Non-Squamous Non-Small Cell Lung Cancer (NSCLC)Phase 2NCT03041181
Single Agent Chemotherapy +/- Nivolumab in Patients With Advanced Squamous or Non-squamous NSCLC With Primary Resistance to Prior PD-1 or PDL-1 Inhibitor
A Phase 2 study testing Docetaxel, Nivolumab and Gemcitabine in people with Non-Squamous Non-Small Cell Lung Cancer (NSCLC) and Adenocarcinoma of the Lung, run by Nasser Hanna, M.D. at 9 sites in United States.
Trial summary
This is a randomized phase II study assessing the activity of single agent chemotherapy combined with nivolumab (Arm A) compared to single agent chemotherapy alone (Arm B) in squamous or non-squamous NSCLC subjects with primary resistance to prior PD-1 or PDL-1 inhibitor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Squamous Non-Small Cell Lung Cancer (NSCLC), Adenocarcinoma of the Lung, Lung Cancer
- What is being tested?
- Docetaxel, Nivolumab and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 9 sitesUnited States
- Study dates
- 27 Jan 2017to 23 May 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subject must meet all of the following applicable inclusion criteria to participate in this study:
- Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- Age ≥ 18 years at the time of consent.
- ECOG Performance Status of 0-2 within 28 days prior to randomization.
- Histological or cytological confirmed squamous or non-squamous non-small cell lung cancer.
- Measurable disease according to RECIST 1.1 within 28 days prior to randomization.
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- A subject with prior brain metastasis may be considered if they have completed their treatment for brain metastasis at least 4 weeks prior to randomization, have been off of corticosteroids for ≥ 2 weeks, and are asymptomatic.
- Subjects must have primary resistance to PD-1 or PDL-1 inhibitors; defined as PD after 3 or fewer treatments with a PD-1 or PDL-1 inhibitor
- Subjects must have progressed on or after previous platinum-based chemotherapy. Chemotherapy may have previously been given with a PD-1 or PD-L1 inhibitor. Subjects must have also progressed on or after receiving any PD-1 or PD-L1 inhibitor (including nivolumab) as their most recent therapy.
- Most recent PD-1 or PD-L1 inhibitor infusion must be completed at least 6 weeks of randomization. The subject must have recovered from all reversible acute toxic effects (other than alopecia) to ≤ Grade 1 or baseline.
- Demonstrate adequate organ function as defined in the table below. All screening labs to be obtained within 28 days prior to randomization.
- White blood cell (WBC) ≥ 2 k/mm3 Absolute Neutrophil Count (ANC) ≥ 1.5 K/mm3 Hemoglobin (Hgb) ≥ 9 g/dL Platelet >100k Estimated creatinine clearance OR ≥ 40 cc/min Serum creatinine ≤ 1.5 x upper limit of normal (ULN) Bilirubin 1.5 ≤ (ULN)2 Aspartate aminotransferase (AST) ≤ 1.5 × ULN Alanine aminotransferase (ALT) ≤ 1.5 × ULN International Normalized Ratio (INR) or Prothrombin Time (PT) Activated Partial Thromboplastin Time (aPTT) ≤ 2 × ULN (Note: use of vitamin K antagonist is not allowed)
- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 14 days prior to registration. These women must also have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of Nivolumab then every 6 weeks thereafter. NOTE: Women are considered of child bearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are post-menopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 62 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL.
- Women of childbearing potential must be willing to abstain from heterosexual activity or use an effective method of contraception from the time of informed consent until 5 months after treatment discontinuation. Women cannot breast feed from the time of informed consent to 5 months after last dose of study treatment. See below for adequate methods of contraception.
- Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Men receiving Nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 7 months after the last dose of investigational product. See below for methods of contraception.
- As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study
Who cannot join
- Prior treatment with the single agent chemotherapy the site investigator chooses to use for this protocol (pemetrexed, taxotere or gemcitabine).
- Previous autoimmune complication from PD-1 or PD-L1 requiring discontinuation of therapy or treatment with steroids (ongoing treatment with more than 10 mg of prednisone or steroid equivalent daily, excluding inhaled or topical steroids).
- Previous discontinuation from PD-1 or PD-L1 due to an adverse event.
- Any serious or uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy.
- Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
- Known additional malignancy that is active and/or progressive requiring treatment; exceptions include basal cell or squamous cell skin cancer, in situ cervical or bladder cancer, or other cancer for which the subject has been disease-free for at least five years.
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- Active central nervous system (CNS) metastases. Subjects with brain metastases are eligible if metastases have been treated and there is no magnetic resonance imaging (MRI) evidence of progression for [lowest minimum is 4 weeks or more] after treatment is complete and within 28 days prior to the first dose of Nivolumab administration. There must also be no requirement for immunosuppressive doses of systemic corticosteroids (> 10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration.
- Treatment with any investigational drug within 30 days prior to registration.
- Subjects whose tumors express EGFR mutations on exons 19 and 21, ALK rearrangement, or ROS1 rearrangement who still have other FDA approved targeted agents available for treatment.
- Subjects with an active or recent history of a known or suspected autoimmune disease or recent history of a syndrome that required systemic corticosteroids/immunosuppressive medications EXCEPT for syndromes which would not be expected to recur in the absence of an external trigger. (Subjects with vitiligo, autoimmune thyroiditis, or type I diabetes mellitus are permitted to enroll.)
- As there is potential for hepatic toxicity with Nivolumab, drugs with a predisposition to hepatoxicity should be used with caution in subjects treated with Nivolumab-containing regimen.
- Subjects should be excluded if they are positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection.
- Subjects should be excluded if they have known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
- History of allergy to study drug components.
- Prior solid organ or stem cell transplant
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
St. Vincent Anderson Regional Hospital
Anderson, Indiana, 46016
University of Virginia Health System
Charlottesville, Virginia, 22908
University of Texas Medical Branch at Galveston
Galveston, Texas, 77555
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
IU Health Central Indiana Cancer Center
Indianapolis, Indiana, 46219
Community Regional Cancer Care
Indianapolis, Indiana, 46256
HealthPartners Institute
Minneapolis, Minnesota, 55440
IU Health Ball Memorial Hospital Cancer Center
Muncie, Indiana, 47303
Community Healthcare System
Munster, Indiana, 46321
About this study
Official title: Randomized Phase II Trial of Single Agent Chemotherapy Plus Nivolumab or Single Agent Chemotherapy Alone in Patients With Advanced Squamous or Non-squamous NSCLC With Primary Resistance to Prior PD-1 or PDL-1 Inhibitor
This is a randomized phase II study assessing the activity of single agent chemotherapy combined with nivolumab (Arm A) compared to single agent chemotherapy alone (Arm B) in squamous or non-squamous NSCLC subjects with primary resistance to prior PD-1 or PDL-1 inhibitor. The single agent chemotherapy chosen is at the discretion of the site investigator and may include pemetrexed, gemcitabine or taxotere. Institutional standards should be used for administration of the single agent chemotherapy. For both treatment arms, 21 days equals 1 cycle of therapy and subjects will be eligible to continue treatment until progressive disease by RECIST v1.1 or unacceptable toxicity.
Upon registration, subjects will be randomized in a 1:1 ratio to either treatment with single agent chemotherapy or single agent chemotherapy in combination with nivolumab. Randomization is un-blinded and open-label; therefore there will be no placebo treatment for subjects randomized to single agent chemotherapy
- Conditions
- Non-Squamous Non-Small Cell Lung Cancer (NSCLC), Adenocarcinoma of the Lung, Lung Cancer, Squamous Cell Lung Cancer
- Being tested
- Docetaxel, Nivolumab, Gemcitabine, Pemetrexed
- Keywords
- Nivolumab, BMS-936558-01, Anti-PD-1 Antibody, Docetaxel, Pemetrexed, Gemcitabine
- Medical subject headings
- Adenocarcinoma of Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
Also called Taxotere
Docetaxel 75 mg/m2 IV Day 1 of each cycle (21 days = 1 cycle)
NivolumabDrug
Also called BMS-936558-01, Opdivo
Nivolumab 360 mg IV Day 1 of each cycle (21 days = 1 cycle)
GemcitabineDrug
Also called Gemzar
Gemcitabine 1000 mg/m2 IV Day 1 and Day 8 of each cycle (21 days = 1 cycle)
PemetrexedDrug
Also called Alimta
Pemetrexed 500 mg/m2 IV Day 1 of each cycle (21 days = 1 cycle)
| Study group | Role | What they receive |
|---|---|---|
| Arm A - Single Agent Chemotherapy + Nivolumab | Experimental | Single Agent Chemotherapy of choice plus nivolumab:
Taxotere Pemetrexed Gemcitabine Receives: Drug: Docetaxel; Drug: Nivolumab; Drug: Gemcitabine; Drug: Pemetrexed |
| Arm B - Single Agent Chemotherapy | Active comparator | Single Agent Chemotherapy of choice Taxotere Pemetrexed Gemcitabine Receives: Drug: Docetaxel; Drug: Gemcitabine; Drug: Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS), as Defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Compare PFS rates for subjects on each treatment arm, per RECIST 1.1. Subjects who have not progressed will be right-censored at the date of the last follow up.
