Stage IIIA Non-Small Cell Lung CancerPhase 2LCCC1407NCT02276560
Cisplatin and Nab-paclitaxel for (N2) Defined NSCLC
A Phase 2 study testing Neoadjuvant Cisplatin, nab-paclitaxel, Adjuvant Cisplatin,nab-paclitaxel and Adjuvant cisplatin+pemetrexed or cisplatin+gemcitabine in people with Stage IIIA Non-Small Cell Lung Cancer, run by UNC Lineberger Comprehensive Cancer Center at 9 sites in United States.
Trial summary
The purpose of this research study is to determine whether giving cisplatin and nab-paclitaxel before surgery will reduce the presence of disease in certain areas of the lung at the time of surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage IIIA Non-Small Cell Lung Cancer
- What is being tested?
- Neoadjuvant Cisplatin, nab-paclitaxel, Adjuvant Cisplatin,nab-paclitaxel and Adjuvant cisplatin+pemetrexed or cisplatin+gemcitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 9 sitesUnited States
- Study dates
- Jan 2015to Jun 2016
- 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
- 18 years of age; no upper age limit
- Diagnosis of NSCLC, histologically or cytologically confirmed
- Pathologic mediastinal staging to include endobronchial ultrasound with or without endoscopic ultrasound (EBUS =/- EUS) including evaluation of N3 nodes
- Systemic staging including CT that covers the chest, liver and adrenal glands or a PET/CT; MRI of the brain is required and must be negative for metastatic spread. If a patient is unable to tolerate MRI or has a contraindication to MRI, a head CT scan with and without contrast is acceptable
- International Association for the Study of Lung Cancer (IASLC) version 7, subset of stage IIIA single station (N2) disease; specifically T1a-T3, N2(+) with no invasion of key structures (e.g., chest wall or diaphragm)
- Surgically resectable disease, and patient deemed an appropriate surgical candidate by a thoracic surgeon prior to enrollment
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- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Adequate organ and bone marrow function as defined by:
- Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3; Hemoglobin ≥ 10g/dL (it is acceptable to reach this through transfusion); Platelets > 100,000 cells/mm3; Creatinine clearance ≥ 60 mg/dL (Cockcroft-Gault equation); Total bilirubin ≤ 1.5 mg/dL; Alkaline phosphatase ≤ 2.5 x upper limit of normal (ULN); Alanine aminotransferase (ALT, SGPT) ≤ 2.5 x ULN; Aspartate aminotransferase (AST, SGOT) ≤ 2.5 x ULN;
- Women of childbearing potential and sexually active men must agree to use effective contraception prior to study entry, for the duration of study participation and for three months after completing treatment. Adequate contraception is defined as any medically recommended method (or combination of methods) per standard of care
- Negative serum or urine Human Chorionic Gonadotropin(b-hCG) pregnancy test within 14 days of D1 of neoadjuvant chemotherapy for women of childbearing potential
- Informed consent obtained and signed
Who cannot join
- Forced expiratory volume (FEV) ≤ 1.2 L/s
- T3 tumor defined by invasion of key structures (only T3 defined by size > 7cm allowed)
- Any lymph code > 3 cm or multistation N2 lymphadenopathy
- Patient better served by concurrent chemoradiotherapy: The protocol recognizes that institutional standards regarding which patients are best served by operative and nonoperative approaches vary. Therefore, consistent with the American College of Chest Physicians (ACCP) guidelines, the protocol recommends multidisciplinary discussion of each patient and enrollment only of patients felt best serviced by the approach described herein
- ≥ Grade 2 pre-existing peripheral neuropathy (per CTCAEv4)
- Prior history of hypersensitivity to taxane or platinum therapy. If either agent was previously administered, the patient must have tolerated it well and have recovered from any adverse events
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- Recurrent disease or second primary lung cancer (only de novo IIIA disease allowed)
- Other active, invasive malignancy requiring ongoing therapy or expected to require systemic therapy within two years; localized squamous cell carcinoma of the skin, basal-cell carcinoma of the skin, carcinoma in-situ of the cervix, or other malignancies requiring locally ablative therapy only will not result in exclusion.
