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Non-Small Cell Lung CancerPhase 1NCT02944396

Study of Veliparib in Combination With Nivolumab and Platinum Doublet Chemotherapy in Participants With Metastatic or Advanced Non-Small Cell Lung Cancer (NSCLC)

A Phase 1 study testing pemetrexed, nivolumab and paclitaxel in people with Non-Small Cell Lung Cancer, run by AbbVie at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study seeks to establish the recommended Phase 2 dose (RPTD) of veliparib in combination with nivolumab and platinum doublet chemotherapy (carboplatin/paclitaxel or carboplatin/pemetrexed) (Phase 1 portion) and to assess whether the addition of nivolumab to veliparib in combination with platinum doublet… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
pemetrexed, nivolumab and paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
6 sitesUnited States
Study dates
23 Dec 2016to 2 Oct 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant must have a life expectancy greater than 12 weeks,
  • Participant must have cytologically or histologically confirmed Non-small Cell Lung Cancer (NSCLC).
  • Participant must have metastatic or advanced NSCLC (Stage IIIB or IV) that is not amenable to surgical resection or radiation or chemoradiation with curative intent at time of study screening.
  • Participant must have at least 1 unidimensional measurable NSCLC lesion on a computed tomography (CT) scan as defined by Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1).
  • Participant must have resolution to Grade 1 or lower of any toxic effects (excepting alopecia) of the most recent therapy prior to Cycle 1 Day 2.
  • Participant must have an Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 to 1.
  • Participant must have adequate bone marrow, renal, and hepatic function.

Who cannot join

  • Participant has received prior cytotoxic chemotherapy (including chemotherapy in combination with radiotherapy) for NSCLC, except for adjuvant or neoadjuvant therapy accompanied by surgery with curative intent that was completed one year prior to Cycle 1 Day -2.
  • Participant has received prior therapy with a Poly-(ADP-ribose)-Polymerase (PARP) inhibitor.
  • Participant has received prior treatment with any anti-programmed cell death protein-1 (anti-PD-1), or PD Ligand-1 (PD-L1) or PD Ligand-2 (PD-L2) agent or an antibody targeting other immunoregulatory receptors or mechanisms.
  • Participant has received radiation therapy to lung greater than 30 Gy within 6 months, or antineoplastic biologic therapy within 21 days, or major surgery within 21 days, or tyrosine kinase inhibitor therapy within 7 days, or palliative radiation within 7 days of the first dose of study medication.
  • Participant has untreated central nervous system (CNS) metastases.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Univ of Colorado Cancer Center /ID# 153820

    Aurora, Colorado, 80045

  • University of Alabama at Birmingham - Main /ID# 155135

    Birmingham, Alabama, 35233

  • University of Chicago /ID# 153824

    Chicago, Illinois, 60637-1443

  • Duke University Medical Center /ID# 153821

    Durham, North Carolina, 27710-3000

  • Goshen Center for Cancer Care /ID# 153822

    Goshen, Indiana, 46526

  • Icri /Id# 155593

    Whittier, California, 90603

Other trials in United States

About this study

Official title: A Phase 1 Dose-Escalation and Phase 2 Randomized, Open-Label Study of Nivolumab and Veliparib in Combination With Platinum Doublet Chemotherapy in Subjects With Metastatic or Advanced Non-Small Cell Lung Cancer (NSCLC)

This study seeks to establish the recommended Phase 2 dose (RPTD) of veliparib in combination with nivolumab and platinum doublet chemotherapy (carboplatin/paclitaxel or carboplatin/pemetrexed) (Phase 1 portion) and to assess whether the addition of nivolumab to veliparib in combination with platinum doublet chemotherapy results will improve progression free survival (PFS) compared to veliparib with platinum doublet chemotherapy alone in participants with metastatic or advanced Non-small Cell Lung Cancer (NSCLC) (Phase 2 portion).

A strategy decision was made not to proceed to Phase 2 portion of this study due to change in standard of care.

