← Back to Search

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
Must not have
Patients with brain metastases are ineligible
Patients must not have received any prior systemic therapy (chemotherapy or other biologic therapy) for lung cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

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.
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.
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
Select...
I have been diagnosed with a specific type of advanced lung cancer that cannot be surgically removed.
Select...
I can carry out all my usual activities without help.
Select...
My lung function test shows FEV1 is more than 1.2 liters/sec or over 50% of what's expected.
Select...
My tumor tissue is available for gene expression tests.
Select...
My kidney function tests are within normal limits.
Select...
I can swallow pills without any issues.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have cancer that has spread to my brain.
Select...
I have not had chemotherapy or biological therapy for lung cancer.
Select...
I have not had chest radiation for my lung cancer.
Select...
I have not had surgery to remove my condition.
Select...
I have not lost more than 10% of my weight in the last 6 months.
Select...
I have no allergies to ABT-888, carboplatin, paclitaxel, or similar drugs.
Select...
I do not have severe numbness or pain in my hands or feet.
Select...
I have never had a seizure.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Carboplatin
Progression-free Survival of Patients Treated With Chemoradiotherapy Plus Veliparib (Phase II)
Secondary study objectives
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%
ANAEMIA
76%
THROMBOCYTOPENIA
71%
NAUSEA
54%
ALOPECIA
50%
FATIGUE
46%
PERIPHERAL SENSORY NEUROPATHY
45%
DIARRHOEA
40%
LEUKOPENIA
36%
HEADACHE
34%
CONSTIPATION
34%
VOMITING
25%
ASTHENIA
24%
HYPOMAGNESAEMIA
24%
DECREASED APPETITE
21%
COUGH
20%
DYSPNOEA
20%
PAIN IN EXTREMITY
20%
DYSGEUSIA
19%
DIZZINESS
19%
OEDEMA PERIPHERAL
18%
DYSPEPSIA
18%
ARTHRALGIA
18%
BACK PAIN
18%
INSOMNIA
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
9%
HYPOCALCAEMIA
9%
PARAESTHESIA
9%
DEPRESSION
9%
PRURITUS
9%
MUCOSAL INFLAMMATION
8%
HYPOPHOSPHATAEMIA
8%
OROPHARYNGEAL PAIN
7%
INFLUENZA LIKE ILLNESS
7%
MUSCULOSKELETAL CHEST PAIN
7%
DRY SKIN
7%
VERTIGO
7%
SINUSITIS
7%
MUSCULOSKELETAL PAIN
7%
DRY EYE
7%
BLOOD ALKALINE PHOSPHATASE INCREASED
6%
HYPERGLYCAEMIA
6%
PALPITATIONS
6%
TINNITUS
6%
WEIGHT INCREASED
6%
NEUROPATHY PERIPHERAL
6%
DYSPNOEA EXERTIONAL
6%
RHINORRHOEA
6%
HYPERTENSION
6%
LYMPHOEDEMA
6%
TOOTHACHE
6%
PAIN
5%
HYPONATRAEMIA
5%
GASTROOESOPHAGEAL REFLUX DISEASE
5%
CHEST PAIN
5%
DEHYDRATION
5%
BREAST PAIN
5%
PRODUCTIVE COUGH
5%
ERYTHEMA
5%
MUSCLE SPASMS
5%
ABDOMINAL DISTENSION
5%
INFLUENZA
5%
RHINITIS
4%
MALIGNANT NEOPLASM PROGRESSION
4%
TACHYCARDIA
4%
RESPIRATORY TRACT INFECTION VIRAL
3%
FEBRILE NEUTROPENIA
2%
PNEUMONIA
1%
APPENDICITIS
1%
CHOLELITHIASIS
1%
ANAPHYLACTIC REACTION
1%
NEUTROPENIC INFECTION
1%
SEPSIS
1%
SEIZURE
1%
PULMONARY EMBOLISM
1%
GASTRITIS
1%
CELLULITIS
1%
DEVICE RELATED INFECTION
1%
ERYSIPELAS
1%
VASCULAR DEVICE INFECTION
1%
METASTASES TO MENINGES
100%
80%
60%
40%
20%
0%
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
3-Dimensional Conformal Radiation Therapy
2010
Completed Phase 3
~7230
Carboplatin
2014
Completed Phase 3
~6120
Paclitaxel
2011
Completed Phase 4
~5810
Veliparib
2012
Completed Phase 3
~4780

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,842 Previous Clinical Trials
41,002,947 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
~4 spots leftby Sep 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top