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Veliparib + Chemoradiation for Advanced Non-Small Cell Lung Cancer

Phase 1 & 2

Waitlist Available

Led By Athanassios (Ethan) Argiris

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Patients must have Zubrod performance status 0-1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is studying the side effects and best dose of veliparib when given with radiation therapy, carboplatin, and paclitaxel to see how well it works in treating patients with stage III non-small cell lung cancer.

Who is the study for?

This trial is for adults with stage III non-small cell lung cancer that can't be surgically removed. They must have certain lung function, not be pregnant or breastfeeding, able to swallow pills, and have no history of seizures or other cancers (with some exceptions). Participants need normal liver and kidney function tests, a performance status showing they're mostly active and capable, and cannot have had prior treatments for lung cancer.Check my eligibility

What is being tested?

The study is testing the effectiveness of veliparib combined with radiation therapy and chemotherapy drugs carboplatin and paclitaxel versus these treatments without veliparib. It's looking at how well patients respond to this combination treatment in terms of tumor growth control. The trial will also determine the best dose of veliparib when used in this way.See study design

What are the potential side effects?

Possible side effects include those from chemotherapy like nausea, hair loss, fatigue; from radiation such as skin irritation; and specific to veliparib which could involve digestive issues or low blood counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a specific type of advanced lung cancer that cannot be surgically removed.

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I can carry out all my usual activities without help.

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My lung function test shows FEV1 is more than 1.2 liters/sec or over 50% of what's expected.

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My tumor tissue is available for gene expression tests.

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My kidney function tests are within normal limits.

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I can swallow pills without any issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Carboplatin

Progression-free Survival of Patients Treated With Chemoradiotherapy Plus Veliparib (Phase II)

Secondary outcome measures

Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II)

Objective Response Rate (Phase II)

Overall Survival (Phase II)