- Prior treatment of any kind for this malignancy
- Have received treatment with any drug that has not received regulatory approval for that indication within the 30 days prior to study entry
- Any serious, uncontrolled medical disorder that would impair the ability of the subject to receive protocol driven therapy
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Emory - Winship Cancer Institute
Atlanta, Georgia, 30322
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599-7295
Case Western Reserve University - Seidman Cancer Center
Cleveland, Ohio, 44106
University of Kansas Cancer Center
Kansas City, Kansas, 66160
Ochsner Cancer Institute
New Orleans, Louisiana, 70121
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Rex Cancer Center and Rex of Wakefield
Raleigh, North Carolina, 27607
Swedish Cancer Institute
Seattle, Washington, 98104
Moffitt Cancer Center
Tampa, Florida, 33612
About this study
Official title: Phase II Multicenter Trial of Neoadjuvant Cisplatin and Nab-paclitaxel for (N2) Defined Stage IIIA Non-Small Cell Lung Cancer (NSCLC)
The purpose of this research study is to determine whether giving cisplatin and nab-paclitaxel before surgery will reduce the presence of disease in certain areas of the lung at the time of surgery.
Read the detailed description
Objectives
To estimate the rate of N2 nodal clearance at time of surgery in patients with NSCLC undergoing treatment with neoadjuvant nab-paclitaxel plus cisplatin and surgery.
Estimate response rate and complete response rate in non-small cell lung cancer (NSCLC) after 3 cycles of neoadjuvant nab-paclitaxel plus cisplatin
Estimate complete pathological response of primary tumor and lymph nodes at the time of surgery in patients with NSCLC undergoing treatment with neoadjuvant nab-paclitaxel plus cisplatin
Estimate disease free survival for all patients who undergo surgery and also stratified by nodal clearance
Patients will be assigned to receive three (3) cycles of cisplatin (mg/m2) and nab-paclitaxel (125 mg/m2). Surgery will then be conducted per standard of care.
Approximately 4-12 weeks after the surgical resection, patients will receive one of three available treatment regimens based on the results of the surgical reports, which include: Two four week cycles of therapy of Cisplatin and Nab-paclitaxel; Four three-week cycles of Cisplatin and Pemetrexed, or four three-week cycles of Cisplatin and Gemcitabine
Thirty (30) days after treatment ends, subjects will be followed for any ongoing serious adverse events, if necessary, and every 3-6 months thereafter for two years.
After the two years of follow-up, subjects will be followed for survival and disease status
Estimate overall survival for entire group and stratified by nodal clearance
To estimate event free survival (EFS)
Estimate time to distant recurrence and time to local recurrence following total study procedures
- Conditions
- Stage IIIA Non-Small Cell Lung Cancer
- Being tested
- Neoadjuvant Cisplatin, nab-paclitaxel, Adjuvant Cisplatin,nab-paclitaxel, Adjuvant cisplatin+pemetrexed or cisplatin+gemcitabine
- Keywords
- main tumor ranging from less than 3cm (T1 up to 7cm (T3)
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant Cisplatin, nab-paclitaxelDrug
Also called Platinol, Abraxane
Cisplatin (75mg/m2) D1, nab-paclitaxel 125 mg/m2) D1, 8, 15; repeat each 28 D cycle x 2 then surgery
Adjuvant Cisplatin,nab-paclitaxelDrug
Also called Platinol, Abraxane
Cisplatin 75mg/m2 D1,nab-paclitaxel 125mg/m2 D1, 8, 15, repeat each 28D cycle x 2
Adjuvant cisplatin+pemetrexed or cisplatin+gemcitabineDrug
Also called Platinol, Alimta, Gemzar
