A Study of Nivolumab +/- Nab-paclitaxel in Non-small Cell Lung Cancer
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ClinicalTrials.gov Identifier: NCT02967133 |
Recruitment Status :
Terminated
(Lack of enrollment)
First Posted : November 18, 2016
Last Update Posted : May 6, 2022
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Condition or disease | Intervention/treatment | Phase |
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Non-Small-Cell Lung Cancer Metastatic Non-Small Cell Carcinoma of Lung, TNM Stage 4 Nonsmall Cell Lung Cancer Non Small Cell Lung Cancer Recurrent | Drug: Nivolumab Drug: nab-paclitaxel | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 7 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Nivolumab With or Without Nab-Paclitaxel in Previously Treated, Advanced Stage, Non-small Cell Lung Cancer: A Randomized Phase II Study |
Actual Study Start Date : | December 2016 |
Actual Primary Completion Date : | January 2018 |
Actual Study Completion Date : | January 2018 |

Arm | Intervention/treatment |
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Active Comparator: Arm A
Nivolumab q 14 days until disease progression/toxicity
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Drug: Nivolumab
Arm A: Nivolumab 240 mg via intravenous infusion (IV) over 30 minutes day 1 of each 14 day cycle until disease progression or not tolerated. Arm B: Nivolumab 360 mg via intravenous infusion (IV) over 30 minutes day 1 of every 21 day treatment cycle until progression or not tolerated. Other Name: Opdivo |
Active Comparator: Arm B
Nivolumab every 21 days until disease progression Nab-paclitaxel every 21 days |
Drug: Nivolumab
Arm A: Nivolumab 240 mg via intravenous infusion (IV) over 30 minutes day 1 of each 14 day cycle until disease progression or not tolerated. Arm B: Nivolumab 360 mg via intravenous infusion (IV) over 30 minutes day 1 of every 21 day treatment cycle until progression or not tolerated. Other Name: Opdivo Drug: nab-paclitaxel Patients in arm B receive nab-paclitaxel at a dose of 100 mg/m2 over intravenous infusion on Days 1 and 8 of each 21 day cycle.
Other Name: abraxane |
- Progression-Free Survival [ Time Frame: The primary endpoint will be defined as the time from the date of randomization to the date of the earliest radiographic disease progression or death. Randomization, treatment and safety follow up is defined as 30 months ]This study will compare the progression-free survival of patients with advanced stage non-small cell lung cancer whose cancer has progressed after standard first-line platinum based doublet chemotherapy is improved with nivolumab plus nab-paclitaxel compared to nivolumab alone.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically or cytologically confirmed, Stage IV non-small cell lung cancer (per the Union Internationale contre le Cancer/American Join Committee on Cancer staging system, 7th edition) or recurrent incurable non-small cell lung cancer that has progressed after first-line chemotherapy.
- Prior Therapy: Platinum doublet chemotherapy for current diagnosis of advanced lung cancer. Only one prior line of chemotherapy for advanced lung cancer allowed. Adjuvant chemotherapy, neoadjuvant chemotherapy, or chemoradiotherapy given for early stage lung cancer at least 6 months prior to diagnosis of recurrent/metastatic disease is not counted as a line of therapy for advanced lung cancer. Patients who received platinum doublet therapy with or without radiotherapy as part of treatment for early stage non-small cell lung cancer less than 6 months after developing stage 4 or recurrent incurable disease will be considered study eligible by the criterion of having received one line of chemotherapy for non-small cell lung cancer.
- EGFR, ALK and ROS biomarker positive tumors are eligible as long as the patient has received at least one standard oral, molecular inhibitor therapy in addition to standard platinum doublet chemotherapy. More than one molecular inhibitor is allowed such as a first generation EGFR inhibitor followed by a next generation EGFR inhibitor when T790 mutation develops. Prior molecular therapy for biomarker positive tumors such as (but not limited to) MET, RET and BRAF allowed but not required.
- Prior chemotherapy must have been completed 21 days prior to initiation of protocol therapy and all toxicities must < grade 2.