Side effects data

From 2024 Phase 3 trial • 509 Patients • NCT02163694

87%

NEUTROPENIA

76%

THROMBOCYTOPENIA

76%

ANAEMIA

71%

NAUSEA

54%

ALOPECIA

50%

FATIGUE

46%

PERIPHERAL SENSORY NEUROPATHY

45%

DIARRHOEA

40%

LEUKOPENIA

36%

HEADACHE

34%

CONSTIPATION

34%

VOMITING

25%

ASTHENIA

24%

DECREASED APPETITE

24%

HYPOMAGNESAEMIA

21%

COUGH

20%

DYSPNOEA

20%

PAIN IN EXTREMITY

20%

DYSGEUSIA

19%

DIZZINESS

19%

OEDEMA PERIPHERAL

18%

BACK PAIN

18%

DYSPEPSIA

18%

INSOMNIA

18%

ARTHRALGIA

18%

EPISTAXIS

17%

MYALGIA

17%

DRUG HYPERSENSITIVITY

16%

ABDOMINAL PAIN UPPER

16%

PYREXIA

16%

NASOPHARYNGITIS

16%

ALANINE AMINOTRANSFERASE INCREASED

14%

ABDOMINAL PAIN

14%

UPPER RESPIRATORY TRACT INFECTION

14%

ASPARTATE AMINOTRANSFERASE INCREASED

13%

LYMPHOPENIA

13%

STOMATITIS

12%

HYPOKALAEMIA

12%

URINARY TRACT INFECTION

12%

BONE PAIN

11%

ANXIETY

11%

RASH

11%

HOT FLUSH

10%

DRY MOUTH

PRURITUS

HYPOCALCAEMIA

PARAESTHESIA

DEPRESSION

MUCOSAL INFLAMMATION

HYPOPHOSPHATAEMIA

OROPHARYNGEAL PAIN

MUSCULOSKELETAL CHEST PAIN

DRY SKIN

INFLUENZA LIKE ILLNESS

VERTIGO

SINUSITIS

MUSCULOSKELETAL PAIN

DRY EYE

BLOOD ALKALINE PHOSPHATASE INCREASED

LYMPHOEDEMA

RHINORRHOEA

PALPITATIONS

DYSPNOEA EXERTIONAL

TINNITUS

WEIGHT INCREASED

HYPERTENSION

HYPERGLYCAEMIA

NEUROPATHY PERIPHERAL

TOOTHACHE

PAIN

CHEST PAIN

DEHYDRATION

GASTROOESOPHAGEAL REFLUX DISEASE

BREAST PAIN

HYPONATRAEMIA

PRODUCTIVE COUGH

ERYTHEMA

MUSCLE SPASMS

ABDOMINAL DISTENSION

INFLUENZA

RHINITIS

MALIGNANT NEOPLASM PROGRESSION

TACHYCARDIA

RESPIRATORY TRACT INFECTION VIRAL

FEBRILE NEUTROPENIA

PNEUMONIA

SEPSIS

NEUTROPENIC INFECTION

GASTRITIS

SEIZURE

ANAPHYLACTIC REACTION

APPENDICITIS

PULMONARY EMBOLISM

CHOLELITHIASIS

CELLULITIS

DEVICE RELATED INFECTION

ERYSIPELAS

VASCULAR DEVICE INFECTION

METASTASES TO MENINGES

100%

80%

60%

40%

20%

Study treatment Arm

Veliparib Placebo With Carboplatin and Paclitaxel

Veliparib With Carboplatin and Paclitaxel

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (RT, veliparib, carboplatin, paclitaxel)Experimental Treatment5 Interventions

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

Group II: Arm II (3D-CRT, placebo, carboplatin, paclitaxel)Active Control5 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboplatin

2014

Completed Phase 3

~6670

Paclitaxel

2011

Completed Phase 4

~5380

Veliparib

2012

Completed Phase 3

~4820

3-Dimensional Conformal Radiation Therapy

2010

Completed Phase 3

~7160

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,933,100 Total Patients Enrolled

Athanassios (Ethan) ArgirisPrincipal InvestigatorSWOG Cancer Research Network

2 Previous Clinical Trials

578 Total Patients Enrolled

Media Library

3-Dimensional Conformal Radiation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT01386385 — Phase 1 & 2

Lung Cancer Research Study Groups: Arm I (RT, veliparib, carboplatin, paclitaxel), Arm II (3D-CRT, placebo, carboplatin, paclitaxel)

Lung Cancer Clinical Trial 2023: 3-Dimensional Conformal Radiation Therapy Highlights & Side Effects. Trial Name: NCT01386385 — Phase 1 & 2

3-Dimensional Conformal Radiation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT01386385 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any US-based medical facilities currently trialing this research?

"At present, the trial is recruiting participants from 100 distinct sites. People in Findlay, Kansas City and Sioux Falls have access to these locations; other clinics are also available. It may be prudent for those hoping to take part in this clinical study to select a centre of participation that limits their required commutes."

Answered by AI

Is recruitment for this experiment ongoing?

"At present, this clinical study is not recruiting. This research was initially posted on June 20th 2011 and last updated on September 20th 2022. If you're seeking other studies, there are currently 3127 trials in search of participants suffering from carcinoma and 1187 investigations involving Veliparib that are still open for enrolment."

Answered by AI

What is the current sample size for this research study?

"Currently, this experiment is not open to new participants. The trial was initially posted on June 20th 2011 and last refreshed September 20th 2022. If you are searching for additional trials, there are 3127 clinical studies actively recruiting patients with carcinoma as well as 1187 Veliparib-related investigations enrolling individuals."

Answered by AI

What other explorations have been conducted with Veliparib as a potential treatment?

"Veliparib was originally studied in 1997 at City of Hope Comprehensive Cancer Centre. Over the last two decades, 2115 trials have been completed and 1187 are presently active with a large number being conducted out of Findlay, Ohio."

Answered by AI

What is the typical application of Veliparib in medical treatment?

"Veliparib is primarily prescribed as a treatment for melanoma, yet it has also been utilized to manage the proliferation of neoplasm metastasis, lymphoma, non-Hodgkin's disease and advanced sarcoma."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2011. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01386385.

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