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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

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

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

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have cancer that has spread to my brain.

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I have not had chemotherapy or biological therapy for lung cancer.

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I have not had chest radiation for my lung cancer.

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I have not had surgery to remove my condition.

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I have not lost more than 10% of my weight in the last 6 months.

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I have no allergies to ABT-888, carboplatin, paclitaxel, or similar drugs.

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I do not have severe numbness or pain in my hands or feet.

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I have never had a seizure.

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

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

HYPOCALCAEMIA

PARAESTHESIA

DEPRESSION

PRURITUS

MUCOSAL INFLAMMATION

HYPOPHOSPHATAEMIA

OROPHARYNGEAL PAIN

INFLUENZA LIKE ILLNESS

MUSCULOSKELETAL CHEST PAIN

DRY SKIN

VERTIGO

SINUSITIS

MUSCULOSKELETAL PAIN

DRY EYE

BLOOD ALKALINE PHOSPHATASE INCREASED

HYPERGLYCAEMIA

PALPITATIONS

TINNITUS

WEIGHT INCREASED

NEUROPATHY PERIPHERAL

DYSPNOEA EXERTIONAL

RHINORRHOEA

HYPERTENSION

LYMPHOEDEMA

TOOTHACHE

PAIN

HYPONATRAEMIA

GASTROOESOPHAGEAL REFLUX DISEASE

CHEST PAIN

DEHYDRATION

BREAST PAIN

PRODUCTIVE COUGH

ERYTHEMA

MUSCLE SPASMS

ABDOMINAL DISTENSION

INFLUENZA

RHINITIS

MALIGNANT NEOPLASM PROGRESSION

TACHYCARDIA

RESPIRATORY TRACT INFECTION VIRAL

FEBRILE NEUTROPENIA

PNEUMONIA

APPENDICITIS

CHOLELITHIASIS

ANAPHYLACTIC REACTION

NEUTROPENIC INFECTION

SEPSIS

SEIZURE

PULMONARY EMBOLISM

GASTRITIS

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

3-Dimensional Conformal Radiation Therapy

2010

Completed Phase 3

~7490

Carboplatin

2014

Completed Phase 3

~6120