update Submit

April 17, 2026

Conditions

Lung Adenocarcinoma Lung Adenocarcinoma, Mixed Subtype Lung Squamous Cell Carcinoma Stage IIIA Lung Non-Small Cell Cancer AJCC v7 Minimally Invasive Lung Adenocarcinoma Lung Large Cell Carcinoma Stage III Lung Non-Small Cell Cancer AJCC v7 Stage IIIB Lung Non-Small Cell Cancer AJCC v7

Outcome Measures

Primary Outcomes (2)

Maximum Tolerated Dose of Veliparib When Given Concurrently With Standard Carboplatin/Paclitaxel and Radiotherapy, Determined According to Incidence of Dose Limiting Toxicity (DLT) (Phase I)
DLTs will be graded using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. DLTs must be attributable (probably, possibly, definitely related) to the study regimen and only occur during RT or 2 weeks after completing RT. DLTs are defined as: 1. Radiation esophagitis or dermatitis radiation Grade 3 that lasts \> 7 consecutive days or Grade 4 2. Grade 4 neutropenia for \> 7 days or neutropenic fever ( ANC \<500 and temperature \>= 38.5 oC) 3. Grade 4 thrombocytopenia 4. Grade 4 nausea/vomiting despite appropriate antiemetic therapy 5. Delays in radiotherapy or chemotherapy or ABT-888 due to toxicity of \> 3 weeks 6. All other non-hematologic toxicities \>= Grade 3, except * anorexia * fatigue * infection without neutropenia * Grade 3 AST/ALT elevations \<= 7 days, infusion reactions * Grade 3 or 4 lymphopenia * Grade 3 or 4 electrolyte abnormalities that are corrected to \<=Grade 2 in \< 48 hours * Grade 3 dehydration lasting \< 7 days
9 weeks
Progression-free Survival of Patients Treated With Chemoradiotherapy Plus Veliparib (Phase II)
Time from date of registration to date of first documentation of progression or symptomatic deterioration or death due to any cause. Participants last known to be alive are censored at date of last contact. Assessed by Response Evaluation Criteria in Solid Tumors, RECIST 1.1
The time from randomization to progression or death due to any cause, assessed up to 5 years

Secondary Outcomes (3)

Overall Survival (Phase II)
Up to 5 years
Objective Response Rate (Phase II)
Up to 5 years
Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II)
Duration of treatment and follow up until death or 5 years post registration

Study Arms (2)

Arm I (RT, veliparib, carboplatin, paclitaxel)

EXPERIMENTAL

Patients undergo 3D-CRT and receive veliparib, carboplatin, and paclitaxel as in Phase I induction and consolidation therapy.

Radiation: 3-Dimensional Conformal Radiation TherapyDrug: CarboplatinOther: Laboratory Biomarker AnalysisDrug: PaclitaxelDrug: Veliparib

Arm II (3D-CRT, placebo, carboplatin, paclitaxel)

ACTIVE COMPARATOR

Patients undergo 3D-CRT as in arm I. Patients also receive placebo PO BID on days 1-43 and carboplatin and paclitaxel as in Phase I. Within 4-6 weeks after completion of chemotherapy and radiation therapy, patients receive placebo on days 1-7 and carboplatin and paclitaxel as in Phase I.

Radiation: 3-Dimensional Conformal Radiation TherapyDrug: CarboplatinOther: Laboratory Biomarker AnalysisDrug: PaclitaxelOther: Placebo Administration

Interventions

Laboratory Biomarker AnalysisOTHER

Correlative studies

Arm I (RT, veliparib, carboplatin, paclitaxel)Arm II (3D-CRT, placebo, carboplatin, paclitaxel)

3-Dimensional Conformal Radiation TherapyRADIATION

Undergo 3D-conformal RT

Also known as: 3-dimensional radiation therapy, 3D Conformal, 3D CONFORMAL RADIATION THERAPY, 3D CRT, 3D radiotherapy, 3D-CRT, Conformal Therapy, Radiation Conformal Therapy, Radiation, 3D Conformal, Three dimensional external beam radiation therapy (procedure)

Arm I (RT, veliparib, carboplatin, paclitaxel)Arm II (3D-CRT, placebo, carboplatin, paclitaxel)

CarboplatinDRUG

Given IV

Also known as: Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carboplatinum, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, JM8, Nealorin, Novoplatinum, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo

Arm I (RT, veliparib, carboplatin, paclitaxel)Arm II (3D-CRT, placebo, carboplatin, paclitaxel)

PaclitaxelDRUG

Given IV

Also known as: Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat

Arm I (RT, veliparib, carboplatin, paclitaxel)Arm II (3D-CRT, placebo, carboplatin, paclitaxel)

Placebo AdministrationOTHER

Given PO

Arm II (3D-CRT, placebo, carboplatin, paclitaxel)

VeliparibDRUG

Given PO

Also known as: ABT 888, ABT-888, ABT888, PARP-1 inhibitor ABT-888

Arm I (RT, veliparib, carboplatin, paclitaxel)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients must have histologically or cytologically-proven new diagnosis of unresectable stage IIIA/IIIB\*, non-small cell lung cancer (adenocarcinoma, bronchioloalveolar cell carcinoma, large cell carcinoma, squamous cell carcinoma, or mixed)
Per the American Joint Committee on Cancer (AJCC) 7th edition, pleural and pericardial are now considered stage M1a disease; when pleural fluid is visible on the computed tomography (CT) scan or on a chest x-ray, a thoracentesis is required to confirm that the pleural fluid is cytologically negative; patients with exudative pleural effusions are excluded, regardless of cytology; patients with effusions that are minimal (i.e. not visible on chest x-ray) that are too small to safely tap are eligible; a small effusion that has positive fludeoxyglucose F 18 (FDG) uptake on positron emission tomography (PET) has to be proven to be malignant per standard of care diagnostic procedures for the patient to be excluded
Patients must have measurable or non-measurable disease documented by CT, magnetic resonance imaging (MRI) or PET/CT; the CT from a combined PET/CT may be used to document only non-measurable disease unless the scan is of diagnostic quality; measurable disease must be assessed by CT within 28 days prior to registration; pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease; non-measurable disease must be assessed within 42 days prior to registration; all disease must be assessed and documented on the Baseline Tumor Assessment Form
Patients with brain metastases are ineligible; all patients must have a pretreatment CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to registration
Patients must not have received any prior systemic therapy (chemotherapy or other biologic therapy) for lung cancer
Patients must not have received prior chest radiation therapy for NSCLC
Patients must not have had a previous surgical resection; however, patients may have undergone exploratory thoracotomy, mediastinoscopy, excisional biopsy or similar surgery for the purpose of determining the diagnosis, stage or potential resectability of newly diagnosed lung tumor; at least 28 days must have elapsed since thoracic surgery (excluding mediastinoscopy or other minor surgeries) and patients should have recovered from all associated toxicities at the time of registration; patients must not be planning to undergo a minor surgical procedure while on this study
Patients must have Zubrod performance status 0-1
Patients must have tumor tissue available for submission to assess gene expression of ERCC1 and XRCC1; patients must also be offered participation in banking for future use of specimens
Absolute neutrophil count \>= 1,500/mcl
Platelets \>= 100,000/mcl
Hemoglobin \>= 9.0 g/dl
Total bilirubin within institutional upper limit of normal (IULN)
Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 2.5 x IULN
Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
+24 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

National Cancer Institute (NCI)lead

Study Sites (234)

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, 98508, United States

Location

Alaska Breast Care and Surgery LLC