Cisplatin 75mg/m2 D1 + pemetrexed 500mg/m2 D1 or Gemcitabine 1000 mg/m2 D1, 8 (if SqCC) repeat each 21 D Cycle x 4
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant Cisplatin,nab-paclitaxel | Experimental | Neoadjuvant cisplatin (75 mg/m2) D1 and nab-paclitaxel (125 mg/m2) D1, 8, 15, repeat each 28D cycle x 3 and then surgery per standard of care Receives: Drug: Neoadjuvant Cisplatin, nab-paclitaxel |
| Adjuvant Cisplatin,nab-paclitaxel | Experimental | Adjuvant cisplatin (75mg/m2) D1, nab-paclitaxel (125 mg/m2)for D1, 8, 15 repeat each 28D x 2 Receives: Drug: Adjuvant Cisplatin,nab-paclitaxel |
| Cisplatin+pemetrexed or gemcitabine | Other | Adjuvant cisplatin (75mg/m2) D1, pemetrexed (500mgm2) D1 or; cisplatin (75 mg/m2),Gemcitabine (1000mg/m2) D1, 8 repeat each 21D cycle x 4 Receives: Drug: Adjuvant cisplatin+pemetrexed or cisplatin+gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of N2 Nodal Clearance
N2 disease is defined as involvement of the ipsilateral mediastinal and/or subcarinal lymph nodes; if disease is cleared form these locations, then there is N2 nodal clearance
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2014 (estimated)
- Study startJan 2015
- Primary completionJun 2016
- Study completionJun 2016
Why it stopped: This study was terminated due to lack of funding.
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 Stage IIIA Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jared Weiss, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02276560
- Sponsor's protocol ID
- LCCC 1407
- Acronym
- LCCC1407
- Status last verified
- Mar 2017
- First submitted
- 21 Oct 2014
- Last updated
- 11 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Multicenter Trial of Neoadjuvant Cisplatin and Nab-paclitaxel for (N2) Defined Stage IIIA Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT02276560
- Acronym / sponsor ID
- LCCC1407 / LCCC 1407
- Conditions
- Stage IIIA Non-Small Cell Lung Cancer
- Keywords
- main tumor ranging from less than 3cm (T1 up to 7cm (T3)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was terminated due to lack of funding.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 28 Oct 2014 (estimated)
- Results
- Posted 11 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to determine whether giving cisplatin and nab-paclitaxel before surgery will reduce the presence of disease in certain areas of the lung at the time of surgery.
Detailed description
Objectives
To estimate the rate of N2 nodal clearance at time of surgery in patients with NSCLC undergoing treatment with neoadjuvant nab-paclitaxel plus cisplatin and surgery.
Estimate response rate and complete response rate in non-small cell lung cancer (NSCLC) after 3 cycles of neoadjuvant nab-paclitaxel plus cisplatin
Estimate complete pathological response of primary tumor and lymph nodes at the time of surgery in patients with NSCLC undergoing treatment with neoadjuvant nab-paclitaxel plus cisplatin
Estimate disease free survival for all patients who undergo surgery and also stratified by nodal clearance
Patients will be assigned to receive three (3) cycles of cisplatin (mg/m2) and nab-paclitaxel (125 mg/m2). Surgery will then be conducted per standard of care.
Approximately 4-12 weeks after the surgical resection, patients will receive one of three available treatment regimens based on the results of the surgical reports, which include: Two four week cycles of therapy of Cisplatin and Nab-paclitaxel; Four three-week cycles of Cisplatin and Pemetrexed, or four three-week cycles of Cisplatin and Gemcitabine
Thirty (30) days after treatment ends, subjects will be followed for any ongoing serious adverse events, if necessary, and every 3-6 months thereafter for two years.