Being tested
pemetrexed, nivolumab, paclitaxel, veliparib, carboplatin
Keywords
metastatic, non-small cell lung cancer, Eastern Cooperative Oncology Group (ECOG), veliparib, nivolumab, Platinum Doublet Chemotherapy, carboplatin, paclitaxel, pemetrexed, Response Evaluation Criteria In Solid Tumors (RECIST), Common Terminology Criteria for Adverse Events (CTCAE), Poly (ADP) ribose polymerase (PARP), Immuno Oncology, Metastatic or Advanced Non-Small Cell Lung Cancer (NSCLC)
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pemetrexedDrug

    Also called Alimta

    intravenous; administered on Day 1 via infusion in a 21-day cycle

  • nivolumabDrug

    Also called Opdivo

    intravenous; administered on Day 1 via infusion in a 21-day cycle

  • paclitaxelDrug

    Also called Taxol

    intravenous; administered on Day 1 via infusion in a 21-day cycle

  • veliparibDrug

    Also called ABT-888

    oral capsule; varying doses administered on Days -2 to 5 in a 21-day cycle

  • carboplatinDrug

    Also called Paraplatin

    intravenous; administered on Day 1 via infusion in a 21-day cycle

Study groups in NCT02944396
Study groupRoleWhat they receive
Veliparib and nivolumab with platinum doublet chemotherapyExperimentalVeliparib and nivolumab in combination with platinum doublet chemotherapy (carboplatin/paclitaxel or carboplatin/pemetrexed)
Receives: Drug: pemetrexed; Drug: nivolumab; Drug: paclitaxel; Drug: veliparib; Drug: carboplatin
Veliparib with platinum doublet chemotherapyExperimentalVeliparib in combination with platinum doublet chemotherapy (carboplatin/paclitaxel or carboplatin/pemetrexed)
Receives: Drug: pemetrexed; Drug: paclitaxel; Drug: veliparib; Drug: carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS)

    PFS is defined as the number of days from the date of randomization to the date of earliest disease progression (radiographic progression per RECIST version 1.1 or clinical disease progression) or death. If the participant does not experience disease progression or death, then the data will be censored at the date of the last disease assessment.

    Measured: Up to approximately 3.5 years

  2. Recommended Phase 2 dose (RPTD) of veliparib (ABT-888) in combination with nivolumab and platinum doublet chemotherapy in participants with metastatic or advanced Non-Small Cell Lung Cancer (NSCLC).

    Measured: Up to 6 weeks

Secondary outcomes (12)

  1. Tmax for pemetrexed

    Measured: Up to approximately 3 weeks

  2. AUC for nivolumab

    Measured: Up to approximately 3.5 years

  3. Overall Survival (OS)

    OS is defined as the number of days from the date of randomization to the date of death. For subjects who did not die, their data will be censored at the date of last study visit or the last known date to be alive, whichever is later.

    Measured: Up to approximately 3.5 years

  4. Tmax for nivolumab

    Measured: Up to approximately 3.5 years

  5. AUC for pemetrexed

    Measured: Up to approximately 3 weeks

  6. Time to Cmax (peak time, Tmax) for veliparib

    Measured: Up to approximately 9 weeks

  7. Area under the plasma concentration-time curve (AUC) for veliparib

    Measured: Up to approximately 9 weeks

  8. Maximum observed serum concentration (Cmax) of nivolumab anti-drug antibody (ADA)

    Measured: Up to approximately 3.5 years

  9. Duration of Overall Response (DOR)

    DOR is defined as the number of days from the date of first response (CR or PR) to the earliest documentation of progressive disease or death due to disease progression.

    Measured: Up to approximately 3.5 years

  10. Maximum observed plasma concentration (Cmax) for pemetrexed

    Measured: Up to approximately 3 weeks

  11. Maximum observed plasma concentration (Cmax) for veliparib

    Measured: Up to approximately 9 weeks

  12. Objective Response Rate (ORR)

    ORR is defined as the proportion of the participants who have a complete response (CR) or partial response (PR).

    Measured: Up to approximately 3.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2016 (estimated)
  2. Study start23 Dec 2016
  3. Primary completion2 Oct 2019
  4. Study completion2 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02944396
Sponsor's protocol ID
M15-534
Other IDs
2016-001658-16, 2016
Status last verified
Oct 2019
First submitted
19 Oct 2016
Last updated
23 Oct 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing pemetrexed, nivolumab and paclitaxel in people with Non-Small Cell Lung Cancer, run by AbbVie at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: Up to approximately 3.5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02944396.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2019.

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