Veliparib + Chemoradiation for Advanced Non-Small Cell Lung Cancer

Recruiting in Palo Alto (17 mi)

+267 other locations

Overseen by Athanassios (Ethan) Argiris

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Athanassios (Ethan) Argiris

Principal Investigator

SWOG Cancer Research Network

Eligibility Criteria

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.

Inclusion Criteria

Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method

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

You need to have evidence of a disease that can be seen on CT, MRI, or PET/CT scans.

Exclusion Criteria

Patients must not have any known immune deficiencies

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

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

Treatment Details

Interventions

• 3-Dimensional Conformal Radiation Therapy (Radiation)
• Carboplatin (Platinum-based Chemotherapy)
• Paclitaxel (Taxane)
• Veliparib (PARP Inhibitor)

Trial Overview 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.

Participant Groups

Group I: Arm I (RT, veliparib, carboplatin, paclitaxel) Experimental Treatment 5 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 Control 5 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.

3-Dimensional Conformal Radiation Therapy is already approved in Canada, Japan, China, Switzerland for the following indications:

Approved in Canada as 3D-CRT for:

• Various types of cancer, including gynecologic cancers

Approved in Japan as 3D-CRT for:

• Various types of cancer, including gynecologic cancers

Approved in China as 3D-CRT for:

• Various types of cancer, including gynecologic cancers

Approved in Switzerland as 3D-CRT for:

• Various types of cancer, including gynecologic cancers

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School