After the two years of follow-up, subjects will be followed for survival and disease status
Estimate overall survival for entire group and stratified by nodal clearance
To estimate event free survival (EFS)
Estimate time to distant recurrence and time to local recurrence following total study procedures
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant Cisplatin,nab-paclitaxel | Experimental | Drug: Neoadjuvant Cisplatin, nab-paclitaxelNeoadjuvant cisplatin (75 mg/m2) D1 and nab-paclitaxel (125 mg/m2) D1, 8, 15, repeat each 28D cycle x 3 and then surgery per standard of care |
| Adjuvant Cisplatin,nab-paclitaxel | Experimental | Drug: Adjuvant Cisplatin,nab-paclitaxelAdjuvant cisplatin (75mg/m2) D1, nab-paclitaxel (125 mg/m2)for D1, 8, 15 repeat each 28D x 2 |
| Cisplatin+pemetrexed or gemcitabine | Other | Drug: Adjuvant cisplatin+pemetrexed or cisplatin+gemcitabineAdjuvant cisplatin (75mg/m2) D1, pemetrexed (500mgm2) D1 or; cisplatin (75 mg/m2),Gemcitabine (1000mg/m2) D1, 8 repeat each 21D cycle x 4 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 18 years of age; no upper age limit
- Diagnosis of NSCLC, histologically or cytologically confirmed
- Pathologic mediastinal staging to include endobronchial ultrasound with or without endoscopic ultrasound (EBUS =/- EUS) including evaluation of N3 nodes
- Systemic staging including CT that covers the chest, liver and adrenal glands or a PET/CT; MRI of the brain is required and must be negative for metastatic spread. If a patient is unable to tolerate MRI or has a contraindication to MRI, a head CT scan with and without contrast is acceptable
- International Association for the Study of Lung Cancer (IASLC) version 7, subset of stage IIIA single station (N2) disease; specifically T1a-T3, N2(+) with no invasion of key structures (e.g., chest wall or diaphragm)
Key exclusion criteria (11 listed)
- Forced expiratory volume (FEV) ≤ 1.2 L/s
- T3 tumor defined by invasion of key structures (only T3 defined by size > 7cm allowed)
- Any lymph code > 3 cm or multistation N2 lymphadenopathy
- Patient better served by concurrent chemoradiotherapy: The protocol recognizes that institutional standards regarding which patients are best served by operative and nonoperative approaches vary. Therefore, consistent with the American College of Chest Physicians (ACCP) guidelines, the protocol recommends multidisciplinary discussion of each patient and enrollment only of patients felt best serviced by the approach described herein
- ≥ Grade 2 pre-existing peripheral neuropathy (per CTCAEv4)
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 |
|---|---|---|
| Neoadjuvant Cisplatin, nab-paclitaxelAlso: Platinol, AbraxaneCisplatin (75mg/m2) D1, nab-paclitaxel 125 mg/m2) D1, 8, 15; repeat each 28 D cycle x 2 then surgery | Drug | Neoadjuvant Cisplatin,nab-paclitaxel |
| Adjuvant Cisplatin,nab-paclitaxelAlso: Platinol, AbraxaneCisplatin 75mg/m2 D1,nab-paclitaxel 125mg/m2 D1, 8, 15, repeat each 28D cycle x 2 | Drug | Adjuvant Cisplatin,nab-paclitaxel |
| Adjuvant cisplatin+pemetrexed or cisplatin+gemcitabineAlso: Platinol, Alimta, GemzarCisplatin 75mg/m2 D1 + pemetrexed 500mg/m2 D1 or Gemcitabine 1000 mg/m2 D1, 8 (if SqCC) repeat each 21 D Cycle x 4 | Drug | Cisplatin+pemetrexed or gemcitabine |
Primary outcome
Rate of N2 Nodal Clearance
Time frame: 3 Months
N2 disease is defined as involvement of the ipsilateral mediastinal and/or subcarinal lymph nodes; if disease is cleared form these locations, then there is N2 nodal clearance
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Clinical Trials - University of North Carolina - Lineberger Comprehensive Cancer CenterLink 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.
Jared Weiss, MD principal investigator
University of North Carolina, Chapel Hill
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 Neoadjuvant Cisplatin, nab-paclitaxel, Adjuvant Cisplatin,nab-paclitaxel and Adjuvant cisplatin+pemetrexed or cisplatin+gemcitabine in people with Stage IIIA Non-Small Cell Lung Cancer, run by UNC Lineberger Comprehensive Cancer Center 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 12 inclusion and 11 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 May 2017. 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 11 May 2017). 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?
Rate of N2 Nodal Clearance (time frame: 3 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 May 2017.