- Patients must have < Grade 2 or pre-existing neuropathy (per CTCAE).
- Palliative radiation must have been completed 2 weeks prior to the initiation of study therapy.
- All patients must have measurable disease. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20mm with conventional techniques or as ≥10mm with spiral CT scan.
- ECOG Performance Status: 0-1
- Second malignancy: No "currently active" second malignancy other than non-melanoma skin cancers.
- Brain metastases: brain metastases must have been treated at least 2 weeks prior to enrollment, be asymptomatic from brain metastases, stable on brain imaging, and not be receiving a supra-physiologic dose of steroids (> 10 mg prednisone daily or equivalent).
- Non-pregnant and non-nursing. The effect of nab-paclitaxel and nivolumab on the fetus is unknown.
- Women of childbearing potential (WOCBP) must be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 6 months after the last dose of study medication. Patients of childbearing potential are those who have not been surgically sterilized or have not been free of menses > 1 year.
- Male patients must agree to use an adequate method of contraception starting with the first dose of study therapy through 7 months after the last dose of study therapy.
- Age ≥18 years.
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Required Initial Laboratory Values:
Leukocytes ≥2000/ µl Hemoglobin >9.0 g/dL Platelets ≥100,000/ µl ANC ≥1,500/mcL
Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL/min (if using the Cockcroft-Gault formula below):
Female CrCl = (140 - age in years) x weight in kg x 0.85 72 x serum creatinine in mg/dL
Male CrCl = (140 - age in years) x weight in kg x 1.00
Total Bilirubin <1.5 mg/dl (except for subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dl) SGOT (AST) <2.5 x ULN ALP <2.5 x ULN in absence of liver metastases (<5 x ULN if liver metastases present PTT <1.5 x ULN
- An archival tumor sample from either a prior core needle biopsy or surgical specimen must be available to be submitted for correlative studies as an eligibility requirement prior to registration. The sample must be shipped within 6 weeks of enrollment. Participants without an available archival tumor sample are considered ineligible.
Exclusion Criteria:
- Prior nab-paclitaxel chemotherapy excluded.
- Prior immune therapy for NSCLC excluded. Patients should be excluded if they have had prior treatment with an anti-PD-1, anti-PD-L1, anti PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways.
- Patients will be excluded if they have an active, known or suspected autoimmune disease. Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger.
- Patients will be excluded if they have a condition requiring systemic treatment with either corticosteroids (>10mg/day prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses >10 mg daily prednisone equivalents are permitted in the absence or active autoimmune disease.
- Patients should be excluded if they test positive for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection.
- Patients should be excluded if they have known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
- Allergies and Adverse Drug Reaction: History of allergy to study drug components

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02967133
United States, Kentucky | |
St. Elizabeth's Healthcare | |
Edgewood, Kentucky, United States, 41017 | |
United States, Minnesota | |
Metro Minnesota community oncology research consortium | |
Saint Louis Park, Minnesota, United States, 55416 | |
United States, Missouri | |
Missouri Baptist Medical Center | |
Saint Louis, Missouri, United States, 63131 | |
United States, Nebraska | |
Nebraska Methodist Hospital | |
Omaha, Nebraska, United States, 68114 |
Principal Investigator: | Monica Bertagnolli, MD | Alliance Foundation Trials, LLC. | |
Study Chair: | Neal Ready, MD, PhD | Alliance Foundation Trials, LLC. |
Publications:
Responsible Party: | Alliance Foundation Trials, LLC. |
ClinicalTrials.gov Identifier: | NCT02967133 |
Other Study ID Numbers: |
AFT-31 |
First Posted: | November 18, 2016 Key Record Dates |
Last Update Posted: | May 6, 2022 |
Last Verified: | July 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Plan Description: | Anonymized (de-identified) data generated from biospecimens used for future correlative research, including somatic and constitutional (germline) genomic data, may be shared with other researchers or deposited in a publicly accessible or controlled-access data repositories. Correlative study results and data will never be returned to individual patients. |
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |
Paclitaxel Nivolumab Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Immunological Immune Checkpoint Inhibitors |