Measured: 24 months
Secondary outcomes (4)
Overall Response Rate (ORR) for Subjects on Each Treatment Arm, as Defined by RECIST 1.1 and Immune-related Response Criteria (irRECIST)
Proportion of subjects on each arm with complete response or partial response, per RECIST 1.1 and irRECIST
Measured: Every 6 weeks beginning with C3D1 and every odd numbered cycle thereafter, assessed for up to 24 months
Clinical Benefit Rate (CBR) for Subjects on Each Treatment Arm, as Defined by RECIST 1.1 and irRECIST
Proportion of subjects on each arm with complete response, partial response or stable disease for at least 3 months, per RECIST 1.1 and irRECIST
Measured: From D1 of treatment until documented disease progression/recurrence, assessed for up to 24 months
Progression Free Survival (PFS), as Defined by irRECIST
Compare PFS rates for subjects on each treatment arm, per irRECIST. From date of randomization until the criteria for disease progression is met or death as a result of any cause, assessed up to 24 months
Measured: 24 months
Number of Participants With Grade 3 or Grade 4 Adverse Events
Assess toxicity of Nivolumab plus single agent chemotherapy compared with single agent chemotherapy alone. Number of grade 3 and 4 toxicities as defined by the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2017 (estimated)
- Study start27 Jan 2017
- Primary completion23 May 2019
- Study completion23 May 2019
Why it stopped: Funder decision - lack of accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-Squamous Non-Small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nasser Hanna, M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- Hoosier Cancer Research Network, Bristol-Myers Squibb
- Responsible party
- Sponsor-investigator, Nasser Hanna, M.D., Hoosier Cancer Research Network
- Investigators
- Nasser Hanna, M.D., Principal investigator, Hoosier Cancer Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03041181
- Sponsor's protocol ID
- HCRN LUN15-233
- Status last verified
- Jul 2022
- First submitted
- 31 Jan 2017
- Last updated
- 11 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Trial of Single Agent Chemotherapy Plus Nivolumab or Single Agent Chemotherapy Alone in Patients With Advanced Squamous or Non-squamous NSCLC With Primary Resistance to Prior PD-1 or PDL-1 Inhibitor
- ClinicalTrials.gov ID
- NCT03041181
- Acronym / sponsor ID
- HCRN LUN15-233
- Conditions
- Non-Squamous Non-Small Cell Lung Cancer (NSCLC), Adenocarcinoma of the Lung, Lung Cancer, Squamous Cell Lung Cancer
- Keywords
- Nivolumab, BMS-936558-01, Anti-PD-1 Antibody, Docetaxel, Pemetrexed, Gemcitabine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funder decision - lack of accrual
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Nasser Hanna, M.D.University, hospital or other
- Collaborators
- Hoosier Cancer Research Network, Bristol-Myers Squibb
- Study start
- 27 Jan 2017 (actual)
- Primary completion
- 23 May 2019 (actual)
- Study completion
- 23 May 2019 (actual)
- First posted
- 2 Feb 2017 (estimated)
- Results
- Posted 29 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized phase II study assessing the activity of single agent chemotherapy combined with nivolumab (Arm A) compared to single agent chemotherapy alone (Arm B) in squamous or non-squamous NSCLC subjects with primary resistance to prior PD-1 or PDL-1 inhibitor. The single agent chemotherapy chosen is at the discretion of the site investigator and may include pemetrexed, gemcitabine or taxotere. Institutional standards should be used for administration of the single agent chemotherapy. For both treatment arms, 21 days equals 1 cycle of therapy and subjects will be eligible to continue treatment until progressive disease by RECIST v1.1 or unacceptable toxicity.
Upon registration, subjects will be randomized in a 1:1 ratio to either treatment with single agent chemotherapy or single agent chemotherapy in combination with nivolumab. Randomization is un-blinded and open-label; therefore there will be no placebo treatment for subjects randomized to single agent chemotherapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A - Single Agent Chemotherapy + Nivolumab | Experimental | Drug: Docetaxel, Drug: Nivolumab, Drug: Gemcitabine, Drug: PemetrexedSingle Agent Chemotherapy of choice plus nivolumab: Taxotere Pemetrexed Gemcitabine |
| Arm B - Single Agent Chemotherapy | Active comparator | Drug: Docetaxel, Drug: Gemcitabine, Drug: PemetrexedSingle Agent Chemotherapy of choice Taxotere Pemetrexed Gemcitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Subject must meet all of the following applicable inclusion criteria to participate in this study:
- Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- Age ≥ 18 years at the time of consent.
- ECOG Performance Status of 0-2 within 28 days prior to randomization.
- Histological or cytological confirmed squamous or non-squamous non-small cell lung cancer.
Key exclusion criteria (15 listed)
- Prior treatment with the single agent chemotherapy the site investigator chooses to use for this protocol (pemetrexed, taxotere or gemcitabine).
- Previous autoimmune complication from PD-1 or PD-L1 requiring discontinuation of therapy or treatment with steroids (ongoing treatment with more than 10 mg of prednisone or steroid equivalent daily, excluding inhaled or topical steroids).
- Previous discontinuation from PD-1 or PD-L1 due to an adverse event.
- Any serious or uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy.
- Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DocetaxelAlso: TaxotereDocetaxel 75 mg/m2 IV Day 1 of each cycle (21 days = 1 cycle) | Drug | Arm A - Single Agent Chemotherapy + Nivolumab, Arm B - Single Agent Chemotherapy |
| NivolumabAlso: BMS-936558-01, OpdivoNivolumab 360 mg IV Day 1 of each cycle (21 days = 1 cycle) | Drug | Arm A - Single Agent Chemotherapy + Nivolumab |
| GemcitabineAlso: GemzarGemcitabine 1000 mg/m2 IV Day 1 and Day 8 of each cycle (21 days = 1 cycle) | Drug | Arm A - Single Agent Chemotherapy + Nivolumab, Arm B - Single Agent Chemotherapy |
| PemetrexedAlso: AlimtaPemetrexed 500 mg/m2 IV Day 1 of each cycle (21 days = 1 cycle) | Drug | Arm A - Single Agent Chemotherapy + Nivolumab, Arm B - Single Agent Chemotherapy |
Primary outcome
Progression Free Survival (PFS), as Defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Time frame: 24 months
Compare PFS rates for subjects on each treatment arm, per RECIST 1.1. Subjects who have not progressed will be right-censored at the date of the last follow up.
4 secondary outcomes
Overall Response Rate (ORR) for Subjects on Each Treatment Arm, as Defined by RECIST 1.1 and Immune-related Response Criteria (irRECIST)
Time frame: Every 6 weeks beginning with C3D1 and every odd numbered cycle thereafter, assessed for up to 24 months
Clinical Benefit Rate (CBR) for Subjects on Each Treatment Arm, as Defined by RECIST 1.1 and irRECIST
Time frame: From D1 of treatment until documented disease progression/recurrence, assessed for up to 24 months
Progression Free Survival (PFS), as Defined by irRECIST
Time frame: 24 months
Number of Participants With Grade 3 or Grade 4 Adverse Events
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Hoosier Cancer Research Network WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nasser Hanna, M.D. principal investigator
Hoosier Cancer Research Network
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Docetaxel, Nivolumab and Gemcitabine in people with Non-Squamous Non-Small Cell Lung Cancer (NSCLC) and Adenocarcinoma of the Lung, run by Nasser Hanna, M.D. at 9 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 16 inclusion and 15 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: stopped early, as of the sponsor's last update on 11 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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), as Defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jul 2022; AzTrials last refreshed its copy on 7 Nov 2026.